CMS (00867) announced that its subsidiary Dermag Pharma Limited (Dermag Pharma, an innovative pharmaceutical company specializing in skin health and currently applying for independent listing on the Main Board of The Stock Exchange of Hong Kong Limited), together with its subsidiaries, has achieved positive results from the Phase III clinical trial of ruxolitinib phosphate cream (ruxolitinib cream) for mild to moderate atopic dermatitis (AD) in China.
The trial was a randomized, double-blind, placebo-controlled, multicenter clinical study conducted in the Chinese population, enrolling 192 patients to evaluate the safety and efficacy of the product in treating mild to moderate AD. The study was led by Shanghai Skin Disease Hospital, with Professor Shi Yuling serving as the principal investigator.
The Phase III clinical study of the product for mild to moderate atopic dermatitis in China successfully achieved its primary endpoint. After 8 weeks of treatment with ruxolitinib cream, the proportion of subjects achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with an improvement of ≥2 points from baseline was significantly higher than placebo (63.0% vs 9.2%, P<0.001).
For the key secondary endpoint, the proportion of subjects achieving at least 75% improvement in Eczema Area and Severity Index score from baseline (EASI 75) after 8 weeks of ruxolitinib cream treatment was also significantly superior to placebo (78.0% vs 15.4%, P<0.001).
Regarding safety, the majority of treatment-emergent adverse events (TEAEs) were mild to moderate in severity. No treatment-emergent adverse events led to discontinuation of study medication, demonstrating good overall safety and tolerability.
Additionally, the Group is actively advancing the New Drug Application (NDA) process for the product in China.