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-treatment-addressing-repigmentation-vitiligo-patients-aged-12-and-older
6. 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
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
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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.
Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/
Source: China Medical System Holdings Ltd.