China Medical System (867.HK; 8A8.SG) Positive Results from China Phase 3 Clinical Trial of Innovative Drug Ruxolitinib Cream with AD Indication

Core Viewpoint - China Medical System Holdings Limited (CMS) announced positive results from a phase 3 clinical trial of ruxolitinib cream for treating mild to moderate atopic dermatitis (AD) in China, indicating significant efficacy and safety of the product [1][3]. Clinical Trial Summary - The phase 3 clinical trial was a randomized, double-blind, placebo-controlled study involving 192 patients, led by Shanghai Dermatology Hospital [2]. - The trial met its primary endpoint, with 63.0% of patients achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at week 8, compared to 9.2% in the placebo group (P<0.001) [3]. - For the key secondary endpoint, 78.0% of patients treated with ruxolitinib cream achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI 75) score at week 8, versus 15.4% in the placebo group (P<0.001) [3]. - The treatment was found to be safe and well-tolerated, with most treatment-emergent adverse events being mild or moderate, and no discontinuations due to adverse events [3]. Product Development and Regulatory Status - CMS is advancing the new drug application (NDA) for ruxolitinib cream in China [4]. - The product has received approval for the treatment of non-segmental vitiligo in Hong Kong and Macau, and is also approved by the Guangdong Provincial Medical Products Administration [7]. - A collaboration and license agreement was established between CMS's subsidiary Dermavon and Incyte for the development and commercialization of ruxolitinib cream in various regions, including Mainland China and Southeast Asia [8][9]. Market Context for Atopic Dermatitis - Atopic dermatitis is a chronic inflammatory skin condition affecting over 54 million patients in China as of 2024, with 73% classified as mild and 25% as moderate [5]. - Traditional treatments like topical corticosteroids have limitations, highlighting the need for novel therapies such as ruxolitinib cream [5]. About Ruxolitinib Cream - Ruxolitinib cream (Opzelura®) is a selective JAK1/JAK2 inhibitor developed by Incyte, approved in the U.S. for non-segmental vitiligo and for mild to moderate AD in patients aged 2 and older [6].