Biophytis announces the operational launch of its joint venture in China.
Biophytis announces the creation of the Chinese subsidiary of its Hong Kong joint venture, named Biophytis Biopharmaceutical Shenzhen, located within a business incubator affiliated with Shenzhen Polytechnic University, as well as its operational launch through the establishment of a dedicated team responsible for initiating the SARA-31 Phase 3 study in sarcopenia in China.
The Shenzhen-based team will be responsible for conducting the clinical study in China, in close coordination with Biophytis’ teams in Paris, which will oversee the overall coordination and conduct of the study in Europe. Its initial work will focus on preparing the regulatory dossier required to initiate the study and submitting it to the relevant authorities.
The creation of Biophytis Biopharmaceutical Shenzhen and the establishment of the team therefore mark the operational launch of Biophytis’ activities in China, in close coordination with its Asian partners. The next step will be the submission of a pre-IND dossier for the Phase 3 protocol to the Chinese drug regulatory authority, the NMPA (National Medical Products Administration).
In parallel with these operational developments, Biophytis and its Asian partners are finalizing the contractual and legal documentation for the Hong Kong joint venture. Once this framework has been approved by the Hong Kong authorities, Biophytis will be able to sign the final licensing and intellectual property contribution agreement with the joint venture. This signature will pave the way for the payment to the joint venture of an initial financing tranche of $3 million, the first step in a financing commitment of up to $20 million over three years.
This momentum confirms Biophytis’ and its Asian partners’ commitment to developing BIO101 in the Chinese market and preparing the launch of SARA-31, an international Phase 3 clinical study designed to evaluate BIO101 in sarcopenia.
