China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 4 November 2024, the New Drug Application (NDA) of ruxolitinib phosphate cream (the “ruxolitinib cream” or the “Product”) has been approved by the Pharmacy & Poisons Board of Hong Kong (PPBHK). The certificate of drug/product registration was obtained on 5 November 2024. The Product is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
About Ruxolitinib Cream
Ruxolitinib cream (Opzelura®), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, and is the first and only treatment for repigmentation approved for use in the United States[1]. Ruxolitinib cream (Opzelura®) is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable[2]. In Europe, ruxolitinib cream (Opzelura®) is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age[3].
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 75 thousand vitiligo patients in Hong Kong. Non-segmental vitiligo patients account for approximately 85% of them[4]. Topical corticosteroids (TCS) and calcineurin inhibitors (CI) are used off-label for non-segmental vitiligo, however, these therapies have clinical deficiencies with long-term adverse reactions of long-term treatment or limited efficacy[5、6].
Currently, the NDA for vitiligo indication of the Product has been accepted by the National Medical Products Administration of China (NMPA) on 24 September 2024. The Product is not approved by the NMPA for any indication in China. However, on 12 August 2023, the Product was approved by Hainan Medical Products Administration for Urgent Clinical Import, and officially became available to applicable patients in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”) on August 18, for the topical treatment of non-segmental vitiligo in adults and adolescents aged 12 and above with facial involvement. Benefiting from the Early and Pilot Implementation Policy granted by the state to Hainan Free Trade Port and the Pilot Zone, patients with vitiligo in China can apply for the Product in Boao Super Hospital first and receive treatment from the expert team. In addition, ruxolitinib cream was approved by the Pharmaceutical Administration Bureau (ISAF) of Macau on 11 April 2024, and subsequently the Product was approved by the Guangdong Provincial Medical Products Administration on 19 August 2024 through the “Hong Kong and Macau Medicine and Equipment Connect” policy, which officially introduced ruxolitinib cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age, providing a novel treatment option for patients with relevant indication into designated medical institutions in the Mainland of Greater Bay Area.
In accordance with the relevant regulations of the drug real-world data application pilot program in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Lecheng Pilot Zone”), a real-world study on ruxolitinib cream has been conducted in China. The results have shown positive efficacy, which is consistent with the key outcomes of global pivotal clinical studies. 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. Meanwhile, through the safety monitoring data of the Lecheng Pilot Zone, no new safety events have been identified. Adverse events mostly had severity levels of grade 1 or 2. No adverse event (AE) leading to discontinuation or withdrawal, and no serious adverse event (SAE) related to the study drug occurred.
The transfer of ruxolitinib cream from overseas production to domestic production (localization technology transfer) is being organized by the Contract Development Manufacturing Organization (CDMO), and the scale-up production have been completed and under process validation. The Group strives to complete the localization study as soon as possible, submit application to NMPA and obtain marketing approval, so as to enable the Chinese patients with vitiligo to use the innovative product.
On 2 December 2022, the Group through a subsidiary of the Company, a dermatology medical aesthetic company (“CMS Skinhealth”) entered into a Collaboration and License Agreement (the “License Agreement”) with Incyte for topical formulations of ruxolitinib for the treatment of autoimmune and inflammatory dermatology diseases. In accordance with the License Agreement, the Group through CMS Skinhealth received an exclusive license to develop, register and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries (Indonesia, Philippines, Vietnam, Thailand, Myanmar, Malaysia, Cambodia, Laos, Singapore, Timor-Leste and Brunei Darussalam) (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory. The License Agreement commenced on its effective date and has a royalty term of ten years from the date of the first commercial sale of the Product in the Territory (the “Royalty Term”). Upon the expiration of the Royalty Term, the License Agreement may be renewed for a period of ten years thereafter (the “Initial Extended Royalty Term”) as per certain conditions defined in the License Agreement. Upon the expiration of the Initial Extended Royalty Term, the License Agreement may be extended for a period otherwise agreed by both sides as per certain conditions defined in the License Agreement.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura®. Opzelura® and the Opzelura® logo are registered trademarks of Incyte.
The Group will promote the commercialization of the Product to benefit vitiligo patients with a novel treatment option.
Reference：
1、Drug approval information can be found on the FDA official website, as follows: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-treatment-addressing-repigmentation-vitiligo-patients-aged-12-and-older
2、Drug approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream
3、Drug approval information can be found on the EMA official website, as follows: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura
4、Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7
5、Consensus on the diagnosis and treatment of vitiligo (2021 version)
6、Kubelis-López DE, Zapata-Salazar NA, Said-Fernández SL, Sánchez-Domínguez CN, Salinas-Santander MA, Martínez-Rodríguez HG, Vázquez-Martínez OT, Wollina U, Lotti T, Ocampo-Candiani J. Updates and new medical treatments for vitiligo (Review). Exp Ther Med. 2021 Aug;22(2):797. doi: 10.3892/etm.2021.10229. Epub 2021 May 25. PMID: 34093753; PMCID: PMC8170669.
CMS Disclaimer and Forward-Looking Statements
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.