Group 1 - Company has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for the innovative drug HSK47388, which is intended for the treatment of autoimmune diseases [1] - HSK47388 is an orally administered, potent, and highly selective drug that has shown significant efficacy in preclinical studies, particularly in rat models of enteritis, demonstrating dose-dependent effects and good tolerability [1] - The application for HSK47388 represents a new clinical trial for an additional indication in the field of autoimmune diseases, potentially providing a new treatment option for patients [1] Group 2 - The clinical trial application for HSK47388 was accepted in June 2025, indicating compliance with the relevant drug registration requirements [1] - The drug is classified as a tablet form and is aimed at treating autoimmune diseases, with the registration number CXHL2500600 for domestic production [1]
海思科: 关于获得创新药HSK47388片新适应症《药物临床试验批准通知书》的公告