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[6-K] Biophytis SA Current Report (Foreign Issuer)

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Biophytis SA has signed a landmark agreement to create a Hong Kong–based joint venture, Biophytis Biopharmaceutical Holding LTD, to advance its BIO101 drug for sarcopenia in Asia. A consortium of Asian partners, including Ronghui Renhe Life Technology, has committed up to US$20 million over three years, with US$10 million expected in the first year and US$3 million at the joint venture’s creation.

Biophytis and its founders will own 29% of the joint venture, while Asian partners will hold 71%, with a board including three Biophytis representatives and two from the partners. The joint venture is expected to be created within 180 days and become operational in the first half of 2026. It will support an international Phase 3 trial, SARA-31, enrolling 942 patients to seek conditional marketing authorization for BIO101 in sarcopenia in Asia and Europe, starting in the second half of 2026 after regulatory approvals in China and Japan.

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Insights

Asia JV and up to US$20 million funding support a pivotal Phase 3 program in sarcopenia.

Biophytis is forming a Hong Kong–based joint venture with Asian partners, including Ronghui Renhe Life Technology, focused on developing and commercializing BIO101 for sarcopenia in China, South Korea, and Japan. Partners commit up to US$20 million over three years, front-loaded with US$10 million in the first twelve months.

Biophytis and its founders retain 29% ownership and three of five board seats, while the consortium holds 71%, balancing control with external capital and local expertise. The joint venture structure aligns governance with shared development and commercialization objectives in key Asian markets.

The plan includes launching the SARA-31 Phase 3 trial with 942 patients to seek conditional marketing authorization for BIO101 in sarcopenia in Asia and Europe. The joint venture is expected to be operational in the first half of 2026, with the Phase 3 study starting in the second half of 2026 after regulatory approvals in China and Japan, building on approvals already obtained in Europe and the United States.

 

 

 

UNITED STATES SECURITIES

AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

Date of report: January 28, 2026

 

Commission File Number: 001-38974

 

BIOPHYTIS S.A.

(Translation of registrant’s name into English)

 

 

Stanislas Veillet
Biophytis S.A.

Sorbonne University—BC 9, Bâtiment A 4ème étage

4 place Jussieu

75005 Paris, France

+33 1 44 27 23 00

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

x Form 20-F ¨  Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 

 

 

 

 

 

 

On January 28, 2026, Biophytis S.A. issued a press release announcing that the company enters strategic agreement in Asia and secures $20 million for launch of Phase 3 trial in sarcopenia. A copy of the press release is attached as Exhibit 99.1 to this Form 6-K.

 

EXHIBIT LIST

 

Exhibit   Description
99.1   Press Release dated January 28, 2026.

 

 

 

 

SIGNATURES

 

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

 

  BIOPHYTIS S.A.
     
Date: January 28, 2026 By: /s/ Stanislas Veillet
    Name: Stanislas Veillet
    Title: Chairman and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

Biophytis enters strategic agreement

in Asia and secures $20 million for

launch of Phase 3 trial in sarcopenia

 

§Signing of a protocol agreement for the creation of a joint venture in Hong Kong.
§Financing secured for up to $20 million over three years, including $10 million in the first year.
§Phase 3 clinical trial expected to begin in the second half of 2026.

 

Paris (France) and Cambridge (Massachusetts, United States), 28 January 2026 – Biophytis SA (Euronext Growth Paris: ALBPS), (“Biophytis” or the “Company”), a pioneer in the development of transformative therapies impacting longevity, today announces the signing of a landmark agreement to create a Hong Kong-based joint venture, Biophytis Biopharmaceutical Holding LTD, designed to accelerate the development and commercialization of BIO101 in sarcopenia in Asian markets.

 

Stanislas Veillet, CEO of Biophytis, states: "This partnership is a historic step in our international development. It gives Biophytis access to Asian markets where the medical needs related to sarcopenia are most significant, while benefiting from the local expertise and financing capabilities of recognized partners. I am delighted by their commitment to working with us, which demonstrates the therapeutic potential of BIO101 and validates Biophytis' ability to address the challenges of mobility in the elderly and the aging population."

 

A Structuring Strategic Partnership for Biophytis

 

With the aim of leveraging the therapeutic potential of BIO101 in China, South Korea, and Japan, this joint venture will bring together Biophytis and a consortium of Asian partners, including Ronghui Renhe Life Technology, a leading Chinese conglomerate primarily involved in the manufacture and distribution of healthcare products.

 

Under the terms of the agreement, Biophytis will contribute its intellectual property related to BIO101 in these territories, while the Asian partners have committed to injecting up to US$20 million over three years, with a total of US$10 million expected during the first twelve months, including US$3 million upon the creation of the joint venture. In terms of capital distribution, Biophytis and its founders will hold 29% of the capital of the new entity, and the consortium of Asian partners will hold 71%.

 

The governance of the joint venture will reflect the spirit of balanced collaboration of this partnership, with a board of directors composed of three representatives from Biophytis and the founders and two representatives from the consortium of Asian partners, ensuring concerted decision-making and combined expertise.

 

A Precise Operational Timetable

 

The partnership will be rolled out according to a structured timetable, with the joint venture expected to be created within a maximum of 180 days. The joint venture is expected to become operational in the first half of 2026, with the injection of the first tranche of investment by the partners ($3 million) and the contribution of industrial property rights in the relevant territories (China, South Korea, and Japan) by Biophytis.

 

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An Ambitious Clinical Development Program

 

At the heart of this collaboration is the launch of an international Phase 3 clinical trial, called SARA-31, aimed at obtaining conditional marketing authorization (MA) for BIO101 in sarcopenia in both Asia and Europe. This multicentred study will include 942 patients strategically distributed as follows:

 

§642 patients in China, under the responsibility of the new entity.
§90 patients in Japan, under the responsibility of the new entity.
§200 patients in Europe, under the direct coordination of Biophytis.

 

Biophytis will oversee the overall coordination of this pivotal study, ensuring the scientific and regulatory consistency of the entire program.

 

This clinical study will commence in the second half of 2026, as soon as regulatory approvals have been obtained in China and Japan, while approvals to commence this Phase 3 study have already been obtained in Europe and the United States.

 

***

 

About BIO101 in Sarcopenia (SARA)

 

BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscle diseases (sarcopenia, Phase 3 ready to start) and metabolic disorders (obesity, Phase 2 ready to start). The SARA program is the world's most advanced clinical program in age-related sarcopenia. For this indication, no approved treatment exists to date, and it is estimated that one in four people over the age of 60 worldwide is affected¹. Living with sarcopenia significantly degrades quality of life and reduces life expectancy by 6 years². The Phase 2 clinical trial demonstrated the efficacy of BIO101 in improving mobility in patients with sarcopenia³. The planned Phase 3 trial will constitute a major step in addressing this unmet medical need and advancing longevity on a global scale.

 

About Biophytis

 

Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start) and metabolic disorders (obesity, Phase 2 ready to start). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company’s ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). For more information, visit www.biophytis.com

 

About Ronghui Renhe

 

Ronghui Renhe Group is a healthcare conglomerate headquartered in Shenzhen, China, with several subsidiaries active in the pharmaceutical, medical device, dermo-cosmetic, and healthcare equipment industries, with a significant presence in pharmaceutical distribution and healthcare product manufacturing.

 

Biophytis contacts

 

Investor Relations

investors@biophytis.com

 

Media contacts

Antoine Denry: antoine.denry@taddeo.fr – +33 6 18 07 83 27

Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50

 

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