China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval in Macau for Opzelura (ruxolitinib) cream, a topical treatment indicated for patients aged 12 and above with non-segmental vitiligo involving the face.
Opzelura, a topical Janus kinase (JAK) inhibitor, was initially approved in the U.S. in September 2021 for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in patients aged 12 and above who are not candidates for traditional topical prescription therapies. It later expanded its U.S. indication in July 2022 to include 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), securing exclusive rights to Opzelura in Greater China, which includes mainland China, Hong Kong, Macao, and Taiwan, as well as in 11 Southeast Asian countries. These countries include Indonesia, Philippines, Vietnam, Thailand, Myanmar, Malaysia, Cambodia, Laos, Singapore, Timor Leste, and Brunei. In August 2023, Opzelura was approved in Hainan as a clinically urgently needed import drug for the local treatment of non-segmental vitiligo in adolescents and adults aged 12 and above with facial involvement. – Flcube.com
