Haisco (002653.SZ) Gains FDA Clearance for Clinical Trials of Innovative Drug HSK47388 Tablets

Stock Track
15 Jul

Haisco Pharmaceutical Group (002653.SZ) has secured regulatory approval from the U.S. Food and Drug Administration (FDA) to advance clinical trials for its investigational drug HSK47388 tablets. The FDA issued a Study May Proceed Letter following thorough evaluation, confirming that the clinical trial application submitted in May 2025 satisfies all necessary pharmaceutical registration requirements.

This breakthrough medication represents Haisco's proprietary innovation – an orally administered, potent, and highly selective therapeutic agent targeting autoimmune disorders. Extensive preclinical research demonstrates HSK47388's ability to suppress inflammatory responses in rat models through dose-dependent mechanisms. The compound simultaneously exhibits exceptional tolerance profiles and a wide therapeutic safety window during testing.

Positioned as a promising developmental candidate, HSK47388 could potentially offer autoimmune disease patients a novel treatment alternative. The drug's dual capacity for targeted efficacy and favorable safety metrics underscores its significant therapeutic potential within the immunology treatment landscape.

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