CMS's Incyte-Licensed Ruxolitinib Ready for China Filing

Chinese company China Medical System (CMS) has reported positive Phase III results for ruxolitinib cream in mild-to-moderate atopic dermatitis, achieving 63.0% investigator global assessment response versus 9.2% for placebo with 78.0% eczema area severity index improvement (EASI) compared to 15.4% control group. The selective JAK1/JAK2 inhibitor demonstrated favourable safety profile with no treatment discontinuations due to adverse events in a 192-patient randomised double-blind study. CMS plans a new drug application (NDA) submission to China's National Medical Products Administration (NMPA) following successful trial outcomes.

The topical formulation addresses limitations of traditional corticosteroids and calcineurin inhibitors offering targeted inflammation control without systemic immunosuppression risks. Originally developed by Incyte Pharmaceuticals, ruxolitinib cream holds US approvals for vitiligo and atopic dermatitis as well as a European marketing authorisation for nonsegmental vitiligo. CMS secured exclusive rights for Greater China and Southeast Asia through a 2022 licensing agreement, with potential to address over 54 million atopic dermatitis patients in China where mild and moderate cases represent 98% of disease burden.

PharmCube's NextBiopharm® database shows that Incyte has licensed ruxolitinib to four developers across different regions. Click here to request a free trial for NextBiopharm®.

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