Haisco Pharmaceutical Group Co.,Ltd. (002653.SZ) announced that the company recently received a "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. Following review, the HSK47388 tablets application submitted in June 2025 meets the relevant requirements for drug registration, and approval has been granted for clinical trials of this product.

HSK47388 tablets are an oral, potent, and highly selective drug independently developed by the company, intended for the treatment of autoimmune diseases. Preclinical study results demonstrate that HSK47388 exhibits significant dose-dependent efficacy in rat colitis models, while also showing good tolerability and a large safety window, making it a drug with substantial development potential.

This application represents another new indication clinical trial application for HSK47388 tablets in the field of autoimmune diseases, and is expected to provide a new treatment option for patients with autoimmune diseases.