Zhongsheng Pharmaceutical: ZSP1601 Tablets Included in Breakthrough Therapy Program

Zhongsheng Pharmaceutical announced that its wholly-owned subsidiary, Zhongsheng Ruichuang, has had its self-developed first-in-class innovative drug ZSP1601 tablets included in the breakthrough therapy program by the Center for Drug Evaluation of the National Medical Products Administration, with a proposed indication for metabolic associated steatohepatitis (MASH). ZSP1601 tablets are a first-in-class innovative drug with global independent intellectual property rights and a novel mechanism of action for treating MASH, designated as a national major new drug creation project. The Phase IIb clinical trial of ZSP1601 tablets for treating MASH has yielded positive data results; after 48 weeks of treatment, the primary efficacy endpoint of pathological improvement was achieved. Additionally, it delivers triple benefits in anti-fibrosis, reduction of liver fat content, and improvement of liver enzymes, with rapid onset, robust efficacy, and excellent safety profile. (Cailian Press)