康哲药业（00867.HK）盘后自愿公告：自研高选择性TYK2抑制剂CMS-D001获NMPA签发系统性红斑狼疮（SLE）适应症药物临床试验批准通知书

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whole or any part of the contents of this announcement.

Voluntary and Business Update Announcement
Approval of Drug Clinical Trials for Systemic Lupus Erythematosus of
Innovative Drug Highly Selective TYK2 Inhibitor CMS-D001
China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the
“Group”) is pleased to announce that, on 11 September 2026, the innovative drug CMS-D001
Tablets (“CMS-D001” or the “Product”) has been granted the Drug Clinical Trial Approval
Notice by the National Medical Products Administration of the People’s Republic of China
(“NMPA”). The approval notice was obtained on 14 September 2026. The NMPA grants
consent to conduct clinical trials evaluating the safety and efficacy of CMS-D001 for the
treatment of systemic lupus erythematosus.
CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor. TYK2 is a member of
the JAK kinase family, which is an important component in immune cell signaling. CMSD001 specifically inhibits the activation of TYK2 and blocks cell signal transduction
mediated by inflammatory cytokines such as IL-23, IL-12 and Type I interferons, thereby
inhibiting the pathological process of autoimmune diseases. CMS-D001 can reduce the
impact on other JAK family kinases and reduce adverse effects while maintaining efficacy.
Systemic lupus erythematosus (“SLE”) is a chronic autoimmune disease that can affect
multiple organs, including the skin, joints, kidneys, blood and nervous system. The disease
alternates between remission and relapse and can cause irreversible damage to vital organs.
According to the China Systemic Lupus Erythematosus Development Report 2020 and the
2009–2019 registry study of the Chinese SLE Treatment and Research Group, there are
approximately one million people with SLE in the Chinese mainland, with nearly 200,000
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*For identification purpose only

new cases annually. Moderate to severe cases account for 32.6% of patients, and the 25- to
30-year survival rate is below 30%. Currently available treatments for SLE include
glucocorticoids,

antimalarial

drugs

(such

as

hydroxychloroquine),

conventional

immunosuppressants (such as cyclophosphamide) and biologics (such as belimumab).
However, disease relapse, cumulative organ damage and the risk of infection remain major
challenges, underscoring the urgent clinical need for safer and more effective treatment
options.
As a highly selective TYK2 inhibitor, CMS-D001 has less impact on other JAK family
kinases than pan-JAK inhibitors, allowing it to maintain efficacy in long-term disease control
while reducing related safety risks. Compared with marketed injectable biologics, orally
administered CMS-D001 offers the advantages of better patient adherence and no risk of antidrug antibody formation. If approved for marketing, CMS-D001 will provide a new treatment
option for patients with SLE in China. It will also synergize with the Group’s marketed
products, such as the innovative drug Metoject (Methotrexate Injection), by leveraging the
Group’s existing expert network and market resources in rheumatology and autoimmune
diseases, collectively enhancing the Group’s competitiveness and market position in this field.
CMS-D001 is self-developed by the Group’s subsidiary, Dermavon Holdings Limited
(“Dermavon”). CMS-D001 was granted approval for drug clinical trials for the indications of
psoriasis, atopic dermatitis, ulcerative colitis and Crohn’s disease. Phase II clinical trials for
the psoriasis and atopic dermatitis indications are currently ongoing. Dermavon has
exclusively licensed the relevant rights relating to SLE and inflammatory bowel disease
(including but not limited to the ulcerative colitis and Crohn’s disease indications) to the
Group (excluding Dermavon).
The Group is actively preparing to initiate relevant clinical trials and strives to launch the
Product as soon as possible.
This announcement is made on a voluntary basis. Shareholders and investors are advised to
exercise caution when dealing in the shares and other securities of the Company.

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

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Hong Kong, 14 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.

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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
創新藥高選擇性TYK2抑制劑CMS-D001
獲得系統性紅斑狼瘡適應症藥物臨床試驗批准通知書
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，於二零二六年九月十一日，創新藥CMS-D001片（「CMS-D001」或「產品」）
獲得中國國家藥品監督管理局（「NMPA」）簽發的藥物臨床試驗批准通知書，於二零
二六年九月十四日收到藥物臨床試驗批准通知書。NMPA同意本集團開展臨床試驗以評
價CMS-D001治療系統性紅斑狼瘡適應症的有效性和安全性。
CMS-D001是高選擇性TYK2（酪氨酸激酶2）抑制劑。TYK2是JAK激酶家族的成員之一，
而JAK激酶家族是免疫細胞信號傳遞上的重要環節。CMS-D001通過特異性抑制TYK2
的激活，阻斷IL-23、IL-12和I型幹擾素等炎性細胞因子的細胞信號通路，從而抑制自身
免疫病的病理過程。CMS-D001可以減少對其他JAK家族激酶的影響，在保持療效的同
時減少毒副作用。
系統性紅斑狼瘡（Systemic lupus erythematosus，「SLE」）是一種累及皮膚、關節、腎
臟、血液及神經系統等多器官的慢性自身免疫性疾病，病程緩解與復發交替，可導致重
要臟器不可逆損傷。根據《中國系統性紅斑狼瘡發展報告2020》和中國系統性紅斑狼瘡
治療與研究組2009至2019年登記研究，我國大陸地區SLE患者約100萬人，每年新增將
近20萬例，中重度患者佔比達32.6%，25至30年生存率不足30%。目前，已上市的SLE
治療藥物包括糖皮質激素、抗瘧藥（羥氯喹等）、傳統免疫抑制劑（環磷醯胺等）及生
物製劑（貝利尤單抗等），但疾病復發、臟器累積損傷及感染風險仍是主要挑戰，臨床
亟需更安全有效的治療選擇。

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*僅供識別

CMS-D001作為高選擇性TYK2抑制劑，相較於泛JAK抑制劑，CMS-D001對其他JAK家
族激酶的影響較小，可在長期疾病控制中維持療效並降低相關安全風險。與已上市注射
型生物製劑相比，CMS-D001口服具有依從性好、無抗藥抗體等優勢。如若獲批上市，
CMS-D001將為中國SLE患者帶來新的用藥選擇，並與創新藥美泰彤（甲氨蝶呤注射液）
等在售產品在本集團現有的風濕自免領域的專家網絡與市場資源高效協同，共同提升集
團在該領域的競爭力與市場地位。
CMS-D001由本集團旗下德鎂醫藥有限公司（「德鎂醫藥」）自主研發。CMS-D001已
分別獲批開展關於銀屑病適應症、特應性皮炎適應症、潰瘍性結腸炎適應症和克羅恩病
適應症的藥物臨床試驗。目前，銀屑病適應症、特應性皮炎適應症的Ⅱ期臨床試驗正在
開展中。德鎂醫藥已將關於SLE及炎症性腸病（包括但不限於潰瘍性結腸炎適應症和克
羅恩病適應症）的相關權利獨家許可予本集團（除德鎂醫藥）。
本集團正積極準備開展相關臨床試驗工作，力爭該產品儘快上市。
本公告乃由本公司自願刊發，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
China Medical System Holdings Limited

主席
林剛
香港，二零二六年九月十四日

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。

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