China Medical System announces NDA acceptance for ruxolitinib cream in China

China Medical System announced that on September 24, 2024, the New Drug Application for vitiligo indication of ruxolitinib phosphate cream has been accepted by the National Medical Products Administration of China. This is another substantial milestone for ruxolitinib cream in China, following the approval for Urgent Clinical Import by Hainan Medical Products Administration and approval for marketing in Macau for vitiligo, and it is also a key step in benefiting over ten million of patients with vitiligo in China. Ruxolitinib cream achieved positive results in Chinese Real-World Study. The primary efficacy endpoint was the proportion of patients in the treatment group who achieved F-VASI 75 response at week 24, which was 49.5%, significantly higher than the target value of 14.1%. The study met its primary endpoint, demonstrating that ruxolitinib cream is effective in treating patients with nonsegmental vitiligo, reducing the area of the lesions, and repigmenting the skin. All secondary efficacy endpoints showed a trend of benefit consistent with the primary efficacy endpoint, and the treatment effect for vitiligo continued to improve with longer treatment duration. Adverse events mostly had severity levels of grade 1 or 2. No adverse event leading to discontinuation or withdrawal, and no serious adverse event related to the study drug occurred. While advancing the process of NDA for the Product, the Group is conducting the transfer of ruxolitinib cream from overseas production to domestic production, which is being orderly promoted by the Contract Development Manufacturing Outsourcing Organization, and the lab-scale and pilot trial studies have been completed and under scale-up production. The Group strives to complete the localization study as soon as possible, register in Mainland China and obtain marketing approval, so as to enable the Chinese patients with vitiligo to use the innovative product.