Breakthrough Therapeutic Drugs
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CMS (867.HK/8A8.SG): Innovative Drug Oral JAK1 Inhibitor Povorcitinib Has Been Included in the List of Breakthrough Therapeutic Drugs in China
Globenewswireยท 2025-12-15 13:19
Core Viewpoint - China Medical System Holdings Limited's subsidiary, Dermavon Holdings Limited, has obtained licensing rights for the innovative oral JAK1 inhibitor povorcitinib, which is aimed at treating non-segmental vitiligo and has been recognized as a Breakthrough Therapeutic Drug by the NMPA, potentially expediting its development and review process in China [1][6]. Group 1: Product Development and Clinical Trials - Povorcitinib is currently undergoing Phase 3 clinical trials for non-segmental vitiligo, moderate to severe hidradenitis suppurativa, and prurigo nodularis in various countries outside China, with a Phase 2 trial for asthma also in progress [2]. - In March 2023, Incyte reported that povorcitinib met the primary endpoint in a global Phase 2b trial for non-segmental vitiligo, showing significant improvement in total body repigmentation after 24 weeks of treatment [3]. - Dermavon received approval from the NMPA in August 2025 to conduct clinical trials for povorcitinib in China, with plans to explore additional indications for skin-related diseases in the future [4]. Group 2: Market Potential and Patient Impact - Vitiligo affects approximately 10.3 million patients in China, with around 8.2 million suffering from non-segmental vitiligo, highlighting a significant unmet medical need for effective treatments [5]. - If approved, povorcitinib could offer a differentiated treatment option for non-segmental vitiligo patients, particularly those with moderate to severe forms of the disease [5]. - The inclusion of povorcitinib in the Breakthrough Therapeutic Drugs list is expected to enhance its clinical and commercial value, potentially benefiting patients with skin diseases through synergy with other Dermavon products [6]. Group 3: Collaboration and Licensing - Dermavon entered into a Collaboration and License Agreement with Incyte on March 31, 2024, granting exclusive rights to develop and commercialize povorcitinib in several regions, including Mainland China and Southeast Asia [7].