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麦得发完成B轮融资!两大百亿医药企业已入局
Core Viewpoint - Zhuhai Maidefa Biotechnology Co., Ltd. (referred to as "Maidefa") has successfully completed a Series B financing round, which is a recognition of its technological strength and market prospects, as well as an important step in accelerating its industrialization process [2][6]. Group 1: Financing Events - Maidefa completed its angel round financing in March 2021, followed by a Series A financing of tens of millions of RMB in May 2022, and a Series A+ financing of several tens of millions of RMB in December 2023 [5]. - The recent Series B financing was led by China Taiping Innovation and Guangzhou Pharmaceutical Capital, with specific amounts undisclosed [2][6]. Group 2: Company Positioning - Maidefa's name "MedPHA" combines "Medicine" and "PHA," indicating its unique positioning as an innovative enterprise in the "medicine + PHA" sector, rather than just a PHA materials company [7]. - The third-largest shareholder, Lijuzhiyuan Pharmaceutical Group Co., Ltd., has been involved with Maidefa since its inception, indicating a deep-rooted strategic partnership rather than a mere financial investment [10]. Group 3: Product Lines - Maidefa has three major product lines: industrial-grade PHA, medical-grade PHA, and beta-hydroxybutyrate (β-hydroxybutyric acid) health-active small molecules, forming a complete PHA value chain [15]. - The industrial-grade PHA includes PHB and P34HB, which are recognized by major companies like Walmart and Costco for applications in biodegradable packaging and utensils [18]. - The medical-grade PHA is a core differentiated product, with Maidefa being the first global supplier to receive regulatory approvals from the National Medical Products Administration and the FDA [19]. - The beta-hydroxybutyric acid product, branded as "Sainao Si," has been launched in Macau and the United States, targeting markets in brain health and anti-aging [20]. Group 4: Milestones - Maidefa achieved significant milestones in 2025, including medical certifications, capacity expansions, and the completion of Series B financing [23]. - The company expanded its industrial-grade PHA production capacity to over 2,000 tons with a new production line in Zhanjiang, which began operations in early 2025 [25]. - Maidefa became the first in China to obtain documentation for medical-grade PHA microspheres, which will serve clinical applications in absorbable medical devices [27]. - The company also received ISO13485:2016 certification for its medical device quality management system, marking a key qualification for entering the medical device market [27].
丽珠医药集团股份有限公司关于莱康奇塔单抗注射液被纳入优先审评审批程序的公告
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]
丽珠集团:公司不存在逾期担保
Zheng Quan Ri Bao Wang· 2026-01-07 13:12
Group 1 - The core point of the article is that LIZHU Group (000513) announced its total guarantee amounting to 1,325,825,000 yuan, with an external guarantee balance of 162,149,500 yuan, which represents 11.7% of the latest audited net assets attributable to shareholders of 1,386,233,420 yuan [1] Group 2 - All guarantees are provided to subsidiaries, with no overdue amounts, no litigation issues, and no external guarantees [1]
丽珠医药(01513):莱康奇塔单抗注射液被纳入优先审评审批程序
智通财经网· 2026-01-07 10:40
Core Viewpoint - Livzon Pharmaceutical Group Inc. has announced that its subsidiary, Zhuhai Livzon Monoclonal Antibody Biotechnology Co., Ltd., in collaboration with Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd., has had its product, Lakanqita Monoclonal Antibody Injection, included in the priority review list by the National Medical Products Administration (NMPA) of China, marking a significant step towards expedited approval for market launch [1] Group 1 - The product Lakanqita Monoclonal Antibody Injection was officially included in the priority review list after the public notice period ended [1] - The inclusion in the priority review list indicates that the product will undergo expedited approval procedures for drug market licensing [1]
丽珠医药:莱康奇塔单抗注射液被纳入优先审评审批程序
Zhi Tong Cai Jing· 2026-01-07 10:40
Core Viewpoint - Livzon Pharmaceutical Group Inc. has announced that its subsidiary, Zhuhai Livzon Monoclonal Antibody Biotechnology Co., Ltd., in collaboration with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd., has had its product, Lakanqita Monoclonal Antibody Injection, included in the priority review list by the National Medical Products Administration of China, marking a significant step towards expedited approval for market entry [1] Group 1 - The product Lakanqita Monoclonal Antibody Injection was officially included in the priority review list after the public announcement period ended [1] - The inclusion in the priority review list indicates that the product will undergo expedited approval procedures for drug market licensing [1]
丽珠医药(01513) - 海外监管公告-关於為子公司提供担保的进展公告
2026-01-07 10:40
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 限公司關於為子公司提供擔保的進展公告》,僅供參閱。 承董事會命 一、担保情况概述 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 二零二六年一月七日 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:2026-0 ...
丽珠医药(01513.HK):莱康奇塔单抗注射液被纳入优先审评审批程序
Ge Long Hui· 2026-01-07 10:39
Core Viewpoint - Livzon Pharmaceutical Group Inc. has successfully entered its product, Lakanqita Monoclonal Antibody Injection, into the priority review list by the National Medical Products Administration of China, indicating a significant step towards obtaining market approval for treating moderate to severe plaque psoriasis in adults [1]. Group 1: Product Development - The product, Lakanqita Monoclonal Antibody Injection, is developed in collaboration with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd. [1] - The application for the product was submitted on December 18, 2025, and it was publicly announced on December 26, 2025 [1]. Group 2: Regulatory Approval - The product has been included in the priority review list, which allows for expedited approval processes under specific regulatory guidelines [1]. - The inclusion in the priority review list is based on compliance with the Drug Registration Management Measures and other relevant announcements by the National Medical Products Administration [1].
丽珠医药(01513) - 自愿公告 莱康奇塔单抗注射液被纳入优先审评审批程序
2026-01-07 10:35
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被納入優先審評審批程序 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」)與北京鑫康合生物醫藥科技有限公司聯合 開發的產品萊康奇塔單抗注射液(「本品」)於 2025 年 12 月 26 日被國家藥品監督管理局 藥品審評中心納入擬優先審評品種公示名單;現公示期滿後,根據國家藥品監督管理局藥品 審評中心網站信息公開顯示,本品已納入優先審評品種名單,正式進入藥品上市許可優先審 評審批程序。現將相關情況公告如下: 藥品基本情況 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。 風險提示 根據藥品註冊相關法律法規要求,新藥上市申請尚需經過審評、藥品臨床試驗現場檢查和審 批等環節,本品能否最終獲得上市批准及上市時間存在不確定性,未來產品的競爭形勢亦有 可能隨著市場環境 ...
丽珠集团莱康奇塔单抗注射液被纳入优先审评审批程序
Zhi Tong Cai Jing· 2026-01-07 10:08
Core Viewpoint - The company has successfully entered the priority review process for its product, indicating a significant advancement in its drug development pipeline [1] Group 1: Company Development - The company's subsidiary, Zhuhai Lizhu Antibody Biotechnology Co., Ltd., has collaborated with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd. to develop the product, Lakanqita Monoclonal Antibody Injection [1] - The product was included in the list of drugs for priority review by the National Medical Products Administration (NMPA) on December 26, 2025, and has now officially entered the priority review approval process [1]
丽珠集团(000513.SZ)莱康奇塔单抗注射液被纳入优先审评审批程序
智通财经网· 2026-01-07 10:03
智通财经APP讯,丽珠集团(000513.SZ)公告,公司控股子公司珠海市丽珠单抗生物技术有限公司("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产品莱康奇塔单抗注射液于2025年12月26日被国 家药品监督管理局药品审评中心纳入拟优先审评品种公示名单;现公示期满后,根据国家药品监督管理 局药品审评中心网站信息公开显示,已纳入优先审评品种名单,正式进入药品上市许可优先审评审批程 序。 ...