On February 3, 2026, CMS (00867) announced that its self-developed innovative drug, the CMS-D017 capsule, has received a drug clinical trial approval notice issued by the National Medical Products Administration (NMPA) of China. The NMPA has approved the Group to conduct a clinical trial in healthy Chinese participants to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMS-D017. CMS-D017 is a novel, selective small-molecule inhibitor of complement factor B. The complement system is a vital component of the innate immune system and can be activated via the classical, lectin, and alternative pathways to exert its biological functions. Complement factor B is a specific serine protease primarily synthesized by the liver; it acts as the "core switch" and "effector amplifier" in the complement alternative pathway, with its activity directly influencing the intensity of the complement response. By targeting and inhibiting complement factor B, CMS-D017 prevents the aberrant activation of the alternative pathway, thereby reducing damage to target tissues and organs caused by the membrane attack complex and alleviating the progression of complement dysregulation-related diseases. In preclinical studies, CMS-D017 demonstrated excellent efficacy and safety, and it is intended for clinical use in treating complement-mediated kidney diseases, including but not limited to IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, and C3 glomerulopathy. Previously, CMS-D017, intended for treating paroxysmal nocturnal hemoglobinuria, had already received a drug clinical trial approval notice on January 30, 2026. In the future, CMS-D017 is also planned to be developed for treating other complement-mediated diseases such as age-related macular degeneration and myasthenia gravis. If approved for marketing, CMS-D017 will significantly enhance the Group's capabilities in the field of nephrology treatment, creating synergies with the Group's commercially available innovative drug Vifor (sucroferric oxyhydroxide chewable tablets, for CKD hyperphosphatemia) and the new drug Desidustat tablets (for renal anemia), which is under review for market approval, leveraging shared expert networks and market resources to collectively boost the Group's competitiveness and market position in this area. The Group is actively preparing to commence the relevant clinical trial work, striving to bring this product to market as soon as possible.
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