Shanghai Fosun Pharmaceutical (02196): "XH-S003" has initiated Phase II clinical trials in China for the treatment of complement abnormal activation related to IgA nephropathy and other glomerular diseases.

Shanghai Fosun Pharmaceutical (02196) announced that its controlling subsidiary, Zhejiang Xinghaopengbo Pharmaceutical Co., Ltd., has initiated Phase II clinical trials in China (excluding Hong Kong, Macau, and Taiwan) for XH-S003 capsules (application registration category: chemical drugs category 1; hereinafter referred to as "XH-S003") for the treatment of complement abnormal activation-related glomerular diseases such as IgA nephropathy. XH-S003 is a small molecule inhibitor independently developed by the group (including the company and its controlling subsidiaries/units) intended for the treatment of complement abnormal activation-related diseases. XH-S003 works by inhibiting the abnormal activation of the complement system, thereby suppressing the generation of complement proteins and immune complexes commonly found in the pathological manifestations of the disease. Preclinical studies have shown that in relevant animal models of glomerulonephritis, XH-S003 can significantly reduce inflammatory damage caused by complement activation, improve kidney function, and demonstrate good safety profiles. As of the date of this announcement (January 14, 2025), XH-S003 has completed Phase I clinical trials in China and Australia respectively. The overall results of these trials have shown that XH-S003 exhibits good safety and tolerability in healthy adults, as well as favorable pharmacokinetic and pharmacodynamic characteristics, including a long half-life (supporting once daily dosing), low effective dose, and up to 100% inhibition of complement-related biomarkers. As of November 2024, the group has invested approximately RMB 97.94 million (unaudited) in the research and development of XH-S003. As of the date of this announcement, there is no small molecule inhibitor with the same molecular mechanism approved for the treatment of complement abnormal activation-related glomerular diseases such as IgA nephropathy in China.