Announcement on Preliminary Results of Phase IIb Clinical Trial of ZSP1601 Tablets for Treating MASH by Subsidiary
The company and all members of the board of directors guarantee the truthfulness, accuracy, and completeness of the information disclosed, and that there are no false records, misleading statements, or material omissions.
Guangdong Zhongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company")'s subsidiary, Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd. (hereinafter referred to as "Ruichuang"), has independently developed a first-in-class innovative drug, ZSP1601 tablets, for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). The company recently obtained the top-line analysis data from the Phase IIb clinical trial for this indication. Preliminary analysis results show that the primary efficacy endpoint response rate in both ZSP1601 tablet dosage groups was significantly superior to the placebo group, demonstrating potential for reversing liver fibrosis. These positive trial results support the continuation of Phase III clinical trials. The relevant details are hereby announced as follows:
I. ZSP1601 Tablet Clinical Trial Status
ZSP1601 tablets are a first-in-class innovative drug (First-in-Class) with independent global intellectual property rights and a novel mechanism of action for treating MASH. It is a key project of the National Major New Drug Innovation Program. Pre-clinical studies in multiple MASH animal pharmacodynamic models have shown that ZSP1601 can improve liver inflammation, steatosis, and necrosis, with a prominent effect on improving fibrosis, and is expected to become a core foundational drug for MASH combination therapy in the future. Results from completed Phase Ib/IIa clinical trials showed that MASH participants receiving ZSP1601 tablets at 50mg BID and 100mg BID for 28 consecutive days had significantly reduced serum transaminases and liver fat content compared to the placebo group, with non-invasive fibrosis indicators and biomarkers also showing a downward trend.