Biophytis launches its Asian joint venture for Bio101, with funding still pending
Biophytis announced on 9 November 2026 the operational launch of its Asian joint venture dedicated to BIO101 in sarcopenia. The funding promised by its Asian partners, however, remains subject to the signing of a licence agreement, which is itself conditional on approval from the Hong Kong authorities.
A team in Shenzhen to lead the Chinese component of the SARA-31 trial
The new entity, Biophytis Biopharmaceutical Shenzhen, is the Chinese subsidiary of the joint venture based in Hong Kong. Located in a business incubator affiliated with the Shenzhen Polytechnic University, it relies on a dedicated team responsible for conducting the clinical study in China, in coordination with the Parisian teams, who will oversee the overall coordination of the study and its conduct in Europe.
Its initial work focuses on preparing the regulatory file required to launch the study and submitting it to the competent authorities. The announced next step is the submission of a pre-IND file for the phase 3 protocol to the NMPA, the Chinese medicines regulator.
The SARA-31 trial, which aims to obtain conditional marketing authorisation for BIO101 in sarcopenia in Asia and Europe, is expected to include 942 patients. The joint venture will be responsible for 642 patients in China and 90 in Japan, while Biophytis will directly coordinate the 200 European patients.
Launch authorisations have already been obtained in Europe and the United States. The study will begin once regulatory approvals are obtained in China and Japan.
Biophytis holds a minority stake but a majority on the board
The joint venture, Biophytis Biopharmaceutical Holding LTD, brings together Biophytis and a consortium of Asian partners, including Ronghui Renhe Life Technology, a Chinese conglomerate active mainly in the manufacturing and distribution of healthcare products. Its scope covers China, South Korea and Japan, markets where, according to the company, no treatment is currently approved for sarcopenia.
Biophytis contributes its intellectual property relating to BIO101. The Asian partners have committed to invest up to 20 million dollars over three years, including 10 million expected during the first twelve months and 3 million upon the establishment of the joint venture.
The payment of this first tranche remains subject to the ongoing finalisation of the joint venture's contractual and legal documentation. Once this framework is approved by the Hong Kong authorities, Biophytis may sign the definitive licence and intellectual property contribution agreement, which will pave the way for payment.
In terms of share capital, Biophytis and its founders hold 29% of the joint venture, compared with 71% for the consortium. However, the board of directors includes three representatives from Biophytis and its founders and two representatives from the consortium.
