康哲药业旗下德镁医药磷酸芦可替尼乳膏（百盧妥®）获NMPA批准轻中度特应性皮炎适应症，系中国首个外用JAK抑制剂获批AD

Hong Kong Exchanges and Clearing Limited, The Stock Exchange of Hong Kong Limited and
Singapore Exchange Securities Trading Limited take no responsibility for the contents of this
announcement, make no representation as to its accuracy or completeness and expressly
disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the
whole or any part of the contents of this announcement.

Voluntary and Business Update Announcement
New Drug Application for Additional Indication Atopic Dermatitis (AD) for
Ruxolitinib Phosphate Cream Lumirix® Approved in China
China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the
“Group”) is pleased to announce that its subsidiary, Dermavon Holdings Limited (together
with its subsidiaries, “Dermavon”, an innovative pharmaceutical company specialized in skin
health which is applying for a separate listing on the Main Board of The Stock Exchange of
Hong Kong Limited, please refer to the announcement published by the Company on 22 April
2025 for details) received the approval from the National Medical Products Administration of
China (NMPA) for the New Drug Application (NDA) of ruxolitinib phosphate cream
Lumirix® (“Lumirix®” or the “Product”) for the treatment of mild to moderate atopic
dermatitis (“AD”) on 2 September 2026. The drug registration certificate was obtained on 3
September 2026. The Product is indicated for the topical short-term and non-continuous
chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult
and pediatric patients 2 years of age and older whose disease is not adequately controlled with
topical prescription therapies or when those therapies are not advisable. The NDA for
indication AD has been approved for inclusion in the Priority Review List by the Center for
Drug Evaluation (CDE) of the NMPA based on its qualification as a “new variety, dosage
form and specification of pediatric drug that conforms to the physiological characteristics of
children”, which effectively shortened the Product's review process and accelerated the
approval for marketing approval in the AD indication.
In January 2026, Lumirix® was approved for marketing by the NMPA, becoming the first
topical JAK inhibitor approved in China for the treatment of vitiligo. The approval of this
1
*For identification purpose only

NDA for the additional indication of AD marks a key milestone in the Product's expansion
into a second therapeutic area, offering a novel treatment option for pediatric patients 2 years
of age and older, adolescent and adult AD patients, with safety and efficacy supported by
clinical data.
For AD, Dermavon has developed a comprehensive “treatment + care” solution, including the
topical formulation Lumirix® for mild-to-moderate AD, the injectable biological agent
Comekibart Injection (MG-K10) for moderate-to-severe AD, the oral small molecule targeted
drug CMS-D001 for moderate-to-severe AD, and the Heling Soothing Product Series for
daily repair, to meet the management needs of AD patients from treatment to daily care.
Ruxolitinib phosphate cream, a novel cream formulation of the selective JAK1/JAK2
inhibitor ruxolitinib developed by Incyte. Lumirix® successfully met its primary endpoint in a
randomized, double-blind, placebo-controlled phase III clinical trial in China for mild to
moderate AD. The study results demonstrated that a significantly higher proportion of
patients treated with Lumirix® achieved IGA (Investigator's Global Assessment) of 0 or 1
with at least two grades of reduction from baseline at week 8, compared with placebo (63.0%
vs 9.2%, P < 0.001). For the key secondary endpoint, the proportion of subjects achieving at
least a 75% improvement from baseline in the Eczema Area and Severity Index score (EASI
75) of treatment with Lumirix® was also significantly higher than that of the placebo group, at
week 8 (78.0% vs 15.4%, P < 0.001). In terms of safety, the severity of treatment-emergent
adverse events (TEAE) during the treatment period was mostly mild or moderate, with no
TEAEs leading to discontinuation of the study drug. Overall, Lumirix® was safe and welltolerated.
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 were over 54
million AD patients in China as of 2024. Based on SCORAD scores, mild to moderate AD
accounts for 98% of these cases, representing over 52.5 million patients. Topical drugs are the
most basic treatment for AD. Traditional topical medications such as topical corticosteroids
(TCS) and topical calcineurin inhibitors (TCIs) have clinical pain points with long-term
adverse reactions or limited efficacy, therefore novel treatments are urgently needed.
Following the approval of Lumirix® for vitiligo, the approval of the NDA for the AD
indication will further broaden the product's clinical utility. Simultaneously, this will
strengthen Dermavon’s strategic layout in the field of skin treatments and create synergies
with

its

commercialized

innovative

drug
2

ILUMETRI

(tildrakizumab

injection),

commercialized exclusive drug Hirudoid (mucopolysaccharide polysulfate cream), and a
series of innovative drugs under development and dermatological skin care products, in terms
of expert network and market resources, thereby potentially enhancing Dermavon's market
competitiveness and brand influence in the field of skin health.
The Group, through Dermavon entered into a Collaboration and License Agreement with
Incyte for ruxolitinib phosphate cream on 2 December 2022, obtaining 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 (the “Territory”) and a non-exclusive license to manufacture the
Product in the Territory. Dermavon has sublicensed the relevant rights for the Product outside
of Mainland China to the Group (excluding Dermavon).
Incyte has worldwide rights for the development and commercialization of ruxolitinib
phosphate cream, marketed in the United States and Europe as Opzelura®. Opzelura® and the
Opzelura® logo are registered trademarks of Incyte. In the U.S., ruxolitinib phosphate cream
is the first topical JAK inhibitor approved by the U.S. Food and Drug Administration (FDA)
for the topical treatment of non-segmental vitiligo in adult and pediatric patients 12 years of
age and older, and for the topical short-term and non-continuous chronic treatment of mild to
moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years
of age and older whose disease is not adequately controlled with topical prescription therapies
or when those therapies are not advisable. In Europe, ruxolitinib phosphate cream is approved
for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents
from 12 years of age, as well as the treatment of moderate atopic dermatitis in adult patients
for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or
inappropriate.
This announcement is made on a voluntary basis by the Company and aims to inform
potential investors and shareholders of the Company of the latest business developments of
the Group. Shareholders and investors are advised to exercise caution in dealing in the shares
and other securities of the Company.

By order of the Board
China Medical System Holdings Limited
Lam Kong
Chairman

3

Hong Kong, 3 September 2026
As at the date of the announcement, the directors of the Company comprise (i) Mr. Lam Kong
and Ms. Chen Yanling as executive directors; (ii) Mr. Leung Chong Shun, Ms. Luo Laura
Ying, Mr. Fung Ching Simon and Mr. Lee Sien Liang, Joseph as independent non-executive
directors.

4

香港交易及結算所有限公司、香港聯合交易所有限公司及新加坡證券交易所有限公司對
本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並表明概不就因本公
告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。

自願性及業務進展公告
創新藥磷酸蘆可替尼乳膏百盧妥®增加特應性皮炎適應症（AD）
中國上市許可申請獲批
China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」）
欣然宣佈，旗下德鎂醫藥有限公司（連同其附屬公司統稱為「德鎂醫藥」，專業聚焦皮
膚健康的創新型醫藥企業，正申請於香港聯合交易所有限公司主板獨立上市，詳見本公
司日期為二零二五年四月二十二日發佈的公告）已於二零二六年九月二日獲得中國國家
藥品監督管理局（NMPA）批准磷酸蘆可替尼乳膏百盧妥®（「百盧妥®」或「產品」）
輕中度特應性皮炎（「AD」）的新藥上市許可申請（NDA），並於二零二六年九月三
日獲得藥品注冊證書。產品用於其他外用藥控制不佳或不建議使用時，非免疫功能受損
的2歲及以上兒童和成人輕中度特應性皮炎的局部短期和非持續性慢性治療。本次AD適
應症的NDA因「符合兒童生理特徵的兒童用藥品新品種、劑型和規格」獲得NMPA藥品
審評中心批准納入優先審評品種名單，有效縮短了審評週期，加快了本次AD適應症的
獲批。
二零二六年一月，百盧妥®中國NDA獲批，成爲中國批准的首款用於白癜風治療的外用
JAK抑制劑。本次AD適應症NDA獲批，標誌著百盧妥®成功拓展至第二適應症領域，將
為2歲及以上兒童、青少年和成人AD患者提供經臨床數據證實具備安全性和有效性的
AD新療法。
德鎂醫藥已針對AD構建「治療+護理」綜合解決方案，包括局部外用製劑-百盧妥®（輕
中度AD）、注射用生物製劑-柯美奇拜單抗注射液MG-K10（中重度AD）、口服小分子
靶向藥-CMS-D001（中重度AD）、日常修護-禾零舒緩產品系列，滿足AD患者從治療到
日常護理的管理需求。

1

*僅供識別

磷酸蘆可替尼乳膏是Incyte開發的選擇性JAK1/JAK2抑制劑蘆可替尼製成的一種創新型
乳膏。百盧妥®已在輕中度AD的一項隨機、雙盲、安慰劑對照中國三期藥物臨床研究成
功達到主要終點，即使用產品治療8周，達到研究者整體評估（IGA）評分為0或1分，
且較基線改善≥2分的受試者比例，顯著高於安慰劑（63.0% vs 9.2%，P<0.001）。關鍵
次要終點，百盧妥®治療8周達到濕疹面積及嚴重程度指數評分較基線至少改善75%
（EASI 75）的受試者比例亦顯著優於安慰劑（78.0% vs 15.4%，P<0.001）。安全性方
面，治療期出現的不良事件（TEAE）的嚴重程度大多數為輕度或中度，未發生導致研
究藥物用藥終止的TEAE，整體安全耐受性良好。AD是一種慢性、復發性、炎症性的皮
膚疾病，臨床主要表現為皮膚乾燥、慢性濕疹樣皮損和明顯瘙癢，可能嚴重影響患者的
生活品質。據估算，2024年中國特應性皮炎患者超過5,400萬人，基於SCORAD評分，
輕中度特應性皮炎的占比為98%，即超過5,250萬患者。外用藥物是AD最基本的治療方
法。傳統外用藥物如外用糖皮質激素（TCS）及外用鈣調神經磷酸酶抑制劑（TCIs）有
長期用藥的不良反應或療效有限的臨床痛點，臨床亟需新的治療選擇。
繼百盧妥®獲批白癜風適應症後，此次AD適應症NDA獲批，將進一步拓展產品的臨床應
用空間。同時，這也將強化德鎂醫藥在皮膚治療領域的戰略佈局，並與現有處於商業化
階段的創新藥益路取（替瑞奇珠單抗注射液）、獨家藥喜遼妥（多磺酸粘多糖乳膏），
以及系列在研創新藥和皮膚學級護膚品等在專家網絡與市場資源等方面產生協同，提升
德鎂醫藥在皮膚健康領域的市場競爭力與品牌影響力。
本集團於二零二二年十二月二日，通過德鎂醫藥與Incyte就磷酸蘆可替尼乳膏訂立合作
和許可協議，獲得在中國大陸、香港特別行政區、澳門特別行政區、臺灣地區及東南亞
十一國（「區域」）研發、注冊及商業化產品的獨家許可權利，以及在區域內生產產品
的非獨家許可權利。德鎂醫藥已將磷酸蘆可替尼乳膏除中國大陸外的其他區域的相關權
利再許可予本集團（不包括德鎂醫藥）。
Incyte擁有磷酸蘆可替尼乳膏全球開發和商業化權利，在美國及歐洲以Opzelura®的名稱
銷售。Opzelura®和Opzelura®標識是Incyte的註冊商標。在美國，磷酸蘆可替尼乳膏是經
美國食品和藥物管理局（FDA）批准的首款局部JAK抑制劑，可用於局部治療成人、12
歲及以上兒童患者的非節段型白癜風；及其他外用藥控制不佳或不建議使用時，非免疫
功能受損的2歲及以上兒童和成人輕中度AD的局部短期和非連續性慢性治療。在歐洲，
磷酸蘆可替尼乳膏被批准用於治療成年及12歲及以上青少年面部受累的非節段型白癜
風，以及用於治療TCS及TCIs療效不佳或不建議使用的成人中度AD。
本公告乃由本公司自願刊發，旨在向潛在投資者及本公司股東通知本集團最新業務進
展，建議股東和投資者在進行公司股票及其他證券的交易時謹慎操作。
承董事會命
2

China Medical System Holdings Limited

主席
林剛
香港，二零二六年九月三日

於本公告日期，本公司董事包括(ⅰ)執行董事：林剛先生及陳燕玲女士；及(ⅱ)獨立非執行
董事：梁創順先生、羅瑩女士、馮征先生及李賢良先生。

3