The innovative drug CMS-D017 capsule developed independently by CMS(00867) has obtained the approval notification for clinical trial of drugs for renal diseases mediated by complement participation adaptation.

CMS (00867) announced that on February 3, 2026, the group's independently developed innovative drug CMS-D017 capsules obtained the drug clinical trial approval notice issued by the National Medical Products Administration (NMPA) of China. The NMPA has agreed for the group to conduct clinical trials in healthy participants in China to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMS-D017. CMS-D017 is a novel selective complement factor B small molecule inhibitor. The complement system is an important component of the innate immune system, which can be activated through the classical pathway, lectin pathway, and alternative pathway to perform biological functions. Complement factor B is a specific serine protease primarily synthesized by the liver, serving as the "core switch" and "amplifier" in the complement alternative pathway, and its activity directly affects the strength of complement response. By targeting and inhibiting complement factor B, CMS-D017 blocks abnormal activation of the complement alternative pathway, reduces damage from membrane attack complexes to target tissues and organs, and alleviates the progression of complement-mediated diseases. CMS-D017 has shown excellent efficacy and safety in preclinical studies, and is clinically intended for the treatment of complement-mediated kidney diseases, including but not limited to IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, and C3 glomerulopathy. Previously, CMS-D017 was intended for the treatment of paroxysmal nocturnal hemoglobinuria, and has already obtained the drug clinical trial approval notice on January 30, 2026. In the future, CMS-D017 is also intended to be developed for the treatment of complement-mediated diseases such as age-related macular degeneration and myasthenia gravis. If approved for market, CMS-D017 will effectively enhance the group's strength in the field of kidney disease treatment, synergizing with the group's commercialized innovative drug Viforay (sucroferric oxyhydroxide chewable tablets for CKD hyperphosphatemia) and the newly submitted drug Desidustat tablets (for renal anemia) in terms of expert network and market resources, collectively boosting the group's competitiveness and market position in this field. The group is actively preparing to conduct relevant clinical trial work, striving to bring the product to market as soon as possible.