CMS (00867.HK): China NDA Approval for Ruxolitinib Phosphate Cream in Atopic Dermatitis Adds a Second Indication

NewTimeSpace News: On September 3, 2026, China Medical System Holdings Limited (stock code: 00867) announced that the New Drug Application (NDA) of ruxolitinib phosphate cream (Bailutuo) for mild-to-moderate atopic dermatitis (AD), developed by its subsidiary Dermavon Holdings Limited (Dermavon), an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, had been approved by the National Medical Products Administration (NMPA) on September 2, 2026, with the drug registration certificate obtained on September 3. The NDA was included in the priority review list for pediatric-friendly new products, dosage forms and specifications matching children's physiological characteristics, which shortened the review cycle.

The product is indicated for the short-term and non-continuous chronic topical treatment of mild-to-moderate AD in immunocompetent children aged 2 years and above and adults, where other topical therapies are inadequately controlled or not recommended. In a Phase III clinical study in China, 63.0% of patients treated for 8 weeks achieved an Investigator's Global Assessment (IGA) score of 0 or 1 with an improvement of at least 2 points from baseline, versus 9.2% for placebo (P<0.001), and 78.0% achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI 75), versus 15.4% for placebo (P<0.001).

In January 2026, ruxolitinib phosphate cream received China NDA approval as the first topical JAK inhibitor approved in China for vitiligo, and the AD approval extends the product to a second indication. It is estimated that China had more than 54 million AD patients in 2024, with mild-to-moderate cases accounting for 98%, or more than 52.5 million patients. Dermavon has built a comprehensive treatment-plus-care solution for AD, spanning Bailutuo (mild-to-moderate disease), comekibart injection (MG-K10) (moderate-to-severe disease), oral small-molecule targeted drug CMS-D001 (moderate-to-severe disease) and the Heling soothing product line, which is expected to synergize with Dermavon's commercialized innovative drug ILUMETRI (tildrakizumab injection) and exclusive drug Hirudoid (mucopolysaccharide polysulfate cream) in expert networks and market resources.

On December 2, 2022, the group through Dermavon entered into a collaboration and license agreement with Incyte, obtaining exclusive rights to develop, register and commercialize ruxolitinib phosphate cream in Mainland China, Hong Kong SAR, Macao SAR, the Taiwan region and 11 Southeast Asian countries, together with non-exclusive rights to manufacture the product within the territory. Incyte retains global development and commercialization rights and markets the product as Opzelura in the United States and Europe, where it was the first topical JAK inhibitor approved by the US FDA.

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