China Medical System wins NMPA nod to start CMKD clinical trials for novel complement factor B inhibitor CMS-D017
Summary:
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China Medical System has received Drug Clinical Trial Approval from China’s NMPA to begin trials of self-developed capsule CMS-D017 in healthy participants for complement-mediated kidney disease (CMKD) indications.
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The Phase 1 study in China will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CMS-D017, a novel selective small-molecule inhibitor of complement factor B targeting abnormal activation of the alternative complement pathway.
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CMS-D017 is being developed for multiple CMKD indications including IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis and C3 glomerulopathy, addressing unmet needs where current steroid and immunosuppressive regimens have limited efficacy and significant side effects.
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The product had already obtained NMPA clinical trial approval on 30 January 2026 for paroxysmal nocturnal hemoglobinuria, with further plans to develop it for age-related macular degeneration, myasthenia gravis and other complement-mediated conditions.
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Upon eventual approval, CMS-D017 is expected to strengthen the group’s nephrology franchise and create synergies with existing assets Velphoro and Desidustat, enhancing China Medical System’s competitiveness and market position in renal disease.