| 药物名称 | 注射液 225Ac-LNC1011 | | --- | --- | | 剂型 | 注射剂 | | 申请事项 | 临床试验 | | IND 号 | CXHL2500697 | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规定，经审查， | | | 你公司提交的 225Ac-LNC1011 注射液临床试验申请符合药 | | | 品注册的有关要求，同意本品开展前列腺癌的临床试验。 | 一、药物的基本情况 二、药物的其他情况 1、公司在研产品 225Ac-LNC1011 注射液是一种靶向前列腺特异性膜抗原 (Prostate Specific Membrane Antigen，以下简称"PSMA") 的α粒子放射性体内 治疗药物，拟用于治疗 PSMA 阳性表达的晚期前列腺癌患者。与传统的ß粒子相 比，α粒子具有短射程（<100 μm）、高能量沉积（80-100 keV/μm）和多级α衰变 的特点，能够针对肿瘤产生更强的细胞杀伤效果，并减少对周围健康组织的潜在 破坏。 证券代码：002675 证券简称：东诚药业 公告编号：2025-063 烟台东诚药业集团股份有限公司 关于控股子公司获得药 ...

格隆汇9月23日丨东诚药业(002675.SZ)公布，控股子公司烟台蓝纳成生物技术股份有限公司（简称"蓝 纳成"）收到中国国家药品监督管理局核准签发的关于Ac-LNC1011注射液的药品临床试验批准通知书， 将于近期开展临床试验。公司在研产品Ac-LNC1011注射液是一种靶向前列腺特异性膜抗原 (ProstateSpecificMembraneAntigen，简称"PSMA")的α粒子放射性体内治疗药物，拟用于治疗PSMA阳性 表达的晚期前列腺癌患者。与传统的粒子相比，α粒子具有短射程（<100μm）、高能量沉积（80- 100keV/μm）和多级α衰变的特点，能够针对肿瘤产生更强的细胞杀伤效果，并减少对周围健康组织的 潜在破坏。 ...

Core Viewpoint - Dongcheng Pharmaceutical announced that its subsidiary, Lanna, has received approval from the National Medical Products Administration for the clinical trial of the 225Ac-LNC1011 injection, which will commence shortly [1] Group 1: Product Information - The 225Ac-LNC1011 injection is a targeted alpha-particle radiotherapy drug aimed at treating patients with advanced prostate cancer who express PSMA [1] - There are currently no similar products available in the domestic or international markets, nor are there any related sales data [1]

Company Overview - Dongcheng Pharmaceutical Co., Ltd. is located in Yantai Economic and Technological Development Zone, Shandong Province, and was established on December 31, 1998. The company was listed on May 25, 2012 [2] - The main business involves the research, production, and sales of heparin sodium raw materials and chondroitin sulfate. The revenue composition is as follows: raw materials related products 44.16%, nuclear medicine products 36.38%, formulation products 13.17%, and others 6.30% [2] Stock Performance - As of September 23, the stock price of Dongcheng Pharmaceutical decreased by 2.08%, trading at 15.10 CNY per share, with a total market capitalization of 12.451 billion CNY [1] - Year-to-date, the stock price has increased by 23.87%, but it has seen a decline of 5.21% over the last five trading days and 13.76% over the last 20 days [2] Financial Performance - For the first half of 2025, Dongcheng Pharmaceutical reported a revenue of 1.384 billion CNY, a year-on-year decrease of 2.60%. The net profit attributable to shareholders was 88.6525 million CNY, down 20.70% year-on-year [2] - The company has distributed a total of 1 billion CNY in dividends since its A-share listing, with 293 million CNY distributed over the last three years [3] Shareholder Information - As of June 30, 2025, the number of shareholders increased to 23,600, up 9.19% from the previous period. The average circulating shares per person decreased by 8.42% to 31,554 shares [2] - Among the top ten circulating shareholders, Hong Kong Central Clearing Limited holds 12.4202 million shares, an increase of 511,700 shares compared to the previous period [3] Market Activity - The net outflow of main funds was 2.1999 million CNY, with large orders accounting for 12.55% of purchases and 14.75% of sales [1]

Investment Rating - The report maintains an "Outperform" rating for the biopharmaceutical industry [1] Core Viewpoints - The growth of healthcare expenses, which reached 9.06 trillion yuan in 2023, is outpacing GDP growth, indicating that commercial health insurance may provide a solution to the pressures faced by the medical insurance system [3][15] - The commercial health insurance sector is expected to grow significantly, with premiums projected to reach 97.74 billion yuan by 2024, driven by low penetration rates and the need for additional funding sources [20][24] - Policies are increasingly supportive of commercial health insurance, particularly in relation to innovative drugs, which are now being included in the commercial health insurance directory [71][76] Summary by Sections Part 1: Healthcare Financing System - The healthcare financing system in China consists of government, social, and personal contributions, with social contributions being the main driver for future growth [10][15] Part 2: Growth of Health Insurance - The commercial health insurance market is expected to fill a significant funding gap, with an estimated shortfall of over 1.7 trillion yuan by 2030 [21][22] - Medical insurance is the primary source of compensation within commercial health insurance, with a compensation rate of approximately 68.79% in 2022 [27][31] Part 3: Core Products of Medical Insurance - The report highlights the importance of medical insurance as a key focus area, noting that it directly compensates for medical expenses, unlike critical illness insurance [31][35] Part 4: Policy Support for Health Insurance Development - A series of policies since 2009 have aimed to promote the development of commercial health insurance, with specific targets for market size and coverage [71][72] Part 5: Investment Recommendations - The report suggests focusing on innovative drug companies with rich pipelines, DTP pharmacies, and companies in the TPA industry, as well as innovative medical devices and high-end medical service providers [77]

Core Viewpoint - Dongcheng Pharmaceutical's decision to spin off its subsidiary, Lanacheng, for a Hong Kong listing is interpreted as a "passive self-rescue" amid ongoing performance pressure and significant financial liabilities [2][14]. Financial Performance - The company has experienced a continuous decline in revenue from 2022 to 2024, with decreases of 8.41%, 8.58%, and 12.42% respectively; net profit attributable to shareholders also fell by 31.75% and 12.35% in 2023 and 2024 [4]. - In the first half of 2025, the company reported revenue of 1.384 billion yuan, a year-on-year decrease of 2.60%, and a net profit of 88.65 million yuan, down 20.70% [7]. Business Segmentation - The traditional raw material drug business remains the largest revenue source but has seen its proportion drop below 50% for the first time in 2024; in the first half of 2025, revenue from raw material drugs fell by 7.02% [4][5]. - The nuclear medicine segment, while showing a slight revenue increase of 0.78% to 503 million yuan in the first half of 2025, has experienced a decline in gross margin from 72.95% to 67.27% [5]. Subsidiary Overview - Lanacheng, the subsidiary being spun off, focuses on innovative radioactive diagnostic and therapeutic drugs but has not generated any revenue since its establishment; it recorded net losses of 38 million yuan, 99 million yuan, and 180 million yuan from 2022 to 2024 [11]. - The company has a significant R&D expenditure, reaching 431 million yuan in 2024, with 86.62% allocated to nuclear medicine research [11]. Goodwill and Risks - Dongcheng Pharmaceutical faces substantial goodwill risks, with a goodwill balance of 2.499 billion yuan, accounting for 55.7% of net assets; this goodwill primarily stems from previous acquisitions in the nuclear medicine sector [15]. - The company has a history of goodwill impairment related to past acquisitions, indicating ongoing risks associated with its growth strategy [16].

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关于分拆所属子公司烟台蓝纳成生物技术股份有限公司至 香港联交所主板上市相关内幕信息知情人 证券代码：002675 证券简称：东诚药业 公告编号：2025-062 烟台东诚药业集团股份有限公司 买卖公司股票情况查询结果的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有 虚假记载、误导性陈述或重大遗漏。 烟台东诚药业集团股份有限公司（以下简称"东诚药业"、"上市公司"或"公 司"）拟将所属子公司烟台蓝纳成生物技术股份有限公司（以下简称"蓝纳成"或 "拟分拆主体"）分拆至香港联合交易所有限公司（以下简称"香港联交所"）主板 上市（以下简称"本次分拆"）。2025 年 8 月 28 日，公司召开第六届董事会第十 三次会议审议通过了《关于<烟台东诚药业集团股份有限公司关于分拆所属子公 司烟台蓝纳成生物技术股份有限公司至香港联合交易所有限公司主板上市的预 案>的议案》等与本次分拆相关的议案，具体内容详见公司在信息披露网站巨潮 资讯网（http://www.cninfo.com.cn）刊登的相关公告。 根据《上市公司分拆规则（试行）》《上市公司重大资产重组管理办法》《公 开发行证券的公司信息披露内容与格 ...

证券代码：002675 证券简称：东诚药业 公告编号：2025-060 烟台东诚药业集团股份有限公司 关于选举第六届董事会职工代表董事的公告 截至目前，孙宏涛先生个人直接持有公司 16,650 股股份，占公司总股本的 0.0020%。孙宏涛先生与公司控股股东及实际控制人不存在关联关系；与持有公司 5%以上股份的股东及公司其他董事、监事、高管无关联关系；未受过中国证监会及 其他有关部门的处罚和证券交易所纪律处分，不存在因涉嫌犯罪被司法机关立案侦 查或者涉嫌违法违规被中国证监会立案稽查，尚未有明确结论的情形；不存在《自 律监管指引第 1 号--主板上市公司规范运作》第 3.2.2 条第一款规定的不得提名为 董事的情形。不是失信被执行人，符合《公司法》等相关法律、法规和规定及《公 司章程》要求的任职条件。 孙宏涛先生的任职资格符合相关法律法规及《公司章程》有关董事任职的资格 和条件。本次选举后，公司第六届董事会中兼任公司高级管理人员以及由职工代表 担任的人数总计未超过公司董事总数的二分之一。 特此公告。 烟台东诚药业集团股份有限公司董事会 2025年9月16日 1 附件：孙宏涛先生简历 孙宏涛，男，中国籍，无永久境 ...

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