Shanghai Fosun Pharmaceutical (02196) subsidiary has received approval for clinical trials of its medication.

Shanghai Fosun Pharmaceutical (02196) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. (hereinafter referred to as Shanghai Fosun Pharmaceutical Industry), has received approval from the National Medical Products Administration for the clinical trial of FXS5626 tablets (original project code: AC-201, hereinafter referred to as FXS5626) for the treatment of non-segmental vitiligo to carry out a Phase II/III adaptive seamless design clinical trial. Shanghai Fosun Pharmaceutical Industry plans to conduct relevant clinical research on this drug within China once conditions are met. FXS5626 is an oral small molecule JAK inhibitor (a dual-target inhibitor of TYK2/JAK1) licensed in by the Group (i.e., the company and its holding subsidiaries/units, hereinafter the same). The Group enjoys exclusive rights for research, development, production, registration, and commercialization of this drug in China and the Hong Kong-Macau region. FXS5626 is primarily intended for the field of autoimmune diseases. As of the date of this announcement (i.e., September 8, 2026, hereinafter the same), the drug has completed Phase II clinical trials for moderate to severe plaque psoriasis in China and is in the Phase II clinical trial stage for non-infectious uveitis. As of August 2026, the Group's cumulative R&D investment in FXS5626 is approximately RMB 108 million (including licensing fees; unaudited). According to the latest data from IQVIA CHPA, in 2025, the sales revenue of JAK inhibitors in China is expected to be about RMB 1.98 billion. As of the date of this announcement, no TYK2/JAK1 dual-target inhibitor has been approved for marketing in China. According to relevant regulatory requirements, FXS5626 still needs to undergo a series of clinical studies in China and be approved by the National Medical Products Administration before it can be marketed. Based on R&D experience, there are certain risks associated with drug development, such as the possibility of clinical trials being terminated due to safety and/or efficacy issues.