CMS (00867) announced that povorcitinib, an innovative oral JAK1 inhibitor (proposed Chinese generic name: phosphate povorcitinib tablets) with licensing rights held by its subsidiary Demai Pharmaceuticals, has been approved by China's National Medical Products Administration (NMPA) for inclusion in the breakthrough therapy list. The intended indication is for non-segmental vitiligo in adult patients. This designation is expected to accelerate the product's development and review process.
Povorcitinib is a selective oral small-molecule JAK1 inhibitor with substance and use patents in specific countries/regions. Currently, it is undergoing Phase 3 clinical trials overseas for non-segmental vitiligo, moderate-to-severe hidradenitis suppurativa (HS), and prurigo nodularis. Additionally, a Phase 2 clinical trial for asthma treatment is underway.
The inclusion in the breakthrough therapy list may expedite its development and regulatory review in mainland China. If approved, povorcitinib could synergize with Demai's marketed innovative drug Ilumetri (tildrakizumab injection), exclusive product Hirudoid (mucopolysaccharide polysulfate cream), and the pending new drug application (NDA) for ruxolitinib phosphate cream, enhancing clinical and commercial value while benefiting more dermatology patients.
Furthermore, povorcitinib and topical ruxolitinib phosphate cream will offer differentiated, comprehensive treatment options for vitiligo patients.
On March 31, 2024, CMS entered a collaboration and licensing agreement with Incyte through Demai's subsidiary, securing exclusive rights to research, develop, register, and commercialize povorcitinib in mainland China, Hong Kong SAR, Macau SAR, Taiwan, and 11 Southeast Asian countries, along with non-exclusive manufacturing rights. Demai's subsidiary has sublicensed the rights outside mainland China to CMS (excluding Demai and its subsidiaries).
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