Group 1: Product Announcement - The product "Lai Kang Qi Ta" monoclonal antibody injection has been included in the priority review list by the National Medical Products Administration (NMPA) as of December 26, 2025, following its application on December 18, 2025 [1][2] - This drug is intended for adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy [1] Group 2: Clinical Trial Results - The drug is the first domestically developed and the second globally in progress IL-17A/F dual-target inhibitor, showing superior efficacy in clinical trials compared to the control group [3] - Key efficacy endpoints were met in a clinical trial, demonstrating faster onset and better short-term and long-term efficacy, with a comparable safety profile to the control group [3] Group 3: Financial Guarantees - The company has approved a maximum guarantee of RMB 14.15 billion for its subsidiaries to secure financing from banks [7] - A guarantee agreement was signed with Zhuhai China Resources Bank, providing a maximum guarantee of RMB 12 million for a specific loan [8] Group 4: Guarantee Overview - As of December 31, 2025, the total amount of guarantees provided by the company is RMB 1,325.83 million, with an external guarantee balance of RMB 162.15 million, representing 11.70% of the company's latest audited net assets [10]

Group 1 - Health元药业's subsidiary, Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd., has received priority review status for its drug, Laikangqita Monoclonal Antibody Injection, which is intended for adult patients with moderate to severe plaque psoriasis [1][2] - The drug is the first domestically developed and the second globally IL-17A/F dual-target inhibitor, showing superior efficacy in clinical trials compared to the control group [3] - The drug's application for marketing authorization was accepted in December 2025, indicating progress towards potential market entry [4] Group 2 - The priority review was granted based on compliance with the relevant regulations and guidelines set by the National Medical Products Administration [2] - Clinical trials demonstrated that Laikangqita Injection achieved primary and secondary efficacy endpoints, with faster onset and better long-term efficacy compared to the control [3] - The safety profile of the drug was comparable to that of the control group, indicating a favorable risk-benefit ratio [3] Group 3 - Health元药业 has announced a change in the audit project partner for its 2025 financial report, appointing Tang Hanlin as the new project partner due to the previous partner's work adjustment [8][9] - The change in audit personnel is not expected to impact the financial reporting and internal control audit for 2025 [12] Group 4 - In December 2025, Health元药业 provided a guarantee of RMB 120 million for its subsidiary, Lizhu Pharmaceutical Group, to support its operational needs [15] - The company has a total guarantee balance of RMB 2,111.52 million as of December 31, 2025, with no overdue guarantees reported [19][20]

Drug Information - The drug "Lai Kang Qi Ta" monoclonal antibody injection has received acceptance for domestic production registration from the National Medical Products Administration (NMPA) [1] - It is classified as a Class 1 therapeutic biological product and is intended for adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy [1] - The drug is a self-developed innovative IL-17A/F dual-target inhibitor, which is the first of its kind in China and the second globally [1][2] Clinical Development - A clinical trial for the drug is set to achieve primary and secondary efficacy endpoints by July 2025, demonstrating superior efficacy compared to the control group [1] - The trial results indicate faster onset, better short-term efficacy, long-lasting effects, and less frequent dosing compared to the control drug [1] - The cumulative R&D investment for the drug is approximately RMB 204.03 million [2] Market Situation - As of the announcement date, there are no approved products in China for psoriasis indications targeting the IL-17A/F dual-target [3] - There are three imported and two domestic products approved for IL-17A and IL-17RA single-target indications [3] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [3]

Group 1 - The core announcement is about the acceptance of the marketing authorization application for "Lai Kang Qi Ta" monoclonal antibody injection by the National Medical Products Administration [1][2] - The drug is a first-in-class, self-developed innovative IL-17A/F dual-target inhibitor for moderate to severe plaque psoriasis in adults [3][4] - The clinical trials showed that the drug achieved superior efficacy compared to the control group, with faster onset and better long-term effects [3] Group 2 - The total research and development expenses incurred for the drug amount to approximately RMB 204.03 million [5] - Currently, there are no approved products for psoriasis indications targeting IL-17A/F dual targets in China, while there are five products targeting IL-17A and IL-17RA [7] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [7] Group 3 - The company has completed a share repurchase program, acquiring 16,193,259 A-shares, which is 1.79% of the total share capital [9][10] - The repurchase was conducted at a total cost of approximately RMB 600.22 million, with a maximum price of RMB 41.99 per share and a minimum price of RMB 33.21 per share [9][10] - All repurchased shares will be canceled, leading to a reduction in registered capital [11][13]

Core Viewpoint - LIZHU Group's subsidiary, Zhuhai Lizhu Antibody Biotechnology Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the domestic production registration application of "Lai Kangi Ta Monoclonal Antibody Injection" [1] Group 1 - The drug is a joint development with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd. [1] - "Lai Kangi Ta Monoclonal Antibody Injection" is the first domestically developed and the second globally progressing innovative IL-17A/F dual-target inhibitor [1] - The drug targets psoriasis, a chronic inflammatory skin disease affecting approximately 100 million patients worldwide [1]

萊康奇塔單抗注射液上市許可申請 獲國家藥品監督管理局受理 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 近日，麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.*（「本公司」）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《受理通知書》（受理號：CXSS2500144），麗珠單抗與北京鑫康合 生物醫藥科技有限公司聯合開發的萊康奇塔單抗注射液（「本品」）境內生產藥品註冊上市 許可申請獲國家藥監局受理。現將相關情況公告如下： 藥品基本情況 藥物名稱：萊康奇塔單抗注射液 劑型：注射劑 規格：160mg（1.6mL）/瓶 申請事項：境內生產藥品註冊上市許可 註冊分類：治療用生物製品 1 類 申請人：珠海市麗珠單抗生物技術有限公司 擬定適應症（或功能主治）：本品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。 1 受理通知書審批結論：根 ...