China Medical System Holdings Limited (“CMS” or the “Group”) is delighted to reveal that its subsidiary, Dermavon Holdings Limited (“Dermavon”, an ingenious pharmaceutical business concentrated on skin health which is getting a different listing on the Main Board of The Stock Exchange of Hong Kong Limited) got the approval from the National Medical Products Administration of China (NMPA) for the New Drug Application (NDA) of ruxolitinib phosphate cream (Lumirix ® )for the treatment of moderate to moderate atopic dermatitis (“ADVERTISEMENT”) on 2 September 2026. The drug registration certificate was acquired on 3 September 2026. The item is shown for the topical short-term and non-continuous persistent treatment of moderate to moderate atopic dermatitis in non-immunocompromised adult and pediatric clients 2 years of age and older whose illness is not sufficiently managed with topical prescription treatments or when those treatments are not recommended.
The NDA for sign advertisement has actually been authorized for addition in the Priority Review List by the Center for Drug Evaluation (CDE) of the NMPA based upon its certification as a “brand-new range, dose type and requirements of pediatric drug that complies with the physiological qualities of kids”, which efficiently reduced the item’s evaluation procedure and sped up the marketing approval for the advertisement sign.
From “First Topical JAK Inhibitor” to Indication Expansion, Lumirix ® Continues to Deliver Clinical Value
In January 2026, Lumirix ® was authorized for marketing by the NMPA, ending up being the very first topical JAK inhibitor authorized in China for the treatment of vitiligo. The approval of this NDA for the extra sign of advertisement provides an unique treatment choice for pediatric clients 2 years of age and older, teen and adult advertisement clients, with security and effectiveness supported by scientific information *.
Formerly, Lumirix ® attained favorable lead to a randomized, double-blind, placebo-controlled stage III scientific trial in China for moderate to moderate advertisement:
· Robust Efficacy: Lumirix ® effectively satisfied its main endpoint– a considerably greater percentage of clients treated with Lumirix ® attained IGA (Investigator’s Global Assessment) of 0 or 1 with a minimum of 2 grades of decrease from standard at week 8, compared to placebo (63.0% vs 9.2%, P <