China Medical System announces NMPA acceptance of MG-K10 NDA

China Medical System (CHSYF)s announced that its subsidiary, Dermavon Holdings, together with its subsidiaries, holds co-development rights and exclusive commercialization rights for the Class 1 drug anti-IL-4Ralpha MG-K10 humanized monoclonal antibody injection. The New Drug Application has been accepted by National Medical Products Administration on 30 October 2025. The product is intended for the treatment of adult with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. MG-K10 is a long-acting anti-IL-4Ralpha humanized monoclonal antibody that simultaneously blocks the signaling of key type 2 inflammatory cytokines IL-4 and IL-13. With a longer half-life, the Product enables a four-week dosing frequency, which is expected to improve patient adherence. MG-K10 is expected to become the world’s first long-acting anti-IL-4Ralpha monoclonal antibody to be launched on the market, and has the potential to become the Best-in-Class. MG-K10 has achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical study in adults with moderate-to-severe AD, meeting the primary research endpoint as designed, and at 52 weeks of treatment with MG-K10, proportion of participants with Investigator Global Assessment score of 0 or 1, also with an improvement of greater than or equal to2 points from baseline is 76.6%; proportion of participants with greater than or equal to75% reduction in Eczema Area and Severity Index from baseline is 94.3 %; proportion of participants with greater than or equal to90% reduction in Eczema Area and Severity Index from baseline is 79.1 %. Regarding safety, most of the Treatment Emergent Adverse Event were Grade 1-2, with no Adverse Event of Special Interest or fatal adverse event occurred. The incidence of common adverse reactions of drugs with the same target is relatively low for MG-K10.