By: IPP Bureau
Last updated : September 04, 2026 9:46 am
Priority-reviewed topical JAK inhibitor now approved for children as young as two, backed by Phase III data showing 63% response rate at eight weeks
China Medical System Holdings Limited announced that its subsidiary Dermavon Holdings Limited has secured approval from the National Medical Products Administration for a new indication of its flagship cream, ruxolitinib phosphate cream (Lumirix), this time targeting mild to moderate atopic dermatitis.
The New Drug Application cleared on September 2, with the official drug registration certificate issued the following day.
The approval marks the second major indication for Lumirix® in under a year. The drug first launched in January 2026 as China's first topical JAK inhibitor, approved then to treat vitiligo.
With this latest clearance, it now extends to non-immunocompromised patients as young as two years old, adolescents, and adults whose atopic dermatitis has not responded adequately to standard topical prescription therapies.
Regulators fast-tracked the review, placing the application on the CDE's Priority Review List after recognizing the formulation as a new pediatric-appropriate variety and dosage suited to children's physiological needs — a designation that meaningfully shortened the path to market.
The approval rests on a randomized, double-blind, placebo-controlled Phase III trial conducted in China. At week eight, 63.0% of patients on Lumirix achieved clear or almost-clear skin with at least a two-grade improvement from baseline, compared with just 9.2% on placebo (P < 0.001).
A key secondary measure told a similar story: 78.0% of treated patients hit a 75% improvement in eczema severity scores, versus 15.4% on placebo. Safety data showed treatment-emergent adverse events were mostly mild to moderate, with no patients discontinuing due to side effects.
Atopic dermatitis affected more than 54 million people in China in 2024, according to a CIC Report cited by the company. Dermavon has been assembling a layered response to that burden, spanning a topical option in Lumirix for milder cases, an injectable biologic, Comekibart, currently under NDA review for moderate-to-severe disease, an oral candidate, CMS-D001, now in Phase II trials, and a marketed skincare line, Heling, for daily maintenance.
Company officials framed the expanded approval as reinforcing Dermavon's broader dermatology footprint, one that already includes commercialized products ILUMETRI and Hirudoid, with expectations that shared expert networks and market resources across the portfolio will strengthen the company's competitive position in skin health as it separately pursues a Main Board listing in Hong Kong.