China Medical System’s Dermavon Achieves Major Regulatory Milestone: Ruxolitinib Phosphate Cream NDA for Atopic Dermatitis Accepted and Granted Priority Review in China

Key Highlights

• Regulatory Breakthrough: Dermavon Holdings Limited, a subsidiary of China Medical System Holdings Limited (“CMS” or “the Company”), has received acceptance from the National Medical Products Administration of China (NMPA) for the New Drug Application (NDA) of ruxolitinib phosphate cream for the treatment of mild to moderate atopic dermatitis (AD). Significantly, the NDA has also been granted inclusion in the Priority Review List, which is expected to accelerate the review process for marketing approval.
• Expanding Indications: Ruxolitinib phosphate cream was already approved by the NMPA in January 2026 as the first and only targeted drug for the treatment of vitiligo in China. The current NDA acceptance for an additional indication—atopic dermatitis—marks a pivotal expansion into a much larger therapeutic area.
• Market Potential: AD is a highly prevalent disease in China, with over 54 million patients as of 2024, and mild to moderate cases accounting for over 52.5 million. Current topical therapies have significant limitations, underscoring the urgent need for novel treatments like ruxolitinib phosphate cream.
• Strong Clinical Results: In a randomized, double-blind, placebo-controlled phase III clinical trial in China, ruxolitinib phosphate cream met its primary endpoint, demonstrating statistically significant improvements in disease severity and extent over placebo. Safety data indicated the drug was well-tolerated, with no discontinuations due to adverse events.
• Strategic Collaborations and Regional Rights: CMS, through Dermavon, holds exclusive development and commercialization rights for ruxolitinib phosphate cream across Mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries, with a non-exclusive license to manufacture in these territories.
• Comprehensive Dermatology Portfolio: Dermavon is enhancing its market competitiveness with a broad “treatment + care” solution for AD, including topical, injectable, and oral therapies, as well as skin care products. The acceptance of the NDA for AD will complement existing products such as ILUMETRI (tildrakizumab injection) and Hirudoid (mucopolysaccharide polysulfate cream).
• Corporate Developments and Listing Plans: Dermavon is currently seeking a separate listing on the Main Board of the Hong Kong Stock Exchange, which could further unlock value for shareholders.

Details for Investors and Shareholders

The acceptance and priority review status of the NDA for ruxolitinib phosphate cream in the treatment of atopic dermatitis are significant, potentially price-sensitive developments for CMS shareholders:

• Accelerated Market Entry: Priority review status means the product could achieve faster time-to-market, enabling CMS to capture a substantial share of the large and underserved AD market in China ahead of competitors.
• Pipeline Synergies: This milestone supports Dermavon’s strategic positioning as a leader in skin health, creating synergies with its existing innovative and exclusive dermatology products. This could enhance both revenue streams and brand influence.
• Potential for Share Price Impact: Given the size of the addressable market, the unmet need for effective therapies, and the competitive advantage conferred by first-mover status in targeted topical AD treatments, successful approval and commercialization could drive significant revenue growth and positively impact share valuation.
• Corporate Structure and Expansion: Dermavon’s planned separate listing could unlock additional shareholder value, provide greater market visibility, and attract strategic investment.
• Exclusive Rights and Partnerships: The exclusive license from Incyte confers CMS a strong competitive moat in China and key Asian markets, with sublicensing arrangements enabling further expansion potential.

Clinical and Regulatory Insights

Ruxolitinib phosphate cream (marketed as Opzelura^® in the US and Europe) is a topical JAK1/2 inhibitor with robust international regulatory credentials:

• US & Europe Approvals: Already approved for both vitiligo and atopic dermatitis in the US and Europe.
• China Clinical Data: In a pivotal phase III trial, 63% of patients achieved clear or almost clear skin (IGA 0/1 with ≥2-grade reduction) at week 8, versus just 9.2% in the placebo group. EASI 75 responses were 78% (active) vs. 15.4% (placebo). Safety profile was favorable, with only mild or moderate adverse events and no drug discontinuations.
• Addressing Unmet Need: Given the limitations of current therapies (corticosteroids, calcineurin inhibitors), ruxolitinib phosphate cream addresses a critical gap, particularly for long-term management.

Strategic Importance for CMS and Dermavon

• Brand and Market Leadership: The expansion into AD, following the vitiligo approval, will consolidate Dermavon’s leadership in dermatology and reinforce its expert and market network.
• Comprehensive Solution Offering: The development of a full suite of AD management options (topical, injectable, oral, and daily care) positions Dermavon to serve a broad spectrum of patient needs, supporting longer-term brand loyalty and market share.

Corporate Governance

As of the announcement date, the board of CMS comprises Mr. Lam Kong (Chairman), Ms. Chen Yanling (Executive Director), and three independent non-executive directors, ensuring robust governance practices.

Conclusion

The acceptance and priority review of ruxolitinib phosphate cream for atopic dermatitis in China is a material event for China Medical System Holdings Limited. It potentially accelerates the company’s entry into a multi-billion-yuan market and strengthens its leading position in skin health. The strategic, clinical, and commercial implications of this development are likely to be viewed positively by investors and could have a meaningful impact on the company’s share price.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should exercise due diligence and consult professional advisors before making investment decisions. The information is based on a company announcement dated 24 February 2026 and may be subject to change.

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