China Medical System Holdings Limited said on Jan, 30 2026 that China’s National Medical Products Administration has approved the company to start Phase I trials of its self-developed oral drug CMS-D017 in healthy volunteers.

CMS-D017 is a small-molecule inhibitor of complement factor B designed to block abnormal activation of the alternative complement pathway. The drug is being developed for paroxysmal nocturnal hemoglobinuria (PNH), with potential follow-on indications that include complement-mediated kidney diseases, age-related macular degeneration and myasthenia gravis.

The planned study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CMS-D017.

If successfully developed and approved, CMS-D017 would expand the group’s nephrology portfolio alongside Velphoro and Oxemia, the latter of which is under regulatory review for renal anemia.

The company said it is preparing to launch the clinical programme promptly and will update investors on further progress.