Haisco gains NMPA approval for new HSK47388 autoimmune disease trials

Haisco Pharmaceutical Group announced it has received a "Notice of Drug Clinical Trial Approval" from the National Medical Products Administration. This approval allows the company to initiate clinical trials for a new indication of its innovative drug, HSK47388 tablets. The application for HSK47388 tablets, filed in June 2025, met drug registration requirements.

The new indication for HSK47388 tablets is for the treatment of autoimmune diseases. HSK47388 is an orally administered, potent, and highly selective drug developed independently by Haisco. Preclinical studies showed significant efficacy in a rat enteritis model, demonstrating a dose-dependent effect, good tolerance, and a wide safety window.

This marks another clinical trial application for HSK47388 tablets in the autoimmune disease field, potentially offering a new treatment option for patients. The company cautioned investors about the inherent risks of innovative drug development, including long cycles, numerous stages, and high uncertainty, and committed to disclose further project advancements.