SHENZHEN, CHINA – 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.

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 medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several 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 promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

Reference:

1. 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

2. 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

3. “Research Report on the Living Conditions of Atopic Dermatitis Patients in China” August 2020

4. Yimi Survey “Atopic Dermatitis Diagnosis and Cognition Survey” October 2023

5. 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-t…

6. Drug approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-an…

7. 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

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.

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Source: China Medical System Holdings Ltd.