丽珠医药莱康奇塔单抗获国家药监局药品注册证书

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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 ANNOUNCEMENT
OBTAINMENT OF THE DRUG REGISTRATION CERTIFICATE FOR
LECANKITUG INJECTION (SUBCUTANEOUS INJECTION)
Recently, Livzon MABPharm Inc.*(珠海市麗珠單抗生物技術有限公司) (“Livzon MAB”), a
controlling subsidiary of Livzon Pharmaceutical Group Inc.*(麗珠醫藥集團股份有限公司) (the
“Company”), received the Drug Registration Certificate (Certificate No.: 2026S03179) approved
and issued by the National Medical Products Administration of the People’s Republic of China*
(國家藥品監督管理局) (“NMPA”). The relevant particulars are announced as follows:
KEY PARTICULARS OF THE DRUG REGISTRATION CERTIFICATE
Generic Name: Lecankitug Injection (Subcutaneous Injection)
English/Latin name: Lecankitug Injection (Subcutaneous Injection)
Trade Name: 麗倍坦
Main Ingredient: Lecankitug
Dosage form: Injection
Specification: 160mg (1.6mL) / vial
Drug Registration Standard No.: YBS01072026
Application Matter: Drug registration (domestic manufacturing)
Registration Classification: Class 1 Therapeutic Biological Product
Shelf Life: 24 months
Marketing Authorization Holder: Livzon MABPharm Inc.
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Manufacturer: Livzon MABPharm Inc.
National Drug Approval Number: 國藥准字 S20260065
Validity Period of Approval Number: 24 August 2031
Approval conclusion of the Acceptance Notice: Upon examination in accordance with the Drug
Administration Law of the People’s Republic of China and relevant provisions, the Product (as
defined below) complies with the requirements for drug registration. Approval is granted for
registration, and the Drug Registration Certificate is issued. The manufacturing process, quality
standards, specifications and labels shall be implemented as attached.
DRUG DEVELOPMENT AND RELATED CONDITIONS
Lecankitug Injection (Subcutaneous Injection) (the “Product”) is jointly developed by Livzon
MAB and Beijing Xinkanghe Biomedical Technology Co., Ltd.* (北京鑫康合生物醫藥科技有限
公司) (“Beijing Xinkanghe”). It is a recombinant anti-human IL-17A/F humanized monoclonal
antibody injection and the first independently developed innovative IL-17A/F dual-target biologic
in China. It acts by simultaneously blocking the pro-inflammatory cytokines IL-17A and IL-17F,
the indication for this registration application is: for the treatment of adult patients with
moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Psoriasis is a recurrent inflammatory skin disease triggered by a combination of genetic and
environmental factors. There are approximately 125 million patients worldwide and over 7 million
patients in China, of whom approximately 80% have plaque psoriasis.
The Product has completed a Phase III clinical trial in patients with moderate-to-severe plaque
psoriasis, with Secukinumab as the active comparator. Data showed that the Product was superior
to the control group in terms of speed of onset, skin clearance rate and long-term efficacy, with a
safety profile comparable to that of the control group. The Product does not require an initial
intensive induction phase and requires less frequent dosing than the comparator, which may
enhance the patient experience and improve treatment adherence.
As at the date of this announcement, the cumulative direct investment in research and development
expenses for the product amounts to approximately RMB223.31 million.

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MARKET LANDSCAPE OF SIMILAR DRUGS
According to the databases of the NMPA and the Center for Drug Evaluation (“CDE”), as at the
date of this announcement, with regard to IL-17A/F dual-target products, one imported product has
been approved for marketing in China, and the Product is the first domestic IL-17A/F dual-target
product approved for marketing in China. Regarding IL-17A and IL-17RA single-target products,
three imported products and four domestic products have been approved for market launch in
China.
According to IQVIA sampling statistical estimates, the domestic terminal sales value of IL-17A and
IL-17RA single-target drugs in China in 2025 was approximately RMB2.976 billion.
IMPACT ON THE COMPANY AND RISK WARNING
After obtaining the Drug Registration Certificate, the Company can manufacture and market the
Product. However, the operating performance of the Product is subject to uncertainties due to
factors such as changes in the market environment. Investors are advised to exercise caution when
making investment decisions and to pay attention to investment risks.

By order of the Board
Livzon Pharmaceutical Group Inc.＊
麗珠醫藥集團股份有限公司
Liu Ning
Company Secretary
Zhuhai, China
27 August 2026
As at the date of this announcement, the executive directors of the Company are Mr. Liu Daping
(President) and Mr. Tang Yanggang (Vice Chairman); the non-executive directors of the Company
are Mr. Zhu Baoguo (Chairman), Mr. Lin Nanqi and Mr. Qiu Qingfeng; the employee
representative director of the Company is Ms. Ran Yongmei; and the independent non-executive
directors of the Company are Mr. Luo Huiyuan, Ms. Cui Lijie, Ms. Wang Zhiyao and Ms. Kang Li.

* For identification purpose only

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香港交易及結算所有限公司及香港聯合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，並明確表示，概不對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。

自願公告
萊康奇塔單抗注射液（皮下注射）關於
獲得《藥品注冊證書》的公告
近日，麗珠醫藥集團股份有限公司（「本公司」）的控股子公司珠海市麗珠單抗生物技術有
限公司（「麗珠單抗」）收到國家藥品監督管理局（「國家藥監局」）核准簽發的《藥品注
冊證書》（證書編號：2026S03179）現將相關情況公告如下：
藥品注冊證書的主要內容
藥品通用名稱：萊康奇塔單抗注射液（皮下注射）
英文名/拉丁名：Lecankitug Injection (Subcutaneous Injection)
商品名稱：麗倍坦
主要成份：萊康奇塔單抗注射液
劑型：注射劑
規格：160mg（1.6mL）/瓶
藥品注冊標准編號：YBS01072026
申請事項：藥品注冊（境內生產）
注冊分類：治療用生物制品 1 類
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藥品有效期：24 個月
上市許可持有人：珠海市麗珠單抗生物技術有限公司
藥品生產企業：珠海市麗珠單抗生物技術有限公司
藥品批准文號：國藥准字 S20260065
藥品批准文號有效期：2031 年 8 月 24 日
審批結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，本品（定義見下文）
符合藥品注冊的有關要求，批准注冊，發給藥品注冊證書。生產工藝、質量標准、說明書及
標簽按所附執行。
藥品研發及相關情況
萊康奇塔單抗注射液（皮下注射）（「本品」）由麗珠單抗與北京鑫康合生物醫藥科技有限
公司聯合開發，為重組抗人 IL-17A/F 人源化單克隆抗體注射液，系中國首個自主研發的
IL-17A/F 雙靶點創新生物製劑，可通過同步阻斷 IL-17A 與 IL-17F 促炎因數發揮作用，本次
註冊申請的適應症為：用於適合接受系統治療或光療的中重度斑塊狀銀屑病成人患者。
銀屑病是一種由遺傳與環境因素共同誘發、易於復發的炎症性皮膚病，全球患者約 1.25 億
人，我國患者超 700 萬人，其中斑塊狀銀屑病占比約 80%。
本品已完成中重度斑塊狀銀屑病的Ⅲ期臨床試驗，該研究以司庫奇尤單抗為陽性對照，數據
表明，本品在起效速度、皮損清除率及長期療效方面均優於對照組，安全性與對照組相當。
本品無需初始密集誘導期，給藥頻次較對照組減少，可提升患者的使用體驗，提高依從性。
截至本公告披露日，本品累計直接投入的研發費用約為人民幣 22,331.36 萬元。

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同類藥物市場情況
根據國家藥監局及藥品審評中心網站資料庫顯示，截至本公告披露日，針對 IL-17A/F 雙靶
點，國內已有 1 個進口產品獲批上市，本品為國內首個獲批上市的國產 IL-17A/F 雙靶點產
品；針對 IL-17A 及 IL-17RA 單靶點，國內共有 3 個進口產品、4 個國產產品獲批上市。
根據 IQVIA 抽樣統計估測數據，2025 年度 IL-17A 及 IL-17RA 單靶點藥物國內終端銷售金
額約為人民幣 29.76 億元。
對本公司的影響及風險提示
公司在取得藥品注冊證書後，可生產本品並上市銷售，產品的經營情況因受市場環境變化等
因素的影響，具有不確定性，敬請廣大投資者謹慎決策，注意投資風險。

承董事會命
麗珠醫藥集團股份有限公司
Livzon Pharmaceutical Group Inc.*
公司秘書
劉寧

中國，珠海
二零二六年八月二十七日
於本公告日期，本公司的執行董事為劉大平先生(總裁)及唐陽剛先生(副董事長);本公司的
非執行董事為朱保國先生(董事長)、林楠棋先生及邱慶豐先生;本公司的職工董事為冉永
梅女士；而本公司的獨立非執行董事為羅會遠先生、崔麗婕女士、王智瑤女士及康立女
士。

*僅供識別

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