China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its Opzelura (ruxolitinib) cream has been approved in Hong Kong. This topical Janus kinase (JAK) inhibitor is now approved for use as a local treatment for non-segmental vitiligo in patients aged 12 years and above, expanding the treatment options available in the region. This indication was previously approved in the US in July 2022.
Opzelura’s US Approval and Indications
Opzelura was first granted approval 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 years and above who are not suited to traditional topical prescription therapies. This approval marked a significant expansion in the treatment options for patients with AD.
Licensing Deal and Regional Expansion
In December 2022, CMS entered into a licensing agreement with US-based Incyte Pharmaceuticals Inc., (NASDAQ: INCY), securing exclusive rights to Opzelura in Greater China, including mainland China, Hong Kong, Macao, and Taiwan, as well as 11 Southeast Asian countries. This deal has been instrumental in expanding the reach of Opzelura in the region. 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. Most recently, in April this year, Opzelura received approval in Macau.- Flcube.com
