Haisco Pharmaceutical Group (002653.SZ): Innovative drug HSK47388 tablet granted FDA approval to conduct clinical trials.

Haisco Pharmaceutical Group (002653.SZ) recently disclosed that it has received a Study May Proceed Letter from the Food and Drug Administration (FDA) of the United States. According to FDA regulations, after review, the clinical trial application for HSK47388 tablets submitted by the company in May 2025 meets the relevant requirements for drug registration, and has been approved to proceed with clinical trials. The announcement stated that HSK47388 tablets are orally administered, potent, and highly selective drugs developed independently by the company, intended for the treatment of autoimmune diseases. Preclinical research results have shown that HSK47388 can dose-dependently inhibit inflammation in rats, while also demonstrating good tolerability and a wide safety window. It is a drug with great development potential, and is expected to provide a new treatment option for patients with autoimmune diseases.