China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) to commence a Phase III clinical study for its Opzelura (ruxolitinib) cream, which is indicated for the treatment of atopic dermatitis (AD). This development marks a significant step forward for CMS in expanding the clinical application of this JAK inhibitor cream in China.
Opzelura, a topical JAK inhibitor designed for external use, was approved in the US in September 2021 for the short-term and non-continuous chronic treatment of mild to moderate AD in patients aged 12 and above, who are not suitable for traditional topical prescription therapies. The compound is under assessment for other immune-mediated skin diseases, including lichen planus and lichen sclerosus. It received its second market approval in the US 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 Incyte Pharmaceuticals Inc., (NSDQ: INCY), securing exclusive rights to the drug in Greater China, which encompasses mainland China, Hong Kong, Macao, and Taiwan, as well as in 11 Southeast Asian countries including 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
