Povorcitinib, a selective oral JAK1 inhibitor
discovered by Incyte, is an investigational medicine being
evaluated for the treatment of non-segmental vitiligo, hidradenitis
suppurativa (HS), prurigo nodularis (PN), asthma and chronic
spontaneous urticaria
Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System
Holdings Limited (“CMS” or the “Group”) are pleased to announce
that on March 31, 2024, Incyte and CMS, through a wholly-owned
dermatology medical aesthetic subsidiary of the Company (“CMS
Skinhealth”), entered into a Collaboration and License Agreement
for the development and commercialization of povorcitinib (the
“Product”), a selective oral JAK1 inhibitor, to research, develop,
register and commercialize the Product in Mainland China, Hong
Kong, Macao, Taiwan Region and eleven Southeast Asian countries
(the “Territory”) and a non-exclusive license to manufacture the
Product in CMS’ Territory.
Under the terms of the agreement, CMS will make an upfront
payment to Incyte and Incyte is eligible to receive additional
potential development and commercial milestones and royalties on
net sales of the licensed product in CMS’ territory.
CMS will receive an exclusive license to develop and
commercialize and a non-exclusive license to manufacture
povorcitinib in autoimmune and inflammatory dermatologic diseases,
including non-segmental vitiligo, hidradenitis suppurativa (HS),
prurigo nodularis (PN), asthma and chronic spontaneous urticaria,
for patients in mainland China, Hong Kong, Macau, Taiwan and
certain countries in Southeast Asia.
“We are excited to announce the addition of this collaboration
for povorcitinib, expanding our relationship with CMS in the
Dermatology space beyond ruxolitinib cream, to include two products
with the potential to help patients with limited treatment
options,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
“There remains a significant need for new, innovative treatment for
vitiligo and other immune-mediated dermatologic conditions, and we
look forward to working together with the CMS team to bringing
these products to market in China.”
Mr. Huang Anjun, the general manager of CMS Skinhealth, stated
that, “We expect that this collaboration will enhance CMS
Skinhealth's portfolio of potential treatments for vitiligo that,
if approved, will provide differentiated treatment options for
vitiligo patients in China. Upon approval, povorcitinib is poised
to synergize with the innovative drugs in the commercialization
stage of our pipeline Ilumetri (tildrakizumab injection),
original/drugs including Hirudoid (mucopolysaccharide polysulfate
cream) and Aethoxysklerol (polidocanol injection) in terms of our
network and market resources, which will help the Product to
realize its clinical and commercial value.”
The transaction is effective immediately upon the execution of
the Collaboration and License Agreement.
About Povorcitinib
Povorcitinib is a selective oral small-molecule JAK1 inhibitor,
with compound and use patents in certain countries/regions in the
Territory. Currently, povorcitinib is in Phase 3 clinical trials
for non-segmental vitiligo and HS in multiple countries outside of
China. Additionally, Phase 2 clinical studies of povorcitinib for
PN, asthma and chronic spontaneous urticaria are also ongoing.
About 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. Overactivity of the
JAK signaling pathway is believed to drive inflammation involved in
the pathogenesis and progression of vitiligo.
It is estimated that there are approximately 14 million vitiligo
patients in China and 6.5 million in the eleven Southeast Asian
countries respectively. Non-segmental vitiligo patients account for
approximately 85% of them1. Vitiligo can occur at any age, although
many patients with vitiligo will experience initial onset before
the age of 302. Currently, therapeutic options for vitiligo are
limited, and the condition is difficult to treat, especially for
patients with moderate to severe extensive vitiligo.
About Hidradenitis Suppurativa (HS)
HS is a chronic recurrent inflammatory skin condition
characterized by the presence of painful inflammatory nodules,
abscesses, ruptures, as well as the formation of sinus tracts and
scarring. Overactivity of the JAK signaling pathway is believed to
drive inflammation involved in the pathogenesis and progression of
HS3.
It is estimated that there are approximately 470 thousand HS
patients in China, about 75% of whom are moderate to severe
patients4. Additionally, it is estimated that there are
approximately 13 thousand HS patients in the six Southeast Asian
countries, comprising Thailand, Singapore, Malaysia, Philippine,
Vietnam and Indonesia. HS has been included in the second batch of
the Rare Disease List in China. Given the debilitating nature of
condition, it can have a profoundly negative effect on patients’
quality of life. However, currently in China, there are no
biologics or small molecule medicines approved by the National
Medical Products Administration for the treatment of HS, creating
an urgent need for effective therapeutic options5.
About Incyte
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or
follow us on social media: LinkedIn, X, Instagram, Facebook,
YouTube.
About CMS Skinhealth
CMS’s Dermatology and Medical Aesthetic Business "CMS
Skinhealth" regards dermatology prescription products as its core,
and extends to dermatology-grade skincare products and light
medical aesthetic products, continually optimizing full lifecycle
skin-health management solutions, and gradually moving toward
becoming "the largest and most professional skin-health management
company in China ". Relying on its strong clinical development and
commercialization advantages, CMS will realize the
commercialization of povorcitinib in the Territory as soon as
possible to meet the clinical needs of oral vitiligo drugs with
efficacy and benefit relevant 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 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.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether and when povorcitinib will be approved for use in
mainland China, Hong Kong, Macau, Taiwan or Southeast Asia; whether
and when CMS will bring povorcitinib to market in mainland China,
Hong Kong, Macau, Taiwan or Southeast Asia; the potential of
povorcitinib to treat patients with vitiligo, hidradenitis
superativa or for any other indication; the potential for Incyte to
receive royalties and payments from CMS for development and
commercial milestones; and the potential for Incyte to broaden its
ability to bring new medicines to patients in Asia and elsewhere,
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on Incyte’s current
expectations and are subject to risks and uncertainties that may
cause actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials;
Incyte’s dependence on its relationships with its collaboration
partners; the efficacy or safety of Incyte’s products and the
products of its collaboration partners; the acceptance of Incyte’s
products and the products of its collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; and other risks detailed from time
to time in Incyte’s reports filed with the Securities and Exchange
Commission, including our quarterly report on Form 10-Q for the
quarter ended December 31, 2023. Incyte disclaims any intent or
obligation to update these forward-looking statements.
CMS 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. This press
release may not be all inclusive and may not contain all of the
information that you may consider material. Any liability in
respect of the contents of or any omission from this press release
is expressly excluded.
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. The
Group assumes no obligation to update any forward-looking
information contained in this press release. 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.
References：
- Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo.
Lancet. 2015 Jul 4;386(9988):74-84. doi:
10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15. PMID:
25596811
- Frisoli M, et al. Vitiligo: mechanisms of pathogenesis and
treatment. Annu. Rev. Immunol. 2020;38(1):621-648
- Solimani, F., Meier, K., & Ghoreschi, K. (2019). Emerging
topical and systemic JAK inhibitors in dermatology. Frontiers in
immunology, 10, 2847
- Prevalence of Acne Inversa (Hidradenitis Suppurativa) in China:
A Nationwide Cross-Sectional Epidemiological Study
- Diagnosis and treatment of acne inversa/hidradenitis
suppurativa in China: an expert consensus statement（2021
version）
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Incyte
Media media@incyte.com
Investors ir@incyte.com
CMS
Investor Relations ir@cms.net.cn
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