On June 25, China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) announced the completion of dosing for the first subject in the phase III bridging trial of ruxolitinib cream (the “Product”) in atopic dermatitis (“AD”) in China. This is another substantial clinical development 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.
This trial is a randomized, double-blind, placebo-controlled phase III clinical trial evaluating the efficacy and safety of ruxolitinib cream in the treatment of atopic dermatitis in Chinese patients. The trial aims to provide more medical evidence to support the Product’s marketing application in China. The trial, led by Professor Shi Yuling, Vice President of Shanghai Skin Disease Hospital, will be conducted in 20 sites nationwide aiming to enroll approximately 192 atopic dermatitis patients.
AD is a chronic, recurrent and inflammatory dermatologic disease, with the main clinical manifestations of dry skin, chronic eczema-like lesions and obvious itching or pruritus, which may seriously affect the quality of life of patients. It is estimated that there are approximately 26 million[1] AD patients in China, of whom about 23 million[2] are mild to moderate. Topical drugs are the most basic treatment for AD. Traditional topical medications such as topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) have long-term adverse reactions or limited efficacy[3] [4], therefore novel treatments are urgently needed, especially for those mild to moderate AD patients who do not need systemic treatment.
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 and Drug Administration (FDA) 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[5]. 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[6]. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. 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[7].
Ruxolitinib cream is not approved by the National Medical Products Administration of China (NMPA) for any indication in Mainland of 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 18 August, 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. The Group is cooperating with Boao Super Hospital to conduct the Real World Research (RWS) for the Product, which could support the registration and launching of the Product in Mainland of China.
Moreover, the Pharmaceutical Administration Bureau (ISAF) of Macau has approved the new drug application of ruxolitinib cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age on 11 April 2024, and it may bring a novel therapeutic option to patients with relevant indication in the area.
Incyte has worldwide rights for the development and commercialization of the Product, marketed in the United States and Europe as Opzelura®. CMS has an exclusive license to develop and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory.
Opzelura and the Opzelura logo are registered trademarks of Incyte.
CMS continues to pay close attention to patients’ needs, and actively promotes the R&D and clinical application of innovative products to address unmet clinical needs, bringing more quality medical products to patients through differentiated innovation breakthroughs.
Reference:
- M.R. Laughter, M.B.C. Maymone, S. Mashayekhi, B.W.M. Arents, C. Karimkhani, S.M. Langan, R.P. Dellavalle, C. Flohr, The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990–2017, British Journal of Dermatology, Volume 184, Issue 2, 1 February 2021, Pages 304–309, https://doi.org/10.1111/bjd.19580
- Chiesa Fuxench ZC, Block JK, Boguniewicz M, Boyle J, Fonacier L, Gelfand JM, Grayson MH, Margolis DJ, Mitchell L, Silverberg JI, Schwartz L, Simpson EL, Ong PY. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019 Mar;139(3):583-590. doi: 10.1016/j.jid.2018.08.028. Epub 2018 Oct 30. PMID: 30389491
- “Research Report on the Living Conditions of Atopic Dermatitis Patients in China” August 2020
- Yimi Survey “Atopic Dermatitis Diagnosis and Cognition Survey” October 2023
- 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
- 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
- Drug approval information can be found on the EMA official website, as follows: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura
CMS Disclaimer and Forward-Looking Statements
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