CMS Receives NMPA Acceptance and Priority Review for Ruxolitinib Cream's Atopic Dermatitis Application

Stock News
02/24

CMS announced that its subsidiary, Demai Pharmaceutical, a specialist in dermatological health currently pursuing an independent listing on the Main Board of the Hong Kong Stock Exchange, has received acceptance from the National Medical Products Administration for its New Drug Application for ruxolitinib phosphate cream for mild to moderate atopic dermatitis. The application was accepted on February 24, 2026. The product is intended for the short-term, non-continuous chronic topical treatment of mild to moderate atopic dermatitis in immunocompetent patients aged 2 years and older, when other topical treatments have provided inadequate control or are not advisable. Furthermore, the NDA has been included in the NMPA's priority review list, as it qualifies under the category of "new pediatric drug varieties, formulations, and specifications that align with children's physiological characteristics." This designation is expected to expedite the review process for the atopic dermatitis indication. Ruxolitinib phosphate cream had previously received marketing approval from the NMPA in January 2026, becoming the first and only targeted therapy approved in China for the treatment of vitiligo. The acceptance of this NDA for the additional atopic dermatitis indication marks a key milestone in the product's expansion into multiple therapeutic areas.

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