What changed in this filing

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Item 1A. Risk Factors

2023-03-31 compared with 2022-03-31 · 957 added, 825 removed, 284 unchanged (86% of the section changed)

in our securities includes a high degree of risk.

Prior to making a decision about investing in our securities, you should consider carefully

the specific factors discussed below, together with all of the other information contained in this report.

If any of the following risks

actually occurs, our business, financial condition, results of operations and future prospects would likely be materially and adversely

This could cause the market price of our Common Stock to decline and could cause you to lose all or part of your investment.

Related to the Company’s Business

global economic conditions, including as a result of health and safety concerns, could adversely affect our business, financial condition

or results of operations.

results of operations could be adversely affected by general conditions in the global economy, including conditions that are outside

of our control, such as the impact of health and safety concerns from the current outbreak of the COVID-19 coronavirus (“COVID-19”).

The spread of the COVID-19, which was declared a pandemic by the World Health Organization in March 2020, has caused different countries

and cities to mandate curfews, including “shelter-in-place” and closures of most non-essential businesses as well as other

measures to mitigate the spread of the virus.

Investing in our securities includes a high

degree of risk.

Prior to making a decision about investing in our securities, you should consider carefully the specific factors discussed

below, together with all of the other information contained in this report.

If any of the following risks actually occurs, our business,

financial condition, results of operations and future prospects would likely be materially and adversely affected.

This could cause the

market price of our Common Stock to decline and could cause you to lose all or part of your investment.

Risks Related to the Company’s Business

Unfavorable global economic conditions,

including as a result of health and safety concerns, could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely

affected by general conditions in the global economy, including conditions that are outside of our control, such as the impact of health

and safety concerns from the current outbreak of the COVID-19 coronavirus (“COVID-19”).

The spread of the COVID-19, which

was declared a pandemic by the World Health Organization in March 2020, has caused different countries and cities to mandate curfews,

including “shelter-in-place” and closures of most non-essential businesses as well as other measures to mitigate the spread

of the virus.

negative impact of COVID-19 on our operations is ongoing and the extent of which remains uncertain and potentially wide-spread, including:

our ability to successfully execute our long-term growth

strategy during these uncertain times;

ability to successfully execute our long-term growth strategy during these uncertain times;

our ability to recruit the necessary number of patients

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maintenance of internal controls.

COVID-19 pandemic remains highly volatile and continues to evolve on a daily basis and therefore, despite our efforts and developments

to combat the virus, there can be no assurance that these measures will prove successful.

The extent to which COVID-19 continues to impact

the Company’s business, sales, and results of operations will depend on future developments, which are highly uncertain and cannot

be predicted.

Company is a development stage biopharmaceutical company and is thus subject to the risks associated with new businesses in that industry.

Company acquired the sole licensing rights to develop and commercialize for therapeutic purposes six compounds from BioLite and the right

to co-develop with BioFirst a medical device (collectively the “ABVC Pipeline Products”).

As such, the Company is a clinical

stage biopharmaceutical company with operations that generate unsubstantial revenues.

The Company is establishing and implementing many

important functions necessary to operate a business, including the clinical research and development of the ABVC Pipeline Products, further

establishment of the Company’s managerial and administrative structure, accounting systems and internal financial controls

and BioKey are expected to continue to have limited revenue and remain unprofitable for an indefinite period of time.

you should consider the Company’s prospects in light of the risks and uncertainties that a pharmaceutical company with a limited

operating history and revenue faces.

In particular, potential investors should consider that there are significant risks that the Company

will not be able to:

implement or execute its

current business plan, or generate profits;

attract and maintain a

skillful management team;

raise sufficient funds

in the capital markets or otherwise to effectuate its business plan;

determine that the processes

and technologies that it has developed are commercially viable;

enter into contracts with

commercial partners, such as licensors and suppliers.

any of the above risks occurs, the Company’s business may fail, in which case you may lose the entire amount of your investment

in the Company.

The Company cannot assure that any of its efforts in business operations will be successful or result in the timely development

of new products, or ultimately produce any material revenue and profits.

a pre-profit biopharmaceutical company, the Company needs to transition from a company with a research and development focus to a company

capable of supporting commercial activities.

The Company may not be able to reach such transition point or make such a transition, which

would have affect our business, financial condition, results of operations and prospects.

the Company fails to raise additional capital, its ability to implement its business model and strategy could be compromised.

Company has limited capital resources and operations.

The CDMO services provided by BioKey generates a limited amount of revenue that

can only partially support the operations of the Company.

To date, the Company’s operations have been funded partially from

the proceeds from financings or loans from its shareholders .

From time to time, we may seek additional financing to provide the

capital required to expand research and development (“R&D”) initiatives and/or working capital, as well as to repay outstanding

loans if cash flow from operations is insufficient to do so.

We cannot predict with certainty the timing or amount of any such capital

requirements.

the Company does not raise sufficient capital to fund its ongoing development activities, it is likely that it will be unable to carry

out its business plans, including R&D development and expansion of production facilities.

Even if the Company obtains financing for

near term operations and product development, the Company may require additional capital beyond the near term.

Furthermore, additional

capital may not be available in sufficient amounts or on reasonable terms, if at all, and our ability to raise additional capital may

be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and

financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic.

If the Company is unable to raise

capital when needed, its business, financial condition and results of operations would be materially adversely affected, and it could

be forced to reduce or discontinue our operations.

Company has no history in obtaining regulatory approval for, or commercializing, any new drug candidate.

The COVID-19 pandemic remains highly volatile

and continues to evolve on a daily basis and therefore, despite our efforts and developments to combat the virus, there can be no assurance

that these measures will prove successful.

The extent to which COVID-19 continues to impact the Company’s business, sales, and

results of operations will depend on future developments, which are highly uncertain and cannot be predicted.

The Company is a development stage biopharmaceutical

company and is thus subject to the risks associated with new businesses in that industry.

The Company acquired the sole licensing rights

to develop and commercialize for therapeutic purposes six compounds from BioLite and the right to co-develop with BioFirst a medical

device (collectively the “ABVC Pipeline Products”).

As such, the Company is a clinical stage biopharmaceutical company with

operations that generate unsubstantial revenues.

The Company is establishing and implementing many important functions necessary to operate

a business, including the clinical research and development of the ABVC Pipeline Products, further establishment of the Company’s

managerial and administrative structure, accounting systems and internal financial controls

BioLite and BioKey are expected to continue to

have limited revenue and remain unprofitable for an indefinite period of time.

Accordingly, you should consider the Company’s

prospects in light of the risks and uncertainties that a pharmaceutical company with a limited operating history and revenue faces.

particular, potential investors should consider that there are significant risks that the Company will not be able to:

or execute its current business plan, or generate profits;

and maintain a skillful management team;

sufficient funds in the capital markets or otherwise to effectuate its business plan;

that the processes and technologies that it has developed are commercially viable;

into contracts with commercial partners, such as licensors and suppliers.

If any of the above risks occurs, the Company’s

business may fail, in which case you may lose the entire amount of your investment in the Company.

The Company cannot assure that any

of its efforts in business operations will be successful or result in the timely development of new products, or ultimately produce any

material revenue and profits.

As a pre-profit biopharmaceutical company, the

Company needs to transition from a company with a research and development focus to a company capable of supporting commercial activities.

The Company may not be able to reach such transition point or make such a transition, which would have affect our business, financial

condition, results of operations and prospects.

If the Company fails to raise additional

capital, its ability to implement its business model and strategy could be compromised.

The Company has limited capital resources and

The CDMO services provided by BioKey generates a limited amount of revenue that can only partially support the operations

of the Company.

To date, the Company’s operations have been funded partially from the proceeds from financings or loans from

its shareholders.

From time to time, we may seek additional financing to provide the capital required to expand research and development

(“R&D”) initiatives and/or working capital, as well as to repay outstanding loans if cash flow from operations is insufficient

We cannot predict with certainty the timing or amount of any such capital requirements.

If the Company does not raise sufficient capital

to fund its ongoing development activities, it is likely that it will be unable to carry out its business plans, including R&D development

and expansion of production facilities.

Currently, the Company has had to put several projects on hold due to a lack of funding.

if the Company obtains financing for near term operations and product development, the Company may require additional capital beyond the

Furthermore, additional capital may not be available in sufficient amounts or on reasonable terms, if at all, and our ability

to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to

and volatility in the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic.

the Company is unable to raise capital when needed, its business, financial condition and results of operations would be materially adversely

affected, and it could be forced to reduce or discontinue our operations.

The Company has no history in obtaining

regulatory approval for, or commercializing, any new drug candidate.

limited operating history, the Company has never obtained regulatory approval for, or commercialized, any new drug candidate.

It is possible

that the FDA may refuse to accept our planned New Drug Application (or “NDA”) for any of the six drug products for substantive

review or may conclude after review of our data that our application is insufficient to obtain regulatory approval of the new drug candidates

or the medical device.

Although our CDMO strategic business department has experience in obtaining abbreviated new drug application (or

“ANDA”) approvals, the processes and timelines of obtaining an NDA approval and ANDA approval can differentiate substantially.

If the FDA does not accept or approve our planned NDA for our product candidates, it may require that we conduct additional clinical,

preclinical or manufacturing validation studies, which may be costly.

Depending on the FDA required studies, approval of any NDA or application

that we submit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have.

delay in obtaining, or inability to obtain, regulatory approvals of any of our drug candidate will prevent us from sublicensing such

It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA.

of these outcomes occurs, we may be forced to abandon our planned NDA for such drug candidate, which materially adversely affects our

business and could potentially cause us to cease operations.

It is possible that the FDA may refuse to accept our planned New Drug Application

(or “NDA”) for any of the six drug products for substantive review or may conclude after review of our data that our application

is insufficient to obtain regulatory approval of the new drug candidates or the medical device.

Although our CDMO strategic business

department has experience in obtaining abbreviated new drug application (or “ANDA”) approvals, the processes and timelines

of obtaining an NDA approval and ANDA approval can differentiate substantially.

If the FDA does not accept or approve our planned NDA

for our product candidates, it may require that we conduct additional clinical, preclinical or manufacturing validation studies, which

may be costly.

Depending on the FDA required studies, approval of any NDA or application that we submit may be significantly delayed,

possibly for several years, or may require us to expend more resources than we have.

Any delay in obtaining, or inability to obtain,

regulatory approvals of any of our drug candidate will prevent us from sublicensing such product.

It is also possible that additional

studies, if performed and completed, may not be considered sufficient by the FDA.

If any of these outcomes occurs, we may be forced to

abandon our planned NDA for such drug candidate, which materially adversely affects our business and could potentially cause us to cease

We face similar regulatory risks in a foreign jurisdiction.

growth is dependent on our ability to successfully develop, acquire or license new drugs.

growth is supported by continuous investment in time, resources and capital to identify and develop new products or new formulations

for the market and market penetration.

If we are unable to either develop new products on our own or acquire licenses for new products

from other parties, our ability to grow revenues and market share will be adversely affected.

In addition, we may not be able to

recover our investment in the development of new drugs and medical devices, given that projects may be interrupted, unsuccessful, not

as profitable as initially contemplated or we may not be able to obtain necessary financing for such development.

Similarly, there is

no assurance that we can successfully secure such rights from third parties on an economically feasible basis.

current products have certain side effects.

If the side effects associated with our current or future products are not identified prior

to their marketing and sale, we may be required to withdraw such products from the market, perform lengthy additional clinical trials

or change the labeling of our products, any of which could adversely impact our growth.

Company researches and develops the following six drug products and one medical device:

Our growth is dependent on our ability

to successfully develop, acquire or license new drugs.

Our growth is supported by continuous investment

in time, resources and capital to identify and develop new products or new formulations for the market and market penetration.

are unable to either develop new products on our own or acquire licenses for new products from other parties, our ability to grow revenues

and market share will be adversely affected.

In addition, we may not be able to recover our investment in the development of new

drugs and medical devices, given that projects may be interrupted, unsuccessful, not as profitable as initially contemplated or we may

not be able to obtain necessary financing for such development.

Similarly, there is no assurance that we can successfully secure such

rights from third parties on an economically feasible basis.

Our current products have certain side

If the side effects associated with our current or future products are not identified prior to their marketing and sale, we

may be required to withdraw such products from the market, perform lengthy additional clinical trials or change the labeling of our products,

any of which could adversely impact our growth.

Company researches and develops the following seven drug products and one medical device:

ABV-1501, ABV-1504, ABV-1505, ABV-1519, ABV-1702,

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edema cerebral, stroke, dyspnea, wheezing, and pruritus.

and ABV-1505 have the same API, “Radix Polygala”, which is known as Polygala tenuifolia Willd or PDC-1421 Capsule (“Polygala

tenuifolia Willd”).

Side effects, or adverse events, associated with ABV-1504 and ABV-1505, coming from administration of the trial

medicine or examination procedure such as the procedure of taking blood (fainting, pain and/or bruising), may lead to gastrointestinal

disorders (abdominal fullness and constipation), nervous system disorders (drowsiness, sleepiness, and oral ulcer).

In addition, long-term

use may cause miscarriages.

safety and preliminary efficacy findings from this study, combined with the unique properties of ABV-1701, are supportive of further

investigation for its use following vitrectomy surgery in patients requiring vitreous replacement.

However, new serious side effects

of ABV-1701 may be uncovered as the clinical trials continue.

occurrence of any of those adverse events would harm our future sales of these medicines and substantially increase the costs and expenses

of marketing these medicines, which in turn could cause our revenues and net income to decline.

In addition, the reputation and

sales of our future medicines could be adversely affected due to the severe side effects discovered.

may be subject to product liability claims in the future, which could divert our resources, cause us to incur substantial liabilities

and limit commercialization of any products that we may develop.

face an inherent business risk of exposure to product liability claims in the event that the uses of our products are alleged to have

caused adverse side effects.

Side effects or marketing or manufacturing problems pertaining to any of our products could result

in product liability claims or adverse publicity.

These risks will exist for those products in clinical development and with respect

to those products that receive regulatory approval for commercial sale.

Furthermore, although we have not historically experienced

any problems associated with claims by users of our products, we do not currently maintain product liability insurance and there

could be no assurance that we are able to acquire product liability insurance with terms that are commercially feasible.

face an inherent risk of product liability claims as a result of the clinical testing of our products and potentially commercially selling

any products that we may develop.

For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise

unsuitable during clinical testing, manufacturing, marketing or sale.

Any such product liability claims may include allegations of defects

in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of

Claims could also be asserted under state consumer protection acts.

If we cannot successfully defend ourselves against product

liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidate.

of the merits or eventual outcome, liability claims may result in:

ABV-1504 and ABV-1505 have the same API, “Radix

Polygala”, which is known as Polygala tenuifolia Willd or PDC-1421 Capsule (“Polygala tenuifolia Willd”).

Side effects,

or adverse events, associated with ABV-1504 and ABV-1505, coming from administration of the trial medicine or examination procedure such

as the procedure of taking blood (fainting, pain and/or bruising), may lead to gastrointestinal disorders (abdominal fullness and constipation),

nervous system disorders (drowsiness, sleepiness, and oral ulcer).

In addition, long-term use may cause miscarriages.

The safety and preliminary efficacy findings

from this study, combined with the unique properties of ABV-1701, are supportive of further investigation for its use following vitrectomy

surgery in patients requiring vitreous replacement.

However, new serious side effects of ABV-1701 may be uncovered as the clinical trials

The occurrence of any of those adverse events

would harm our future sales of these medicines and substantially increase the costs and expenses of marketing these medicines, which

in turn could cause our revenues and net income to decline.

In addition, the reputation and sales of our future medicines could

be adversely affected due to the severe side effects discovered.

We may be subject to product liability

claims in the future, which could divert our resources, cause us to incur substantial liabilities and limit commercialization of any

products that we may develop.

We face an inherent business risk of exposure

to product liability claims in the event that the uses of our products are alleged to have caused adverse side effects.

or marketing or manufacturing problems pertaining to any of our products could result in product liability claims or adverse publicity.

risks will exist for those products in clinical development and with respect to those products that receive regulatory approval for commercial

Furthermore, although we have not historically experienced any problems associated with claims by users of our products, we

do not currently maintain product liability insurance and there could be no assurance that we are able to acquire product liability

insurance with terms that are commercially feasible.

We face an inherent risk of product liability

claims as a result of the clinical testing of our products and potentially commercially selling any products that we may develop.

example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing,

manufacturing, marketing or sale.

Any such product liability claims may include allegations of defects in manufacturing, defects in design,

a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.

Claims could also be asserted

under state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial

liabilities or be required to limit commercialization of our product candidate.

Regardless of the merits or eventual outcome, liability

claims may result in:

decreased demand for our product candidates or products

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the inability to commercialize any products that we

currently have insurance policies to cover liabilities under the clinic trials but do not maintain general liability insurance;

if we have a general liability insurance in the future, this insurance may not fully cover potential liabilities that we may incur.

cost of any product liability litigation or other proceeding, even if resolved in our favor, could be substantial.

We would need to increase

our insurance coverage if and when we begin selling any product candidate that receives marketing approval.

In addition, insurance coverage

is becoming increasingly expensive.

If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to

otherwise protect against potential product liability claims, it could prevent or inhibit the development and commercial production and

sale of our product candidate, which could adversely affect our business, financial condition, results of operations and prospects.

have conducted, and may in the future conduct, clinical trials for certain of our product candidates at sites outside the United States,

and the FDA may not accept data from trials conducted in such locations.

have conducted and may in the future choose to conduct one or more of our clinical trials outside the United States.

Although the FDA

may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed

For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance

with ethical principles.

The trial population must also adequately represent the U.S.

population, and the data must be applicable to

We currently have insurance policies to cover

liabilities under the clinic trials but do not maintain general liability insurance;

and even if we have a general liability insurance

in the future, this insurance may not fully cover potential liabilities that we may incur.

The cost of any product liability litigation

or other proceeding, even if resolved in our favor, could be substantial.

We would need to increase our insurance coverage if and when

we begin selling any product candidate that receives marketing approval.

In addition, insurance coverage is becoming increasingly expensive.

If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential

product liability claims, it could prevent or inhibit the development and commercial production and sale of our product candidate, which

could adversely affect our business, financial condition, results of operations and prospects.

We have conducted, and may in the future

conduct, clinical trials for certain of our product candidates at sites outside the United States, and the FDA may not accept data from

trials conducted in such locations.

We have conducted and may in the future choose

to conduct one or more of our clinical trials outside the United States.

Although the FDA may accept data from clinical trials conducted

outside the United States, acceptance of this data is subject to certain conditions imposed by the FDA.

For example, the clinical trial

must be well designed and conducted and performed by qualified investigators in accordance with ethical principles.

The trial population

must also adequately represent the U.S.

population, and the data must be applicable to the U.S.

population and U.S.

medical practice in ways that the FDA deems clinically meaningful.

In addition, while these clinical trials

are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also complied

with all applicable U.S.

medical practice

in ways that the FDA deems clinically meaningful.

In addition, while these clinical trials are subject to the applicable local laws,

FDA acceptance of the data will be dependent upon its determination that the trials also complied with all applicable U.S.

laws and regulations.

There can be no assurance that the FDA will accept data from trials conducted outside

of the United States.

If the FDA does not accept the data from any of our clinical trials that we determine to conduct outside the United

States, it would likely result in the need for additional trials, which would be costly and time-consuming and delay or permanently halt

our development of the product candidate.

addition, the conduct of clinical trials outside the United States could have a significant impact on us.

Risks inherent in conducting

international clinical trials include:

There can be no assurance that the FDA will accept data from trials conducted outside of the United States.

If the FDA does not accept

the data from any of our clinical trials that we determine to conduct outside the United States, it would likely result in the need for

additional trials, which would be costly and time-consuming and delay or permanently halt our development of the product candidate.

In addition, the conduct of clinical trials outside

the United States could have a significant impact on us.

Risks inherent in conducting international clinical trials include:

foreign regulatory requirements that could restrict

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diminished protection of intellectual property in some

clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S.

regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete the development and

commercialization of our product candidates.

are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval

from the FDA.

If clinical trials of our product candidates

fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S.

regulators, we may incur additional costs

or experience delays in completing, or ultimately be unable to complete the development and commercialization of our product candidates.

We are not permitted to commercialize, market,

promote or sell any product candidate in the United States without obtaining marketing approval from the FDA.

Comparable non-U.S.

regulatory authorities impose similar restrictions.

authorities impose similar restrictions.

We may never receive such approvals.

We must complete

extensive preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidate in humans before

we will be able to obtain these approvals.

testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.

inability to successfully complete preclinical and clinical development could result in additional costs to us and impair our ability

to generate revenues from product sales, regulatory and commercialization milestones and royalties.

In addition, if (1) we are required

to conduct additional clinical trials or other testing of our product candidate beyond the trials and testing that we contemplate, (2)

we are unable to successfully complete clinical trials of our product candidate or other testing, (3) the results of these trials or

tests are unfavorable, uncertain or are only modestly favorable, or (4) there are unacceptable safety concerns associated with our product

candidate, we, in addition to incurring additional costs, may:

We must complete extensive preclinical development and

clinical trials to demonstrate the safety and efficacy of our product candidate in humans before we will be able to obtain these approvals.

Clinical testing is expensive, difficult to design

and implement, can take many years to complete and is inherently uncertain as to outcome.

Any inability to successfully complete preclinical

and clinical development could result in additional costs to us and impair our ability to generate revenues from product sales, regulatory

and commercialization milestones and royalties.

In addition, if (1) we are required to conduct additional clinical trials or other testing

of our product candidate beyond the trials and testing that we contemplate, (2) we are unable to successfully complete clinical trials

of our product candidate or other testing, (3) the results of these trials or tests are unfavorable, uncertain or are only modestly favorable,

or (4) there are unacceptable safety concerns associated with our product candidate, we, in addition to incurring additional costs, may:

be delayed in obtaining

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product from the market after obtaining marketing approval.

if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients,

third party payors and others in the medical community necessary for commercial success and the market opportunity for the product candidate

may be smaller than we estimate.

Even if any of our product candidates receives

marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third party payors and others in

the medical community necessary for commercial success and the market opportunity for the product candidate may be smaller than we estimate.

have never completed a new drug or new medical device FDA application process from Phase I to FDA approval and commercialization.

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recommend switching products or they are required to switch therapies due to lack of reimbursement for existing therapies.

potential market opportunities for our products are difficult to estimate precisely.

Our estimates of the potential market opportunities

are predicated on many assumptions, including industry knowledge and publications, third party research reports and other surveys.

we believe that our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of

our management, are inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source.

If any of the assumptions proves to be inaccurate, the actual markets for our products could be smaller than our estimates of the potential

market opportunities.

may seek to enter into collaborations with third parties for the development and commercialization of our product candidates.

to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential

of our product candidates.

may seek third-party collaborators for development and commercialization of our products.

Our likely collaborators for any marketing,

distribution, development, licensing or broader collaboration arrangements include large and mid-size pharmaceutical companies, regional

and national pharmaceutical companies, non-profit organizations, government agencies, and biotechnology companies.

Our ability to generate

revenues from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned

to them in these arrangements.

Collaborations

involving our products will pose the following risks to us:

The potential market opportunities for our products

are difficult to estimate precisely.

Our estimates of the potential market opportunities are predicated on many assumptions, including

industry knowledge and publications, third party research reports and other surveys.

While we believe that our internal assumptions are

reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain and

the reasonableness of these assumptions has not been assessed by an independent source.

If any of the assumptions proves to be inaccurate,

the actual markets for our products could be smaller than our estimates of the potential market opportunities.

We may seek to enter into collaborations

with third parties for the development and commercialization of our product candidates.

If we fail to enter into such collaborations,

or such collaborations are not successful, we may not be able to capitalize on the market potential of our product candidates.

We may seek third-party collaborators for development

and commercialization of our products.

Our likely collaborators for any marketing, distribution, development, licensing or broader collaboration

arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies, non-profit organizations,

government agencies, and biotechnology companies.

Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities

to successfully perform the functions assigned to them in these arrangements.

Collaborations involving our products will pose

the following risks to us:

collaborators may have

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repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

collaborators

could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidate

if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under

terms that are more economically attractive than ours;

collaborators could independently

develop, or develop with third parties, products that compete directly or indirectly with our product candidate if the collaborators

believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more

economically attractive than ours;

collaborators with marketing

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product candidates.

Collaborative

agreements may not lead to development or commercialization of our product candidate in the most efficient manner or at all.

If a collaborator

of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization

program could be delayed, diminished or terminated.

through BioLite, may not be able to receive the full amounts available under the collaboration agreement by and between BioLite, Inc.

and BioHopeKing, which could increase its burden to seek additional capital to fund the business operations.

February and December 2015, BioLite, Inc., a subsidiary of BioLite, entered into a total of three collaboration agreements with BioHopeKing

to jointly develop ABV-1501 for TNBC (or BLI-1401-2 as used by BioLite internally) and ABV-1504 for MDD (or BLI-1005 as used by BioLite

internally) in most Asian countries and BLI-1006, which has been later replaced with BLI-1008 for ADHD in Asia, excluding Japan.

and BioLite are co-developing ABV-1501 for TNBC and ABV-1504 for MDD pursuant to the Collaboration Agreement and its Addendum entered

by and between BriVision and BioLite Taiwan where ABVC and BriVision are responsible for the clinical trials of such two new drug candidates.

In accordance with the terms of the BioHopeKing Collaboration Agreement for ABV-1501 or BLI-1401-2 and the Addendum thereto, BioLite

shall receive payments of a total of $10 million in cash and equity of BioHopeKing or equity securities owned by it at various stages

on a schedule dictated by BioLite’s achievements of certain milestones and twelve per cent (12%) of net sales of the drug products

when ABV-1501 or BLI-1401-2 is approved for sale in the licensed territories.

If BioLite fails to reach any of the milestones in a timely

manner, it may not receive the rest of the payments from BioHopeKing.

As a result of BioLite’s potential inability to receive the

full payments under those collaboration agreements with BioHopeKing, ABVC may have to seek other sources of financing to fund its operation

and its Subsidiaries may not be successful in establishing and maintaining additional strategic partnerships, which could adversely affect

ABVC’s ability to develop and commercialize products, negatively impacting its operating results.

addition to ABVC’s current collaboration with BioHopeKing for selected Asian markets, a part of its strategy is to evaluate and,

as deemed appropriate, enter into additional partnerships in the future with major biotechnology or pharmaceutical companies.

products may prove to be difficult to effectively license out as planned.

Various regulatory, commercial and manufacturing factors may

impact ABVC’s ability to seek co-developers of or grow revenues from licensing out any of the six products in the pipeline, none

of which has been fully licensed out.

Specifically, ABVC may encounter difficulty by virtue of:

Collaborative agreements may not lead to development

or commercialization of our product candidate in the most efficient manner or at all.

If a collaborator of ours were to be involved in

a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed,

diminished or terminated.

ABVC, through BioLite, may not be able

to receive the full amounts available under the collaboration agreement by and between BioLite, Inc.

and BioHopeKing, which could increase

its burden to seek additional capital to fund the business operations.

In February and December 2015, BioLite, Inc.,

a subsidiary of BioLite, entered into a total of three collaboration agreements with BioHopeKing to jointly develop ABV-1501 for TNBC

(or BLI-1401-2 as used by BioLite internally) and ABV-1504 for MDD (or BLI-1005 as used by BioLite internally) in most Asian countries

and BLI-1006, which has been later replaced with BLI-1008 for ADHD in Asia, excluding Japan.

ABVC and BioLite are co-developing ABV-1501

for TNBC and ABV-1504 for MDD pursuant to the Collaboration Agreement and its Addendum entered by and between BriVision and BioLite Taiwan

where ABVC and BriVision are responsible for the clinical trials of such two new drug candidates.

In accordance with the terms of the

BioHopeKing Collaboration Agreement for ABV-1501 or BLI-1401-2 and the Addendum thereto, BioLite shall receive payments of a total of

$10 million in cash and equity of BioHopeKing or equity securities owned by it at various stages on a schedule dictated by BioLite’s

achievements of certain milestones and twelve per cent (12%) of net sales of the drug products when ABV-1501 or BLI-1401-2 is approved

for sale in the licensed territories.

If BioLite fails to reach any of the milestones in a timely manner, it may not receive the rest

of the payments from BioHopeKing.

As a result of BioLite’s potential inability to receive the full payments under those collaboration

agreements with BioHopeKing, ABVC may have to seek other sources of financing to fund its operation activities.

ABVC and its Subsidiaries may not be successful

in establishing and maintaining additional strategic partnerships, which could adversely affect ABVC’s ability to develop and commercialize

products, negatively impacting its operating results.

In addition to ABVC’s current collaboration

with BioHopeKing for selected Asian markets, a part of its strategy is to evaluate and, as deemed appropriate, enter into additional

partnerships in the future with major biotechnology or pharmaceutical companies.

ABVC’s products may prove to be difficult to effectively

license out as planned.

Various regulatory, commercial and manufacturing factors may impact ABVC’s ability to seek co-developers

of or grow revenues from licensing out any of the seven products in the pipeline, none of which has been fully licensed out.

Specifically,

ABVC may encounter difficulty by virtue of:

its inability to effectively

2 unchanged sentences

Disorder, ABV-1505 to treat Attention-Deficit Hyperactivity Disease, ABV-1501 for the treatment of Triple Negative Breast Cancer,

ABV-1703 to the treatment of Pancreatic Cancer, ABV-1601 to treat Depression in Cancer Patients and ABV-1702 to treat Myelodysplastic

syndromes and ABV-1701 Vitargus for the treatments of Retinal Detachment or Vitreous Hemorrhage;

ABV-1519 to treat of Non-Small Cell Lung Cancer, ABV-1703 to the treatment of Pancreatic Cancer, ABV-1601 to treat Depression in

Cancer Patients and ABV-1702 to treat Myelodysplastic syndromes and ABV-1701 Vitargus for the treatments of Retinal Detachment or

Vitreous Hemorrhage;

its inability to secure

3 unchanged sentences

collaborators outside the U.S.

faces significant competition in seeking appropriate partners for its therapeutic candidates, and the negotiation process is time-consuming

In order for ABVC to successfully partner its autoimmune, CNS and hematology therapeutic candidates, as well as Vitargus,

its medical device, potential partners must view these medicinal candidates as economically valuable in markets they determine to be

attractive in light of the terms that ABVC is seeking and compared to other available products for licensing by other companies.

if ABVC is successful in its efforts to establish new strategic partnerships, the terms that ABVC agrees upon may not be favorable, and

it may not be able to maintain such strategic partnerships if, for example, development or approval of an autoimmune therapeutic is delayed

or sales of an approved product are disappointing.

Any delay in entering into new strategic partnership agreements related to any of

ABVC’s therapeutic candidates could delay the development and commercialization of such candidates and reduce its competitiveness

even if it reaches the market.

ABVC fails to establish and maintain additional strategic partnerships or collaboration related to its therapeutic candidates that have

not been fully licensed, it will bear all of the risk and costs related to the development of any such drug candidate, and it may need

to seek additional financing, hire additional employees and otherwise develop expertise for which it has not budgeted.

This could negatively

affect the development of any incompletely partnered new drug candidates.

licensors may choose to terminate any of the license agreements with ABVC.

As a result, ABVC’s research and development of new

drug candidates that contain the underlying API may be terminated abruptly.

ABVC’s Subsidiary BioLite materially breaches any license agreements it has with Yukiguni Maitake Co.

(“Yukiguni”),

Medical and Pharmaceutical Industry Technology and Development Center (“MPITDC”) or Industrial Technology Research Institute

(“ITRI”), or any of such license agreement terminates unexpectedly, BioLite may not be able to continue its research and

development of the new drug candidate which contains the underlying API whose license has been terminated.

Pursuant to the Yukiguni License

Agreement, if BioLite fails to meet the milestone sales requirement or submit certain applications to the appropriate health authorities

on a schedule prescribed therein, Yukiguni shall have the right to terminate the Yukiguni License Agreement.

If the Yukiguni License

Agreement is terminated involuntarily, BioLite will be forced to discontinue its new drug development of ABV-1703, ABV-1502 and ABV-1501

and terminate the collaboration agreements relating to the three new drug candidates.

The termination of the right to use the underlying

API will materially disrupt the operations of ABVC.

Pursuant to the license agreement between BioLite Taiwan and ITRI, if BioLite Taiwan

fails to complete the research submission milestones according to the schedule set forth therein without reasons or with reasons unstatisfied

with ITRI, ITRI shall have the right to terminate the license agreement with BioLite Taiwan without refund to BioLite Taiwan.

Taiwan and BioLite have submitted the IND for PDC-1421 and subsequently conducted Phase II clinical trials of two drug candidiates developed

from PDC-1421 according to the schedule listed in the license agreement between BioLite Taiwan and MPITDC.

Subsidiary BioLite depends on one supplier for the API of ABV-1703, ABV-1502 and ABV-1501 and any failure of such supplier to deliver

sufficient quantities of the API that meets its quality standard could have a material adverse effect on its research of these three

drug candidates.

BioLite relies primarily on Yukiguni, a Japanese supplier, to provide Yukiguni Maitake Extract 404, the API which is contained in ABV-1703,

ABV-1502 and ABV-1501, three of the six drug candidates in BioLite’s oncology/hematology portfolio.

It has entered into the Yukiguni

License Agreement, among other things, for the delivery of Yukiguni Maitake Extract 404,.

BioLite agrees to fulfill its demand of the

Yukiguni Maitake Extract 404 by purchasing first from Yukiguni respecting the therapeutic products and Yukiguni represents that it will

provide sufficient quantities of such API that meets cGMP standards.

If the supplies of Yukiguni Maitake Extract 404 were interrupted

for any reason, BioLite’s research and development activities of these three drug candidates could be delayed.

These delays could

be extensive and expensive, especially in situations where a substitution is not readily available.

is currently negotiating with another supplier of Yukiguni Maitake Extract 404 that is located in Canada.

However, there can be no assurance

that the negotiation will be successful.

Failure to obtain adequate supplies of high quality Yukiguni Maitake Extract 404 in a timely

manner could have a disruptive effect on ABVC and BioLite’s research and development activities of ABV-1703, ABV-1502 and ABV-1501,

resulting in a material adverse effect on the Company’s business, financial condition and results of operations.

may use hazardous chemicals and biological materials in its business.

Any claims relating to improper handling, storage or disposal of

these materials could be time consuming and costly.

research and development may involve the controlled use of hazardous materials, including chemicals and biological materials.

eliminate the risk of accidental contamination or discharge and any resulting injury from these materials.

ABVC may be sued for any injury

or contamination that results from its use or the use by third parties of these materials, and its liability may exceed any insurance

coverage and its total assets.

Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal

of these hazardous materials and specified waste products, as well as the discharge of pollutants into the environment and human health

and safety matters.

Although ABVC makes its best efforts to comply with environmental laws and regulations despite the associated high

costs and inconvenience, ABVC cannot guarantee that it will not mishandle any hazardous materials in the future.

If it fails to comply

with these requirements or any improper handling of hazardous materials occurs, it could incur substantial costs, including civil or

criminal fines and penalties, clean-up costs or capital expenditures for control equipment or operational changes necessary to achieve

and maintain compliance.

In addition, ABVC cannot predict the impact on its business of new or amended environmental laws or regulations

or any changes in the way existing and future laws and regulations are interpreted and enforced.

facilities where the samples of drug candidates are manufactured need to be maintained and monitored in compliance with the good manufacturing

practice standards, the failure of such maintenance could contaminate the results of our clinical trials and adversely affect our operations.

Subsidiary BioKey operates a laboratory facility that is a certified good manufacturing practice facility (“cGMP”) and some

of its contract clinical trial service providers use cGMP facilities to conduct clinical studies.

ABVC cannot be certain that ABVC or

its present or future contract manufacturers or suppliers will be able to comply with cGMPs regulations and other FDA regulatory requirements.

Failure to comply with these requirements may result in, among other things, total or partial suspension of production activities, failure

of the FDA to grant approval for marketing, and withdrawal, suspension, or revocation of marketing approvals.

Related to Intellectual Property

Pharmaceutical

patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to the Company, could

negatively impact its respective licensors’ patent position and interrupt its research activities.

patent positions of pharmaceutical companies and research institutions can be highly uncertain and involve complex legal and factual

The interpretation and breadth of claims allowed in some patents covering pharmaceutical compositions may be uncertain and

difficult to determine, and are often affected materially by the facts and circumstances that pertain to the patented compositions and

the related patent claims.

The standards of the U.S.

Patent and Trademark Office, or USPTO, are sometimes uncertain and could change

in the future.

Consequently, the issuance and scope of patents cannot be predicted with certainty.

Patents, if issued, may be challenged,

invalidated or circumvented.

patents and patent applications may also be subject to interference proceedings, and U.S.

be subject to re-examination proceedings, post-grant review and/or inter parties review in the USPTO.

Foreign patents may be subject

to opposition or comparable proceedings in the corresponding foreign patent office, which could result in either loss of the patent or

denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application.

In addition, such interference, re-examination, post-grant review, inter parties review and opposition proceedings may be costly.

rights under any issued patents may not provide the Company with sufficient protection against competitive products or processes.

addition, changes in or different interpretations of patent laws in the U.S.

and foreign countries may permit others to use discoveries

of the Company or to develop and commercialize their new drug candidates without providing any compensation thereto, or may limit the

number of patents or claims the Company can obtain.

The laws of some countries do not protect intellectual property rights to the same

extent as U.S.

laws and those countries may lack adequate rules and procedures for defending the intellectual property rights of the

the Company fails to obtain and maintain patent protection and trade secret protection of its respective products, the Company could

lose their competitive advantages and competition it faces would increase, reducing any potential revenues and adversely affecting its

ability to attain or maintain profitability.

in patent law could have a negative impact on the Company’s Licensors’ patent positions and the Company’s business.

time to time, the U.S.

Supreme Court, other federal courts, the U.S.

Congress or the USPTO may change the standards of patentability

and any such changes could have a negative impact on the Company’s business.

addition, the Leahy-Smith America Invents Act, or the America Invents Act, which was signed into law in 2011, includes a number of significant

changes to U.S.

These changes include a transition from a “first-to-invent” system to a “first-to-file”

system, changes the way issued patents are challenged, and changes the way patent applications are disputed during the examination process.

These changes may favor larger and more established companies that have greater resources to devote to patent application filing and

The USPTO has developed regulations and procedures to govern the full implementation of the America Invents Act, and many

of the substantive changes to patent law associated with the America Invents Act, and, in particular, the first-to-file provisions, became

effective on March 16, 2013.

Substantive changes to patent law associated with the America Invents Act may affect the Company, BioLite

and BioKey’s ability to obtain patents, and if obtained, to enforce or defend them.

Accordingly, it is not clear what, if any,

impact the America Invents Act will ultimately have on the cost of prosecuting the Company’s patent applications, its ability to

obtain patents based on its discoveries and its ability to enforce or defend its patents.

the Company is unable to protect the confidentiality of its trade secrets, its business and competitive position would be harmed, respectively.

addition to patent protection, because the Company operates in the highly technical field of discovery and development of therapies,

it relies in part on trade secret protection in order to protect its proprietary technology and processes.

However, trade secrets are

difficult to protect.

The Company has entered into confidentiality and non-disclosure agreements with its employees, consultants, outside

scientific and commercial collaborators, sponsored researchers, and other advisors.

These agreements generally require that the other

party keep confidential and not disclose to third parties any confidential information developed by the party or made known to the party

by the Company during the course of the party’s relationship therewith.

These agreements also generally provide that inventions

conceived by the party in the course of rendering services to the Company will be ABVC’s exclusive property.

However, these agreements

may not be honored and may not effectively assign intellectual property rights to the Company.

addition to contractual measures, the Company tries to protect the confidential nature of its proprietary information using physical

and technological security measures.

Such measures may not, for example, in the case of misappropriation of a trade secret by an employee

or third party with authorized access, provide adequate protection for the Company.

The Company’s security measures may not prevent

an employee or consultant from misappropriating its trade secrets and providing them to a competitor, and recourse it takes against such

misconduct may not provide an adequate remedy to protect the Company’s interests fully.

Enforcing a claim that a party illegally

disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome is unpredictable.

courts outside the U.S.

may be less willing to protect trade secrets.

Trade secrets may be independently developed by others in a manner

that could prevent legal recourse by the Company.

If the Company’s confidential or proprietary information, such as the trade secrets,

were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, its competitive position

could be harmed.

parties may assert that the Company’s employees or consultants have wrongfully used or disclosed confidential information or misappropriated

trade secrets.

Company might employ individuals who were previously employed at universities or other biopharmaceutical companies, including its competitors

or potential competitors.

Although through certain non-disclosure covenants and employment agreements with its officers and employees,

the Company tries to ensure that its employees and consultants do not use the proprietary information or know-how of others in the work

for the Company, the Company may be subject to claims that it or its employees, consultants or independent contractors have inadvertently

or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer

or other third parties.

Litigation may be necessary to defend against these claims.

If the Company fails in defending any such claims,

in addition to paying monetary damages, the Company may lose valuable intellectual property rights or personnel.

Even if the Company

is successful in defending against such claims, litigation could result in substantial costs and be a distraction to the Company’s

management and other employees.

ability to compete may decline if it does not adequately protect its proprietary rights or if it is barred by the intellectual property

rights of others.

commercial success depends on obtaining and maintaining proprietary rights to its drug candidates as well as successfully defending these

rights against third-party challenges.

ABVC obtains its rights to use and research certain proprietary information to further develop

the drug candidates primarily from three institutions, MPITDC, ITRI and Yukiguni (collectively the “Licensors”).

institutions own the intellectual property rights in the products that have been licensed to us and may prosecute new patents of the

drug candidates that are invented or discovered within the licensed scope of use under the respective license agreements.

ABVC will only

be able to protect its new drug candidates from unauthorized use by third parties to the extent that its valid and enforceable patents,

or effectively protected trade secrets and know-how, cover them.

ability to obtain new patent protection for its new drug candidates is uncertain due to a number of factors, including that:

ABVC faces significant competition in seeking

appropriate partners for its therapeutic candidates, and the negotiation process is time-consuming and complex.

In order for ABVC to

successfully partner its autoimmune, CNS and hematology therapeutic candidates, as well as Vitargus, its medical device, potential partners

must view these medicinal candidates as economically valuable in markets they determine to be attractive in light of the terms that ABVC

is seeking and compared to other available products for licensing by other companies.

Even if ABVC is successful in its efforts to establish

new strategic partnerships, the terms that ABVC agrees upon may not be favorable, and it may not be able to maintain such strategic partnerships

if, for example, development or approval of an autoimmune therapeutic is delayed or sales of an approved product are disappointing.

delay in entering into new strategic partnership agreements related to any of ABVC’s therapeutic candidates could delay the development

and commercialization of such candidates and reduce its competitiveness even if it reaches the market.

If ABVC fails to establish and maintain additional

strategic partnerships or collaboration related to its therapeutic candidates that have not been fully licensed, it will bear all of

the risk and costs related to the development of any such drug candidate, and it may need to seek additional financing, hire additional

employees and otherwise develop expertise for which it has not budgeted.

This could negatively affect the development of any incompletely

partnered new drug candidates.

ABVC’s licensors may choose to terminate

any of the license agreements with ABVC.

As a result, ABVC’s research and development of new drug candidates that contain the underlying

API may be terminated abruptly.

If ABVC’s Subsidiary BioLite materially

breaches any license agreements it has with Yukiguni Maitake Co.

(“Yukiguni”), Medical and Pharmaceutical Industry Technology

and Development Center (“MPITDC”) or Industrial Technology Research Institute (“ITRI”), or any of such license

agreement terminates unexpectedly, BioLite may not be able to continue its research and development of the new drug candidate which contains

the underlying API whose license has been terminated.

Pursuant to the Yukiguni License Agreement, if BioLite fails to meet the milestone

sales requirement or submit certain applications to the appropriate health authorities on a schedule prescribed therein, Yukiguni shall

have the right to terminate the Yukiguni License Agreement.

If the Yukiguni License Agreement is terminated involuntarily, BioLite will

be forced to discontinue its new drug development of ABV-1703, ABV-1502 and ABV-1501 and terminate the collaboration agreements relating

to the three new drug candidates.

The termination of the right to use the underlying API will materially disrupt the operations of ABVC.

Pursuant to the license agreement between BioLite Taiwan and ITRI, if BioLite Taiwan fails to complete the research submission milestones

according to the schedule set forth therein without reasons or with reasons unstatisfied with ITRI, ITRI shall have the right to terminate

the license agreement with BioLite Taiwan without refund to BioLite Taiwan.

BioLite Taiwan and BioLite have submitted the IND for PDC-1421

and subsequently conducted Phase II clinical trials of two drug candidiates developed from PDC-1421 according to the schedule listed

in the license agreement between BioLite Taiwan and MPITDC.

ABVC’s Subsidiary BioLite depends

on one supplier for the API of ABV-1703, ABV-1519, ABV-1502 and ABV-1501 and any failure of such supplier to deliver sufficient quantities

of the API that meets its quality standard could have a material adverse effect on its research of these four drug candidates.

Currently BioLite relies primarily on Yukiguni, a Japanese supplier,

to provide Yukiguni Maitake Extract 404, the API which is contained in ABV-1703, ABV-1519, ABV-1502 and ABV-1501, four of the seven drug

candidates in BioLite’s oncology/hematology portfolio.

It has entered into the Yukiguni License Agreement, among other things, for

the delivery of Yukiguni Maitake Extract 404.

BioLite agrees to fulfill its demand of the Yukiguni Maitake Extract 404 by purchasing first

from Yukiguni respecting the therapeutic products and Yukiguni represents that it will provide sufficient quantities of such API that

meets cGMP standards.

If the supplies of Yukiguni Maitake Extract 404 were interrupted for any reason, BioLite’s research and development

activities of these four drug candidates could be delayed.

These delays could be extensive and expensive, especially in situations where

a substitution is not readily available.

BioLite is currently negotiating with another

supplier of Yukiguni Maitake Extract 404 that is located in Canada.

However, there can be no assurance that the negotiation will be successful.

Failure to obtain adequate supplies of high quality Yukiguni Maitake Extract 404 in a timely manner could have a disruptive effect on

ABVC and BioLite’s research and development activities of ABV-1703, ABV-1519, ABV-1502 and ABV-1501, resulting in a material adverse

effect on the Company’s business, financial condition and results of operations.

ABVC may use hazardous chemicals and biological

materials in its business.

Any claims relating to improper handling, storage or disposal of these materials could be time consuming and

ABVC’s research and development may involve

the controlled use of hazardous materials, including chemicals and biological materials.

ABVC cannot eliminate the risk of accidental

contamination or discharge and any resulting injury from these materials.

ABVC may be sued for any injury or contamination that results

from its use or the use by third parties of these materials, and its liability may exceed any insurance coverage and its total assets.

Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of these hazardous materials

and specified waste products, as well as the discharge of pollutants into the environment and human health and safety matters.

ABVC makes its best efforts to comply with environmental laws and regulations despite the associated high costs and inconvenience, ABVC

cannot guarantee that it will not mishandle any hazardous materials in the future.

If it fails to comply with these requirements or any

improper handling of hazardous materials occurs, it could incur substantial costs, including civil or criminal fines and penalties, clean-up

costs or capital expenditures for control equipment or operational changes necessary to achieve and maintain compliance.

ABVC cannot predict the impact on its business of new or amended environmental laws or regulations or any changes in the way existing

and future laws and regulations are interpreted and enforced.

The facilities where the samples of drug

candidates are manufactured need to be maintained and monitored in compliance with the good manufacturing practice standards, the failure

of such maintenance could contaminate the results of our clinical trials and adversely affect our operations.

ABVC’s Subsidiary BioKey operates a laboratory

facility that is a certified good manufacturing practice facility (“cGMP”) and some of its contract clinical trial service

providers use cGMP facilities to conduct clinical studies.

ABVC cannot be certain that ABVC or its present or future contract manufacturers

or suppliers will be able to comply with cGMPs regulations and other FDA regulatory requirements.

Failure to comply with these requirements

may result in, among other things, total or partial suspension of production activities, failure of the FDA to grant approval for marketing,

and withdrawal, suspension, or revocation of marketing approvals.

Risks Related to Intellectual Property

Pharmaceutical patents and patent applications

involve highly complex legal and factual questions, which, if determined adversely to the Company, could negatively impact its respective

licensors’ patent position and interrupt its research activities.

The patent positions of pharmaceutical companies

and research institutions can be highly uncertain and involve complex legal and factual questions.

The interpretation and breadth of

claims allowed in some patents covering pharmaceutical compositions may be uncertain and difficult to determine, and are often affected

materially by the facts and circumstances that pertain to the patented compositions and the related patent claims.

The standards of the

Patent and Trademark Office, or USPTO, are sometimes uncertain and could change in the future.

Consequently, the issuance and scope

of patents cannot be predicted with certainty.

Patents, if issued, may be challenged, invalidated or circumvented.

patents and patent

applications may also be subject to interference proceedings, and U.S.

patents may be subject to re-examination proceedings, post-grant

review and/or inter parties review in the USPTO.

Foreign patents may be subject to opposition or comparable proceedings in the corresponding

foreign patent office, which could result in either loss of the patent or denial of the patent application or loss or reduction in the

scope of one or more of the claims of the patent or patent application.

In addition, such interference, re-examination, post-grant review,

inter parties review and opposition proceedings may be costly.

Accordingly, rights under any issued patents may not provide the Company

with sufficient protection against competitive products or processes.

In addition, changes in or different interpretations

of patent laws in the U.S.

and foreign countries may permit others to use discoveries of the Company or to develop and commercialize

their new drug candidates without providing any compensation thereto, or may limit the number of patents or claims the Company can obtain.

The laws of some countries do not protect intellectual property rights to the same extent as U.S.

laws and those countries may lack adequate

rules and procedures for defending the intellectual property rights of the Company.

If the Company fails to obtain and maintain patent

protection and trade secret protection of its respective products, the Company could lose their competitive advantages and competition

it faces would increase, reducing any potential revenues and adversely affecting its ability to attain or maintain profitability.

Developments in patent law could have a

negative impact on the Company’s Licensors’ patent positions and the Company’s business.

From time to time, the U.S.

Supreme Court, other

federal courts, the U.S.

Congress or the USPTO may change the standards of patentability and any such changes could have a negative impact

on the Company’s business.

In addition, the Leahy-Smith America Invents

Act, or the America Invents Act, which was signed into law in 2011, includes a number of significant changes to U.S.

changes include a transition from a “first-to-invent” system to a “first-to-file” system, changes the way issued

patents are challenged, and changes the way patent applications are disputed during the examination process.

These changes may favor

larger and more established companies that have greater resources to devote to patent application filing and prosecution.

The USPTO has

developed regulations and procedures to govern the full implementation of the America Invents Act, and many of the substantive changes

to patent law associated with the America Invents Act, and, in particular, the first-to-file provisions, became effective on March 16,

Substantive changes to patent law associated with the America Invents Act may affect the Company, BioLite and BioKey’s ability

to obtain patents, and if obtained, to enforce or defend them.

Accordingly, it is not clear what, if any, impact the America Invents

Act will ultimately have on the cost of prosecuting the Company’s patent applications, its ability to obtain patents based on its

discoveries and its ability to enforce or defend its patents.

If the Company is unable to protect the

confidentiality of its trade secrets, its business and competitive position would be harmed, respectively.

In addition to patent protection, because the

Company operates in the highly technical field of discovery and development of therapies, it relies in part on trade secret protection

in order to protect its proprietary technology and processes.

However, trade secrets are difficult to protect.

The Company has entered

into confidentiality and non-disclosure agreements with its employees, consultants, outside scientific and commercial collaborators,

sponsored researchers, and other advisors.

These agreements generally require that the other party keep confidential and not disclose

to third parties any confidential information developed by the party or made known to the party by the Company during the course of the

party’s relationship therewith.

These agreements also generally provide that inventions conceived by the party in the course of

rendering services to the Company will be ABVC’s exclusive property.

However, these agreements may not be honored and may not effectively

assign intellectual property rights to the Company.

In addition to contractual measures, the Company

tries to protect the confidential nature of its proprietary information using physical and technological security measures.

Such measures

may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access, provide

adequate protection for the Company.

The Company’s security measures may not prevent an employee or consultant from misappropriating

its trade secrets and providing them to a competitor, and recourse it takes against such misconduct may not provide an adequate remedy

to protect the Company’s interests fully.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret

can be difficult, expensive, and time-consuming, and the outcome is unpredictable.

In addition, courts outside the U.S.

may be less willing

to protect trade secrets.

Trade secrets may be independently developed by others in a manner that could prevent legal recourse by the

If the Company’s confidential or proprietary information, such as the trade secrets, were to be disclosed or misappropriated,

or if any such information was independently developed by a competitor, its competitive position could be harmed.

Third parties may assert that the Company’s

employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.

The Company might employ individuals who were

previously employed at universities or other biopharmaceutical companies, including its competitors or potential competitors.

through certain non-disclosure covenants and employment agreements with its officers and employees, the Company tries to ensure that

its employees and consultants do not use the proprietary information or know-how of others in the work for the Company, the Company may

be subject to claims that it or its employees, consultants or independent contractors have inadvertently or otherwise used or disclosed

intellectual property, including trade secrets or other proprietary information, of a former employer or other third parties.

may be necessary to defend against these claims.

If the Company fails in defending any such claims, in addition to paying monetary damages,

the Company may lose valuable intellectual property rights or personnel.

Even if the Company is successful in defending against such

claims, litigation could result in substantial costs and be a distraction to the Company’s management and other employees.

ABVC’s ability to compete may decline

if it does not adequately protect its proprietary rights or if it is barred by the intellectual property rights of others.

ABVC’s commercial success depends on obtaining

and maintaining proprietary rights to its drug candidates as well as successfully defending these rights against third-party challenges.

ABVC obtains its rights to use and research certain proprietary information to further develop the drug candidates primarily from three

institutions, MPITDC, ITRI and Yukiguni (collectively the “Licensors”).

These three institutions own the intellectual property

rights in the products that have been licensed to us and may prosecute new patents of the drug candidates that are invented or discovered

within the licensed scope of use under the respective license agreements.

ABVC will only be able to protect its new drug candidates from

unauthorized use by third parties to the extent that its valid and enforceable patents, or effectively protected trade secrets and know-how,

ABVC’s ability to obtain new patent protection

for its new drug candidates is uncertain due to a number of factors, including that:

ABVC may not have been

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ABVC’s patent claims to produce competitive products which fall outside of the scope of its patents.

if ABVC has or obtains new patents covering its new drug candidates, ABVC may still be barred from making, using and selling them because

of the patent rights of others.

Others may have filed, and in the future may file, patent applications covering products that are similar

or identical to ABVC.

There are many issued U.S.

and foreign patents relating to therapeutic products and some of these relate to ABVC’s

new drug candidates.

These could materially affect ABVC’s ability to develop its drug candidates.

Because patent applications can

take many years to issue, there may be currently pending applications unknown to ABVC that may later result in issued patents that its

new drug candidates may infringe.

Even if ABVC has or obtains new patents covering

its new drug candidates, ABVC may still be barred from making, using and selling them because of the patent rights of others.

may have filed, and in the future may file, patent applications covering products that are similar or identical to ABVC.

There are many

and foreign patents relating to therapeutic products and some of these relate to ABVC’s new drug candidates.

could materially affect ABVC’s ability to develop its drug candidates.

Because patent applications can take many years to issue,

there may be currently pending applications unknown to ABVC that may later result in issued patents that its new drug candidates may

These patent applications may have priority over patent applications filed by ABVC.

Company and its respective licensors may not be able to enforce their intellectual property rights throughout the world.

laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the U.S.

Many companies

have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.

legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property

protection, especially those relating to pharmaceuticals and medical devices.

This could make it difficult for the Company and its respective

licensors to stop the infringement of some of the Licensors’ patents, or the misappropriation of their other intellectual property

For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties.

In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors.

In these countries, patents may provide limited or no benefit.

Patent protection must ultimately be sought on a country-by-country basis,

which is an expensive and time-consuming process with uncertain outcomes.

Accordingly, the Company and its licensors have chosen in the

past and may choose in the future not to seek patent protection in certain countries, and as a result the Company will not have the benefit

of patent protection in such countries.

Moreover, the Company may choose in the future not to seek patent protection in certain countries,

and as a result it will not have the benefit of patent protection in such countries.

to enforce the Company’s and its licensors’ patent rights in foreign jurisdictions could result in substantial costs and

divert its efforts and attention from other aspects of the businesses.

Accordingly, the efforts to protect the Company’s intellectual

property rights in such countries may be inadequate.

The Company and its respective licensors

may not be able to enforce their intellectual property rights throughout the world.

The laws of some foreign countries do not protect

intellectual property rights to the same extent as the laws of the U.S.

Many companies have encountered significant problems in protecting

and defending intellectual property rights in certain foreign jurisdictions.

The legal systems of some countries, particularly developing

countries, do not favor the enforcement of patents and other intellectual property protection, especially those relating to pharmaceuticals

and medical devices.

This could make it difficult for the Company and its respective licensors to stop the infringement of some of the

Licensors’ patents, or the misappropriation of their other intellectual property rights.

For example, many foreign countries have

compulsory licensing laws under which a patent owner must grant licenses to third parties.

In addition, many countries limit the enforceability

of patents against third parties, including government agencies or government contractors.

In these countries, patents may provide limited

or no benefit.

Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process

with uncertain outcomes.

Accordingly, the Company and its licensors have chosen in the past and may choose in the future not to seek

patent protection in certain countries, and as a result the Company will not have the benefit of patent protection in such countries.

Moreover, the Company may choose in the future not to seek patent protection in certain countries, and as a result it will not have the

benefit of patent protection in such countries.

Proceedings to enforce the Company’s and

its licensors’ patent rights in foreign jurisdictions could result in substantial costs and divert its efforts and attention from

other aspects of the businesses.

Accordingly, the efforts to protect the Company’s intellectual property rights in such countries

may be inadequate.

In addition, changes in the law and legal decisions by courts in the U.S.

countries may affect the Company’s ability to obtain adequate protection for its technology and the enforcement of intellectual

Risks Relating to Biopharmaceutical Business

Company is subject to various government regulations.

manufacture and sale of human therapeutic and diagnostic products in the U.S.

and foreign jurisdictions are governed by a variety of

statutes and regulations.

These laws require approval of manufacturing facilities, controlled research and testing of products and government

review and approval of a submission containing manufacturing, preclinical and clinical data in order to obtain marketing approval based

on establishing the safety and efficacy of the product for each use sought, including adherence to current PIC/S Guide to Good Manufacturing

Practice for Medicinal products during production and storage, and control of marketing activities, including advertising and labeling.

products the Company is currently developing will require significant development, preclinical and clinical testing and investment of

substantial funds prior to its commercialization.

The process of obtaining required approvals can be costly and time-consuming, and there

can be no assurance that future products will be successfully developed and will prove to be safe and effective in clinical trials or

receive applicable regulatory approvals.

Markets other than the U.S.

and foreign countries may affect the Company’s

ability to obtain adequate protection for its technology and the enforcement of intellectual property.

Regulatory Risks Relating to Biopharmaceutical Business

The Company is subject to various government regulations.

The manufacture and sale of human therapeutic

and diagnostic products in the U.S.

and foreign jurisdictions are governed by a variety of statutes and regulations.

These laws require

approval of manufacturing facilities, controlled research and testing of products and government review and approval of a submission

containing manufacturing, preclinical and clinical data in order to obtain marketing approval based on establishing the safety and efficacy

of the product for each use sought, including adherence to current PIC/S Guide to Good Manufacturing Practice for Medicinal products

during production and storage, and control of marketing activities, including advertising and labeling.

The products the Company is currently developing

will require significant development, preclinical and clinical testing and investment of substantial funds prior to its commercialization.

The process of obtaining required approvals can be costly and time-consuming, and there can be no assurance that future products will

be successfully developed and will prove to be safe and effective in clinical trials or receive applicable regulatory approvals.

other than the U.S.

have similar restrictions.

Potential investors and shareholders

should be aware of the risks, problems, delays, expenses and difficulties which we may encounter in view of the extensive regulatory

environment which controls our business.

Company cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, any of its current or

future product candidates.

Company may not be able to develop any current or future product candidates.

The Company’s new drug candidates will require substantial

additional clinical development, testing, and regulatory approval before the commencement of commercialization.

The clinical trials of

the Company’s drug candidates are, and the manufacturing and marketing of our new drug candidates will be subject to extensive

and rigorous review and regulation by numerous government authorities in the U.S.

and in other countries where the Company intend to

test and, if approved, market any new drug candidate.

Before obtaining regulatory approvals for the commercial sale of any product candidate,

the Company must demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for use

in each target indication.

This process can take many years and may include post-marketing studies and surveillance, which will require

the expenditure of substantial resources.

Of the large number of drugs in development in the U.S., only a small percentage successfully

completes the FDA regulatory approval process and is commercialized.

Accordingly, even if the Company is able to obtain the requisite

financing to continue to fund its development and clinical programs, it cannot assure the investors that any of the product candidates

will be successfully developed or commercialized.

Company is not permitted to market a therapeutic product in the U.S.

until it receives approval of an NDA or ANDA, for that product from

the FDA, or in any foreign countries until they receive the requisite approval from such countries.

Obtaining approval of an NDA is a

complex, lengthy, expensive and uncertain process, and the FDA may delay, limit or deny approval of any product candidate for many reasons,

including, among others:

Potential investors and shareholders should be aware of the risks, problems, delays, expenses

and difficulties which we may encounter in view of the extensive regulatory environment which controls our business.

The Company cannot be certain that it will

be able to obtain regulatory approval for, or successfully commercialize, any of its current or future product candidates.

The Company may not be able to develop any current

or future product candidates.

The Company’s new drug candidates will require substantial additional clinical development, testing,

and regulatory approval before the commencement of commercialization.

The clinical trials of the Company’s drug candidates are,

and the manufacturing and marketing of our new drug candidates will be subject to extensive and rigorous review and regulation by numerous

government authorities in the U.S.

and in other countries where the Company intend to test and, if approved, market any new drug candidate.

Before obtaining regulatory approvals for the commercial sale of any product candidate, the Company must demonstrate through pre-clinical

testing and clinical trials that the product candidate is safe and effective for use in each target indication.

This process can take

many years and may include post-marketing studies and surveillance, which will require the expenditure of substantial resources.

large number of drugs in development in the U.S., only a small percentage successfully completes the FDA regulatory approval process

and is commercialized.

Accordingly, even if the Company is able to obtain the requisite financing to continue to fund its development

and clinical programs, it cannot assure the investors that any of the product candidates will be successfully developed or commercialized.

The Company is not permitted to market a therapeutic

product in the U.S.

until it receives approval of an NDA or ANDA, for that product from the FDA, or in any foreign countries until they

receive the requisite approval from such countries.

Obtaining approval of an NDA is a complex, lengthy, expensive and uncertain process,

and the FDA may delay, limit or deny approval of any product candidate for many reasons, including, among others:

Unable to demonstrate that

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approval policies or adopt new regulations.

same risks apply to applicable foreign regulatory agencies from which the Company, through BioLite, may seek approval for any of our

new drug candidates.

of these factors, many of which are beyond the Company’s control, could jeopardize its ability to obtain regulatory approval for

and successfully market any new drug candidate.

As a result, any such setback in the Company’s pursuit of initial or additional

regulatory approval would have a material adverse effect on its business and prospects.

the Company does not successfully complete pre-clinical and Phase I and II clinical development, it will be unable to receive full payments

under their respective collaboration agreements, find future collaborators or partners to take the drug candidates to Phase III clinical

Even if the Company successfully completes all Phase I and II clinical trials, those results are not necessarily predictive of

results of additional trials that may be needed before an NDA for Phase III trials may be submitted to the FDA.

Although there are a

large number of drugs in development in the U.S.

and other countries, only a very small percentage result in commercialization, and even

fewer achieve widespread physician and consumer acceptance following the regulatory approval.

addition, the Company may encounter delays or drug candidate rejections based on new governmental regulations, future legislative or

administrative actions, or changes in FDA policy or interpretation during the period of product development.

If the Company obtains required

regulatory approvals, such approvals may later be withdrawn.

These same risks apply to applicable foreign

regulatory agencies from which the Company, through BioLite, may seek approval for any of our new drug candidates.

Any of these factors, many of which are beyond

the Company’s control, could jeopardize its ability to obtain regulatory approval for and successfully market any new drug candidate.

As a result, any such setback in the Company’s pursuit of initial or additional regulatory approval would have a material adverse

effect on its business and prospects.

If the Company does not successfully complete

pre-clinical and Phase I and II clinical development, it will be unable to receive full payments under their respective collaboration

agreements, find future collaborators or partners to take the drug candidates to Phase III clinical trials.

Even if the Company successfully

completes all Phase I and II clinical trials, those results are not necessarily predictive of results of additional trials that may be

needed before an NDA for Phase III trials may be submitted to the FDA.

Although there are a large number of drugs in development in the

and other countries, only a very small percentage result in commercialization, and even fewer achieve widespread physician and consumer

acceptance following the regulatory approval.

In addition, the Company may encounter delays

or drug candidate rejections based on new governmental regulations, future legislative or administrative actions, or changes in FDA policy

or interpretation during the period of product development.

If the Company obtains required regulatory approvals, such approvals may

later be withdrawn.

Delays or failures in obtaining regulatory approvals may result in:

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drug candidates may have or attain.

if the Company fails to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, the

Company may encounter or be subject to:

Furthermore, if the Company fails to comply with

applicable FDA and other regulatory requirements at any stage during this regulatory process, the Company may encounter or be subject

delays or termination in clinical trials or commercialization;

5 unchanged sentences

fines, civil penalties, and criminal prosecutions.

Company faces substantial competition from companies with considerably more resources and experience than the Company has, which may

result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than the Company.

Company competes with companies that research, develop, manufacture and market already-existing and new pharmaceutical products in the

fields of CNS, hematology/oncology and autoimmune.

The Company anticipates that it will face increased competition in the future as new

companies enter the market with new drugs and/or technologies and/or their competitors improve their current products.

One or more of

their competitors may offer new drugs superior to the Company’s and render the Company’s drugs uneconomical.

Company’s current competitors, as well as many of its respective potential competitors, have greater name recognition, more substantial

intellectual property portfolios, longer operating histories, significantly greater resources to invest in new drug development, more

substantial experience in product marketing and new product development, greater regulatory expertise, more extensive manufacturing capabilities

and the distribution channels to deliver products to customers.

If the Company is not able to compete successfully, it may not generate

sufficient revenue to become profitable.

The Company faces substantial competition

from companies with considerably more resources and experience than the Company has, which may result in others discovering, developing,

receiving approval for, or commercializing products before or more successfully than the Company.

The Company competes with companies that research,

develop, manufacture and market already-existing and new pharmaceutical products in the fields of CNS, hematology/oncology and autoimmune.

The Company anticipates that it will face increased competition in the future as new companies enter the market with new drugs and/or

technologies and/or their competitors improve their current products.

One or more of their competitors may offer new drugs superior to

the Company’s and render the Company’s drugs uneconomical.

A lot of the Company’s current competitors, as well as many

of its respective potential competitors, have greater name recognition, more substantial intellectual property portfolios, longer operating

histories, significantly greater resources to invest in new drug development, more substantial experience in product marketing and new

product development, greater regulatory expertise, more extensive manufacturing capabilities and the distribution channels to deliver

products to customers.

If the Company is not able to compete successfully, it may not generate sufficient revenue to become profitable.

The Company’s ability to compete successfully will depend largely on its ability to:

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its product candidates.

pharmaceutical companies devote significant financial resources to discovering, developing or licensing novel compounds that could make

the Company’s products and product candidates obsolete.

Our competitors may obtain patent protection, receive FDA approval, and

commercialize medicines before we do.

Other companies are or may become engaged in the discovery of compounds or botanical materials

that may compete with the drug candidates the Company is developing.

Company competes with a large number of well-established pharmaceutical companies that may have more resources than the Company does

in developing therapeutics in the fields of CNS, oncology/hematology and ophthalmology.

new drug candidate the Company is developing or commercializing that competes with a currently-approved product must demonstrate compelling

advantages in efficacy, convenience, tolerability and/or safety in order to address price competition and be commercially successful.

If the Company is not able to compete effectively against its current and future competitors, its business will not grow and its financial

condition and operations will suffer.

Relating to Doing Business Outside the United States

part of ABVC’s pharmaceutical research and development is conducted outside of the U.S., the Company is subject to the risks of

doing business internationally, including periodic foreign economic downturns and political instability, which may adversely affect the

Company’s revenue and cost of doing business in Taiwan.

collaborates with partners whose primary place of business is in Taiwan, Republic of China and the Company has certain key employees

Foreign economic downturns may affect our results of operations in the future.

Additionally, other facts relating to the operation

of the Company’s business outside of the U.S.

may have a material adverse effect on the Company’s business, financial condition

and results of operations, including:

Established pharmaceutical companies devote significant

financial resources to discovering, developing or licensing novel compounds that could make the Company’s products and product

candidates obsolete.

Our competitors may obtain patent protection, receive FDA approval, and commercialize medicines before we do.

companies are or may become engaged in the discovery of compounds or botanical materials that may compete with the drug candidates the

Company is developing.

The Company competes with a large number of well-established

pharmaceutical companies that may have more resources than the Company does in developing therapeutics in the fields of CNS, oncology/hematology

and ophthalmology.

Any new drug candidate the Company is developing

or commercializing that competes with a currently-approved product must demonstrate compelling advantages in efficacy, convenience, tolerability

and/or safety in order to address price competition and be commercially successful.

If the Company is not able to compete effectively

against its current and future competitors, its business will not grow and its financial condition and operations will suffer.

Risks Relating to Doing Business Outside the

United States

Because part of ABVC’s pharmaceutical

research and development is conducted outside of the U.S., the Company is subject to the risks of doing business internationally, including

periodic foreign economic downturns and political instability, which may adversely affect the Company’s revenue and cost of doing

business in Taiwan.

ABVC collaborates with partners whose primary

place of business is in Taiwan, Republic of China and the Company has certain key employees in Taiwan.

Foreign economic downturns may

affect our results of operations in the future.

Additionally, other facts relating to the operation of the Company’s business outside

may have a material adverse effect on the Company’s business, financial condition and results of operations, including:

international economic and political changes;

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China-Taiwan geo-political

the Company continues to operate its business globally, its success will depend in part, on its ability to anticipate and effectively

manage these risks.

The impact of any one or more of these factors could materially adversely affect the Company’s business, financial

condition and results of operations.

Company may be exposed to liabilities under the U.S.

As the Company continues to operate its business

globally, its success will depend in part, on its ability to anticipate and effectively manage these risks.

The impact of any one or

more of these factors could materially adversely affect the Company’s business, financial condition and results of operations.

The Company may be exposed to liabilities

under the U.S.

Foreign Corrupt Practices Act (“FCPA”) and Chinese anti-corruption law.

Company is subject to the FCPA, and other laws that prohibit improper payments or offers of payments to foreign governments, foreign

government officials and political parties by U.S.

The Company is subject to the FCPA, and other

laws that prohibit improper payments or offers of payments to foreign governments, foreign government officials and political parties

persons as defined by the statute for purposes of obtaining or retaining businesses.

The Company may have agreements with third parties who may make sales in mainland China and the U.S., during the process of which the

Company may be exposed to corruption.

Activities in Taiwan create the risk of unauthorized payments or offers of payments by an employee,

consultant or agent of the Company, because these parties are not always subject to the Company’s control.

the Company believes to date it has complied in all material aspects with the provisions of the FCPA and Chinese anti-corruption law,

the existing safeguards and any future improvements may prove to be less than effective and any of the Company’s employees, consultants

or agents may engage in corruptive conduct for which the Company might be held responsible.

Violations of the FCPA or Chinese anti-corruption

law may result in severe criminal or civil sanctions against the Company and individuals and therefore could negatively affect the Company’s

business, operating results and financial condition.

In addition, the Taiwanese government may seek to hold the Company liable as a successor

for FCPA violations committed by companies in which the Company invests or acquires.

International

operations expose the Company to currency exchange and repatriation risks, and the Company cannot predict the effect of future exchange

rate fluctuations on its business and operating results.

Company has business operations in Taiwan and collaborative activities in the U.S.

Substantial amounts of revenues are received

and expenses are incurred in New Taiwan Dollars and U.S.

The Company may have agreements with third

parties who may make sales in mainland China and the U.S., during the process of which the Company may be exposed to corruption.

in Taiwan create the risk of unauthorized payments or offers of payments by an employee, consultant or agent of the Company, because

these parties are not always subject to the Company’s control.

Although the Company believes to date it has

complied in all material aspects with the provisions of the FCPA and Chinese anti-corruption law, the existing safeguards and any future

improvements may prove to be less than effective and any of the Company’s employees, consultants or agents may engage in corruptive

conduct for which the Company might be held responsible.

Violations of the FCPA or Chinese anti-corruption law may result in severe criminal

or civil sanctions against the Company and individuals and therefore could negatively affect the Company’s business, operating

results and financial condition.

In addition, the Taiwanese government may seek to hold the Company liable as a successor for FCPA violations

committed by companies in which the Company invests or acquires.

International operations expose the Company

to currency exchange and repatriation risks, and the Company cannot predict the effect of future exchange rate fluctuations on its business

and operating results.

The Company has business operations in Taiwan

and collaborative activities in the U.S.

Substantial amounts of revenues are received and expenses are incurred in New Taiwan

Dollars and U.S.

Thus, the Company has exposure to currency fluctuations.

cannot assure you that the effect of currency exchange fluctuations will not materially affect its revenues and net income in the future.

conduct our operations internationally and the effect of business, legal and political risks associated with international operations

may seriously harm our business.

to customers outside the United States accounted for 7 % and 0% for the year ended December 31, 2021 and 2020, respectively.

Our international sales and operations are subject to a wide range of risks, which may vary from country to country or region to region.

The Company cannot assure you that the effect of currency

exchange fluctuations will not materially affect its revenues and net income in the future.

We conduct our operations internationally

and the effect of business, legal and political risks associated with international operations may seriously harm our business.

Sales to customers outside the United States accounted for 66 %

and 7% for the years ended December 31, 2022 and 2021, respectively.

Our international sales and operations are subject to a wide range

of risks, which may vary from country to country or region to region.

These risks include the following:

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of currency exchange controls or taxes that make it impracticable or costly to repatriate funds from foreign countries.

cannot assure you that risks relating to our international operations will not seriously harm our business.

the Company becomes directly subject to the recent scrutiny, criticism and negative publicity involving U.S.-listed Chinese companies,

we may have to expend significant resources to investigate and resolve the matters.

Any unfavorable results from the investigations could

harm our business operations, this offering and our reputation.

public companies that have substantially all of their operations in China, have been subjects of intense scrutiny, criticism and

negative publicity by investors, financial commentators and regulatory agencies, such as the SEC.

Much of the scrutiny, criticism and

negative publicity has centered on financial and accounting irregularities, lack of effective internal control over financial accountings,

inadequate corporate governance and ineffective implementation thereof and, in many cases, allegations of fraud.

As a result of enhanced

scrutiny, criticism and negative publicity, the publicly traded stocks of many U.S.

listed Chinese companies have sharply decreased in

value and, in some cases, have become virtually worthless or illiquid.

Many of these companies are now subject to shareholder lawsuits

and SEC enforcement actions and are conducting internal and external investigations into the allegations.

It is not clear what effects

the sector-wide investigations will have on the Company.

If the Company becomes a subject of any unfavorable allegations, whether such

allegations are proven to be true or untrue, the Company will have to expend significant resources to investigate such allegations and

defend the Company.

If such allegations were not proven to be baseless, the Company would be severely hampered and the price of the stock

of the Company could decline substantially.

If such allegations were proven to be groundless, the investigation might have significantly

distracted the attention of the Company’s management.

Related to the Company’s Financial Condition

existing indebtedness may adversely affect our ability to obtain additional funds and may increase our vulnerability to economic or business

We cannot assure you that risks relating to our

international operations will not seriously harm our business.

If the Company becomes directly subject

to the recent scrutiny, criticism and negative publicity involving U.S.-listed Chinese companies, we may have to expend significant resources

to investigate and resolve the matters.

Any unfavorable results from the investigations could harm our business operations, this offering

and our reputation.

Recently, U.S.

public companies that have substantially

all of their operations in China, have been subjects of intense scrutiny, criticism and negative publicity by investors, financial commentators

and regulatory agencies, such as the SEC.

Much of the scrutiny, criticism and negative publicity has centered on financial and accounting

irregularities, lack of effective internal control over financial accountings, inadequate corporate governance and ineffective implementation

thereof and, in many cases, allegations of fraud.

As a result of enhanced scrutiny, criticism and negative publicity, the publicly traded

stocks of many U.S.-listed Chinese companies have sharply decreased in value and, in some cases, have become virtually worthless or illiquid.

Many of these companies are now subject to shareholder lawsuits and SEC enforcement actions and are conducting internal and external

investigations into the allegations.

It is not clear what effects the sector-wide investigations will have on the Company.

If the Company

becomes a subject of any unfavorable allegations, whether such allegations are proven to be true or untrue, the Company will have to

expend significant resources to investigate such allegations and defend the Company.

If such allegations were not proven to be baseless,

the Company would be severely hampered and the price of the stock of the Company could decline substantially.

If such allegations were

proven to be groundless, the investigation might have significantly distracted the attention of the Company’s management.

Risks Related to the Company’s Financial

Our existing indebtedness may adversely

affect our ability to obtain additional funds and may increase our vulnerability to economic or business downturns.

are subject to a number of risks associated with our indebtedness, including:

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current liabilities were approximately $5.8 million, which consisted primarily of short-term bank loans and accrued expenses.

April 5 and 20, 2020, we entered into certain exchange agreements separately with certain U.S.

5 and 20, 2020, we entered into certain exchange agreements separately with certain U.S.

holders of certain convertible

9 unchanged sentences

their deferred salaries in an aggregate amount of $1,090,360.

to maintain the effectiveness of our disclosure controls and procedures may lead to restatement of our financial statements, harm our

operating results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information

and have a negative effect on the market prices for our Common Stock.

Sarbanes-Oxley Act of 2002 and the Securities and Exchange Commission (SEC) have requirements that we may fail to meet or we may fall

out of compliance with, such as the internal controls auditor attestation required under Section 404 of the Sarbanes-Oxley Act of 2002,

with which we are not currently required to comply as we are a smaller reporting company.

If we fail to achieve and maintain the adequacy

of our internal controls, as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that

we can conclude on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404

of the Sarbanes-Oxley Act of 2002.

Moreover, effective internal controls, particularly those related to revenue recognition, are necessary

for us to produce reliable financial reports and are important to help prevent financial fraud.

If we cannot provide reliable financial

reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial

information, and the trading price of our stock could drop significantly.

articles of incorporation allow for our board to create new series of preferred stock without further approval by our shareholders, which

could adversely affect the rights of the holders of our Common Stock.

Board of Directors has the authority to fix and determine the relative rights and preferences of preferred stock without shareholder

As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would grant to holders

the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders

of Common Stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our Common Stock.

In addition, our Board of Directors could authorize the issuance of a series of preferred stock that has greater voting power than our

Common Stock or that is convertible into our Common Stock, which could decrease the relative voting power of our Common Stock or result

in dilution to our existing shareholders.

may create any additional series of preferred stock and issue such shares in the future although we do not have any present intention

may not be able to secure financing needed for future operating needs on acceptable terms, or on any terms at all.

time to time, we may seek additional financing to provide the capital required to expand our production facilities, Research and development

(“R&D”) initiatives and/or working capital, as well as to repay outstanding loans if cash flow from operations is insufficient

We cannot predict with certainty the timing or amount of any such capital requirements.

If such financing is not

available on satisfactory terms, we may be unable to expand our business or to develop new business at the rate desired.

able to incur debt, we may be subject to certain restrictions imposed by the terms of the debt and the repayment of such debt may limit

our cash flow and growth.

If we are unable to incur debt, we may be forced to issue additional equity, which could have a dilutive

effect on our current shareholders.

internal computer systems, or those of our third-party contractors or consultants, may fail or suffer security breaches, which could

result in a material disruption of our product development programs.

the implementation of security measures, our internal computer systems and those of our third-party contractors and consultants are vulnerable

to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

While we do not believe that we have experienced any such system failure, accident, or security breach to date, if such an event were

to occur and cause interruptions in our operations, it could result in a loss of clinical trial data for our new drug candidates which

could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications

relating to our technology or new drug candidates, or inappropriate disclosure of confidential or proprietary information, we could incur

liabilities and the further development of our product candidates could be delayed.

elimination of personal liability against our directors and officers under Nevada law and the existence of indemnification rights held

by our directors, officers and employees may result in substantial expenses.

Bylaws eliminate the personal liability of our directors and officers to us and our shareholders for damages for breach of fiduciary

duty as a director or officer to the extent permissible under Nevada law.

Further, our Bylaws provide that we are obligated to indemnify

each of our directors or officers to the fullest extent authorized by Nevada law and, subject to certain conditions, advance the expenses

incurred by any director or officer in defending any action, suit or proceeding prior to its final disposition.

Those indemnification

obligations could expose us to substantial expenditures to cover the cost of settlement or damage awards against our directors or officers,

which we may be unable to afford.

Further, those provisions and resulting costs may discourage us or our shareholders from bringing a

lawsuit against any of our current or former directors or officers for breaches of their fiduciary duties, even if such actions might

otherwise benefit our shareholders.

Related to the Company’s Common Stock

share price of our Common Stock is volatile and may be influenced by numerous factors, some of which are beyond our control.

is currently only a limited public market for our Common Stock, which is listed on the Nasdaq Capital Market, and there can be no assurance

that a trading market will develop further or be maintained for our Common Stock in the future.

The trading price of our Common Stock

is likely to be highly volatile, and could be subject to wide fluctuations in response to various factors, some of which are beyond our

In addition to the factors discussed in this “Risk Factors” section and elsewhere in this reports, these factors

Failure to remediate a material weakness

in internal accounting controls could result in material misstatements in our financial statements.

Our management has identified a material weakness

in our internal control over financial reporting related to not having sufficient and skilled accounting personnel with appropriate level

of technical accounting knowledge and experience in the application of accounting principles generally accepted in the United States commensurate

with the Company’s financial reporting requirements and has concluded that, due to such material weakness, our disclosure controls

and procedures were not effective as of December 31, 2022.

If not remediated, or if we identify further material weaknesses in our internal

controls, our failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting

could result in material misstatements in our financial statements and a failure to meet our reporting and financial obligations, each

of which could have a material adverse effect on our financial condition and the trading price of our common stock.

Failure to maintain the effectiveness of

our disclosure controls and procedures may lead to restatement of our financial statements, harm our operating results, subject us to

regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information and have a negative effect

on the market prices for our Common Stock.

The Sarbanes-Oxley Act of 2002 and the Securities

and Exchange Commission (SEC) have requirements that we may fail to meet or we may fall out of compliance with, such as the internal

controls auditor attestation required under Section 404 of the Sarbanes-Oxley Act of 2002, with which we are not currently required to

comply as we are a smaller reporting company.

If we fail to achieve and maintain the adequacy of our internal controls, as such standards

are modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on an ongoing basis that we

have effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002.

effective internal controls, particularly those related to revenue recognition, are necessary for us to produce reliable financial reports

and are important to help prevent financial fraud.

If we cannot provide reliable financial reports or prevent fraud, our business and

operating results could be harmed, investors could lose confidence in our reported financial information, and the trading price of our

stock could drop significantly.

Our articles of incorporation allow for

our board to create new series of preferred stock without further approval by our shareholders, which could adversely affect the rights

of the holders of our Common Stock.

Our Board of Directors has the authority to fix

and determine the relative rights and preferences of preferred stock without shareholder approval.

As a result, our Board of Directors

could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation,

the right to receive dividend payments before dividends are distributed to the holders of Common Stock and the right to the redemption

of the shares, together with a premium, prior to the redemption of our Common Stock.

In addition, our Board of Directors could authorize

the issuance of a series of preferred stock that has greater voting power than our Common Stock or that is convertible into our Common

Stock, which could decrease the relative voting power of our Common Stock or result in dilution to our existing shareholders.

We may create any additional series of preferred

stock and issue such shares in the future although we do not have any present intention of doing so.

We may not be able to secure financing

needed for future operating needs on acceptable terms, or on any terms at all.

From time to time, we may seek additional financing

to provide the capital required to expand our production facilities, Research and development (“R&D”) initiatives and/or

working capital, as well as to repay outstanding loans if cash flow from operations is insufficient to do so.

We cannot predict

with certainty the timing or amount of any such capital requirements.

If such financing is not available on satisfactory terms,

we may be unable to expand our business or to develop new business at the rate desired.

If we are able to incur debt, we may be

subject to certain restrictions imposed by the terms of the debt and the repayment of such debt may limit our cash flow and growth.

we are unable to incur debt, we may be forced to issue additional equity, which could have a dilutive effect on our current shareholders.

Our internal computer systems, or those

of our third-party contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our

product development programs.

Despite the implementation of security measures,

our internal computer systems and those of our third-party contractors and consultants are vulnerable to damage from computer viruses,

unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

While we do not believe that we

have experienced any such system failure, accident, or security breach to date, if such an event were to occur and cause interruptions

in our operations, it could result in a loss of clinical trial data for our new drug candidates which could result in delays in our regulatory

approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or security

breach results in a loss of or damage to our data or applications or other data or applications relating to our technology or new drug

candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development

of our product candidates could be delayed.

The elimination of personal liability against

our directors and officers under Nevada law and the existence of indemnification rights held by our directors, officers and employees

may result in substantial expenses.

ABVC Bylaws eliminate the personal liability

of our directors and officers to us and our shareholders for damages for breach of fiduciary duty as a director or officer to the extent

permissible under Nevada law.

Further, our Bylaws provide that we are obligated to indemnify each of our directors or officers to the

fullest extent authorized by Nevada law and, subject to certain conditions, advance the expenses incurred by any director or officer

in defending any action, suit or proceeding prior to its final disposition.

Those indemnification obligations could expose us to substantial

expenditures to cover the cost of settlement or damage awards against our directors or officers, which we may be unable to afford.

those provisions and resulting costs may discourage us or our shareholders from bringing a lawsuit against any of our current or former

directors or officers for breaches of their fiduciary duties, even if such actions might otherwise benefit our shareholders.

Risks Related to the Company’s Common

The share price of our Common Stock is

volatile and may be influenced by numerous factors, some of which are beyond our control.

There is currently only a limited public market

for our Common Stock, which is listed on the Nasdaq Capital Market, and there can be no assurance that a trading market will develop

further or be maintained for our Common Stock in the future.

The trading price of our Common Stock is likely to be highly volatile, and

could be subject to wide fluctuations in response to various factors, some of which are beyond our control.

In addition to the factors

discussed in this “Risk Factors” section and elsewhere in this report, these factors include:

the new drug candidates we acquire for commercialization;

49 unchanged sentences

many of which are beyond our control.

addition, the stock market in general, and the stocks of small-cap healthcare, biotechnology and pharmaceutical companies in particular,

have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance

of these companies.

Broad market and industry factors may negatively affect the market price of our Common Stock, regardless of our actual

operating performance.

The realization of any of the above risks or any of a broad range of other risks, including those described in

these “Risk Factors,” could have a dramatic and material adverse impact on the market price of our Common Stock.

have substantial control over us, and they could delay or prevent a change in our corporate control even if our other shareholders wanted

executive officers, directors, and principal shareholders own, in the aggregate, approximately 70.8% of our outstanding Common

As a result of their stockholdings, these shareholders are able to assert substantial control over matters requiring shareholder

approval, including the election of directors and approval of significant corporate transactions.

This could delay or prevent an

outside party from acquiring or merging with us even if our other shareholders wanted it to occur.

market price of our Common Stock may be volatile and there may not be sufficient liquidity in the market for our securities

in order for investors to sell their securities.

market price of our Common Stock has been and will likely continue to be highly volatile, as is the stock market in general.

that may materially affect the market price of our Common Stock are beyond our control, these factors may materially adversely affect

the market price of our Common Stock, regardless of our performance.

In addition, the public stock markets have experienced

extreme price and trading volume volatility.

These broad market fluctuations may influence the market price of our Common Stock.

There is currently only a limited public market for our Common Stock, which is listed on the Nasdaq Capital Market, and there can be

no assurance that a trading market will develop further or be maintained in the future.

stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity

securities of many companies, including very recently in connection with the ongoing COVID-19 pandemic, which has resulted in decreased

stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects.

fluctuations have often been unrelated or disproportionate to the operating performance of those companies.

In addition, the stock market in general, and

the stocks of small-cap healthcare, biotechnology and pharmaceutical companies in particular, have experienced extreme price and volume

fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Broad market and industry

factors, including potentially worsening economic conditions and other adverse effects or developments relating to the ongoing COVID-19

pandemic, political, regulatory and other market conditions, may negatively affect the market price of shares of our common stock, regardless

of our actual operating performance.

The market price of shares of our common stock may decline and you may lose some or all of your

have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to

the value of our shares.

have never paid any cash dividends on our Common Stock and do not anticipate paying any cash dividends in the foreseeable future, and

any return on investment may be limited to the value of our Common Stock.

factors may negatively affect the market price of our Common Stock, regardless of our actual operating performance.

The realization of

any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors,” could have

a dramatic and material adverse impact on the market price of our Common Stock.

Insiders have substantial control over

us, and they could delay or prevent a change in our corporate control even if our other shareholders wanted it to occur.

Our executive officers, directors, and principal

shareholders own, in the aggregate, approximately 61.4% of our outstanding Common Stock.

As a result of their stockholdings, these

shareholders are able to assert substantial control over matters requiring shareholder approval, including the election of directors and

approval of significant corporate transactions.

This could delay or prevent an outside party from acquiring or merging with us even

if our other shareholders wanted it to occur.

The market price of our Common Stock may

be volatile and there may not be sufficient liquidity in the market for our securities in order for investors to sell

their securities.

The market price of our Common Stock has been

and will likely continue to be highly volatile, as is the stock market in general.

Factors that may materially affect the market price

of our Common Stock are beyond our control, these factors may materially adversely affect the market price of our Common Stock, regardless

of our performance.

In addition, the public stock markets have experienced extreme price and trading volume volatility.

broad market fluctuations may influence the market price of our Common Stock.

There is currently only a limited public market for our

Common Stock, which is listed on the Nasdaq Capital Market, and there can be no assurance that a trading market will develop further

or be maintained in the future.

The stock markets have experienced extreme price

and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies, including

very recently in connection with the ongoing COVID-19 pandemic, which has resulted in decreased stock prices for many companies notwithstanding

the lack of a fundamental change in their underlying business models or prospects.

These fluctuations have often been unrelated or disproportionate

to the operating performance of those companies.

Broad market and industry factors, including potentially worsening economic conditions

and other adverse effects or developments relating to the ongoing COVID-19 pandemic, political, regulatory and other market conditions,

may negatively affect the market price of shares of our common stock, regardless of our actual operating performance.

The market price

of shares of our common stock may decline and you may lose some or all of your investment.

We have not paid dividends in the past

and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our shares.

We have never paid any cash dividends on our

Common Stock and do not anticipate paying any cash dividends in the foreseeable future, and any return on investment may be limited to

the value of our Common Stock.

We plan to retain any future earnings to finance growth.

applicable Nevada law, we, as a Nevada corporation, generally may not make a distribution if i) we would not be able to pay our debts

as they become due in the usual course of business, or ii) our total assets would be less than the sum of our total liabilities plus

the amount that would be needed, if we were to be dissolved at the time of distribution, to satisfy the preferential rights upon dissolution

of shareholders whose preferential rights are superior to those receiving the distribution.

securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price

and any trading volume could decline.

Under applicable Nevada law, we, as a Nevada

corporation, generally may not make a distribution if i) we would not be able to pay our debts as they become due in the usual course

of business, or ii) our total assets would be less than the sum of our total liabilities plus the amount that would be needed, if we

were to be dissolved at the time of distribution, to satisfy the preferential rights upon dissolution of shareholders whose preferential

rights are superior to those receiving the distribution.

If securities or industry analysts do not

publish research or publish inaccurate or unfavorable research about our business, our stock price and any trading volume could decline.

trading market for our Common Stock that may develop will depend in part on the research and reports that securities or industry analysts

7 unchanged sentences

volume to decline.

sales and issuances of our Common Stock or rights to purchase Common Stock, including pursuant to our equity incentive plan or otherwise,

could result in dilution of the percentage ownership of our shareholders and could cause our stock price to fall.

expect that we will need significant additional capital in the future to continue our planned operations.

To raise capital, we may sell

Common Stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from

time to time.

If we sell Common Stock, convertible securities or other equity securities in more than one transaction, including issuance

of equity securities pursuant to any future stock incentive plan to our officers, directors, employees and non-employee consultants for

their services to us, investors in a prior transaction may be materially diluted by subsequent sales.

Additionally, any such sales may

result in material dilution to our existing shareholders, and new investors could gain rights, preferences and privileges senior to those

of holders of our Common Stock.

Further, any future sales of our Common Stock by us or resales of our Common Stock by our existing shareholders

could cause the market price of our Common Stock to decline.

Any future grants of options, warrants or other securities exercisable or

convertible into our Common Stock, or the exercise or conversion of such shares, and any sales of such shares in the market, could have

an adverse effect on the market price of our Common Stock.

On October 29, 2021, we filed a registration statement on Form S-3, as amended

on November 16, 2021, which was declared effective on November 29, 2021.

As of the date hereof, we have not yet issued any shares through

the Form S-3, but may in the future, which would further dilute your ownership.

Common Stock may be subject to the “penny stock” rules of the Securities and Exchange Commission, which may make it more

difficult for shareholders to sell our Common Stock.

SEC has adopted Rule 15g-9 which establishes the definition of a “penny stock,” for the purposes relevant to us, as any equity

security that has a market price of less than $5.00 per share, subject to certain exceptions.

For any transaction involving a penny stock,

unless exempt, the rules require that a broker or dealer approve a person’s account for transactions in penny stocks, and the broker

or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock

to be purchased.

order to approve a person’s account for transactions in penny stocks, the broker or dealer must obtain financial information and

investment experience objectives of the person, and make a reasonable determination that the transactions in penny stocks are suitable

for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of

transactions in penny stocks.

broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to

the penny stock market, which, in highlight form sets forth the basis on which the broker or dealer made the suitability determination,

and that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

brokers may be less willing to execute transactions in securities subject to the “penny stock” rules.

This may make it more

difficult for investors to dispose of the Company’s Common Stock if and when such shares are eligible for sale and may cause a

decline in the market value of its stock.

also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions

payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies

available to an investor in cases of fraud in penny stock transactions.

Finally, monthly statements have to be sent disclosing recent

price information for the penny stock held in the account and information on the limited market in penny stock.

failure to meet the continued listing requirements of the Nasdaq Capital Market could result in a delisting of our Common Stock .

we fail to satisfy the continued listing requirements of the Nasdaq Capital Market, such as the corporate governance requirements or

the minimum closing bid price requirement, the Nasdaq Capital Market may take steps to delist our common stock.

Such a delisting would

likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when

you wish to do so.

In the event of a delisting, we anticipate that we would take actions to restore our compliance with the Nasdaq Capital

Market or another national exchange’s listing requirements, but we can provide no assurance that any such action taken by us would

allow our Common Stock to remain listed on the Nasdaq Capital Market, stabilize our market price, improve the liquidity of our common

stock, prevent our common stock from dropping below the Nasdaq Capital Market’s minimum bid price requirement, or prevent future

non-compliance with the Nasdaq Capital Market or another national exchange’s listing requirements.

will continue to incur significant increased costs as a result of operating as a public company, and our management will be required

to devote substantial time to new compliance requirements as a result of our Common Stock being listed on the Nasdaq Capital Market.

will continue to incur significant increased costs as a result of operating as a public company, and our management will be required

to devote substantial time to new compliance requirements of the Nasdaq Capital Market.

As a public company, we will continue to incur

significant legal, accounting and other expenses.

We are subject to mandatory reporting requirements of the Exchange Act, which require,

among other things, that we continue to file with the SEC annual, quarterly and current reports with respect to our business and financial

condition, that we were not required to file as a voluntary reporting company (though we did file such reports with the SEC on a voluntary

We have incurred and will continue to incur costs associated with the preparation and filing of these SEC reports.

we are subject to mandatory new corporate governance and other compliance requirements of the Nasdaq Capital Market.

In addition, the

Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC, the Dodd-Frank Wall Street Reform and Consumer Protection Act

and the Nasdaq Capital Market or another national exchange have imposed various other requirements on public companies.

Stockholder activism,

the current political environment and the current high level of government intervention and regulatory reform may lead to substantial

new regulations and disclosure obligations, which may lead to additional compliance costs and impact (in ways we cannot currently anticipate)

the way we operate our business.

Our management and other personnel will need to devote a substantial amount of time to these compliance

Moreover, these rules and regulations have and will continue to increase our legal and financial compliance costs and will

make some activities more time-consuming and costly.

addition, if and when we cease to be a smaller reporting company and become subject to Section 404(b) of the Sarbanes-Oxley Act, we will

be required to furnish an attestation report on internal control over financial reporting issued by our independent registered public

accounting firm.

To achieve compliance with Section 404 within the prescribed time period, we will continue to be engaged in a process

to document and evaluate our internal control over financial reporting, which is both costly and challenging.

In this regard, we will

need to dedicate substantially greater internal resources, potentially engage outside consultants and adopt a detailed work plan to assess

and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate

through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal

control over financial reporting.

Despite our efforts, there is a risk that our independent registered public accounting firm, when required,

will not be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required

by Section 404.

This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our

financial statements.

Future sales and issuances of our Common

Stock or rights to purchase Common Stock, including pursuant to our equity incentive plan or otherwise, could result in dilution of the

percentage ownership of our shareholders and could cause our stock price to fall.

We expect that we will need significant additional

capital in the future to continue our planned operations.

To raise capital, we may sell Common Stock, convertible securities or other

equity securities in one or more transactions at prices and in a manner we determine from time to time.

If we sell Common Stock, convertible

securities or other equity securities in more than one transaction, including issuance of equity securities pursuant to any future stock

incentive plan to our officers, directors, employees and non-employee consultants for their services to us, investors in a prior transaction

may be materially diluted by subsequent sales.

Additionally, any such sales may result in material dilution to our existing shareholders,

and new investors could gain rights, preferences and privileges senior to those of holders of our Common Stock.

Further, any future sales

of our Common Stock by us or resales of our Common Stock by our existing shareholders could cause the market price of our Common Stock

Any future grants of options, warrants or other securities exercisable or convertible into our Common Stock, or the exercise

or conversion of such shares, and any sales of such shares in the market, could have an adverse effect on the market price of our Common

On October 29, 2021, we filed a registration statement on Form S-3, as amended on November 16, 2021, which was declared effective

on November 29, 2021.

On May 11, 2022, we agreed to issue 2,000,000 shares of Common Stock, par value $0.001 per share, at a price of

$2.11 per share and 5-year warrants to purchase up to 2,000,000 shares of Common Stock, exercisable at a price of $2.45 per share pursuant

to certain securities purchase agreement dated May 11, 2022, which was effected as a takedown off the Company’s shelf registration

statement on Form S-3, as amended.

We also issued the co-placement agents warrants to purchase up to 160,000 shares of Common Stock,

on the same terms as the investors warrants in connection with the transaction.

We may issue shares of Common Stock through the Form

S-3 in the future, which would further dilute your ownership.

Our Common Stock may be subject to the

“penny stock” rules of the Securities and Exchange Commission, which may make it more difficult for shareholders to sell

our Common Stock.

The SEC has adopted Rule 15g-9 which establishes

the definition of a “penny stock,” for the purposes relevant to us, as any equity security that has a market price of less

than $5.00 per share, subject to certain exceptions.

For any transaction involving a penny stock, unless exempt, the rules require that

a broker or dealer approve a person’s account for transactions in penny stocks, and the broker or dealer receive from the investor

a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.

In order to approve a person’s account

for transactions in penny stocks, the broker or dealer must obtain financial information and investment experience objectives of the

person, and make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient

knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

The broker or dealer must also deliver, prior

to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which, in highlight

form sets forth the basis on which the broker or dealer made the suitability determination, and that the broker or dealer received a

signed, written agreement from the investor prior to the transaction.

Generally, brokers may be less willing to execute

transactions in securities subject to the “penny stock” rules.

This may make it more difficult for investors to dispose of

the Company’s Common Stock if and when such shares are eligible for sale and may cause a decline in the market value of its stock.

Disclosure also has to be made about the risks

of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer

and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases

of fraud in penny stock transactions.

Finally, monthly statements have to be sent disclosing recent price information for the penny stock

held in the account and information on the limited market in penny stock.

Our failure to meet the continued listing

requirements of the Nasdaq Capital Market could result in a delisting of our Common Stock .

If we fail to satisfy the continued listing requirements

of the Nasdaq Capital Market, such as the corporate governance requirements or the minimum closing bid price requirement, the Nasdaq

Capital Market may take steps to delist our common stock.

Such a delisting would likely have a negative effect on the price of our common

stock and would impair your ability to sell or purchase our common stock when you wish to do so.

On August 19, 2022, we received a deficiency

letter from the Nasdaq Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”)

notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00

per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (“Rule 5550(a)(2)”).

Under the Nasdaq Listing Rules, we have until February 14, 2023 to regain compliance.

Since we did not regain compliance by such date,

we requested and received an additional 180 days, until August 14, 2023, to comply with Rule 5550(a)(2).

If we fail to regain compliance on or prior to

August 14, 2023, we could be subject to suspension and delisting proceedings, unless we timely appeal for a hearing before a Nasdaq Hearings

The request for a hearing will stay any suspension or delisting action pending the issuance of the decision of the Nasdaq Hearings

Panel following the hearing and the expiration of any additional extension granted by the Nasdaq Hearings Panel.

The deficiency has no

immediate effect on the listing of our common stock, and our common stock continues to trade on the Nasdaq Capital Market under the symbol

“ABVC” at this time.

However, there can be no assurance that we will be able to regain compliance with the bid price requirement

under Nasdaq Listing Rule 5550(a)(2).

If our common stock were delisted from the Nasdaq,

trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the

OTCQB or the Pink Market maintained by OTC Markets Group Inc.

An investor would likely find it less convenient to sell, or to obtain

accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell

our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed

on a national exchange or other reasons.

In addition, as a delisted security, our common stock would be subject to SEC rules as a “penny

stock,” which impose additional disclosure requirements on broker-dealers.

The regulations relating to penny stocks, coupled with

the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing

a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade

in our common stock.

In the event of a delisting, we anticipate that

we would take actions to restore our compliance with the Nasdaq Capital Market or another national exchange’s listing requirements,

but we can provide no assurance that any such action taken by us would allow our Common Stock to remain listed on the Nasdaq Capital

Market, stabilize our market price, improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq

Capital Market’s minimum bid price requirement, or prevent future non-compliance with the Nasdaq Capital Market or another national

exchange’s listing requirements.

We will continue to incur significant increased

costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance

requirements as a result of our Common Stock being listed on the Nasdaq Capital Market.

We will continue to incur significant increased

costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance

requirements of the Nasdaq Capital Market.

As a public company, we will continue to incur significant legal, accounting and other expenses.

We are subject to mandatory reporting requirements of the Exchange Act, which require, among other things, that we continue to file with

the SEC annual, quarterly and current reports with respect to our business and financial condition, that we were not required to file

as a voluntary reporting company (though we did file such reports with the SEC on a voluntary basis).

We have incurred and will continue

to incur costs associated with the preparation and filing of these SEC reports.

Furthermore, we are subject to mandatory new corporate

governance and other compliance requirements of the Nasdaq Capital Market.

In addition, the Sarbanes-Oxley Act, as well as rules subsequently

implemented by the SEC, the Dodd-Frank Wall Street Reform and Consumer Protection Act and the Nasdaq Capital Market or another national

exchange have imposed various other requirements on public companies.

Stockholder activism, the current political environment and the

current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations,

which may lead to additional compliance costs and impact (in ways we cannot currently anticipate) the way we operate our business.

management and other personnel will need to devote a substantial amount of time to these compliance initiatives.

Moreover, these rules

and regulations have and will continue to increase our legal and financial compliance costs and will make some activities more time-consuming

In addition, if and when we cease to be a smaller

reporting company and become subject to Section 404(b) of the Sarbanes-Oxley Act, we will be required to furnish an attestation report

on internal control over financial reporting issued by our independent registered public accounting firm.

To achieve compliance with

Section 404 within the prescribed time period, we will continue to be engaged in a process to document and evaluate our internal control

over financial reporting, which is both costly and challenging.

In this regard, we will need to dedicate substantially greater internal

resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control

over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning

as documented and implement a continuous reporting and improvement process for internal control over financial reporting.

efforts, there is a risk that our independent registered public accounting firm, when required, will not be able to conclude within the

prescribed timeframe that our internal control over financial reporting is effective as required by Section 404.

This could result in

an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

UNRESOLVED STAFF COMMENTS

applicable to us since we are not an accelerated filer, a large accelerated filer or a well-known seasoned issuer under SEC rules.

Not applicable to us since we are not an accelerated

filer, a large accelerated filer or a well-known seasoned issuer under SEC rules.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors