China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA).
Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in the U.S. in September 2021 for the short-term and non-continuous treatment of mild to moderate atopic dermatitis (AD) in patients aged 12 and older who are not suitable for traditional topical prescription therapies. The cream gained a second approval in the U.S. in July 2022 for the local treatment of non-segmental vitiligo in patients aged 12 and above.
In December 2022, CMS entered into a licensing agreement with U.S.-based Incyte Pharmaceuticals Inc. (NASDAQ: INCY), acquiring exclusive rights to Opzelura in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan, as well as 11 Southeast Asian countries, including Indonesia, the Philippines, and Vietnam. The drug was approved in Hainan in August 2023 as a clinically urgently needed import for the local treatment of non-segmental vitiligo in adolescents and adults aged 12 and above with facial involvement. Additionally, Opzelura received approval in Macau in April of this year.- Flcube.com
