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 ...

Group 1 - The company, LIZHU Group, announced the completion of its share repurchase program, which was effective from December 25, 2024, to November 7, 2025 [1] - A total of 16,193,259 A-shares were repurchased, representing 1.79% of the company's total share capital [1] - The repurchase was conducted through centralized bidding, with the highest purchase price at RMB 41.99 per share and the lowest at RMB 33.21 per share, totaling RMB 600,217,787.75 used (excluding transaction fees) [1]

丽珠集团公告，控股子公司珠海市丽珠单抗生物技术有限公司收到国家药品监督管理局核准签发的《受 理通知书》，丽珠单抗与北京鑫康合生物医药科技有限公司联合开发的"莱康奇塔单抗注射液"的境内生 产药品注册上市许可申请获国家药监局受理。该药品拟用于适合接受系统治疗或光疗的中重度斑块状银 屑病成人患者。 ...

Core Viewpoint - The company, Lizhu Group, has announced the completion of its A-share buyback plan, which involved repurchasing a total of 16,193,259 shares, accounting for 1.79% of its total share capital, with a total expenditure of 600 million yuan (excluding transaction fees) [1] Group 1 - The buyback was executed through centralized bidding transactions [1] - The highest purchase price was 41.99 yuan per share, while the lowest was 33.21 yuan per share [1] - The buyback aligns with the company's plan and regulatory requirements, and it will not have a significant adverse impact on the company [1] Group 2 - All repurchased shares will be canceled, leading to a reduction in registered capital [1] - The company will proceed with the necessary procedures and registration changes related to the buyback [1]

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。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而刊發。 茲載列麗珠醫藥集團股份有限公司於深圳證券交易所網站刊發之《麗珠醫藥集團股份 有限公司關於 A 股股份回購結果暨股份變動公告》，僅供參閱。 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 二零二五年十二月二十四日 於本公告日期，本公司的執行董事為唐陽剛先生 ( 總裁 ) 及徐國祥先生 ( 副董事長及副總裁 ); 本 公司的非執行董事為朱保國先生 ( 董事長 ) 、陶德勝先生 ( 副董事長 ) 、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白華先生、羅會遠先生、 崔麗婕女士及王智瑤女士。 * 僅供識別 证券代码：000513、01513 证券简称：丽珠集团、丽珠医药 公告编号：2025-080 ...

Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita Monoclonal Antibody (LZM012/XKH004) for the treatment of plaque psoriasis [2] Group 1: Product Development - Lakanqita Monoclonal Antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [4] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has exclusive rights for the global development, registration, production, sales, and sublicensing of this product [4] Group 2: Clinical Trial Results - In July, Lijun Pharmaceutical announced that Lakanqita Monoclonal Antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [4] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [4] - The overall safety profile of Lakanqita Monoclonal Antibody was good, with the incidence of common adverse events comparable to that of the control group [4]

Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita monoclonal antibody (LZM012/XKH004) for the treatment of plaque psoriasis [1] Group 1: Product Development - Lakanqita monoclonal antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [2] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has obtained exclusive rights for the global development, registration, production, sales, and sublicensing of this product [2] Group 2: Clinical Trials - In July, Lijun Pharmaceutical announced that Lakanqita monoclonal antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [3] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [3] - The overall safety profile of Lakanqita monoclonal antibody was good, with the incidence of common adverse events comparable to that of the control group [3]

Core Viewpoint - Lijun Group's subsidiary, Lijun Pharmaceutical Factory, has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression [2] Group 1 - The approval includes a new indication for NS-041 tablets specifically targeting the treatment of depression [2] - The clinical trial approval notification numbers are 2025LP03436 and 2025LP03437 [2]

Core Viewpoint - Lijun Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression, expanding its indications beyond epilepsy [1] Group 1: Company Developments - Lijun Pharmaceutical's wholly-owned subsidiary, Lijun Group Lijun Pharmaceutical Factory, has been granted a clinical trial approval notice for NS-041 tablets, specifically for the treatment of depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, making it the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] - The clinical trial for the epilepsy indication of NS-041 was approved on December 27, 2023, and is currently undergoing Phase II clinical research [1] Group 2: Drug Mechanism and Efficacy - Research indicates that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms related to depression [1] - In preclinical studies for the depression indication, NS-041 demonstrated significant antidepressant effects in classical acute and chronic depression models in mice [1] - The selectivity of NS-041 is higher than that of other drugs targeting the same pathway currently under investigation, and no potential ocular toxicity risks have been identified [1]

Core Viewpoint - Lijun Pharmaceutical's subsidiary has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy [1][2] Group 1: Clinical Trial Approval - Lijun Pharmaceutical's subsidiary, Lijun Group, has been granted a clinical trial approval notice by the National Medical Products Administration for NS-041 tablets to treat depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist, currently the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] Group 2: Clinical Research and Efficacy - The clinical trial for the depression indication follows the approval for epilepsy, with the latter currently in Phase II clinical research [1] - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, improving symptoms of depression [1] - NS-041 has shown good antidepressant effects in classical acute and chronic depression models in mice, with higher target selectivity than other drugs in development and no potential ocular toxicity risks identified [1] Group 3: Financial Investment - As of the announcement date, the total direct investment in the research and development of NS-041 has reached approximately RMB 58.54 million [2]