What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-11-15 compared with 2021-08-12 · 882 added, 909 removed, 298 unchanged (86% of the section changed)

11 unchanged sentences

substantial revenue from its medical device and new drug development.

For the six months ended June 30, 2021, the Company generated $294,591

in revenue, contributed by $293,503 from the sale of Contract Development & Manufacturing Organization (“CDMO”) services,

and $1,088 from consulting services provided to a related party.

For the nine months ended September 30, 2021, the Company generated

$393,509 in revenue, contributed by $389,843 from the sale of Contract Development & Manufacturing Organization (“CDMO”)

services, and $3,747 from consulting services provided to a related party.

Business Overview

115 unchanged sentences

Stock on the four-year anniversary of its issuance.

As of June 30, 2021, no Series A Convertible Preferred

Stock has been issued by the Company.

As of September 30, 2021, no Series A Convertible

Preferred Stock has been issued by the Company.

Increasing the Authorized Shares

27 unchanged sentences

The Comp Warrants are exercisable on a cashless basis, at the holder’s

Financing in October 2020

On October 23, 2020, we entered into a Securities

Purchase Agreement (the “ October SPA ”) with one accredited investor.

Pursuant to the October SPA, the Company sold

and issued a convertible promissory note (the “ October Note ”) in the principal amount of $2,500,000 to the investor

and received the payment from such investor on October 30, 2020.

The October Note was issued on October 23, 2020

and the maturity date of the October Note is the twenty-four (24) month anniversary from the issuance date (the “ Maturity Date ”).

Upon the Maturity Date, the Company shall pay to the holder, in cash, an amount representing all outstanding principal amount and accrued

and unpaid interest under the October Note.

The October Note bears an interest rate of ten percent (10%) per annum and may be convertible

into shares of the Company’s common stock at a fixed conversion price of $2.25 per share.

The October Note was initially only convertible

at the holder’s discretion.

However, on May 17, 2021, the parties signed an amendment, pursuant to which the October Note shall

now also automatically convert into shares of Common Stock immediately following the Company’s receipt of conditional approval

to list its Common Stock on the NASDAQ stock market, if and when we receive such approval, which cannot be guaranteed, at a conversion

price equal to the then current conversion price.

The Company may prepay the outstanding amount at any time, in whole or in part, without

In connection with the October Note and pursuant

in October 2020

October 23, 2020, we entered into a Securities Purchase Agreement (the “ October SPA ”) with one accredited investor.

Pursuant to the October SPA, the Company sold and issued a convertible promissory note (the “ October Note ”) in the

principal amount of $2,500,000 to the investor and received the payment from such investor on October 30, 2020.

October Note was issued on October 23, 2020 and the maturity date of the October Note is the twenty-four (24) month anniversary from

the issuance date (the “ Maturity Date ”).

Upon the Maturity Date, the Company shall pay to the holder, in cash, an

amount representing all outstanding principal amount and accrued and unpaid interest under the October Note.

The October Note bears an

interest rate of ten percent (10%) per annum and may be convertible into shares of the Company’s common stock at a fixed conversion

price of $2.25 per share.

The October Note was initially only convertible at the holder’s discretion.

However, on May 17, 2021,

the parties signed an amendment, pursuant to which the October Note shall now also automatically convert into shares of Common Stock

immediately following the Company’s receipt of conditional approval to list its Common Stock on the NASDAQ stock market, if and

when we receive such approval, which cannot be guaranteed, at a conversion price equal to the then current conversion price.

may prepay the outstanding amount at any time, in whole or in part, without any penalty.

connection with the October Note and pursuant to the terms of an agreement entered into between the Company and a FINRA member firm,

such firm shall receive (i) a cash success fee of $78,750 and (ii) upon conversion of the October Note, warrants equal to 7.0% of the

number of shares of Common Stock received by the investor at the time of conversion (“ Note Warrants ”).

are exercisable on a cashless basis, at the holder’s discretion.

issuance and sale of the Common Stock, the Investor Warrants, Comp Warrants, Note Warrants and the shares of Common Stock underlying

the Investor Warrants, the Comp Warrants and the October Note were made in reliance on an exemption from registration contained in either Regulation

D or Regulation S of the Securities Act.

May 2020, the Company received capital contributions of approximately $1,697,051 in cash from 42 investors through private placements

with the term of $2.25 per share and a free warrant attaches with each Common stock that was purchased.

The exercise price of the warrant

will be at $6.00 with a mandatory exercise price of $9.00.

to the terms of an agreement entered into between the Company and a FINRA member firm, such firm shall receive (i) a cash success fee

of $78,750 and (ii) upon conversion of the October Note, warrants equal to 7.0% of the number of shares of Common Stock received by the

investor at the time of conversion (“ Note Warrants ”).

The warrants are exercisable on a cashless basis, at the holder’s

The issuance and sale of the Common Stock, the

Investor Warrants, Comp Warrants, Note Warrants and the shares of Common Stock underlying the Investor Warrants, the Comp Warrants and

the October Note were made in reliance on an exemption from registration contained in either Regulation D or Regulation

S of the Securities Act.

Financing in May 2020

In May 2020, the Company received capital contributions

of approximately $1,697,051 in cash from 42 investors through private placements with the term of $2.25 per share and a free warrant attaches

with each Common stock that was purchased.

The exercise price of the warrant will be at $6.00 with a mandatory exercise price of $9.00.

Pursuant to the terms of an agreement entered

into between the Company and a FINRA member firm, such firm shall receive (i) a cash success fee of $60,831.65 (ii) a warrant to purchase

37,852 shares of Common Stock with an exercise price of $2.25 per share, and (iii) a warrant to purchase 37,852 shares of Common Stock

with an exercise price of $6.00 per share.

Financing in April 2020

On January 21, 2020, the Company entered into

three note agreements with existing note investors who executed the agreements in 2018.

These three investors are Guoliang Yu and Yingfei

Wei Family Trust, Keypoint Technology Ltd., and Yoshinobu Odaira.

The new agreements bear the same term as other notes investors who executed

the contract in 2019.

On April 5, 2020, the Company entered into exchange agreements with such note holders.

Pursuant to the exchange

agreements, the Holders agreed to deliver the Notes to the Company for cancellation, of which the aggregate principal amount plus accrued

interest expenses are $931,584, and the Company agreed to issue to the Holders an aggregate of 506,297 shares of the Company’s common

stock and warrants to purchase 506,297 shares of the Company’s common stock.

On August 28, 2019 and September 4, 2019, the

Company issued convertible promissory notes in the aggregate principal amount plus accrued interest expenses are $515,196 to Kuo, Li Shen,

Chang, Ping Shan, Lin, Shan Tyan, and Liu, Ching Hsuan.

On April 20, 2020, the Company entered into separate exchange agreements with

each note holder.

Pursuant to the exchange agreements, the note holders agreed to cancel the notes and the Company agreed to issue to

the holders an aggregate of 289,438 shares of the Company’s common stock and warrants to purchase 289,438 shares of the Company’s

common stock.

Recent PPP Loan

On April 14, 2020, the Company received a loan

in the amount of $124,400 under the Paycheck Protection Program (“PPP”) administered by the United States Small Business Administration

(the “SBA”) from East West Bank.

According to the Coronavirus Aid, Relief, and Economic Security Act (the “Cares Act”),

PPP loan provides for forgiveness of up to the full principal amount and accrued interest if the funds are used for payroll costs, interest

on mortgages, rent, and utilities.

However, at least 60% of the forgiven amount must have been used for payroll.

The loan was granted

pursuant to a promissory note dated April 14, 2020 issued by the Company, which matures on April 13, 2022 and bears interest at a rate

of 1.00% per annum.

The Company will pay the principal in one payment of all outstanding principal plus all accrued unpaid interest on

that date that is two years after the date of the promissory note.

On October 23, ABVC BioPharma, Inc.(the “Company”) has

started the application with the US Government regarding the loan forgiveness program.

of $60,831.65 (ii) a warrant to purchase 37,852 shares of Common Stock with an exercise price of $2.25 per share, and (iii) a warrant

to purchase 37,852 shares of Common Stock with an exercise price of $6.00 per share.

in April 2020

January 21, 2020, the Company entered into three note agreements with existing note investors who executed the agreements in 2018.

three investors are Guoliang Yu and Yingfei Wei Family Trust, Keypoint Technology Ltd., and Yoshinobu Odaira.

The new agreements bear

the same term as other notes investors who executed the contract in 2019.

On April 5, 2020, the Company entered into exchange agreements

with such note holders.

Pursuant to the exchange agreements, the Holders agreed to deliver the Notes to the Company for cancellation,

of which the aggregate principal amount plus accrued interest expenses are $931,584, and the Company agreed to issue to the Holders an

aggregate of 506,297 shares of the Company’s common stock and warrants to purchase 506,297 shares of the Company’s common

August 28, 2019 and September 4, 2019, the Company issued convertible promissory notes in the aggregate principal amount plus accrued

interest expenses are $515,196 to Kuo, Li Shen, Chang, Ping Shan, Lin, Shan Tyan, and Liu, Ching Hsuan.

On April 20, 2020, the Company

entered into separate exchange agreements with each note holder.

Pursuant to the exchange agreements, the note holders agreed to cancel

the notes and the Company agreed to issue to the holders an aggregate of 289,438 shares of the Company’s common stock and warrants

to purchase 289,438 shares of the Company’s common stock.

April 14, 2020, the Company received a loan in the amount of $124,400 under the Paycheck Protection Program (“PPP”) administered

by the United States Small Business Administration (the “SBA”) from East West Bank.

According to the Coronavirus Aid, Relief,

and Economic Security Act (the “Cares Act”), PPP loan provides for forgiveness of up to the full principal amount and accrued

interest if the funds are used for payroll costs, interest on mortgages, rent, and utilities.

However, at least 60% of the forgiven amount

must have been used for payroll.

The loan was granted pursuant to a promissory note dated April 14, 2020 issued by the Company, which

matures on April 13, 2022 and bears interest at a rate of 1.00% per annum.

The Company will pay the principal in one payment of all outstanding

principal plus all accrued unpaid interest on that date that is two years after the date of the promissory note.

On October 23, ABVC

BioPharma, Inc.(the “Company”) has started the application with the US Government regarding the loan forgiveness program.

On January 29, 2021, BioKey received a loan

13 unchanged sentences

No collateral or personal guarantees are required.

On September 28, 2021, the “SBA” accepted the loan forgiveness application in the amount of $132,331 under the PPP.

On February 7, 2021, the Company received a loan

in the amount of $104,167 under the Paycheck Protection Program (“PPP”) administered by the United States Small Business Administration

(the “SBA”) from Cathay Bank.

According to the Coronavirus Aid, Relief, and Economic Security Act (the “Cares Act”),

PPP loan provides for forgiveness of up to the full principal amount and accrued interest if the funds are used for payroll costs, interest

on mortgages, rent, and utilities.

in the amount of $104,167 under the Paycheck Protection Program (“PPP”) administered by the United States Small Business

Administration (the “SBA”) from Cathay Bank.

According to the Coronavirus Aid, Relief, and Economic Security Act (the “Cares

Act”), PPP loan provides for forgiveness of up to the full principal amount and accrued interest if the funds are used for payroll

costs, interest on mortgages, rent, and utilities.

However, at least 60% of the forgiven amount must have been used for payroll.

The loan was granted

pursuant to a promissory note dated February 7, 2021 issued by the Company, which matures on February 6, 2026 and bears interest at a

rate of 1.00% per annum.

The Company will pay the principal in one payment of all outstanding principal plus all accrued unpaid interest

on that date that is five years after the date of the promissory note.

In addition, the Company will start the application with the US

Government regarding the loan forgiveness program as soon as the US Government allows.

No collateral or personal guarantees are required.

Recent Research Results

On May 23, 2019, the Company announced its internal

Phase II clinical study results of ABV-1504 for Major Depression Disorder (“MDD”).

The clinical study results showed that

PDC-1421, the active pharmaceutical ingredient of ABV-1504, met the pre-specified primary endpoint of the Phase II clinical trial and

significantly improved the symptoms of MDD.

The Phase II clinical study was a randomized,

double-blind, placebo-controlled, multi-center trial, in which 60 adult patients with confirmed moderate to severe MDD were treated with

PDC-1421 in either low dose (380 mg) or high dose (2 x 380 mg) compared with placebo administration, three times a day for six weeks.

PDC-1421 high dose (2 x 380 mg) met the pre-specified primary endpoint by demonstrating a highly significant 13.2-point reduction in the

Montgomery-Åsberg Depression Rating Scale (MADRS) total score by Intention-To-Treat (ITT) analysis, averaged over the 6-week treatment

period (overall treatment effect) from baseline, as compared to 9.2-point reduction of the placebo group.

By Per-Protocol (PP) analysis,

PDC-1421 showed a dose dependent efficacy toward MDD in which high dose (2 x 380 mg) gave 13.4-point reduction in MADRS total score from

baseline and low dose (380 mg) gave 10.4-point reduction as compared to a 8.6-point in the placebo group.

The Company has decided to use

the high dose formula in the Phase III clinical trial of ABV-1504.

On September 9, 2020, the Company issued a full

clinical study report (CSR) of Vitargus® First-in-Human Phase I Clinical Trial .

The safety and preliminary efficacy findings

from this study, combined with the unique properties of Vitargus® (BFC-1401), are supportive of further development for its use during

vitrectomy surgery in patients requiring vitreous replacement.

The study was an open label, Phase I study undertaken

at a single study center in Sydney, Australia.

A total of 11 participants were enrolled for the study in which each participant had

been diagnosed with either (1) a complex or rhegmatogenous retinal detachment or chronic retinal detachment with failure of gas or silicone

oil treatment or (2) a vitreous hemorrhage that requires vitrectomy surgery.

The study found that Vitargus® was well-tolerated as

a vitreous substitute without any apparent toxicity to ocular tissues.

Further, there was no indication of an increased overall safety

risk with Vitargus®.

On November 9, 2020 the Company issued a full

clinical study report (CSR) of its ABV-1505 Phase II Part I clinical trial conducted at the University of California, San Francisco (UCSF)

for the treatment of Adult Attention-Deficit Hyperactivity Disorder (ADHD).

The Phase II Part I clinical study for treating ADHD found

that the active ingredient of ABV-1505, PDC-1421, was safe, well tolerated and efficacious during its treatment and the follow-up period

with six adult patients.

For the primary endpoints, the percentages of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating

Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline to 8 weeks treatment were 83.3% (N=5) in the Intention-To-Treat (ITT) population

and 80.0% (N=4) in the Per-Protocol (PP) population.

Both low and high doses of PDC-1421 Capsule met the primary end points by passing

the required 40% population in ADHD-RS-IV test scores.

Overall, the results from this study, which demonstrate the therapeutic value of

PDC-1421, support further clinical development of ABV-1505 for the treatment of adult ADHD.

On November 4, 2020, the Company executed an amendment

to its collaboration agreement with BioFirst to add BFC-1403 Intraocular Irrigation Solution and BFC-1404 Corneal Storage Solution to

our agreement.

BFC-1404 is utilized during a corneal transplant procedure to replace a damaged or diseased cornea while BFC-1403 has broader

utilization during a variety of ocular procedures.

Initially the Company will focus on BFC-1404,

a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness cornea transplant) or endothelial

keratoplasty (back layer cornea transplant).

Designated ABV-2002 under the Company’s product identification system, the solution

is comprised of a specific poly amino acid that protects ocular tissue from damage caused by external osmolarity exposure during pre-surgery

The specific polymer in ABV 2002 can adjust osmolarity to maintain a range of 330 to 390 mOsM thereby permitting hydration within

the corneal stroma during the storage period.

Stromal hydration results in (a) maintaining acceptable corneal transparency and (b) prevents

donor cornea swelling.

ABV-2002 also contains an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial

properties and neuroprotection.

Early testing by BioFirst indicates that ABV-2002

may be more effective for protecting the cornea and retina during long-term storage than other storage media available today and can be

manufactured at lower cost.

Categorized as a Class I Medical Device which has the lowest risk to patients, the Company intends to submit

a Premarket Notification 510(K) submission to the FDA before the end of 2021 to demonstrate the device is at least as safe and effective

as current products on the market.

Key elements of our business strategy include:

Advancing to the pivotal trial phase of ABV-1701 Vitargus for the treatments of Retinal Detachment or Vitreous Hemorrhage, which we expect to generate revenues in the future.

Focusing on licensing ABV-1504 for the treatment of major depressive disorder, MDD, after the successful completion of its Phase II clinical trials.

Completing Phase II, Part 2 clinical trial for ABV-1505 for the treatment of attention deficit hyperactivity disorder, ADHD.

Out licensing drug candidates and medical device candidates to major pharmaceutical companies for phase III and pivotal clinical trials, as applicable, and further marketing if approved by the FDA.

We plan to augment our core research and development

capability and assets by conducting Phase I and II clinical trials for investigational new drugs and medical devices in the fields of

CNS, Hematology/Oncology and Ophthalmology.

Our management team has extensive experiences

across a wide range of new drug and medical device development and we have in-licensed new drug and medical device candidates from large

research institutes and universities in both the U.S.

Through an assertive product development approach, we expect that we

will build a substantial portfolio of Oncology/ Hematology, CNS and Ophthalmology products.

We primarily focus on Phase I and II research

of new drug candidates and out license the post-Phase-II products to pharmaceutical companies;

we do not expect to devote substantial

efforts and resources to building the disease-specific distribution channels.

Business Objectives

The Company is operating its core business based

on collaborative activities that can generate current and future revenues through research, development and/or commercialization joint

venture agreements.

The terms of these agreements typically include payment to the Company related to one or more of the following:

nonrefundable upfront license fees,

development and commercial milestones,

partial or complete reimbursement of research and development costs and

royalties on net sales of licensed products.

Each type of payments results in revenue except

for revenue from royalties on net sales of licensed products, which are classified as royalty revenues.

To date, we have not received

any royalty revenues.

Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service

to the joint venture partner.

As part of the accounting for these arrangements,

the Company applies judgment to determine whether the performance obligations are distinct and develop assumptions in determining the

stand-alone selling price for each distinct performance obligation identified in the collaboration agreements.

To determine the stand-alone

selling price, the Company relies on assumptions which may include forecasted revenues, development timelines, reimbursement rates for

R&D personnel costs, discount rates and probabilities of technical and regulatory success.

The Company had multiple deliverables under the

collaborative agreements, including deliverables relating to grants of technology licenses, regulatory and clinical development, and marketing

Estimation of the performance periods of the Company’s deliverables requires the use of management’s judgment.

Significant factors considered in management’s evaluation of the estimated performance periods include, but are not limited to,

the Company’s experience in conducting clinical development, regulatory and manufacturing activities.

The Company reviews the estimated

duration of its performance periods under its collaborative agreements on an annually basis, and makes any appropriate adjustments on

a prospective basis.

Future changes in estimates of the performance period under its collaborative agreements could impact the timing

of future revenue recognition.

(i) Nonrefundable upfront payments

If a license to the Company’s intellectual

property is determined to be distinct from the other performance obligations identified in an arrangement, the Company recognizes revenue

from the related nonrefundable upfront payments based on the relative standalone selling price prescribed to the license compared to the

total selling price of the arrangement.

The revenue is recognized when the license is transferred to the collaboration partners and the

collaboration partners are able to use and benefit from the license.

To date, the receipt of nonrefundable upfront fees was solely for

the compensation of past research efforts and contributions made by the Company before the collaborative agreements entered into and it

does not relate to any future obligations and commitments made between the Company and the collaboration partners in the collaborative

(ii) Milestone payments

The Company is eligible to receive milestone payments

under the collaborative agreement with collaboration partners based on achievement of specified development, regulatory and commercial

Management evaluated the nature of the events triggering these contingent payments, and concluded that these events fall into

two categories:

(a) events which involve the performance of the Company’s obligations under the collaborative agreement with collaboration

partners, and (b) events which do not involve the performance of the Company’s obligations under the collaborative agreement with

collaboration partners.

The former category of milestone payments consists

of those triggered by development and regulatory activities in the territories specified in the collaborative agreements.

Management concluded

that each of these payments constitute substantive milestone payments.

This conclusion was based primarily on the facts that (i) each

triggering event represents a specific outcome that can be achieved only through successful performance by the Company of one or more

of its deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would result in additional

payments becoming due to the Company, (iii) each of the milestone payments is nonrefundable, (iv) substantial effort is required to complete

each milestone, (v) the amount of each milestone payment is reasonable in relation to the value created in achieving the milestone, (vi)

a substantial amount of time is expected to pass between the upfront payment and the potential milestone payments, and (vii) the milestone

payments relate solely to past performance.

Based on the foregoing, the Company recognizes any revenue from these milestone payments in

the period in which the underlying triggering event occurs.

(iii) Multiple Element Arrangements

The Company evaluates multiple element arrangements

to determine (1) the deliverables included in the arrangement and (2) whether the individual deliverables represent separate units of

accounting or whether they must be accounted for as a combined unit of accounting.

This evaluation involves subjective determinations

and requires management to make judgments about the individual deliverables and whether such deliverables are separate from other aspects

of the contractual relationship.

loan was granted pursuant to a promissory note dated February 7, 2021 issued by the Company, which matures on February 6, 2026 and bears

interest at a rate of 1.00% per annum.

The Company will pay the principal in one payment of all outstanding principal plus all accrued

unpaid interest on that date that is five years after the date of the promissory note.

In addition, the Company will start the application

with the US Government regarding the loan forgiveness program as soon as the US Government allows.

No collateral or personal guarantees

are required.

Research Results

May 23, 2019, the Company announced its internal Phase II clinical study results of ABV-1504 for Major Depression Disorder (“MDD”).

The clinical study results showed that PDC-1421, the active pharmaceutical ingredient of ABV-1504, met the pre-specified primary endpoint

of the Phase II clinical trial and significantly improved the symptoms of MDD.

Phase II clinical study was a randomized, double-blind, placebo-controlled, multi-center trial, in which 60 adult patients with confirmed

moderate to severe MDD were treated with PDC-1421 in either low dose (380 mg) or high dose (2 x 380 mg) compared with placebo administration,

three times a day for six weeks.

PDC-1421 high dose (2 x 380 mg) met the pre-specified primary endpoint by demonstrating a highly significant

13.2-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score by Intention-To-Treat (ITT) analysis,

averaged over the 6-week treatment period (overall treatment effect) from baseline, as compared to 9.2-point reduction of the placebo

By Per-Protocol (PP) analysis, PDC-1421 showed a dose dependent efficacy toward MDD in which high dose (2 x 380 mg) gave 13.4-point

reduction in MADRS total score from baseline and low dose (380 mg) gave 10.4-point reduction as compared to a 8.6-point in the placebo

The Company has decided to use the high dose formula in the Phase III clinical trial of ABV-1504.

September 9, 2020, the Company issued a full clinical study report (CSR) of Vitargus® First-in-Human Phase I Clinical Trial .

safety and preliminary efficacy findings from this study, combined with the unique properties of Vitargus® (BFC-1401), are supportive

of further development for its use during vitrectomy surgery in patients requiring vitreous replacement.

study was an open label, Phase I study undertaken at a single study center in Sydney, Australia.

A total of 11 participants were

enrolled for the study in which each participant had been diagnosed with either (1) a complex or rhegmatogenous retinal detachment or

chronic retinal detachment with failure of gas or silicone oil treatment or (2) a vitreous hemorrhage that requires vitrectomy surgery.

The study found that Vitargus® was well-tolerated as a vitreous substitute without any apparent toxicity to ocular tissues.

there was no indication of an increased overall safety risk with Vitargus®.

November 9, 2020 the Company issued a full clinical study report (CSR) of its ABV-1505 Phase II Part I clinical trial conducted at the

University of California, San Francisco (UCSF) for the treatment of Adult Attention-Deficit Hyperactivity Disorder (ADHD).

II Part I clinical study for treating ADHD found that the active ingredient of ABV-1505, PDC-1421, was safe, well tolerated and efficacious

during its treatment and the follow-up period with six adult patients.

For the primary endpoints, the percentages of improvement in Adult

Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline to 8 weeks treatment were

83.3% (N=5) in the Intention-To-Treat (ITT) population and 80.0% (N=4) in the Per-Protocol (PP) population.

Both low and high doses of

PDC-1421 Capsule met the primary end points by passing the required 40% population in ADHD-RS-IV test scores.

Overall, the results from

this study, which demonstrate the therapeutic value of PDC-1421, support further clinical development of ABV-1505 for the treatment of

November 4, 2020, the Company executed an amendment to its collaboration agreement with BioFirst to add BFC-1403 Intraocular Irrigation

Solution and BFC-1404 Corneal Storage Solution to our agreement.

BFC-1404 is utilized during a corneal transplant procedure to replace

a damaged or diseased cornea while BFC-1403 has broader utilization during a variety of ocular procedures.

the Company will focus on BFC-1404, a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness

cornea transplant) or endothelial keratoplasty (back layer cornea transplant).

Designated ABV-2002 under the Company’s product

identification system, the solution is comprised of a specific poly amino acid that protects ocular tissue from damage caused by external

osmolarity exposure during pre-surgery storage.

The specific polymer in ABV 2002 can adjust osmolarity to maintain a range of 330 to

390 mOsM thereby permitting hydration within the corneal stroma during the storage period.

Stromal hydration results in (a) maintaining

acceptable corneal transparency and (b) prevents donor cornea swelling.

ABV-2002 also contains an abundant phenolic phytochemical found

in plant cell walls that provides antioxidant antibacterial properties and neuroprotection.

testing by BioFirst indicates that ABV-2002 may be more effective for protecting the cornea and retina during long-term storage than

other storage media available today and can be manufactured at lower cost.

Categorized as a Class I Medical Device which has the lowest

risk to patients, the Company intends to submit a Premarket Notification 510(K) submission to the FDA before the end of 2021 to demonstrate

the device is at least as safe and effective as current products on the market.

elements of our business strategy include:

to the pivotal trial phase of ABV-1701 Vitargus for the treatments of Retinal Detachment or Vitreous Hemorrhage, which we expect

to generate revenues in the future.

on licensing ABV-1504 for the treatment of major depressive disorder, MDD, after the successful completion of its Phase II clinical

Phase II, Part 2 clinical trial for ABV-1505 for the treatment of attention deficit hyperactivity disorder, ADHD.

licensing drug candidates and medical device candidates to major pharmaceutical companies for phase III and pivotal clinical trials,

as applicable, and further marketing if approved by the FDA.

plan to augment our core research and development capability and assets by conducting Phase I and II clinical trials for investigational

new drugs and medical devices in the fields of CNS, Hematology/Oncology and Ophthalmology.

management team has extensive experiences across a wide range of new drug and medical device development and we have in-licensed new

drug and medical device candidates from large research institutes and universities in both the U.S.

Through an assertive

product development approach, we expect that we will build a substantial portfolio of Oncology/ Hematology, CNS and Ophthalmology products.

We primarily focus on Phase I and II research of new drug candidates and out license the post-Phase-II products to pharmaceutical companies;

we do not expect to devote substantial efforts and resources to building the disease-specific distribution channels.

Company is operating its core business based on collaborative activities that can generate current and future revenues through research,

development and/or commercialization joint venture agreements.

The terms of these agreements typically include payment to the Company

related to one or more of the following:

nonrefundable

upfront license fees,

and commercial milestones,

or complete reimbursement of research and development costs and

on net sales of licensed products.

type of payments results in revenue except for revenue from royalties on net sales of licensed products, which are classified as royalty

To date, we have not received any royalty revenues.

Revenue is recognized upon satisfaction of a performance obligation by

transferring control of a good or service to the joint venture partner.

part of the accounting for these arrangements, the Company applies judgment to determine whether the performance obligations are distinct

and develop assumptions in determining the stand-alone selling price for each distinct performance obligation identified in the collaboration

To determine the stand-alone selling price, the Company relies on assumptions which may include forecasted revenues, development

timelines, reimbursement rates for R&D personnel costs, discount rates and probabilities of technical and regulatory success.

Company had multiple deliverables under the collaborative agreements, including deliverables relating to grants of technology licenses,

regulatory and clinical development, and marketing activities.

Estimation of the performance periods of the Company’s deliverables

requires the use of management’s judgment.

Significant factors considered in management’s evaluation of the estimated performance

periods include, but are not limited to, the Company’s experience in conducting clinical development, regulatory and manufacturing

The Company reviews the estimated duration of its performance periods under its collaborative agreements on an annually basis,

and makes any appropriate adjustments on a prospective basis.

Future changes in estimates of the performance period under its collaborative

agreements could impact the timing of future revenue recognition.

Nonrefundable upfront payments

a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified

in an arrangement, the Company recognizes revenue from the related nonrefundable upfront payments based on the relative standalone selling

price prescribed to the license compared to the total selling price of the arrangement.

The revenue is recognized when the license is

transferred to the collaboration partners and the collaboration partners are able to use and benefit from the license.

To date, the receipt

of nonrefundable upfront fees was solely for the compensation of past research efforts and contributions made by the Company before the

collaborative agreements entered into and it does not relate to any future obligations and commitments made between the Company and the

collaboration partners in the collaborative agreements.

Milestone payments

Company is eligible to receive milestone payments under the collaborative agreement with collaboration partners based on achievement

of specified development, regulatory and commercial events.

Management evaluated the nature of the events triggering these contingent

payments, and concluded that these events fall into two categories:

(a) events which involve the performance of the Company’s obligations

under the collaborative agreement with collaboration partners, and (b) events which do not involve the performance of the Company’s

obligations under the collaborative agreement with collaboration partners.

former category of milestone payments consists of those triggered by development and regulatory activities in the territories specified

in the collaborative agreements.

Management concluded that each of these payments constitute substantive milestone payments.

This conclusion

was based primarily on the facts that (i) each triggering event represents a specific outcome that can be achieved only through successful

performance by the Company of one or more of its deliverables, (ii) achievement of each triggering event was subject to inherent risk

and uncertainty and would result in additional payments becoming due to the Company, (iii) each of the milestone payments is nonrefundable,

(iv) substantial effort is required to complete each milestone, (v) the amount of each milestone payment is reasonable in relation to

the value created in achieving the milestone, (vi) a substantial amount of time is expected to pass between the upfront payment and the

potential milestone payments, and (vii) the milestone payments relate solely to past performance.

Based on the foregoing, the Company

recognizes any revenue from these milestone payments in the period in which the underlying triggering event occurs.

Multiple Element Arrangements

Company evaluates multiple element arrangements to determine (1) the deliverables included in the arrangement and (2) whether the individual

deliverables represent separate units of accounting or whether they must be accounted for as a combined unit of accounting.

This evaluation

involves subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables

are separate from other aspects of the contractual relationship.

Deliverables are considered separate units of accounting provided that:

(i) the delivered item(s) has

value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item(s),

delivery or performance of the undelivered item(s) is considered probable and substantially within its control.

In assessing whether an

item under a collaboration has standalone value, the Company considers factors such as the research, manufacturing, and commercialization

capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace.

The Company also

considers whether its collaboration partners can use the other deliverable(s) for their intended purpose without the receipt of the remaining

element(s), whether the value of the deliverable is dependent on the undelivered item(s), and whether there are other vendors that can

provide the undelivered element(s).

The Company recognizes arrangement consideration

allocated to each unit of accounting when all of the revenue recognition criteria in ASC 606 are satisfied for that particular unit of

In the event that a deliverable does not represent a separate unit of accounting, the Company recognizes revenue from the

combined unit of accounting over the Company’s contractual or estimated performance period for the undelivered elements, which is

typically the term of the Company’s research and development obligations.

If there is no discernible pattern of performance or objectively

measurable performance measures do not exist, then the Company recognizes revenue under the arrangement on a straight-line basis over

the period the Company is expected to complete its performance obligations.

Conversely, if the pattern of performance in which the service

is provided to the customer can be determined and objectively measurable performance measures exist, then the Company recognizes revenue

under the arrangement using the proportional performance method.

Revenue recognized is limited to the lesser of the cumulative amount

of payments received or the cumulative amount of revenue earned, as determined using the straight-line method or proportional performance

method, as applicable, as of the period ending date.

At the inception of an arrangement that includes

milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent

nature of the milestone.

(i) the delivered item(s) has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return

relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially within

In assessing whether an item under a collaboration has standalone value, the Company considers factors such as the research,

manufacturing, and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the

general marketplace.

The Company also considers whether its collaboration partners can use the other deliverable(s) for their intended

purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependent on the undelivered item(s),

and whether there are other vendors that can provide the undelivered element(s).

Company recognizes arrangement consideration allocated to each unit of accounting when all of the revenue recognition criteria in ASC

606 are satisfied for that particular unit of accounting.

In the event that a deliverable does not represent a separate unit of accounting,

the Company recognizes revenue from the combined unit of accounting over the Company’s contractual or estimated performance period

for the undelivered elements, which is typically the term of the Company’s research and development obligations.

If there is no

discernible pattern of performance or objectively measurable performance measures do not exist, then the Company recognizes revenue under

the arrangement on a straight-line basis over the period the Company is expected to complete its performance obligations.

if the pattern of performance in which the service is provided to the customer can be determined and objectively measurable performance

measures exist, then the Company recognizes revenue under the arrangement using the proportional performance method.

Revenue recognized

is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using

the straight-line method or proportional performance method, as applicable, as of the period ending date.

the inception of an arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive and at

risk to both parties on the basis of the contingent nature of the milestone.

This evaluation includes an assessment of whether:

(1) the consideration is commensurate with either the Company’s

performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting

from its performance to achieve the milestone, (2) the consideration relates solely to past performance and (3) the consideration is reasonable

relative to all of the deliverables and payment terms within the arrangement.

The Company evaluates factors such as the scientific, clinical,

regulatory, commercial, and other risks that must be overcome to achieve the particular milestone and the level of effort and investment

required to achieve the particular milestone in making this assessment.

There is considerable judgment involved in determining whether

a milestone satisfies all of the criteria required to conclude that a milestone is substantive.

Milestones that are not considered substantive

are recognized as earned if there are no remaining performance obligations or over the remaining period of performance, assuming all other

revenue recognition criteria are met.

(iv) Royalties and Profit Sharing Payments

Under the collaborative agreement with the collaboration

partners, the Company is entitled to receive royalties on sales of products, which is at certain percentage of the net sales.

recognizes revenue from these events based on the revenue recognition criteria set forth in ASC 606.

Based on those criteria, the Company

considers these payments to be contingent revenues, and recognizes them as revenue in the period in which the applicable contingency is

Revenues Derived from Research and Development

Activities Services — Revenues related to research and development and regulatory activities are recognized when the related services

or activities are performed, in accordance with the contract terms.

The Company typically has only one performance obligation at the inception

of a contract, which is to perform research and development services.

The Company may also provide its customers with an option to request

that the Company provides additional goods or services in the future, such as active pharmaceutical ingredient, API, or IND/NDA/ANDA/510K

The Company evaluates whether these options are material rights at the inception of the contract.

If the Company determines

an option is a material right, the Company will consider the option a separate performance obligation.

If the Company is entitled to reimbursement from

its customers for specified research and development expenses, the Company accounts for the related services that it provides as separate

performance obligations if it determines that these services represent a material right.

The Company also determines whether the reimbursement

of research and development expenses should be accounted for as revenues or an offset to research and development expenses in accordance

with provisions of gross or net revenue presentation.

The Company recognizes the corresponding revenues or records the corresponding offset

to research and development expenses as it satisfies the related performance obligations.

The Company then determines the transaction price

by reviewing the amount of consideration the Company is eligible to earn under the contracts, including any variable consideration.

the outstanding contracts, consideration typically includes fixed consideration and variable consideration in the form of potential milestone

At the start of an agreement, the Company’s transaction price usually consists of the payments made to or by the Company

based on the number of full-time equivalent researchers assigned to the project and the related research and development expenses incurred.

The Company does not typically include any payments that the Company may receive in the future in its initial transaction price because

the payments are not probable.

The Company would reassess the total transaction price at each reporting period to determine if the Company

should include additional payments in the transaction price.

The Company receives payments from its customers

based on billing schedules established in each contract.

Upfront payments and fees may be recorded as advance from customers upon receipt

or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these

arrangements.

Amounts are recorded as accounts receivable when the right of the Company to consideration is unconditional.

does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period

between payment by the customers and the transfer of the promised goods or services to the customers will be one year or less.

Examples of collaborative agreements the Company

has entered into are as follows:

Collaborative agreements with BHK

In February and December of 2015, BioLite, Inc.

entered into a total of three joint venture agreements with BioHopeKing to jointly develop ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.

The agreements granted marketing rights to BioHopeKing for certain Asian countries in return for a series of milestone payments totaling $10 million in cash and equity of BioHopeKing or equity securities owned by BioHopeKing.

The milestone payments are determined

by a schedule of BioLite development achievements as shown below:

consideration is commensurate with either the Company’s performance to achieve the milestone or the enhancement of the value of

the delivered item(s) as a result of a specific outcome resulting from its performance to achieve the milestone, (2) the consideration

relates solely to past performance and (3) the consideration is reasonable relative to all of the deliverables and payment terms within

the arrangement.

The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be

overcome to achieve the particular milestone and the level of effort and investment required to achieve the particular milestone in making

this assessment.

There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to

conclude that a milestone is substantive.

Milestones that are not considered substantive are recognized as earned if there are no remaining

performance obligations or over the remaining period of performance, assuming all other revenue recognition criteria are met.

Royalties and Profit Sharing Payments

the collaborative agreement with the collaboration partners, the Company is entitled to receive royalties on sales of products, which

is at certain percentage of the net sales.

The Company recognizes revenue from these events based on the revenue recognition criteria

set forth in ASC 606.

Based on those criteria, the Company considers these payments to be contingent revenues, and recognizes them as

revenue in the period in which the applicable contingency is resolved.

Derived from Research and Development Activities Services — Revenues related to research and development and regulatory activities

are recognized when the related services or activities are performed, in accordance with the contract terms.

The Company typically has

only one performance obligation at the inception of a contract, which is to perform research and development services.

The Company may

also provide its customers with an option to request that the Company provides additional goods or services in the future, such as active

pharmaceutical ingredient, API, or IND/NDA/ANDA/510K submissions.

The Company evaluates whether these options are material rights at

the inception of the contract.

If the Company determines an option is a material right, the Company will consider the option a separate

performance obligation.

the Company is entitled to reimbursement from its customers for specified research and development expenses, the Company accounts for

the related services that it provides as separate performance obligations if it determines that these services represent a material right.

The Company also determines whether the reimbursement of research and development expenses should be accounted for as revenues or an

offset to research and development expenses in accordance with provisions of gross or net revenue presentation.

The Company recognizes

the corresponding revenues or records the corresponding offset to research and development expenses as it satisfies the related performance

Company then determines the transaction price by reviewing the amount of consideration the Company is eligible to earn under the contracts,

including any variable consideration.

Under the outstanding contracts, consideration typically includes fixed consideration and variable

consideration in the form of potential milestone payments.

At the start of an agreement, the Company’s transaction price usually

consists of the payments made to or by the Company based on the number of full-time equivalent researchers assigned to the project and

the related research and development expenses incurred.

The Company does not typically include any payments that the Company may receive

in the future in its initial transaction price because the payments are not probable.

The Company would reassess the total transaction

price at each reporting period to determine if the Company should include additional payments in the transaction price.

Company receives payments from its customers based on billing schedules established in each contract.

Upfront payments and fees may be

recorded as advance from customers upon receipt or when due, and may require deferral of revenue recognition to a future period until

the Company performs its obligations under these arrangements.

Amounts are recorded as accounts receivable when the right of the Company

to consideration is unconditional.

The Company does not assess whether a contract has a significant financing component if the expectation

at contract inception is such that the period between payment by the customers and the transfer of the promised goods or services to

the customers will be one year or less.

of collaborative agreements the Company has entered into are as follows:

Collaborative

agreements with BHK

February and December of 2015, BioLite, Inc.

entered into a total of three joint venture agreements with BioHopeKing to jointly develop

ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.

The agreements granted marketing rights

to BioHopeKing for certain Asian countries in return for a series of milestone payments totaling $10 million in cash and equity of

BioHopeKing or equity securities owned by BioHopeKing.

milestone payments are determined by a schedule of BioLite development achievements as shown below:

Execution of BHK Co-Development Agreement

3 unchanged sentences

New Drug Application (NDA) Submission

In December of 2015, BHK paid the initial cash payment of $1 million upon the execution of the BHK Agreement.

The Company concluded that certain deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this cash payment as collaboration revenue when all research, technical, and development data was delivered to BHK in 2015.

The payment included compensation for past research efforts and contributions made by BioLite Taiwan before the BHK agreement was signed and does not relate to any future commitments made by BioLite Taiwan and BHK in the BHK Agreement.

In August 2016, the Company received the second milestone payment of $1 million, and recognized collaboration revenue for the year ended December 31, 2016.

As of June 30, 2021, the Company had not completed the first phase II clinical trial.

In addition to the milestone payments, BioLite Taiwan is entitled to receive a royalty equal to 12% of BHK’s net sales related to ABV-1501, ABV-1504 and ABV-1505 Products.

As of June 30, 2021, the Company has not earned royalties under the BHK Co-Development Agreement.

The BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial sale of the Product in in Asia excluding Japan.

Co-Development agreement with Rgene Corporation,

a related party

On May 26, 2017, BriVision entered into a co-development

agreement (the “Rgene Agreement”) with Rgene Corporation (the “Rgene”), a related party under common control by

the controlling beneficiary shareholder of YuanGene Corporation and the Company (See Note 12).

Pursuant to the Rgene Agreement, BriVision

and Rgene agreed to co-develop and commercialize ABV-1507 HER2/neu Positive Breast Cancer Combination Therapy, ABV-1703 Pancreatic Cancer

Combination Therapy and ABV-1527 Ovary Cancer Combination Therapy.

Under the terms of the Rgene Agreement, Rgene is required to pay

the Company $3,000,000 in cash or stock of Rgene with equivalent value by August 15, 2017 as compensation of BriVision’s past research

efforts and contributions made by BriVision before the Rgene Agreement was executed.

The payment does not relate to any future milestones

attained by BriVision.

In addition to $3,000,000, the Company is entitled to receive 50% of the future net licensing income or net sales

profit earned by Rgene.

All development costs shall be equally shared by both BriVision and Rgene.

On June 1, 2017, the Company delivered all research,

technical data and development data to Rgene pursuant to the Rgene Agreement in return for a cash payment of $450,000 and 1,530,000 common

shares of Rgene stock valued at $2,550,000, which in 2018 was accounted for using the equity method long-term investment.

31, 2018, the Company determined to fully write off this investment based on the Company’s assessment of the severity and duration

of the impairment, and qualitative and quantitative analysis of the operating performance of the investee, adverse changes in market conditions,

the regulatory or economic environment, changes in operating structure of Rgene, additional funding requirements and Rgene’s ability

to remain in business.

All research projects that were initiated will be managed and funded equally by the Company and Rgene.

The Company and Rgene signed an amendment to the

Rgene Agreement on November 10, 2020, pursuant to which both parties agreed to delete AB-1507 HER2/neu Positive Breast Cancer Combination

Therapy and AB-1527 Ovary Cancer Combination Therapy and add ABV-1519 EGFR Positive Non-Small Cell Lung Cancer Combination Therapy and

ABV-1526 Large Intestine / Colon / Rectal Cancer Combination Therapy to the products to be co-developed and commercialized.

Other provisions

of the Rgene Agreement remain in full force and effect.

Collaborative agreement with BioFirst Corporation,

a related party

On July 24, 2017, BriVision entered into a collaborative

agreement (the “BioFirst Agreement”) with BioFirst Corporation, a corporation incorporated under the laws of Taiwan (“BioFirst”),

pursuant to which BioFirst granted the Company global licensing rights to medical use of ABV-1701 Vitreous Substitute for Vitrectomy.

BioFirst is a related party to the Company because a controlling beneficiary shareholder of YuanGene Corporation and the Company is a

Director and shareholders of BioFirst (See Note 12).

Pursuant to the BioFirst Agreement, the Company

and BioFirst will co-develop and commercialize BFC-1401.

The Company will pay BioFirst a total amount of $3,000,000 in cash or stock of

the Company before September 30, 2018 as payment in full for BioFirst’s past research efforts and contributions made by BioFirst

before the BioFirst Agreement was executed.

The Company is entitled to receive 50% of any future net licensing revenue or net profit associated

with Vitargus.

All development cost will be equally shared by both BriVision and BioFirst.

On September 25, 2017, BioFirst delivered all

research, technical, data and development data to BriVision.

For the year ended September 30, 2017, the Company determined to fully expense

the entire amount of $3,000,000 since the related licensing rights do not have alternative future uses.

According to ASC 730-10-25-1,

absent alternative future uses the acquisition of product rights to be used in research and development activities must be charged to

research and development expenses immediately.

Hence, the entire amount of $3,000,000 is fully expensed as research and development expense

during the year ended September 30, 2017.

On June 30, 2019, BriVision entered into a Stock

Purchase Agreement (the “Purchase Agreement”) with BioFirst.

Pursuant to the Purchase Agreement, the Company issued 428,571

shares of the Company’s common stock to BioFirst as payment for $3,000,000 owed by the Company to BioFirst in connection with the

BioFirst Agreement.

On August 5, 2019, BriVision entered into a second

Stock Purchase Agreement with BioFirst whereby the Company issued 414,702 shares of the Company’s common stock to BioFirst as repayment

in full for a loan in the amount of $2,902,911 provided to BriVision from BioFirst.

On November 4, 2020, the Company executed an amendment

to the BioFirst Agreement with BioFirst to add ABV-2001 Intraocular Irrigation Solution and ABV-2002 Corneal Storage Solution to the agreement.

ABV-2002 is utilized during a corneal transplant procedure to replace a damaged or diseased cornea while ABV-2001 has broader utilization

during a variety of ocular procedures.

Initially the Company will focus on ABV-2002,

a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness cornea transplant) or endothelial

keratoplasty (back layer cornea transplant).

ABV-2002 is a solution comprised of a specific poly amino acid that protects ocular tissue

from damage caused by external osmolarity exposure during pre-surgery storage.

The specific polymer in ABV-2002 can adjust osmolarity

to maintain a range of 330 to 390 mOsM thereby permitting hydration within the corneal stroma during the storage period.

Stromal hydration

results in (a) maintaining acceptable corneal transparency and (b) prevents donor cornea swelling.

ABV-2002 also contains an abundant

phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial properties and neuroprotection.

Early testing by BioFirst indicates that ABV-2002

may be more effective for protecting the cornea and retina during long-term storage than other storage media available today and can be

manufactured at lower cost.

Categorized as a lower risk Class I Medical Device, the Company intends to submit a Premarket Notification

510(K) submission to the FDA before the end of 2021 to demonstrate the device is at least as safe and effective as current products on

BioKey Revenues

In addition to collaborative agreements, ABVC

earns revenue through its wholly owned BioKey subsidiary which provides a wide range of Contract Development & Manufacturing Organization

(“CDMO”) services including API characterization, pre-formulation studies, formulation development, analytical method development,

stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials (from Phase I through Phase III) and commercial

manufacturing of pharmaceutical products.

In addition, BioKey provides a variety of regulatory

services tailored to the needs of its customers, which include proofreading and regulatory review of submission documents related to formulation

development, clinical trials, marketed products, generics, nutraceuticals and OTC products and training presentations.

In addition to

supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and DMFs to the FDA, on ABVC’s behalf in compliance

with new electronic submission guidelines of the FDA.

Impact of COVID-19 Outbreak

On January 30, 2020, the World Health Organization

declared the coronavirus outbreak a “Public Health Emergency of International Concern” and on March 10, 2020, declared it

to be a pandemic.

Actions taken around the world to help mitigate the spread of the coronavirus include restrictions on travel, and quarantines

in certain areas, and forced closures for certain types of public places and businesses.

The coronavirus and actions taken to mitigate

it have had and are expected to continue to have an adverse impact on the economies and financial markets of many countries, including

the geographical area in which the Company operates.

While the closures and limitations on movement, domestically and internationally,

are expected to be temporary, if the outbreak continues on its current trajectory the duration of the supply chain disruption could reduce

the availability, or result in delays, of materials or supplies to and from the Company, which in turn could materially interrupt the

Company’s business operations.

Given the speed and frequency of the continuously evolving developments with respect to this pandemic,

the Company cannot reasonably estimate the magnitude of the impact to its consolidated results of operations.

We have taken every precaution

possible to ensure the safety of our employees.

Due to the COVID-19, our revenue for the first

half of fiscal 2020 and 2021 were significantly impacted.

As we have not seen a stronger signal to indicate that overall global economic

will be back to normal in the third quarter, our business’s overall revenue stream may be impacted further until the restrictions

of COVID-19 can be released, then the company can start operating normally.

The global pandemic of COVID-19 continues to evolve rapidly,

and we will continue to monitor the situation closely, including its potential effect on our plans and timelines.

Additionally, it is reasonably possible that estimates

made in the financial statements have been, or will be, materially and adversely impacted in the near term as a result of these conditions,

including losses on inventory;

impairment losses related to goodwill and other long-lived assets and current obligations.

Summary of Critical Accounting Policies

Basis of Presentation

The accompanying consolidated financial statements

have been prepared in accordance with the generally accepted accounting principles in the United States of America (the “U.S.

All significant intercompany transactions and account balances have been eliminated.

This basis of accounting involves the application

of accrual accounting and consequently, revenues and gains are recognized when earned, and expenses and losses are recognized when incurred.

December of 2015, BHK paid the initial cash payment of $1 million upon the execution of the BHK Agreement.

The Company concluded

that certain deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone

basis and recognized this cash payment as collaboration revenue when all research, technical, and development data was delivered

to BHK in 2015.

The payment included compensation for past research efforts and contributions made by BioLite Taiwan before the BHK

agreement was signed and does not relate to any future commitments made by BioLite Taiwan and BHK in the BHK Agreement.

August 2016, the Company received the second milestone payment of $1 million, and recognized collaboration revenue for the year ended

December 31, 2016.

As of September 30, 2021, the Company had not completed the first phase II clinical trial.

addition to the milestone payments, BioLite Taiwan is entitled to receive a royalty equal to 12% of BHK’s net sales related

to ABV-1501, ABV-1504 and ABV-1505 Products.

As of September 30, 2021, the Company has not earned royalties under the BHK Co-Development

BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial sale of the Product in in

Asia excluding Japan.

Co-Development

agreement with Rgene Corporation, a related party

May 26, 2017, BriVision entered into a co-development agreement (the “Rgene Agreement”) with Rgene Corporation (the “Rgene”),

a related party under common control by the controlling beneficiary shareholder of YuanGene Corporation and the Company (See Note 12).

Pursuant to the Rgene Agreement, BriVision and Rgene agreed to co-develop and commercialize ABV-1507 HER2/neu Positive Breast Cancer

Combination Therapy, ABV-1703 Pancreatic Cancer Combination Therapy and ABV-1527 Ovary Cancer Combination Therapy.

Under the terms of

the Rgene Agreement, Rgene is required to pay the Company $3,000,000 in cash or stock of Rgene with equivalent value by August 15,

2017 as compensation of BriVision’s past research efforts and contributions made by BriVision before the Rgene Agreement was executed.

The payment does not relate to any future milestones attained by BriVision.

In addition to $3,000,000, the Company is entitled to receive

50% of the future net licensing income or net sales profit earned by Rgene.

All development costs shall be equally shared by both BriVision

June 1, 2017, the Company delivered all research, technical data and development data to Rgene pursuant to the Rgene Agreement in return

for a cash payment of $450,000 and 1,530,000 common shares of Rgene stock valued at $2,550,000, which in 2018 was accounted for using

the equity method long-term investment.

On December 31, 2018, the Company determined to fully write off this investment based on the

Company’s assessment of the severity and duration of the impairment, and qualitative and quantitative analysis of the operating

performance of the investee, adverse changes in market conditions, the regulatory or economic environment, changes in operating structure

of Rgene, additional funding requirements and Rgene’s ability to remain in business.

All research projects that were initiated

will be managed and funded equally by the Company and Rgene.

Company and Rgene signed an amendment to the Rgene Agreement on November 10, 2020, pursuant to which both parties agreed to delete AB-1507

HER2/neu Positive Breast Cancer Combination Therapy and AB-1527 Ovary Cancer Combination Therapy and add ABV-1519 EGFR Positive Non-Small

Cell Lung Cancer Combination Therapy and ABV-1526 Large Intestine / Colon / Rectal Cancer Combination Therapy to the products to be co-developed

and commercialized.

Other provisions of the Rgene Agreement remain in full force and effect.

Collaborative

agreement with BioFirst Corporation, a related party

July 24, 2017, BriVision entered into a collaborative agreement (the “BioFirst Agreement”) with BioFirst Corporation, a corporation

incorporated under the laws of Taiwan (“BioFirst”), pursuant to which BioFirst granted the Company global licensing rights

to medical use of ABV-1701 Vitreous Substitute for Vitrectomy.

BioFirst is a related party to the Company because a controlling beneficiary

shareholder of YuanGene Corporation and the Company is a Director and shareholders of BioFirst (See Note 12).

to the BioFirst Agreement, the Company and BioFirst will co-develop and commercialize BFC-1401.

The Company will pay BioFirst a total

amount of $3,000,000 in cash or stock of the Company before September 30, 2018 as payment in full for BioFirst’s past research

efforts and contributions made by BioFirst before the BioFirst Agreement was executed.

The Company is entitled to receive 50% of any

future net licensing revenue or net profit associated with Vitargus.

All development cost will be equally shared by both BriVision and

September 25, 2017, BioFirst delivered all research, technical, data and development data to BriVision.

For the year ended September

30, 2017, the Company determined to fully expense the entire amount of $3,000,000 since the related licensing rights do not have alternative

According to ASC 730-10-25-1, absent alternative future uses the acquisition of product rights to be used in research and

development activities must be charged to research and development expenses immediately.

Hence, the entire amount of $3,000,000 is fully

expensed as research and development expense during the year ended September 30, 2017.

September 30, 2019, BriVision entered into a Stock Purchase Agreement (the “Purchase Agreement”) with BioFirst.

to the Purchase Agreement, the Company issued 428,571 shares of the Company’s common stock to BioFirst as payment for $3,000,000

owed by the Company to BioFirst in connection with the BioFirst Agreement.

August 5, 2019, BriVision entered into a second Stock Purchase Agreement with BioFirst whereby the Company issued 414,702 shares of the

Company’s common stock to BioFirst as repayment in full for a loan in the amount of $2,902,911 provided to BriVision from BioFirst.

November 4, 2020, the Company executed an amendment to the BioFirst Agreement with BioFirst to add ABV-2001 Intraocular Irrigation Solution

and ABV-2002 Corneal Storage Solution to the agreement.

ABV-2002 is utilized during a corneal transplant procedure to replace a damaged

or diseased cornea while ABV-2001 has broader utilization during a variety of ocular procedures.

the Company will focus on ABV-2002, a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness

cornea transplant) or endothelial keratoplasty (back layer cornea transplant).

ABV-2002 is a solution comprised of a specific poly amino

acid that protects ocular tissue from damage caused by external osmolarity exposure during pre-surgery storage.

The specific polymer

in ABV-2002 can adjust osmolarity to maintain a range of 330 to 390 mOsM thereby permitting hydration within the corneal stroma during

the storage period.

Stromal hydration results in (a) maintaining acceptable corneal transparency and (b) prevents donor cornea swelling.

ABV-2002 also contains an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial properties

and neuroprotection.

testing by BioFirst indicates that ABV-2002 may be more effective for protecting the cornea and retina during long-term storage than

other storage media available today and can be manufactured at lower cost.

Categorized as a lower risk Class I Medical Device, the Company

intends to submit a Premarket Notification 510(K) submission to the FDA before the end of 2021 to demonstrate the device is at least

as safe and effective as current products on the market.

addition to collaborative agreements, ABVC earns revenue through its wholly owned BioKey subsidiary which provides a wide range of Contract

Development & Manufacturing Organization (“CDMO”) services including API characterization, pre-formulation studies, formulation

development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials

(from Phase I through Phase III) and commercial manufacturing of pharmaceutical products.

addition, BioKey provides a variety of regulatory services tailored to the needs of its customers, which include proofreading and regulatory

review of submission documents related to formulation development, clinical trials, marketed products, generics, nutraceuticals and OTC

products and training presentations.

In addition to supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and

DMFs to the FDA, on ABVC’s behalf in compliance with new electronic submission guidelines of the FDA.

of COVID-19 Outbreak

January 30, 2020, the World Health Organization declared the coronavirus outbreak a “Public Health Emergency of International Concern”

and on March 10, 2020, declared it to be a pandemic.

Actions taken around the world to help mitigate the spread of the coronavirus include

restrictions on travel, and quarantines in certain areas, and forced closures for certain types of public places and businesses.

coronavirus and actions taken to mitigate it have had and are expected to continue to have an adverse impact on the economies and financial

markets of many countries, including the geographical area in which the Company operates.

While the closures and limitations on movement,

domestically and internationally, are expected to be temporary, if the outbreak continues on its current trajectory the duration of the

supply chain disruption could reduce the availability, or result in delays, of materials or supplies to and from the Company, which in

turn could materially interrupt the Company’s business operations.

Given the speed and frequency of the continuously evolving developments

with respect to this pandemic, the Company cannot reasonably estimate the magnitude of the impact to its consolidated results of operations.

We have taken every precaution possible to ensure the safety of our employees.

Due to the COVID-19

pandemic, our revenue for the first half of fiscal 2020 and 2021 were significantly impacted.

As we have not seen a stronger signal to

indicate that overall global economies will be back to normal in the fourth quarter, our business’s overall revenue stream may

be impacted further until the restrictions of COVID-19 can be released, then the company can start operating normally.

The COVID-19 pandemic,

including variants, has adversely affected, and is expected to continue to adversely affect, elements of our CDMO business sector.

COVID-19 pandemic controls constrained researcher access to labs globally.

These constraints limited scientific discovery capacity

and we observed that demand in those labs fell well below historic levels.

As constraints on social distancing were gradually lifted around

the world recently, labs were able to increase research activity.

While we believe that underlying demand is still not yet at pre-COVID-19 levels

as lab operations remain below their normal capacity, we are hopeful that the vaccination programs that are underway combined with policy

changes planned for the summer will further increase research activity and support a return to pre-COVID-19 demand levels worldwide.

The global pandemic

of COVID-19 continues to evolve rapidly, and we will continue to monitor the situation closely, including its potential effect on our

plans and timelines.

Additionally,

it is reasonably possible that estimates made in the financial statements have been, or will be, materially and adversely impacted in

the near term as a result of these conditions, including losses on inventory;

impairment losses related to goodwill and other long-lived

assets and current obligations.

of Critical Accounting Policies

of Presentation

accompanying consolidated financial statements have been prepared in accordance with the generally accepted accounting principles in

the United States of America (the “U.S.

All significant intercompany transactions and account balances have been

basis of accounting involves the application of accrual accounting and consequently, revenues and gains are recognized when earned, and

expenses and losses are recognized when incurred.

The Company’s financial statements are expressed in U.S.

The Company changed its fiscal year from the period

beginning on October 1st and ending on September 30th to the period beginning on January 1st and ending on December 31st, beginning January

All references herein to a fiscal year prior to December 31, 2017 refer to the twelve months ended September 30th of such year.

Use of Estimates

The preparation of financial statements in conformity

with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that

affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated

financial statements and the amount of revenues and expenses during the reporting periods.

Actual results could differ materially from

those results.

Inventory consists of raw materials, work-in-process,

finished goods, and merchandise.

Inventories are stated at the lower of cost or market and valued on a moving weighted average cost basis.

Company changed its fiscal year from the period beginning on October 1st and ending on September 30th to the period beginning on January

1st and ending on December 31st, beginning January 1, 2018.

All references herein to a fiscal year prior to December 31, 2017 refer to

the twelve months ended September 30th of such year.

preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires

management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent

assets and liabilities at the date of the consolidated financial statements and the amount of revenues and expenses during the reporting

Actual results could differ materially from those results.

consists of raw materials, work-in-process, finished goods, and merchandise.

Inventories are stated at the lower of cost or market and

valued on a moving weighted average cost basis.

Market is determined based on net realizable value.

The Company periodically reviews the age and turnover of its inventory to determine

whether any inventory has become obsolete or has declined in value, and incurs a charge to operations for known and anticipated inventory

obsolescence.

The Company periodically reviews

the age and turnover of its inventory to determine whether any inventory has become obsolete or has declined in value, and incurs a charge

to operations for known and anticipated inventory obsolescence.

Reclassifications

Certain classifications have been made to the

prior year financial statements to conform to the current year presentation.

The reclassification had no impact on previously reported

net loss or accumulated deficit.

Forward Stock Split

On March 21, 2016, the Board of Directors of the

Company approved an amendment to Articles of Incorporation to effect a forward split at a ratio of 1 to 3.141 and increase the number

of our authorized shares of Common Stock, par value $0.001 per share, to 360,000,000, which was effective on April 8, 2016.

Stock Reverse Split

On March 12, 2019, the Board of Directors of the

Company by unanimous written consent in lieu of a meeting approved to i) effect a stock reverse split at the ratio of 1-for-18 (the “Reverse

Split”) of both the authorized common stock of the Company (the “Common Stock”) and the issued and outstanding Common

Stock and ii) to amend the articles of incorporation of the Company to reflect the Reverse Split.

The Board approved and authorized the

Reverse Split without obtaining approval of the Company’s shareholders pursuant to Section 78.207 of Nevada Revised Statutes.

May 3, 2019, the Company filed a certificate of amendment to the Company’s articles of incorporation (the “Amendment”)

to effect the Reverse Split with the Secretary of State of Nevada.

The Financial Industry Regulatory Authority (“FINRA”) informed

the Company that the Reverse Split was effective on May 8, 2019.

All shares and related financial information in this Form 10-Q reflect

this 1-for-18 reverse stock split.

Fair Value Measurements

FASB ASC 820, “Fair Value Measurements”

defines fair value for certain financial and nonfinancial assets and liabilities that are recorded at fair value, establishes a framework

for measuring fair value and expands disclosures about fair value measurements.

It requires that an entity measure its financial instruments

to base fair value on exit price, maximize the use of observable units and minimize the use of unobservable inputs to determine the exit

It establishes a hierarchy which prioritizes the inputs to valuation techniques used to measure fair value.

This hierarchy increases

the consistency and comparability of fair value measurements and related disclosures by maximizing the use of observable inputs and minimizing

the use of unobservable inputs by requiring that observable inputs be used when available.

Observable inputs are inputs that reflect the

assumptions market participants would use in pricing the assets or liabilities based on market data obtained from sources independent

of the Company.

Unobservable inputs are inputs that reflect the Company’s own assumptions about the assumptions market participants

would use in pricing the asset or liability developed based on the best information available in the circumstances.

The hierarchy prioritizes

the inputs into three broad levels based on the reliability of the inputs as follows:

Level 1 - Inputs are quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Valuation of these instruments does not require a high degree of judgment as the valuations are based on quoted prices in active markets that are readily and regularly available.

Level 2 - Inputs other than quoted prices in active markets that are either directly or indirectly observable as of the measurement date, such as quoted prices for similar assets or liabilities;

classifications have been made to the prior year financial statements to conform to the current year presentation.

The reclassification

had no impact on previously reported net loss or accumulated deficit.

March 21, 2016, the Board of Directors of the Company approved an amendment to Articles of Incorporation to effect a forward split at

a ratio of 1 to 3.141 and increase the number of our authorized shares of Common Stock, par value $0.001 per share, to 360,000,000, which

was effective on April 8, 2016.

Reverse Split

March 12, 2019, the Board of Directors of the Company by unanimous written consent in lieu of a meeting approved to i) effect a stock

reverse split at the ratio of 1-for-18 (the “Reverse Split”) of both the authorized common stock of the Company (the “Common

Stock”) and the issued and outstanding Common Stock and ii) to amend the articles of incorporation of the Company to reflect the

Reverse Split.

The Board approved and authorized the Reverse Split without obtaining approval of the Company’s shareholders pursuant

to Section 78.207 of Nevada Revised Statutes.

On May 3, 2019, the Company filed a certificate of amendment to the Company’s articles

of incorporation (the “Amendment”) to effect the Reverse Split with the Secretary of State of Nevada.

The Financial Industry

Regulatory Authority (“FINRA”) informed the Company that the Reverse Split was effective on May 8, 2019.

All shares and related

financial information in this Form 10-Q reflect this 1-for-18 reverse stock split.

Value Measurements

ASC 820, “Fair Value Measurements” defines fair value for certain financial and nonfinancial assets and liabilities that

are recorded at fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements.

requires that an entity measure its financial instruments to base fair value on exit price, maximize the use of observable units and

minimize the use of unobservable inputs to determine the exit price.

It establishes a hierarchy which prioritizes the inputs to valuation

techniques used to measure fair value.

This hierarchy increases the consistency and comparability of fair value measurements and related

disclosures by maximizing the use of observable inputs and minimizing the use of unobservable inputs by requiring that observable inputs

be used when available.

Observable inputs are inputs that reflect the assumptions market participants would use in pricing the assets

or liabilities based on market data obtained from sources independent of the Company.

Unobservable inputs are inputs that reflect the

Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability developed based

on the best information available in the circumstances.

The hierarchy prioritizes the inputs into three broad levels based on the reliability

of the inputs as follows:

1 - Inputs are quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at

the measurement date.

Valuation of these instruments does not require a high degree of judgment as the valuations are based on quoted

prices in active markets that are readily and regularly available.

2 - Inputs other than quoted prices in active markets that are either directly or indirectly observable as of the measurement date,

such as quoted prices for similar assets or liabilities;

quoted prices in markets that are not active;

or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 - Valuations based on inputs that are unobservable and not corroborated by market data.

The fair value for such assets and liabilities is generally determined using pricing models, discounted cash flow methodologies, or similar techniques that incorporate the assumptions a market participant would use in pricing the asset or liability.

The carrying values of certain assets and liabilities

of the Company, such as cash and cash equivalents, restricted cash, accounts receivable, due from related parties, inventory, prepaid

expenses and other current assets, accounts payable, accrued liabilities, and due to related parties approximate fair value due to their

relatively short maturities.

The carrying value of the Company’s short-term bank loan, convertible notes payable, and accrued interest

approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short.

The carrying value of the Company’s long-term bank loan approximates fair value because the interest rates approximate market rates

that the Company could obtain for debt with similar terms and maturities.

Cash and Cash Equivalents

The Company considers highly liquid investments

with maturities of three months or less, when purchased, to be cash equivalents.

As of June 30, 2021 and December 31, 2020, the Company’s

cash and cash equivalents amounted $924,841 and $4,273,208, respectively.

or other inputs that are observable

or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

3 - Valuations based on inputs that are unobservable and not corroborated by market data.

The fair value for such assets and liabilities

is generally determined using pricing models, discounted cash flow methodologies, or similar techniques that incorporate the assumptions

a market participant would use in pricing the asset or liability.

carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, restricted cash, accounts receivable,

due from related parties, inventory, prepaid expenses and other current assets, accounts payable, accrued liabilities, and due to related

parties approximate fair value due to their relatively short maturities.

The carrying value of the Company’s short-term bank loan,

convertible notes payable, and accrued interest approximates their fair value as the terms of the borrowing are consistent with current

market rates and the duration to maturity is short.

The carrying value of the Company’s long-term bank loan approximates fair value

because the interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities.

and Cash Equivalents

The Company considers highly liquid investments with maturities of

three months or less, when purchased, to be cash equivalents.

As of September 30, 2021 and December 31, 2020, the Company’s cash

and cash equivalents amounted $3,715,609 and $4,273,208, respectively.

Some of the Company’s cash deposits are held in financial

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this financial institution is of high credit quality.

Restricted Cash Equivalents

Cash Equivalents

Restricted cash equivalents primarily consist

of cash held in a reserve bank account in Taiwan.

As of June 30, 2021 and December 31, 2020, the Company’s restricted cash equivalents

amounted $732,163 and $728,163, respectively.

Concentration of Credit Risk

The Company’s financial instruments that

are exposed to concentrations of credit risk consist primarily of cash and cash equivalents.

The Company places its cash and temporary

cash investments in high quality credit institutions, but these investments may be in excess of Taiwan Central Deposit Insurance Corporation

As of September 30, 2021 and December 31, 2020, the Company’s restricted cash

equivalents amounted $734,163 and $728,163, respectively.

Concentration

of Credit Risk

Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash and cash equivalents.

The Company places its cash and temporary cash investments in high quality credit institutions, but these investments may be in excess

of Taiwan Central Deposit Insurance Corporation and the U.S.

Federal Deposit Insurance Corporation’s insurance limits.

The Company does not enter into financial instruments for

hedging, trading or speculative purposes.

Revenue Recognition

During the fiscal year 2018, the Company adopted

Accounting Standards Codification (“ASC”), Topic 606 (ASC 606), Revenue from Contracts with Customers, using the modified

retrospective method to all contracts that were not completed as of January 1, 2018, and applying the new revenue standard as an adjustment

to the opening balance of accumulated deficit at the beginning of 2018 for the cumulative effect.

The results for the Company’s

reporting periods beginning on and after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and

continue to be reported under the accounting standards in effect for the prior period.

Based on the Company’s review of existing

collaborative agreements as of January 1, 2018, the Company concluded that the adoption of the new guidance did not have a significant

change on the Company’s revenue during all periods presented.

Pursuant to ASC 606, the Company recognizes revenue

when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the Company expects

to receive in exchange for those goods or services.

To determine revenue recognition for arrangements that the Company determines is within

the scope of ASC 606, the Company performs the following five steps:

(i) identify the contract(s) with a customer;

(ii) identify the performance

obligations in the contract;

does not enter into financial instruments for hedging, trading or speculative purposes.

the fiscal year 2018, the Company adopted Accounting Standards Codification (“ASC”), Topic 606 (ASC 606), Revenue from Contracts

with Customers, using the modified retrospective method to all contracts that were not completed as of January 1, 2018, and applying

the new revenue standard as an adjustment to the opening balance of accumulated deficit at the beginning of 2018 for the cumulative effect.

The results for the Company’s reporting periods beginning on and after January 1, 2018 are presented under ASC 606, while prior

period amounts are not adjusted and continue to be reported under the accounting standards in effect for the prior period.

Company’s review of existing collaborative agreements as of January 1, 2018, the Company concluded that the adoption of the new

guidance did not have a significant change on the Company’s revenue during all periods presented.

to ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects

the consideration that the Company expects to receive in exchange for those goods or services.

To determine revenue recognition for arrangements

that the Company determines is within the scope of ASC 606, the Company performs the following five steps:

(i) identify the contract(s)

with a customer;

(ii) identify the performance obligations in the contract;

(iii) determine the transaction price;

(iv) allocate the transaction price to the performance obligations

in the contract;

and (v) recognize revenue when (or as) the Company satisfies a performance obligation.

The Company only applies the five-step

model to contracts when it is probable that the Company will collect the consideration the Company is entitled to in exchange for the

goods or services the Company transfers to the customers.

At inception of the contract, once the contract is determined to be within the

scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations,

and assesses whether each promised good or service is distinct.

The Company then recognizes as revenue the amount of the transaction price

that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Property and Equipment

Property and equipment is carried at cost net

of accumulated depreciation.

(iv) allocate the

transaction price to the performance obligations in the contract;

and (v) recognize revenue when (or as) the Company satisfies a performance

The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration

the Company is entitled to in exchange for the goods or services the Company transfers to the customers.

At inception of the contract,

once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract,

determines those that are performance obligations, and assesses whether each promised good or service is distinct.

The Company then recognizes

as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance

obligation is satisfied.

and Equipment

and equipment is carried at cost net of accumulated depreciation.

Repairs and maintenance are expensed as incurred.

Expenditures that improve the functionality of the related

asset or extend the useful life are capitalized.

When property and equipment is retired or otherwise disposed of, the related gain or

loss is included in operating income.

Leasehold improvements are depreciated on the straight-line method over the shorter of the remaining

lease term or estimated useful life of the asset.

Depreciation is calculated on the straight-line method, including property and equipment

under capital leases, generally based on the following useful lives:

Expenditures that

improve the functionality of the related asset or extend the useful life are capitalized.

When property and equipment is retired or otherwise

disposed of, the related gain or loss is included in operating income.

Leasehold improvements are depreciated on the straight-line method

over the shorter of the remaining lease term or estimated useful life of the asset.

Depreciation is calculated on the straight-line method,

including property and equipment under capital leases, generally based on the following useful lives:

Estimated Life

Buildings and leasehold improvements

Machinery and equipment

Office equipment

Impairment of Long-Lived Assets

The Company has adopted Accounting Standards Codification

subtopic 360-10, Property, Plant and Equipment (“ASC 360-10”).

ASC 360-10 requires that long-lived assets and certain identifiable

intangibles held and used by the Company be reviewed for impairment whenever events or changes in circumstances indicate that the carrying

amount of an asset may not be recoverable.

The Company evaluates its long-lived assets for impairment annually or more often if events

and circumstances warrant.

Events relating to recoverability may include significant unfavorable changes in business conditions, recurring

losses, or a forecasted inability to achieve break-even operating results over an extended period.

Should impairment in value be indicated,

the carrying value of intangible assets will be adjusted, based on estimates of future discounted cash flows resulting from the use and

ultimate disposition of the asset.

ASC 360-10 also requires assets to be disposed of be reported at the lower of the carrying amount or

the fair value less costs to sell.

Long-term Equity Investment

The Company acquires the equity investments to

promote business and strategic objectives.

The Company accounts for non-marketable equity and other equity investments for which the Company

does not have control over the investees as:

Equity method investments when the Company has the ability to exercise significant influence, but not control, over the investee.

Its proportionate share of the income or loss is recognized monthly and is recorded in gains (losses) on equity investments.

Non-marketable cost method investments when the equity method does not apply.

Significant judgment is required to identify whether

an impairment exists in the valuation of the Company’s non-marketable equity investments, and therefore the Company considers this

a critical accounting estimate.

Its yearly analysis considers both qualitative and quantitative factors that may have a significant impact

on the investee’s fair value.

Qualitative analysis of its investments involves understanding the financial performance and near-term

prospects of the investee, changes in general market conditions in the investee’s industry or geographic area, and the management

and governance structure of the investee.

Quantitative assessments of the fair value of its investments are developed using the market

and income approaches.

The market approach includes the use of comparable financial metrics of private and public companies and recent

financing rounds.

The income approach includes the use of a discounted cash flow model, which requires significant estimates regarding

the investees’ revenue, costs, and discount rates.

The Company’s assessment of these factors in determining whether an impairment

exists could change in the future due to new developments or changes in applied assumptions.

Other-Than-Temporary Impairment

The Company’s long-term equity investments

are subject to a periodic impairment review.

and leasehold improvements

and equipment

of Long-Lived Assets

Company has adopted Accounting Standards Codification subtopic 360-10, Property, Plant and Equipment (“ASC 360-10”).

360-10 requires that long-lived assets and certain identifiable intangibles held and used by the Company be reviewed for impairment whenever

events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.

The Company evaluates its long-lived

assets for impairment annually or more often if events and circumstances warrant.

Events relating to recoverability may include significant

unfavorable changes in business conditions, recurring losses, or a forecasted inability to achieve break-even operating results over

an extended period.

Should impairment in value be indicated, the carrying value of intangible assets will be adjusted, based on estimates

of future discounted cash flows resulting from the use and ultimate disposition of the asset.

ASC 360-10 also requires assets to be disposed

of be reported at the lower of the carrying amount or the fair value less costs to sell.

Equity Investment

Company acquires the equity investments to promote business and strategic objectives.

The Company accounts for non-marketable equity

and other equity investments for which the Company does not have control over the investees as:

method investments when the Company has the ability to exercise significant influence, but not control, over the investee.

Its proportionate

share of the income or loss is recognized monthly and is recorded in gains (losses) on equity investments.

Non-marketable

cost method investments when the equity method does not apply.

judgment is required to identify whether an impairment exists in the valuation of the Company’s non-marketable equity investments,

and therefore the Company considers this a critical accounting estimate.

Its yearly analysis considers both qualitative and quantitative

factors that may have a significant impact on the investee’s fair value.

Qualitative analysis of its investments involves understanding

the financial performance and near-term prospects of the investee, changes in general market conditions in the investee’s industry

or geographic area, and the management and governance structure of the investee.

Quantitative assessments of the fair value of its investments

are developed using the market and income approaches.

The market approach includes the use of comparable financial metrics of private

and public companies and recent financing rounds.

The income approach includes the use of a discounted cash flow model, which requires

significant estimates regarding the investees’ revenue, costs, and discount rates.

The Company’s assessment of these factors

in determining whether an impairment exists could change in the future due to new developments or changes in applied assumptions.

Other-Than-Temporary

Company’s long-term equity investments are subject to a periodic impairment review.

Impairments affect earnings as follows:

Marketable equity securities include the consideration of general market conditions, the duration and extent to which the fair value is below cost, and our ability and intent to hold the investment for a sufficient period of time to allow for recovery of value in the foreseeable future.

The Company also considers specific adverse conditions related to the financial health of, and the business outlook for, the investee, which may include industry and sector performance, changes in technology, operational and financing cash flow factors, and changes in the investee’s credit rating.

The Company records other-than-temporary impairments on marketable equity securities and marketable equity method investments in gains (losses) on equity investments.

Non-marketable equity investments based on the Company’s assessment of the severity and duration of the impairment, and qualitative and quantitative analysis of the operating performance of the investee;

equity securities include the consideration of general market conditions, the duration and extent to which the fair value is below

cost, and our ability and intent to hold the investment for a sufficient period of time to allow for recovery of value in the foreseeable

The Company also considers specific adverse conditions related to the financial health of, and the business outlook for,

the investee, which may include industry and sector performance, changes in technology, operational and financing cash flow factors,

and changes in the investee’s credit rating.

The Company records other-than-temporary impairments on marketable equity securities

and marketable equity method investments in gains (losses) on equity investments.

Non-marketable

equity investments based on the Company’s assessment of the severity and duration of the impairment, and qualitative and quantitative

analysis of the operating performance of the investee;

adverse changes in market conditions and the regulatory or economic environment;

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additional funding requirements;

and the investee’s ability to remain in business.

A series of operating losses of an investee or other factors may indicate that a decrease in value of the investment has occurred that is other than temporary and that shall be recognized even though the decrease in value is in excess of what would otherwise be recognized by application of the equity method.

A loss in value of an investment that is other than a temporary decline shall be recognized.

Evidence of a loss in value might include, but would not necessarily be limited to, absence of an ability to recover the carrying amount of the investment or inability of the investee to sustain an earnings capacity that would justify the carrying amount of the investment.

The Company records other-than-temporary impairments for non-marketable cost method investments and equity method investments in gains (losses) on equity investments.

Other-than-temporary impairments of equity investments were $0 for the three and six months ended June 30, 2021.

Other-than-temporary impairments of equity investments were $944,204 for the three and six months ended June 30, 2020.

The Company evaluates goodwill for impairment

annually or more frequently when an event occurs or circumstances change that indicate the carrying value may not be recoverable.

goodwill for impairment, the Company may elect to utilize a qualitative assessment to evaluate whether it is more likely than not that

the fair value of a reporting unit is less than its carrying amount.

If the qualitative assessment indicates that goodwill impairment

is more likely than not, the Company performs a two-step impairment test.

The Company tests goodwill for impairment under the two-step

impairment test by first comparing the book value of net assets to the fair value of the reporting units.

If the fair value is determined

to be less than the book value or qualitative factors indicate that it is more likely than not that goodwill is impaired, a second step

is performed to compute the amount of impairment as the difference between the estimated fair value of goodwill and the carrying value.

and the investee’s ability to

remain in business.

A series of operating losses of an investee or other factors may indicate that a decrease in value of the investment

has occurred that is other than temporary and that shall be recognized even though the decrease in value is in excess of what would

otherwise be recognized by application of the equity method.

A loss in value of an investment that is other than a temporary decline

shall be recognized.

Evidence of a loss in value might include, but would not necessarily be limited to, absence of an ability to

recover the carrying amount of the investment or inability of the investee to sustain an earnings capacity that would justify the

carrying amount of the investment.

The Company records other-than-temporary impairments for non-marketable cost method investments

and equity method investments in gains (losses) on equity investments.

Other-than-temporary impairments of equity investments were

$0 for the three and nine months ended September 30, 2021.

Other-than-temporary impairments of equity investments were $944,204 for

the three and nine months ended September 30, 2020.

Company evaluates goodwill for impairment annually or more frequently when an event occurs or circumstances change that indicate the

carrying value may not be recoverable.

In testing goodwill for impairment, the Company may elect to utilize a qualitative assessment

to evaluate whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount.

If the qualitative

assessment indicates that goodwill impairment is more likely than not, the Company performs a two-step impairment test.

The Company tests

goodwill for impairment under the two-step impairment test by first comparing the book value of net assets to the fair value of the reporting

If the fair value is determined to be less than the book value or qualitative factors indicate that it is more likely than not

that goodwill is impaired, a second step is performed to compute the amount of impairment as the difference between the estimated fair

value of goodwill and the carrying value.

The Company estimates the fair value of the reporting units using discounted cash flows.

Forecasts of future cash flows are based on our

best estimate of future net sales and operating expenses, based primarily on expected category expansion, pricing, market segment share,

and general economic conditions.

The Company completed the required testing of

goodwill for impairment as of June 30, 2021, and determined that goodwill was impaired because of the current financial condition of the

Company and the Company’s inability to generate future operating income without substantial sales volume increases, which are highly

Furthermore, the Company anticipates future cash flows indicate that the recoverability of goodwill is not reasonably assured.

Research and Development Expenses

The Company accounts for the cost of using licensing

rights in research and development cost according to ASC Topic 730-10-25-1.

This guidance provides that absent alternative future uses

the acquisition of product rights to be used in research and development activities must be charged to research and development expenses

when incurred.

For CDMO business unit, the Company accounts for

R&D costs in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development (“ASC 730”).

Research and development expenses are charged to expense as incurred unless there is an alternative future use in other research and development

projects or otherwise.

Research and development expenses are comprised of costs incurred in performing research and development activities,

including personnel-related costs, facilities-related overhead, and outside contracted services including clinical trial costs, manufacturing

and process development costs for both clinical and preclinical materials, research costs, and other consulting services.

Non-refundable

advance payment for goods and services that will be used in future research and development activities are expensed when the activity

has been performed or when the goods have been received rather than when the payment is made.

In instances where the Company enters into

agreements with third parties to provide research and development services, costs are expensed as services are performed.

Post-retirement and post-employment benefits

of future cash flows are based on our best estimate of future net sales and operating expenses, based primarily on expected category

expansion, pricing, market segment share, and general economic conditions.

Company completed the required testing of goodwill for impairment as of September 30, 2021, and determined that goodwill was impaired

because of the current financial condition of the Company and the Company’s inability to generate future operating income without

substantial sales volume increases, which are highly uncertain.

Furthermore, the Company anticipates future cash flows indicate that

the recoverability of goodwill is not reasonably assured.

and Development Expenses

Company accounts for the cost of using licensing rights in research and development cost according to ASC Topic 730-10-25-1.

This guidance

provides that absent alternative future uses the acquisition of product rights to be used in research and development activities must

be charged to research and development expenses when incurred.

CDMO business unit, the Company accounts for R&D costs in accordance with Accounting Standards Codification (“ASC”) 730,

Research and Development (“ASC 730”).

Research and development expenses are charged to expense as incurred unless there is

an alternative future use in other research and development projects or otherwise.

Research and development expenses are comprised of

costs incurred in performing research and development activities, including personnel-related costs, facilities-related overhead, and

outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and preclinical

materials, research costs, and other consulting services.

Non-refundable advance payment for goods and services that will be used in

future research and development activities are expensed when the activity has been performed or when the goods have been received rather

than when the payment is made.

In instances where the Company enters into agreements with third parties to provide research and development

services, costs are expensed as services are performed.

Post-retirement

and post-employment benefits

The Company’s subsidiaries in Taiwan adopted

7 unchanged sentences

The total amounts for such employee

benefits, which were expensed as incurred, were $2,859 and $3,759 for the three months ended June 30, 2021 and 2020, respectively.

total amounts for such employee benefits, which were expensed as incurred, were $5,362 and $7,357 for the six months ended June 30, 2021

benefits, which were expensed as incurred, were $2,906 and $3,759 for the three months ended September 30, 2021 and 2020, respectively.

The total amounts for such employee benefits, which were expensed as incurred, were $8,268 and $7,357 for the nine months ended September

30, 2021 and 2020, respectively.

Other than the above, the Company does not provide any other post-retirement or post-employment benefits.

Stock-based Compensation

The Company measures expense associated with all

employee stock-based compensation awards using a fair value method and recognizes such expense in the consolidated financial statements

on a straight-line basis over the requisite service period in accordance with FASB ASC Topic 718 “Compensation-Stock Compensation”.

Total employee stock-based compensation expenses were $0 for the three and six months ended June 30, 2021 and 2020, respectively.

Company measures expense associated with all employee stock-based compensation awards using a fair value method and recognizes such expense

in the consolidated financial statements on a straight-line basis over the requisite service period in accordance with FASB ASC Topic

718 “Compensation-Stock Compensation”.

Total employee stock-based compensation expenses were $0 for the three and nine months

ended September 30, 2021 and 2020, respectively.

The Company accounted for stock-based compensation

2 unchanged sentences

earlier of the performance commitment date or the date service is completed and recognized over the period the service is provided.

non-employee stock-based compensation expenses were $475,740 and $75 for the three months ended June 30, 2021 and 2020, respectively.

Total non-employee stock-based compensation expenses were $701,480 and $600 for the six months ended June 30, 2021 and 2020, respectively.

Beneficial Conversion Feature

From time to time, the Company may issue convertible

notes that may contain an imbedded beneficial conversion feature.

A beneficial conversion feature exists on the date a convertible note

is issued when the fair value of the underlying common stock to which the note is convertible into is in excess of the remaining unallocated

proceeds of the note after first considering the allocation of a portion of the note proceeds to the fair value of the warrants, if related

warrants have been granted.

The intrinsic value of the beneficial conversion feature is recorded as a debt discount with a corresponding

amount to additional paid in capital.

The debt discount is amortized to interest expense over the life of the note using the effective

interest method.

The Company accounts for income taxes using the

asset and liability approach which allows the recognition and measurement of deferred tax assets to be based upon the likelihood of realization

of tax benefits in future years.

Under the asset and liability approach, deferred taxes are provided for the net tax effects of temporary

differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax

A valuation allowance is provided for deferred tax assets if it is more likely than not these items will expire before the Company

is able to realize their benefits, or future deductibility is uncertain.

Under ASC 740, a tax position is recognized as

a benefit only if it is “more likely than not” that the tax position would be sustained in a tax examination, with

a tax examination being presumed to occur.

non-employee stock-based compensation expenses were $225,740 and $0 for the three months ended September 30, 2021 and 2020, respectively.

Total non-employee stock-based compensation expenses were $927,220 and $999,820 for the nine months ended September 30, 2021 and 2020,

respectively.

Conversion Feature

time to time, the Company may issue convertible notes that may contain an imbedded beneficial conversion feature.

A beneficial conversion

feature exists on the date a convertible note is issued when the fair value of the underlying common stock to which the note is convertible

into is in excess of the remaining unallocated proceeds of the note after first considering the allocation of a portion of the note proceeds

to the fair value of the warrants, if related warrants have been granted.

The intrinsic value of the beneficial conversion feature is

recorded as a debt discount with a corresponding amount to additional paid in capital.

The debt discount is amortized to interest expense

over the life of the note using the effective interest method.

Company accounts for income taxes using the asset and liability approach which allows the recognition and measurement of deferred tax

assets to be based upon the likelihood of realization of tax benefits in future years.

Under the asset and liability approach, deferred

taxes are provided for the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial

reporting purposes and the amounts used for income tax purposes.

A valuation allowance is provided for deferred tax assets if it is more

likely than not these items will expire before the Company is able to realize their benefits, or future deductibility is uncertain.

ASC 740, a tax position is recognized as a benefit only if it is “more likely than not” that the tax position would

be sustained in a tax examination, with a tax examination being presumed to occur.

The evaluation of a tax position is a two-step process.

The first step is to determine whether

it is more-likely-than-not that a tax position will be sustained upon examination, including the resolution of any related appeals or

litigations based on the technical merits of that position.

The second step is to measure a tax position that meets the more-likely-than-not

threshold to determine the amount of benefits recognized in the financial statements.

A tax position is measured at the largest amount

of benefit that is greater than 50 percent likely of being realized upon ultimate settlement.

Tax positions that previously failed to

meet the more-likely-than-not recognition threshold should be recognized in the first subsequent period in which the threshold is met.

Previously recognized tax positions that no longer meet the more-likely-than-not criteria should be de-recognized in the first subsequent

financial reporting period in which the threshold is no longer satisfied.

Penalties and interest incurred related to underpayment of income

tax are classified as income tax expense in the year incurred.

No significant penalty or interest relating to income taxes has been incurred

for the six months ended June 30, 2021 and 2020.

GAAP also provides guidance on de-recognition, classification, interest and penalties,

accounting in interim periods, disclosures and transition.

On December 22, 2017, the SEC issued Staff Accounting

Bulletin (“SAB 118”), which provides guidance on accounting for tax effects of the Tax Act.

SAB 118 provides a measurement

period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740.

In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Act for which the accounting under ASC

740 is complete.

To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is

able to determine a reasonable estimate, it must record a provisional estimate to be included in the financial statements.

cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of

the provision of the tax laws that were in effect immediately before the enactment of the Tax Act.

While the Company is able to make reasonable

estimates of the impact of the reduction in corporate rate and the deemed repatriation transition tax, the final impact of the Tax Act

may differ from these estimates, due to, among other things, changes in our interpretations and assumptions, additional guidance that

may be issued by the I.R.S., and actions the Company may take.

The Company is continuing to gather additional information to determine

the final impact.

Valuation of Deferred Tax Assets

A valuation allowance is recorded to reduce the

Company’s deferred tax assets to the amount that is more likely than not to be realized.

In assessing the need for the valuation

allowance, management considers, among other things, projections of future taxable income and ongoing prudent and feasible tax planning

If the Company determines that sufficient negative evidence exists, then it will consider recording a valuation allowance

against a portion or all of the deferred tax assets in that jurisdiction.

If, after recording a valuation allowance, the Company’s

projections of future taxable income and other positive evidence considered in evaluating the need for a valuation allowance prove, with

the benefit of hindsight, to be inaccurate, it could prove to be more difficult to support the realization of its deferred tax assets.

As a result, an additional valuation allowance could be required, which would have an adverse impact on its effective income tax rate

Conversely, if, after recording a valuation allowance, the Company determines that sufficient positive evidence exists in

the jurisdiction in which the valuation allowance was recorded, it may reverse a portion or all of the valuation allowance in that jurisdiction.

In such situations, the adjustment made to the deferred tax asset would have a favorable impact on its effective income tax rate and results

in the period such determination was made.

Loss Per Share of Common Stock

The Company calculates net loss per share in accordance

with ASC Topic 260, “Earnings per Share”.

Basic loss per share is computed by dividing the net loss by the weighted average

number of common shares outstanding during the period.

Diluted loss per share is computed similar to basic loss per share except that

the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common

stock equivalents had been issued and if the additional common shares were dilutive.

Diluted earnings per share excludes all dilutive

potential shares if their effect is anti-dilutive.

Commitments and Contingencies

The Company has adopted ASC Topic 450 “Contingencies”

subtopic 20, in determining its accruals and disclosures with respect to loss contingencies.

Accordingly, estimated losses from loss contingencies

are accrued by a charge to income when information available before financial statements are issued or are available to be issued indicates

that it is probable that an assets had been impaired or a liability had been incurred at the date of the financial statements and the

amount of the loss can be reasonably estimated.

Legal expenses associated with the contingency are expensed as incurred.

If a loss contingency

is not probable or reasonably estimable, disclosure of the loss contingency is made in the financial statements when it is at least reasonably

possible that a material loss could be incurred.

Foreign-currency Transactions

For the Company’s subsidiaries in Taiwan,

the foreign-currency transactions are recorded in New Taiwan dollars (“NTD”) at the rates of exchange in effect when the transactions

Gains or losses resulting from the application of different foreign exchange rates when cash in foreign currency is converted into

New Taiwan dollars, or when foreign-currency receivables or payables are settled, are credited or charged to income in the year of conversion

or settlement.

On the balance sheet dates, the balances of foreign-currency assets and liabilities are restated at the prevailing exchange

rates and the resulting differences are charged to current income except for those foreign currencies denominated investments in shares

of stock where such differences are accounted for as translation adjustments under the Statements of Stockholders’ Equity (Deficit).

Translation Adjustment

The accounts of the Company’s subsidiaries

in Taiwan were maintained, and their financial statements were expressed, in New Taiwan Dollar (“NT$”).

Such financial statements

were translated into U.S.

Dollars (“$” or “USD”) in accordance ASC 830, “Foreign Currency Matters”,

with the NT$ as the functional currency.

According to the Statement, all assets and liabilities are translated at the current exchange

rate, shareholder’s deficit are translated at the historical rates and income statement items are translated at an average exchange

rate for the period.

The resulting translation adjustments are reported under other comprehensive income (loss) as a component of shareholders’

equity (deficit).

Recent Accounting Pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt

with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging- Contracts in Entity’s Own Equity (Subtopic 815-40) ,

to reduce the complexity associated with applying U.S.

GAAP principles for certain financial instruments with characteristics of liabilities

The amendments in this ASU reduce the number of accounting models for convertible instruments and expand the existing disclosure

requirements over earnings per share as it relates to convertible instruments.

This ASU will be effective for the fiscal year beginning

January 1, 2022 and interim periods therein.

Early adoption is permitted, but no earlier than fiscal years beginning after December 15,

The amendments may be adopted through either a modified retrospective method, or a fully retrospective method.

The Company is currently

evaluating the impact of adopting ASU 2020-06.

Estimates and Assumptions

In preparing our consolidated financial statements,

we use estimates and assumptions that affect the reported amounts and disclosures.

Our estimates are often based on complex judgments,

probabilities and assumptions that we believe to be reasonable, but that are inherently uncertain and unpredictable.

We are also subject

to other risks and uncertainties that may cause actual results to differ from estimated amounts.

Results of Operations — Three Months

Ended June 30, 2021 Compared to Three Months Ended June 30, 2020.

The following table presents, for the three months

indicated, our consolidated statements of operations information.

The first step is to determine whether it is more-likely-than-not that a tax position will be sustained upon examination, including the

resolution of any related appeals or litigations based on the technical merits of that position.

The second step is to measure a tax

position that meets the more-likely-than-not threshold to determine the amount of benefits recognized in the financial statements.

tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement.

Tax positions that previously failed to meet the more-likely-than-not recognition threshold should be recognized in the first subsequent

period in which the threshold is met.

Previously recognized tax positions that no longer meet the more-likely-than-not criteria should

be de-recognized in the first subsequent financial reporting period in which the threshold is no longer satisfied.

Penalties and interest

incurred related to underpayment of income tax are classified as income tax expense in the year incurred.

No significant penalty or interest

relating to income taxes has been incurred for the nine months ended September 30, 2021 and 2020.

GAAP also provides guidance on de-recognition,

classification, interest and penalties, accounting in interim periods, disclosures and transition.

December 22, 2017, the SEC issued Staff Accounting Bulletin (“SAB 118”), which provides guidance on accounting for tax effects

of the Tax Act.

SAB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies

to complete the accounting under ASC 740.

In accordance with SAB 118, a company must reflect the income tax effects of those aspects

of the Act for which the accounting under ASC 740 is complete.

To the extent that a company’s accounting for certain income tax

effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate to be included

in the financial statements.

If a company cannot determine a provisional estimate to be included in the financial statements, it should

continue to apply ASC 740 on the basis of the provision of the tax laws that were in effect immediately before the enactment of the Tax

While the Company is able to make reasonable estimates of the impact of the reduction in corporate rate and the deemed repatriation

transition tax, the final impact of the Tax Act may differ from these estimates, due to, among other things, changes in our interpretations

and assumptions, additional guidance that may be issued by the I.R.S., and actions the Company may take.

The Company is continuing to

gather additional information to determine the final impact.

of Deferred Tax Assets

valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount that is more likely than not to be realized.

In assessing the need for the valuation allowance, management considers, among other things, projections of future taxable income and

ongoing prudent and feasible tax planning strategies.

If the Company determines that sufficient negative evidence exists, then it will

consider recording a valuation allowance against a portion or all of the deferred tax assets in that jurisdiction.

If, after recording

a valuation allowance, the Company’s projections of future taxable income and other positive evidence considered in evaluating

the need for a valuation allowance prove, with the benefit of hindsight, to be inaccurate, it could prove to be more difficult to support

the realization of its deferred tax assets.

As a result, an additional valuation allowance could be required, which would have an adverse

impact on its effective income tax rate and results.

Conversely, if, after recording a valuation allowance, the Company determines that

sufficient positive evidence exists in the jurisdiction in which the valuation allowance was recorded, it may reverse a portion or all

of the valuation allowance in that jurisdiction.

In such situations, the adjustment made to the deferred tax asset would have a favorable

impact on its effective income tax rate and results in the period such determination was made.

Per Share of Common Stock

Company calculates net loss per share in accordance with ASC Topic 260, “Earnings per Share”.

Basic loss per share is computed

by dividing the net loss by the weighted average number of common shares outstanding during the period.

Diluted loss per share is computed

similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would

have been outstanding if the potential common stock equivalents had been issued and if the additional common shares were dilutive.

earnings per share excludes all dilutive potential shares if their effect is anti-dilutive.

and Contingencies

Company has adopted ASC Topic 450 “Contingencies” subtopic 20, in determining its accruals and disclosures with respect to

loss contingencies.

Accordingly, estimated losses from loss contingencies are accrued by a charge to income when information available

before financial statements are issued or are available to be issued indicates that it is probable that an assets had been impaired or

a liability had been incurred at the date of the financial statements and the amount of the loss can be reasonably estimated.

Legal expenses

associated with the contingency are expensed as incurred.

If a loss contingency is not probable or reasonably estimable, disclosure of

the loss contingency is made in the financial statements when it is at least reasonably possible that a material loss could be incurred.

Foreign-currency

the Company’s subsidiaries in Taiwan, the foreign-currency transactions are recorded in New Taiwan dollars (“NTD”)

at the rates of exchange in effect when the transactions occur.

Gains or losses resulting from the application of different foreign exchange

rates when cash in foreign currency is converted into New Taiwan dollars, or when foreign-currency receivables or payables are settled,

are credited or charged to income in the year of conversion or settlement.

On the balance sheet dates, the balances of foreign-currency

assets and liabilities are restated at the prevailing exchange rates and the resulting differences are charged to current income except

for those foreign currencies denominated investments in shares of stock where such differences are accounted for as translation adjustments

under the Statements of Stockholders’ Equity (Deficit).

accounts of the Company’s subsidiaries in Taiwan were maintained, and their financial statements were expressed, in New Taiwan

Dollar (“NT$”).

Such financial statements were translated into U.S.

Dollars (“$” or “USD”) in accordance

ASC 830, “Foreign Currency Matters”, with the NT$ as the functional currency.

According to the Statement, all assets and

liabilities are translated at the current exchange rate, shareholder’s deficit are translated at the historical rates and income

statement items are translated at an average exchange rate for the period.

The resulting translation adjustments are reported under other

comprehensive income (loss) as a component of shareholders’ equity (deficit).

Accounting Pronouncements

August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-

Contracts in Entity’s Own Equity (Subtopic 815-40) , to reduce the complexity associated with applying U.S.

GAAP principles

for certain financial instruments with characteristics of liabilities and equity.

The amendments in this ASU reduce the number of accounting

models for convertible instruments and expand the existing disclosure requirements over earnings per share as it relates to convertible

This ASU will be effective for the fiscal year beginning January 1, 2022 and interim periods therein.

Early adoption is

permitted, but no earlier than fiscal years beginning after December 15, 2020.

The amendments may be adopted through either a modified

retrospective method, or a fully retrospective method.

The Company is currently evaluating the impact of adopting ASU 2020-06.

and Assumptions

preparing our consolidated financial statements, we use estimates and assumptions that affect the reported amounts and disclosures.

estimates are often based on complex judgments, probabilities and assumptions that we believe to be reasonable, but that are inherently

uncertain and unpredictable.

We are also subject to other risks and uncertainties that may cause actual results to differ from estimated

of Operations — Three Months Ended September 30, 2021 Compared to Three Months Ended September 30, 2020.

following table presents, for the three months indicated, our consolidated statements of operations information.

September 30,

Cost of revenues

14 unchanged sentences

Other income (expense)

Government grant income

Total other income (expenses)

12 unchanged sentences

We generated $98,999

and $226,513 in revenues for the three months ended June 30, 2021 and 2020, respectively;

and incurred $646 and $4,236 in cost of sales

for the three months ended June 30, 2021 and 2020, respectively.

The decrease in revenues was mainly due to the impact of COVID-19 on

our CDMO business sector.

and $115,553 in revenues for the three months ended September 30, 2021 and 2020, respectively;

and incurred $393 and $8,619 in cost of

sales for the three months ended September 30, 2021 and 2020, respectively.

The decrease in revenues was mainly due to the impact of COVID-19

on our CDMO business sector.

Operating Expenses.

operating expenses have increased by $650,020, or 46%, to $2,066,310 for the three months ended June 30, 2021 from $1,416,290 for the

three months ended June 30, 2020.

Such increase in operating expenses was mainly due to the increase in selling, general and administrative

expenses and research and development expenses.

operating expenses have increased by $672,460, or 48%, to $2,069,160 for the three months ended September 30, 2021 from $1,396,700 for

the three months ended September 30, 2020.

Such increase in operating expenses was mainly due to the increase in selling, general and

administrative expenses and research and development expenses.

Our selling, general and administrative expenses

1 unchanged sentence

Our research and development expenses increased

by $219,796 or approximately 158% primarily because of new service agreements signed with vendors during the three months ended June

by $128,923 or approximately 96% primarily because of new service agreements signed with vendors during the three months ended September

Other Income (Expense).

expense was $77,005 for the three months ended June 30, 2021 as compared to $1,038,688 for the three months ended June 30, 2020.

was principally caused by the decrease in impairment loss of $944,204 during the quarter, and increase in interest income and rental

income, as well as decreasing loss on investment in equity securities, while deducted from decrease in net other income.

income (expense) was $8,643 and ($886,100) for the three months ended September 30, 2021 and 2020, respectively.

The change was principally

caused by the decrease in interest income and rental income, as well as decreasing loss on investment in equity securities and the

increase in government grant income.

Interest income was $9,333 for the three months

ended June 30, 2021 as compared to $9,350 for the three months ended June 30, 2020.

The increase of $1,372, or approximately 15%, was

primarily due to the interest income for various related-party loans.

ended September 30, 2021 as compared to $19,571 for the three months ended September 30, 2020.

The decrease of $10,238, or approximately

49%, was primarily due to the repayment of certain related-party loans.

Loss on investment in equity securities was $0

for the three months ended June 30, 2021 as compared to $109,656 for the three months ended June 30, 2020.

The decrease of $56,065, or

approximately 51%, was primarily due to the loss on investment in BioFirst.

Other income and government grant income totaled

$162 for the three months ended June 30, 2021 as compared to $170,179 for the three months ended June 30, 2020.

The decrease of $170,017,

or approximately 100%, was primarily due to the tax refund for greenlight project recorded in the first half year of 2020.

As a result of the above factors, our

net loss was $2,052,956 for the three months ended June 30, 2021 compared to $2,184,057 for the three months ended June 30, 2020, representing

a decrease of $131,101, or 6%.

Results of Operations — Six Months Ended

June 30, 2021 Compared to Six Months Ended June 30, 2020.

The following table presents, for the six months

indicated, our consolidated statements of operations information.

for the three months ended September 30, 2021 as compared to $8,507 for the three months ended September 30, 2020.

The decrease was primarily

due to the loss on investment in BioFirst in 2020.

Other income and

government grant income totaled $131,927 for the three months ended September 30, 2021 as compared to other expense of $171 for

the three months ended September 30, 2020.

The increase of $132,098, or approximately 77,250%, was primarily due to the receipt of the

second round of PPP loan forgiveness during the third quarter of 2021.

As a result of the

above factors, our net loss was $1,886,244 for the three months ended September 30, 2021 compared to $2,131,131 for the three months ended

September 30, 2020, representing a decrease of $244,887, or 11%.

of Operations — Nine months Ended September 30, 2021 Compared to Nine months Ended September 30, 2020.

following table presents, for the nine months indicated, our consolidated statements of operations information.

September 30,

Cost of revenues

29 unchanged sentences

We generated $393,590

and $305,299 in revenues for the six months ended June 30, 2021 and 2020, respectively;

and incurred $1,891 and $8,195 in cost of sales

for the six months ended June 30, 2021 and 2020, respectively.

The decrease in revenues was mainly due to the recovery from the impact

of COVID-19 onto our CDMO business sector.

and $420,852 in revenues for the nine months ended September 30, 2021 and 2020, respectively;

and incurred $2,284 and $16,814 in cost

of sales for the nine months ended September 30, 2021 and 2020, respectively.

The decrease in revenues was mainly due to the impact of

COVID-19 onto our CDMO business sector.

Operating Expenses.

operating expenses have increased by $918,466, or 34%, to $3,580,960 for the six months ended June 30, 2021 from $2,662,494 for the six

months ended June 30, 2020.

Such increase in operating expenses was mainly due to the increase in research and development expenses and

stock-based compensation.

operating expenses have increased by $1,590,925, or 39%, to $5,650,120 for the nine months ended September 30, 2021 from $4,059,195 for

the nine months ended September 30, 2020.

Such increase in operating expenses was mainly due to the increase in selling, general and administrative

expenses and research and development expenses.

Our selling, general and administrative expenses

1 unchanged sentence

Our research and development expenses increased

by $248,321 or approximately 107% primarily because of new service agreements signed with vendors during the six months ended June 30,

by $377,243 or approximately 103% primarily because of new service agreements signed with vendors during the nine months ended September

Other Income (Expense).

expense was $70,607 for the six months ended June 30, 2021 as compared to $1,217,141 for the six months ended June 30, 2020.

was principally caused by the increase in government grant income of $124,400 during the quarter, due to the grant of the PPP loan,

as well as increase in interest income and rental income and decreasing loss on investment in equity securities and other income.

Interest income was $63,251 for the six months

ended June 30, 2021 as compared to $20,070 for the six months ended June 30, 2020.

The increase of $43,181, or approximately 215%, was

primarily due to the interest income for various related-party loans.

expense was $61,964 for the nine months ended September 30, 2021 as compared to $2,103,240 for the nine months ended September 30, 2020.

The change was principally caused by the decrease in the impairment loss and loss on investment in equity securities, and the increase in

government grant income of $256,731 due to the forgiveness of PPP loans during the nine months ended September 30, 2021.

Interest income was $72,584 for the nine months

ended September 30, 2021 as compared to $39,641 for the nine months ended September 30, 2020.

The increase of $32,943, or approximately

83%, was primarily due to the increase of certain related-party loans.

Loss on investment in equity securities was $193,147

for the six months ended June 30, 2021 as compared to $180,067 for the six months ended June 30, 2020.

The decrease of $78,685, or approximately

44%, was primarily due to the loss on investment in BioFirst.

for the nine months ended September 30, 2021 as compared to $1,067,298 for the nine months ended September 30, 2020.

The decrease was

primarily due to the loss on investment in BioFirst in 2020.

Other income and government grant income totaled

$124,633 for the six months ended June 30, 2021 as compared to $176,501 for the six months ended June 30, 2020.

The decrease of $51,868,

or approximately 29%, was primarily due to the grant of the PPP loans, offsetting the decrease in other income of $176,268.

$256,560 for the nine months ended September 30, 2021 as compared to $176,330 for the nine months ended September 30, 2020.

of $80,230, or approximately 45%, was primarily due to the forgiveness of the PPP loans of $256,731, offsetting the decrease in other

income of $176,501.

As a result of the

above factors, our net loss was $3,248,279 for the six months ended June 30, 2021 compared to $3,493,319 for the six months ended June

30, 2020, representing a decrease of $245,040, or 7%.

Liquidity and Capital Resources

Working Capital

above factors, our net loss was $5,134,523 for the nine months ended September 30, 2021 compared to $5,624,450 for the nine months ended

September 30, 2020, representing a decrease of $489,927, or 9%.

and Capital Resources

September 30,

Current Assets

1 unchanged sentence

Working Capital (deficit)

Cash Flow from Operating Activities

During the six months ended June 30, 2021 and

2020, the net cash used in operating activities were $2,857,078 and $2,047,071, respectively.

Flow from Operating Activities

During the nine months ended September 30, 2021

and 2020, the net cash used in operating activities were $5,541,538 and $2,375,873, respectively.

The increase in the amount used in operating

activities of $810,007 was primarily due to the increased accounts receivables, prepaid expenses and deposits, and accrued expenses and

other current liabilities, decreased non-cash investment loss, and increased non-cash government grant income, partially offset by the

decrease in amount due from related parties, increase in non-cash stock based compensation for nonemployees and decrease in net loss during

the six months ended June 30, 2021.

Cash Flow from Investing Activities

During the six months ended June 30, 2021,

the net cash used in investing activities was $421,974, compared to the net cash provided by investing activities was $33,300 for

the six months ended June 30, 2020.

The increase was due to the prepayment for equity investment during the six months ended

June 30, 2021.

Cash Flow from Financing Activities

During the six months ended June 30, 2021, the

net cash used in financing activities was $74,734, while the net cash provided by the six months ended June 30, 2020 was $2,255,107, respectively.

The decrease in net cash provided by financing activities were primarily due to proceeds from private placement, partially offset by the

repayment of convertible notes during the six months ended June 30, 2021.

Off-Balance Sheet Arrangements

As of June 30, 2021, we did not have any off-balance

sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial

condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that is material to investors.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT

As a smaller reporting company, we are not required

to provide the information required by this item.

activities of $3,165,665 was primarily due to the increased accounts receivables, prepaid expenses and deposits, non-cash government grant

income, and decreased accrued expenses and other current liabilities, non-cash investment loss, the decrease in amount due from related

parties, decrease in non-cash stock based compensation for nonemployees and decrease in net loss during the nine months ended September

Flow from Investing Activities

During the nine months ended September 30, 2021,

the net cash used in investing activities was $764,377, compared to the net cash used in investing activities was $332,539 for the nine

months ended September 30, 2020.

The increase was due to the prepayment for equity investment during the nine months ended September

Flow from Financing Activities

During the nine months ended September 30, 2021,

the net cash used in financing activities was $5,742,737, while the net cash provided by the nine months ended September 30, 2020 was

$2,698,793, respectively.

The increase in net cash provided by financing activities were primarily due to proceeds from issuance of common

stock, partially offset by the repayment of convertible notes during the nine months ended September 30, 2021.

Sheet Arrangements

of September 30, 2021, we did not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future

effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures,

or capital resources that is material to investors.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

a smaller reporting company, we are not required to provide the information required by this item.

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-Q

Item 2. Management’s Discussion and Analysis