China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo. Opzelura, a topical Janus kinase (JAK) inhibitor, was approved in the US 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. The molecule is also under assessment for other immune-mediated skin diseases, including lichen planus and lichen sclerosus, and received a second US market approval in July this year as a local treatment for non-segmental vitiligo in patients aged 12 and above.
In December 2022, CMS entered into a licensing agreement with US-based Incyte Pharmaceuticals Inc., (NSDQ: INCY), securing exclusive rights to the drug in Greater China, including mainland China, Hong Kong, Macao, and Taiwan, as well as 11 Southeast Asian countries. Opzelura was approved in Hainan in August 2023 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
