CMS (00867) has announced that its subsidiary, Demei Pharma, obtained approval from China's National Medical Products Administration (NMPA) on September 2, 2026, for the New Drug Application (NDA) of ruxolitinib phosphate cream (brand name: Bailuotuo) as a treatment for mild-to-moderate atopic dermatitis (AD). The pharmaceutical registration certificate was formally received on September 3, 2026. The product is indicated for short-term and non-continuous chronic topical treatment of mild-to-moderate AD in non-immunocompromised children aged 2 years and above, as well as adults, in cases where other topical therapies are inadequately controlled or not recommended.

The NDA for this AD indication was granted priority review status by the NMPA's Center for Drug Evaluation due to its classification as a "new pediatric drug variety, dosage form, and specification tailored to children's physiological characteristics," which significantly shortened the review timeline and expedited approval. In January 2026, Bailuotuo's NDA for vitiligo was approved, making it the first topical JAK inhibitor approved in China for that indication. With this AD approval, Bailuotuo has now successfully expanded into a second therapeutic area, offering a clinically validated new treatment option for pediatric, adolescent, and adult AD patients.

Demei Pharma has developed a comprehensive "treatment plus care" ecosystem for AD management, featuring topical ruxolitinib cream (Bailuotuo) for mild-to-moderate cases, the injectable biologic MG-K10 for moderate-to-severe AD, the oral small-molecule targeted therapy CMS-D001 for moderate-to-severe cases, and the Heling soothing product line for daily skin maintenance, addressing the full spectrum of patient needs from acute therapy to ongoing skincare.

Ruxolitinib phosphate cream is an innovative formulation developed by Incyte, incorporating ruxolitinib, a selective JAK1/JAK2 inhibitor. In a randomized, double-blind, placebo-controlled Phase III clinical trial conducted in China for mild-to-moderate AD, Bailuotuo achieved its primary endpoint: after 8 weeks of treatment, the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with at least a 2-point improvement from baseline was significantly higher than placebo (63.0% vs. 9.2%, P<0.001). On the key secondary endpoint, the proportion of patients achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) at 8 weeks 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, with no TEAEs leading to discontinuation of study medication, demonstrating a favorable overall safety and tolerability profile.

AD is a chronic, relapsing inflammatory skin condition characterized by dry skin, eczematous lesions, and pronounced pruritus, which can significantly impair quality of life. It is estimated that over 54 million people in China were living with AD in 2024, with mild-to-moderate cases accounting for 98%—more than 52.5 million patients. Topical therapies remain the cornerstone of AD management, yet traditional options like topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs) are hampered by long-term adverse effects or limited efficacy, underscoring a pressing clinical need for novel treatments.

Following the vitiligo approval, this AD indication approval for Bailuotuo further broadens its clinical utility and strengthens Demei Pharma's strategic positioning in dermatology. It is expected to generate synergies with existing commercial-stage innovative drugs such as Yiluqu (tirichizumab injection) and the proprietary Hylatopic (mucopolysaccharide polysulfate cream), alongside a pipeline of investigational therapies and dermocosmetic products, enhancing market access and brand influence within the skin health sector.

On December 2, 2022, Demei Pharma entered into a collaboration and license agreement with Incyte for ruxolitinib phosphate cream, securing exclusive rights to develop, register, and commercialize the product in mainland China, Hong Kong SAR, Macau SAR, Taiwan, and eleven Southeast Asian countries, along with non-exclusive manufacturing rights in these territories. Demei Pharma has sublicensed rights for regions outside mainland China to CMS (excluding Demei Pharma itself). Incyte retains global development and commercialization rights for ruxolitinib phosphate cream, marketed as Opzelura® in the U.S. and Europe, with Opzelura® being a registered trademark of Incyte. In the U.S., the cream was the first topical JAK inhibitor approved by the FDA, indicated for nonsegmental vitiligo in adults and children aged 12 years and older, as well as for mild-to-moderate AD in non-immunocompromised adults and children aged 2 years and older when other topical therapies are inadequately controlled or not recommended. In Europe, it is approved for the treatment of nonsegmental vitiligo with facial involvement in adults and adolescents aged 12 years and older, and for moderate AD in adults for whom TCS or TCIs are ineffective or not recommended.