0001213900-24-033598.txt : 20240417 0001213900-24-033598.hdr.sgml : 20240417 20240417083010 ACCESSION NUMBER: 0001213900-24-033598 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 17 CONFORMED PERIOD OF REPORT: 20240417 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240417 DATE AS OF CHANGE: 20240417 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABVC BIOPHARMA, INC. CENTRAL INDEX KEY: 0001173313 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 260014658 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40700 FILM NUMBER: 24849418 BUSINESS ADDRESS: STREET 1: 44370 OLD WARM SPRINGS BLVD. CITY: FREMONT STATE: CA ZIP: 94538 BUSINESS PHONE: 510-668-0881 MAIL ADDRESS: STREET 1: 44370 OLD WARM SPRINGS BLVD. CITY: FREMONT STATE: CA ZIP: 94538 FORMER COMPANY: FORMER CONFORMED NAME: American BriVision (Holding) Corp DATE OF NAME CHANGE: 20160111 FORMER COMPANY: FORMER CONFORMED NAME: METU BRANDS, INC. DATE OF NAME CHANGE: 20150908 FORMER COMPANY: FORMER CONFORMED NAME: ECOLOGY COATINGS, INC. DATE OF NAME CHANGE: 20080821 8-K 1 ea0203971-8k_abvcbio.htm CURRENT REPORT
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 17, 2024

 

ABVC BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

 

Nevada   001-40700   26-0014658
(State or other jurisdiction
of incorporation)		   (Commission File Number)   (IRS Employer
Identification No.)

 

44370 Old Warm Springs Blvd.

Fremont, CA

   94538
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number including area code: (510) 668-0881

 

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol   Name of each exchange on which registered
Common Stock, par value $0.001 per share   ABVC   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

Item 1.01 Entry into Material Definitive Agreements 

 

On April 16, 2024, the Company entered into a definitive agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands ("Oncox"), pursuant to which the Company will grant Oncox an exclusive right to develop and commercialize ABVC's single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer (the “Licensed Products”), within North America for 20 years (the “Oncox Agreement”). In consideration thereof, Oncox shall pay ABVC $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share1) 30 days after entering into the Oncox Agreement and $625,000 30 days following the completion of Oncox’s next round of fundraising, of which there is no guarantee; ABC is also entitled to 5% royalties based on the Net Sales, as defined in the Oncox Agreement, from the first commercial sale of the Licensed Product in North America. Oncox entered into the same agreement with ABVC’s affiliate, Rgene Corporation.

 

The foregoing description of the agreements is not complete and is qualified in its entirety by reference to the full text of the agreements, copies of which are attached as Exhibit 10.1 and Exhibit 10.2 to this Current Report on Form 8-K and incorporated herein by reference.

 

Neither this Current Report on Form 8-K, nor any exhibit attached hereto, is an offer to sell or the solicitation of an offer to buy the Securities described herein. Such disclosure does not constitute an offer to sell, or the solicitation of an offer to buy nor shall there be any sales of the Company’s securities in any state in which such an offer, solicitation or sale would be unlawful. The securities mentioned herein have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws.

 

Item 9.01 Financial Statement and Exhibits

  

(d) Exhibits

 

Exhibit No.   Description
10.1   Definitive License Agreement between the Company and OncoX BioPharma, Inc.
10.2  

Definitive License Agreement between Rgene and OncoX BioPharma, Inc.

99.1   Press Release.
104   Cover Page Interactive Data File, formatted in Inline XBRL

 

 

1Price was determined through private negotiations between the parties; no third party valuation was completed.

 

1

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  ABVC BioPharma, Inc.

 

April 17, 2024 By: /s/ Uttam Patil
    Uttam Patil
    Chief Executive Officer

 

 

2

 

 

 EX-10.1 2 ea020397101ex10-1_abvcbio.htm DEFINITIVE LICENSE AGREEMENT BETWEEN THE COMPANY AND ONCOX BIOPHARMA, INC

Exhibit 10.1

 

Definitive Licensing Agreement

 

This Definitive Licensing Agreement (“Agreement”) is entered into this April 16, 2024 (the “Effective Date”) by and between:

 

(1)ABVC BioPharma, Inc., a company registered in Nevada. (“ABVC”); and

 

(2)OncoX BioPharma, Inc. (“ONCOX”), a company registered in the British Virgin Islands.; and

 

ABVC and ONCOX shall be referred to individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, the parties have agreed to the Key Terms (see Exhibit A) as outlined in the Term Sheet, and now formalize their understanding in this Definitive Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the parties agree as follows:

 

1. Upon signing this Definitive Agreement, ONCOX shall have the exclusive right, until the expiration of this agreement, to negotiate and execute a definitive licensing agreement for the licensed products with ABVC.

 

2. ONCOX has the right to team with partner(s) or transfer the right to a third party to negotiate and execute a definitive licensing agreement for the licensed products with ABVC.

 

3. ONCOX has satisfactorily completed a due diligence investigation of the Licensed Product.

 

4. ABVC and its Representatives shall deal exclusively with ONCOX with respect to any licensing in the same scope or similar arrangement surrounding the Licensed Product.

 

IN WITNESS WHEREOF, the parties hereto have executed this Definitive Agreement as of the Effective Date.

 

 

 

 

[Signature Page]

 

ABVC BioPharma, Inc.   OncoX BioPharma, Inc.
Authorized Signature/Seal   Authorized Signature/Seal
     
Name:                    Name:                
Uttam Yashwant Patil   Yen Wen Pin
Title:     Title:  
CEO   CEO

 

2

 

 

Exhibit A

 

LICENSEE OncoX BioPharma, Inc. (“ONCOX”)
LICENSOR ABVC BioPharma, Inc. (“ABVC”) and its affiliates
THIRD PARTY “Third Party” means a person or entity other than ONCOX or ABVC or their respective affiliates.
EFFECTIVE DATE The effective dates of Definitive Agreement related to the Licensed Product that would be the result of Parties’ discussions

LICENSED PRODUCT

 

 ABVC's BLEX 404, single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer
TERRITORY North America
GOVERNING LAW Laws of the United States
FIELD OF USE Non-Small Cell Lung Cancer

RIGHTS GRANTED

 

 ABVC shall grant to ONCOX an exclusive right within the Territory license to develop and commercialize the Licensed Product in the Territory within the Field of Use.

RESPONSIBILITIES & OBLIGATIONS

 

ABVC will be responsible for conducting the clinical development of the Licensed Product outside Territory and communicating the results as part of the Product Transfer (PT), which includes delivering the Licensed Product sufficient to support the clinical studies in Territory, delivering associated documents, manufacturing protocols, QC protocols, to enable ONCOX to develop and commercialize the Licensed Product in Territory.

 

ABVC will be responsible to secure the supply of the Licensed Product to ONCOX in the Territory with an agreed price and quantity while A will secure the purchase of the Licensed Products from ABVC in the Territory with committed volume. Further details are to be defined in the Definitive Agreement.

 

ONCOX shall be responsible for completing regulatory filing of IND in the Territory.

 

ABVC will be responsible for providing the Licensed Product to ONCOX at cost, to support clinical development in the Field of Use in the Territory.

 

ONCOX will be responsible for further development and commercialization of the Licensed Product in the Field of Use in the Territory, including any clinical development, regulatory affairs (including regulatory filings and approvals), and commercialization of the Licensed Product.

 

As part of this license, ONCOX will grant ABVC a perpetual, royalty-free right to use and reference any development, regulatory, and market data associated with the Licensed Product in ONCOX’s control.

EXCLUSIVITY/

NON-COMPETE

 During the collaboration, neither Parties or its affiliates will work on development of or commercialize in Territory any products containing Maitake Mushroom as the sole active ingredient or in combination with one or more other active ingredients outside of this Agreement or without a specific mutually agreed to written plan for depression indication.

 

3

 

 

TECHNOLOGY SHARING After the Effective Date, and at a time to be agreed upon by ONCOX and ABVC in the Definitive Agreement, ABVC would transfer to ONCOX in English that data related to any Licensed Products in ABVC’s possession and control that is required by regulatory authorities for opening an IND, NDA.

INTELLECTUAL PROPERTY RIGHTS

 

Intellectual Property means any patent, copyright, trade secret, trademark or other proprietary right；including all their applications , registrations, renewals and extensions.

 

Each Party or its Affiliates owns all rights, title and interest of the Intellectual Property developed or controlled by itself and will be responsible for filing and maintaining the Intellectual Property in the Territory at its own cost.

 

Each Party warrants it does not and will not infringe, violate or misappropriate any trademark, patent, copyright, industrial design, trade secret or any other intellectual property or proprietary right of any Third Party.

 

No right, title or interest is granted to the other Party in the Definitive Agreement, whether expressly or by implication, to any technology or Intellectual Property rights owned by a Party other than pursuant to the terms of the Definitive Agreement.

 

Each Party will retain an unconditional and unlimited right of access, inclusion, citation, electronic or photo copy, and regulatory cross reference, without limitation, to any and all regulatory, technical, and scientific documentations, and any and all communications with any and all regulatory authorities in the other Party’s Territory for all matters related to each Licensed Product during the License Term.

MILESTONE & ROYALTY PAYMENTS See Exhibit B.

TAX

 

 Payments to Licensor as detailed in Exhibit B are likely considered Licensor’s income generated in Territory. Licensor is responsible for income tax, value-added tax, and other related fees levied by Territory government authorities on these payments. If and to the extent that provision is made in law or regulation of Territory for withholding of taxes with respect to any such payment, Licensee shall pay such taxes on behalf of Licensor and provide Licensor with original receipt of such tax payments or withholding.
NET SALES

“Net Sales” means the total amount of invoices issued by the Licensee for selling the Product of each pack size in the Territory to the Third Parties responsible for distribution / logistics, minus the amount of allowable deduction items related to the Product actually provided to non-affiliates as follows:

 

a)                  sales value added tax

 

b)                  allowance, discount or rebate for rejection, defect, recall, return, retroactive price reduction

 

Net Sales shall be accounted in accordance with arm-length principles, industry standards and practices of the Territory, covering all sales of the Product to the Field of Use in the Territory. Any allowance, discount or rebate for any Third Party sales and marketing activities shall not be deducted from the Net Sales calculation.

 

Licensee shall allow Licensor to appoint a Third Party independent auditor to audit the financial accounts of Licensee or its affiliates to confirm the reasonableness and accuracy of the Net Sales calculation of the Product each year during the License Term.

LICENSE TERMS The term of licensing for the Licensed Product in the Territory is 20 years.

MANUFACTURING

 

Both Parties desire Licensee is responsible for the Licensed Product API manufacturing under CMO model as global primary supplier. Both Parties agree further study and analysis are to be performed for the feasibility from technical and financial perspective before the execution of related manufacturing agreement.

 

Manufacturing of Licensed Product finished product is subject to negotiation by both Parties.

 

4

 

 

Exhibit B

 

All payments below are pre-tax total payments in USD.

 

Milestones Timeline Payment to ABVC
Upfront Due 30 days after the signature of the Investment Agreement

$6,250,000

(or 1,250,000 shares of ONCOX at $5/share)

Completion Of Fundraising

 Due 30 days upon completion of next round fundraising US $625,000
Total Licensing Fee $6,875,000
Royalties

 

5% of annual Net Sales, accumulated to a total of US$6,250,000

 

Royalties shall be payable quarterly on annual Net Sales of the Licensed Product from the first commercial sale of a Licensed Product in the Territory to the end of License Terms.

 

 

5

 

 EX-10.2 3 ea020397101ex10-2_abvcbio.htm DEFINITIVE LICENSE AGREEMENT BETWEEN RGENE AND ONCOX BIOPHARMA, INC.

Exhibit 10.2

 

Definitive Licensing Agreement

 

This Definitive Licensing Agreement (“Agreement”) is entered into this April 16, 2024 (the “Effective Date”) by and between:

 

(1)Rgene Corporation., a company registered in Nevada. (“RGENE”); and

 

(2)OncoX BioPharma, Inc. (“ONCOX”), a company registered in the British Virgin Islands.; and

 

RGENE and ONCOX shall be referred to individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, the parties have agreed to the Key Terms (see Exhibit A) as outlined in the Term Sheet, and now formalize their understanding in this Definitive Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the parties agree as follows:

 

1. Upon signing this Definitive Agreement, ONCOX shall have the exclusive right, until the expiration of this agreement, to negotiate and execute a definitive licensing agreement for the licensed products with RGENE.

 

2. ONCOX has the right to team with partner(s) or transfer the right to a third party to negotiate and execute a definitive licensing agreement for the licensed products with RGENE.

 

3. ONCOX has satisfactorily completed a due diligence investigation of the Licensed Product.

 

4. RGENE and its Representatives shall deal exclusively with ONCOX with respect to any licensing in the same scope or similar arrangement surrounding the Licensed Product.

 

IN WITNESS WHEREOF, the parties hereto have executed this Definitive Agreement as of the Effective Date.

 

 

 

 

[Signature Page]

 

Rgene Corporation.   OncoX BioPharma, Inc.
Authorized Signature/Seal   Authorized Signature/Seal
     
Name:                    Name:                
Tsung Shann Jiang   Yen Wen Pin
Title:     Title:  
Chairman   CEO

 

2

 

 

Exhibit A

 

LICENSEE OncoX BioPharma, Inc. (“ONCOX”)
LICENSOR

RGENE CORPORATION (“RGENE”) and its affiliates

THIRD PARTY “Third Party” means a person or entity other than ONCOX or RGENE or their respective affiliates.
EFFECTIVE DATE The effective dates of Definitive Agreement related to the Licensed Product that would be the result of Parties’ discussions

LICENSED PRODUCT

 

 RGENE's BLEX 404, single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer
TERRITORY North America
GOVERNING LAW Laws of the United States
FIELD OF USE Non-Small Cell Lung Cancer

RIGHTS GRANTED

 

 RGENE shall grant to ONCOX an exclusive right within the Territory license to develop and commercialize the Licensed Product in the Territory within the Field of Use.

RESPONSIBILITIES & OBLIGATIONS

 

RGENE will be responsible for conducting the clinical development of the Licensed Product outside Territory and communicating the results as part of the Product Transfer (PT), which includes delivering the Licensed Product sufficient to support the clinical studies in Territory, delivering associated documents, manufacturing protocols, QC protocols, to enable ONCOX to develop and commercialize the Licensed Product in Territory.

 

RGENE will be responsible to secure the supply of the Licensed Product to ONCOX in the Territory with an agreed price and quantity while A will secure the purchase of the Licensed Products from RGENE in the Territory with committed volume. Further details are to be defined in the Definitive Agreement.

 

ONCOX shall be responsible for completing regulatory filing of IND in the Territory.

 

RGENE will be responsible for providing the Licensed Product to ONCOX at cost, to support clinical development in the Field of Use in the Territory.

 

ONCOX will be responsible for further development and commercialization of the Licensed Product in the Field of Use in the Territory, including any clinical development, regulatory affairs (including regulatory filings and approvals), and commercialization of the Licensed Product.

 

As part of this license, ONCOX will grant RGENE a perpetual, royalty-free right to use and reference any development, regulatory, and market data associated with the Licensed Product in ONCOX’s control.

EXCLUSIVITY/

NON-COMPETE

 During the collaboration, neither Parties or its affiliates will work on development of or commercialize in Territory any products containing Maitake Mushroom as the sole active ingredient or in combination with one or more other active ingredients outside of this Agreement or without a specific mutually agreed to written plan for depression indication.

 

3

 

 

TECHNOLOGY SHARING After the Effective Date, and at a time to be agreed upon by ONCOX and RGENE in the Definitive Agreement, RGENE would transfer to ONCOX in English that data related to any Licensed Products in RGENE’s possession and control that is required by regulatory authorities for opening an IND, NDA.

INTELLECTUAL PROPERTY RIGHTS

 

Intellectual Property means any patent, copyright, trade secret, trademark or other proprietary right；including all their applications , registrations, renewals and extensions.

 

Each Party or its Affiliates owns all rights, title and interest of the Intellectual Property developed or controlled by itself and will be responsible for filing and maintaining the Intellectual Property in the Territory at its own cost.

 

Each Party warrants it does not and will not infringe, violate or misappropriate any trademark, patent, copyright, industrial design, trade secret or any other intellectual property or proprietary right of any Third Party.

 

No right, title or interest is granted to the other Party in the Definitive Agreement, whether expressly or by implication, to any technology or Intellectual Property rights owned by a Party other than pursuant to the terms of the Definitive Agreement.

 

Each Party will retain an unconditional and unlimited right of access, inclusion, citation, electronic or photo copy, and regulatory cross reference, without limitation, to any and all regulatory, technical, and scientific documentations, and any and all communications with any and all regulatory authorities in the other Party’s Territory for all matters related to each Licensed Product during the License Term.

MILESTONE & ROYALTY PAYMENTS See Exhibit B.

TAX

 

 Payments to Licensor as detailed in Exhibit B are likely considered Licensor’s income generated in Territory. Licensor is responsible for income tax, value-added tax, and other related fees levied by Territory government authorities on these payments. If and to the extent that provision is made in law or regulation of Territory for withholding of taxes with respect to any such payment, Licensee shall pay such taxes on behalf of Licensor and provide Licensor with original receipt of such tax payments or withholding.
NET SALES

“Net Sales” means the total amount of invoices issued by the Licensee for selling the Product of each pack size in the Territory to the Third Parties responsible for distribution / logistics, minus the amount of allowable deduction items related to the Product actually provided to non-affiliates as follows:

 

a)                  sales value added tax

 

b)                  allowance, discount or rebate for rejection, defect, recall, return, retroactive price reduction

 

Net Sales shall be accounted in accordance with arm-length principles, industry standards and practices of the Territory, covering all sales of the Product to the Field of Use in the Territory. Any allowance, discount or rebate for any Third Party sales and marketing activities shall not be deducted from the Net Sales calculation.

 

Licensee shall allow Licensor to appoint a Third Party independent auditor to audit the financial accounts of Licensee or its affiliates to confirm the reasonableness and accuracy of the Net Sales calculation of the Product each year during the License Term.

LICENSE TERMS The term of licensing for the Licensed Product in the Territory is 20 years.

MANUFACTURING

 

Both Parties desire Licensee is responsible for the Licensed Product API manufacturing under CMO model as global primary supplier. Both Parties agree further study and analysis are to be performed for the feasibility from technical and financial perspective before the execution of related manufacturing agreement.

 

Manufacturing of Licensed Product finished product is subject to negotiation by both Parties.

 

4

 

 

Exhibit B

 

All payments below are pre-tax total payments in USD.

 

Milestones Timeline Payment to RGENE
Upfront Due 30 days after the signature of the Investment Agreement

$6,250,000

(or 1,250,000 shares of ONCOX at $5/share)

Completion Of Fundraising

 Due 30 days upon completion of next round fundraising US $625,000
Total Licensing Fee $6,875,000
Royalties

 

5% of annual Net Sales, accumulated to a total of US$6,250,000

 

Royalties shall be payable quarterly on annual Net Sales of the Licensed Product from the first commercial sale of a Licensed Product in the Territory to the end of License Terms.

 

 

5

 
 EX-99.1 4 ea0203971ex99-1_abvcbio.htm PRESS RELEASE

Exhibit 99.1

 

 

ABVC Biopharma Executes a Global Licensing Definitive Agreement for the Treatment of NSCLC, Expecting Aggregate Income of $13.75M and Royalties of up to $12.50M

 

Fremont, CA (April 16, 2024) – ABVC BioPharma, Inc. (NASDAQ: ABVC) (“Company”), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and Oncology/Hematology, announced today that the Company, together with its affiliate Rgene Corporation    entered into a comprehensive licensing agreement with OncoX, a private company registered in the British Virgin Islands that specializes in dietary supplements for Oncology. We are hopeful that this agreement will facilitate the advancement of treatments for Non-Small Cell Lung Cancer (NSCLC) since it covers the license for the clinical trial, registration, manufacturing, supply, and distribution rights of ABVC’s single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer. ABVC and its affiliate are set to receive an aggregate license fee of $12,500,000 in the form of cash or shares of OncoX securities   within 30 days of executing the agreement, with an additional milestone payment of $1,250,000 in cash after OncoX’s next round of fundraising, of which there can be no guarantee; ABVC and its affiliate are also entitled to royalties of 5% of net sales, up to $12,500,000, after the launch of the licensed product.

 

The United States Food & Drug Administration (US FDA) has approved four INDs: ABV-1501 (IND 129575) for Triple Negative Breast Cancer (TNBC), ABV-1519 (IND 161602) for Non-Small Cell Lung Cancer (NSCLC)  , ABV-1702 (IND 131300) for Myelodysplastic Syndrome (MDS), and ABV-1703 (IND 136309) for Pancreatic Cancer Therapy. The Investigational New Drug (IND) application for ABV-1519 proposed the clinical investigation of BLEX 404 as a Combination Therapy Drug with Chemotherapy. The active ingredient of BLEX 404 is the β-glucan extracted from Grifola frondosa (maitake mushrooms), an edible fungus with high medical and commercial values in Asia; it contains various bioactive constituents such as polysaccharides, pyrrole alkaloids, ergosterol, etc., and has been widely served as functional foods for a long time in daily life.1

 

Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC’s four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404  , a promising therapeutic agent for the treatment of NSCLC. We believe that this collaboration leverages the respective strengths of both companies to accelerate the availability  of this vital treatment to patients worldwide.

 

“We are thrilled to finalize this licensing agreement with OncoX, an emerging frontrunner in the healthcare industry,” said Dr. Uttam Patil, ABVC’s Chief Executive Officer. “This collaboration represents a significant step forward in our mission to combat NSCLC and underscores our commitment to delivering innovative therapies to needy patients. “He added that ABVC brings its cutting-edge research and development capabilities. With a deep understanding of NSCLC and a commitment to improving patient outcomes, ABVC will spearhead the development of BLEX 404, which has demonstrated promising results in clinical studies.”

 

“OncoX is well-positioned to bring BLEX 404 to the market efficiently and effectively. Through this partnership, patients suffering from NSCLC will gain access to a treatment option that has the potential to transform their lives. This licensing agreement exemplifies ABVC and OncoX’s shared dedication to advancing medical science and improving patient care. Both companies are committed to working closely to ensure the successful development and commercialization of BLEX 404,” said Wen-Pin Yen, CEO of OncoX.

 

NSCLC often develops resistance to single-agent therapies. Thus, combining different drug classes, such as chemotherapy with targeted therapy or immunotherapy, can help overcome resistance mechanisms and improve treatment outcomes.2 We believe combination therapy often leads to higher response rates than monotherapy, particularly in aggressive or advanced NSCLC, where a robust initial response is crucial for patient outcomes. Synergistic effects have been shown when β-glucan is used alongside chemotherapy in cancer patients.3 Studies of patients being treated with Combination Therapy show an increase in the overall survival rate for lung cancer.4 Combination Therapy represents a promising approach to address the unmet demands in NSCLC treatment by improving efficacy, overcoming resistance, and providing patients with more personalized and targeted therapeutic options. MSKCC, a prominent research institute in the USA, has conducted two Clinical trials to evaluate the safety of BLEX 404.5,6

 

 

1https://www.sciencedirect.com/science/article/abs/pii/S0960852407001083?via%3Dihub

2

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10203373/
3

https://pubmed.ncbi.nlm.nih.gov/12126464/
4https://lcfamerica.org/treatment/combination-therapy/#:~:text=Combining%20pembrolizumab%20with%20conventional%20chemotherapy,cell%20lung%20cancer%20(NSCLC).
5https://pubmed.ncbi.nlm.nih.gov/19253021/

6

https://pubmed.ncbi.nlm.nih.gov/25351719/

 

 

 

  

The terms of the agreement include upfront payments, milestone payments upon achievement of certain developmental milestones, and royalties on net sales of BLEX 404, which cannot be guaranteed.   

 

Management believes the Company’s product pipeline has excellent market potential. The global cancer therapeutics market is expected to be worth around US$393.61 billion by 2032, up from US$164 billion in 2022, growing at a CAGR of 9.20% from 2023 to 2032.7 Lung Cancer Market is valued at US$ 29.5 billion in 2022 and is projected to grow at 11% CAGR through 2032.8

 

For more information about ABVC and its subsidiaries, stay updated on the latest updates or visit https://abvcpharma.com. ABVC urges its shareholders to sign up on the Company’s website for the latest news alerts; visit https://abvcpharma.com/?page_id=17707

 

About ABVC BioPharma & Its Industry

 

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company’s network of research institutions includes Stanford University, the University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III.

 

Forward-Looking Statements

 

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company’s securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company’s securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

 

Contact:

Leeds Chow

Email: leedschow@ambrivis.com

 

  

 

7https://www.precedenceresearch.com/cancer-therapeutics-market
8https://www.gminsights.com/industry-analysis/lung-cancer-market#:~:text=Lung%20Cancer%20Market%20size%20was,raise%20awareness%20about%20the%20disease.

 

 

 

 

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