By Fineline Cube 
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) of China for its Category 1 investigational chemical drug HSK47388. This approval follows the drug’s approval for clinical trials by the US Food and Drug Administration (FDA) in July 2025, marking a significant milestone in its development.
Drug Profile
HSK47388 is an oral, highly selective drug targeting autoimmune diseases. Preclinical studies have shown that it can dose-dependently inhibit inflammatory responses in rats while demonstrating favorable tolerability and a wide safety margin. These results highlight its potential as a promising treatment option for patients with autoimmune conditions.
Global Development
With clinical trial approvals from both the NMPA and the FDA, Haisco is well-positioned to advance the global development of HSK47388. The company is dedicated to addressing unmet medical needs and improving treatment outcomes for patients with autoimmune diseases.-Fineline Info & Tech