China Medical System Holdings Limited (CMS) announced that subsidiary Dermavon Holdings obtained National Medical Products Administration (NMPA) approval on 2 September 2026 for a New Drug Application expanding ruxolitinib phosphate cream Lumirix® to treat mild-to-moderate atopic dermatitis (AD) in patients aged ≥2 years. The formal drug registration certificate was issued on 3 September 2026.
The AD approval—granted under the Center for Drug Evaluation’s Priority Review pathway as a “new pediatric variety, dosage form and specification”—is Lumirix®’s second Chinese indication following its January 2026 launch for vitiligo, positioning the topical Janus kinase (JAK1/JAK2) inhibitor as a novel alternative to traditional corticosteroids and calcineurin inhibitors.
Phase III China data underpinning the filing showed: • 63.0 % of Lumirix®-treated patients achieved an Investigator’s Global Assessment score of 0/1 with ≥2-grade improvement at Week 8, versus 9.2 % for placebo (P < 0.001). • 78.0 % reached ≥75 % EASI improvement, versus 15.4 % for placebo (P < 0.001). • Treatment-emergent adverse events were predominantly mild or moderate, with no drug-related discontinuations.
China hosts an estimated 54.00 million AD patients as of 2024, of which 98 %—around 52.50 million—present with mild to moderate disease. CMS is building a “treatment + care” platform for this population, combining Lumirix® for mild-to-moderate AD, Comekibart Injection (MG-K10) and oral small-molecule CMS-D001 for moderate-to-severe AD, and the Heling Soothing skincare line for daily management.
Dermavon licenses ruxolitinib phosphate cream from Incyte for Mainland China, Hong Kong, Macau, Taiwan and 11 Southeast Asian countries, while retaining non-exclusive manufacturing rights. The product is marketed as Opzelura® in the United States and Europe.
Management expects the newly added AD indication to reinforce Dermavon’s dermatology portfolio alongside marketed ILUMETRI (tildrakizumab injection) and Hirudoid (mucopolysaccharide polysulfate cream), leveraging shared physician networks and commercial infrastructure to enhance competitiveness in the skin-health segment.
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