On 19 August, at the Launching Conference for the Pilot Project of ruxolitinib cream, China Medical System Holdings Limited (“CMS”) announced that ruxolitinib cream, has been approved by the Health Commission and Medical Products Administration of the Hainan Province, under the early access program in the Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”), for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Through this program, the first prescription of ruxolitinib cream was filled in China at the Boao Super Hospital, a designated medical institution of Hainan, for an eligible vitiligo patient.
The Pilot Zone allows individuals with urgent unmet needs to access innovative drugs, medical devices and technologies that have not yet been approved by NMPA in China but that have been approved by regulatory authorities overseas.
Through the program, Chinese patients can apply to use ruxolitinib cream and receive treatment from specialized physicians in Boao Super Hospital. CMS will collaborate with Boao Super Hospital to conduct real-world research on ruxolitinib cream as quickly as possible, which may help to advance the registration of the product in China more efficiently, and could benefit more vitiligo patients sooner.
Ruxolitinib cream, a topical JAK inhibitor, is not approved by the NMPA for any indication in China, except for the early access program in Boao Lecheng International Medical Tourism Pilot Zone for the treatment of eligible vitiligo patients, who currently do not have approved treatments in China.
Ruxolitinib cream is first and only topical JAK inhibitor approved by the U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) for repigmentation in vitiligo.
Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which results from the loss of pigment-producing cells known as melanocytes. It is estimated that there are approximately 14 million vitiligo patients in China. Non-segmental vitiligo patients account for approximately 85% of them1. Since vitiligo is more likely to occur in areas with exposed skin such as the face, neck and limbs, patients have a relatively high urgency for treatment.
In July 2022, ruxolitinib cream was approved by the U.S. FDA for the topical treatment of nonsegmental vitiligo in adults and pediatric patients aged 12 years of age and older, becoming the first and only FDA-approved product for repigmentation in vitiligo. Two pivotal clinical studies showed that after 24 weeks of treatment, compared with vehicle, the facial and total body repigmentation of patients treated with ruxolitinib cream was significantly improved, and 52-week data showed continuous improvement in repigmentation with the extension of treatment.
In April 2023, the EMA granted a marketing authorization for ruxolitinib cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. It is the first and only approved treatment in the European Union to offer support for repigmentation in eligible patients with non-segmental vitiligo.
In December 2022, CMS announced its Collaboration and License Agreement with Incyte, a U.S.-based global biopharmaceutical company, whereby CMS gained an exclusive license to develop and commercialize (and a non-exclusive license to manufacture) ruxolitinib cream in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
CMS stated that leveraging the favorable policies of the “Pilot Zone” eligible patients will be able to access ruxolitinib cream first in Lecheng. In the future, CMS will continue to collaborate extensively with global innovation sources to improve the accessibility of innovative drugs and benefit more Chinese patients.
About CMS
CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet healthcare needs.
CMS focuses on developing first- or best-in-class innovative products and has made the layout of 30 differentiated pipeline products with strong market potential. CMS deeply engages in specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to strengthen the competitiveness of its cardio-cerebrovascular/gastroenterology business, and independently operated dermatology and medical aesthetic business, and ophthalmology business, whilst enhancing the scale and efficiency. CMS also entered into the Southeast Asian market to create new opportunities to further enhance its sustainable development.
[1] Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7