Hangzhou Jiuyuan Genetic Biopharmaceutical Co., Ltd. (Jiuyuan Gene, 02566) disclosed that China’s National Medical Products Administration (NMPA) has cleared the Company’s investigational new drug (IND) application for JY47 Injection, authorising the commencement of clinical trials in patients with metabolic dysfunction-associated steatohepatitis (MASH) accompanied by liver fibrosis.

JY47 is a monoclonal antibody that antagonises signal-regulatory protein-alpha (SIRPα). The CD47-SIRPα pathway is recognised for its inhibitory role in immune regulation; blocking SIRPα is expected to restore immune cell activity, improve tissue micro-environment, and help re-establish metabolic homeostasis. Pre-clinical studies showed encouraging effects in both in-vitro organoid and in-vivo disease models of MASH.

The Board emphasised that JY47 is independently developed within Jiuyuan Gene’s biologics pipeline, illustrating progress in the Group’s R&D strategy. No financial figures or projected timelines were provided in the announcement.

Shareholders and potential investors are advised to exercise caution when dealing in the Company’s shares.