Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary LNC PHARMA PTE.LTD. received FDA approval for the clinical trial of 225Ac-LNC1011 injection, which will soon commence Phase I clinical trials [1] Summary by Relevant Sections - **FDA Approval**: The FDA has completed the safety review of the 225Ac-LNC1011 injection application and has issued a Study May Proceed Letter (SMP), allowing the proposed prostate cancer clinical study to move forward [1] - **Next Steps**: Following the issuance of the SMP, the 225Ac-LNC1011 injection must undergo clinical trials and receive FDA review and approval before it can be marketed and sold in the United States [1]

Group 1 - Dongcheng Pharmaceutical (SZ 002675, latest price: 17.56 CNY) announced on August 22 that its subsidiary LNC PHARMA PTE. LTD. received approval from the U.S. Food and Drug Administration for the clinical trial of Ac-LNC1011 injection, with Phase I trials to commence shortly [2] - For the first half of 2025, Dongcheng Pharmaceutical's revenue composition is 100.0% from the biopharmaceutical industry [2]

Group 1 - The core point of the article is that Dongcheng Pharmaceutical's subsidiary, LNC PHARMA PTE. LTD., has received FDA approval for a clinical trial of the drug 225Ac-LNC1011, which is intended for treating advanced prostate cancer patients with PSMA-positive expression [1] Group 2 - The clinical trial is set to begin shortly, indicating progress in the development of this potential treatment [1]

Core Viewpoint - Yantai Dongcheng Pharmaceutical Group Co., Ltd. announced that its subsidiary LNC PHARMA PTE. LTD. received FDA approval for the clinical trial of 225Ac-LNC1011 injection, which will soon commence Phase I clinical trials [1][2]. Drug Information - The drug 225Ac-LNC1011 is an injectable formulation intended for the treatment of advanced prostate cancer expressing Prostate Specific Membrane Antigen (PSMA) [2]. - The drug utilizes alpha particle radiation therapy, which has a short range (<100 μm) and high energy deposition (80-100 keV/μm), providing stronger cell-killing effects on tumors while minimizing damage to surrounding healthy tissues [2]. - Previous animal and human trials have shown excellent pharmacokinetic properties and significant efficacy, indicating its potential as a more effective PSMA-targeted therapy for metastatic castration-resistant prostate cancer (mCRPC) [2]. Financial Investment - The total research and development expenses incurred for the 225Ac-LNC1011 project to date amount to approximately 14.1648 million yuan [3].

Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary LNC PHARMA PTE. LTD. received FDA approval for the clinical trial of 225Ac-LNC1011 injection, with Phase I trials to commence shortly [1] Group 1 - The FDA issued a Study May Proceed Letter (SMP) for the clinical trial of 225Ac-LNC1011 injection [1] - The clinical trial is set to begin in the near future [1]

Core Viewpoint - Dongcheng Pharmaceutical (002675) announced that its subsidiary LNC PHARMA PTE.LTD. received FDA approval for the clinical trial of 225Ac-LNC1011 injection, which will soon commence Phase I clinical trials for treating advanced prostate cancer patients with PSMA-positive expression [1] Company Summary - Dongcheng Pharmaceutical's subsidiary, LNC PHARMA PTE.LTD., has been granted FDA approval for a clinical trial [1] - The drug 225Ac-LNC1011 is intended for the treatment of advanced prostate cancer patients [1] Industry Summary - The approval of 225Ac-LNC1011 marks a significant step in the development of targeted therapies for prostate cancer [1] - The focus on PSMA-positive expression in advanced prostate cancer highlights the industry's trend towards precision medicine [1]

Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary LNC PHARMA PTE. LTD. received FDA approval for the clinical trial of 225Ac-LNC1011 injection, which will soon commence Phase I clinical trials [1] Summary by Relevant Sections - **FDA Approval**: The FDA has completed the safety review of the 225Ac-LNC1011 injection application and has issued a Study May Proceed Letter (SMP), allowing the proposed prostate cancer clinical study to move forward [1] - **Next Steps**: Following the issuance of the SMP, the 225Ac-LNC1011 injection must undergo clinical trials and receive FDA review and approval before it can be marketed and sold in the United States [1]

证券代码：002675 证券简称：东诚药业 公告编号：2025-046 现将 225Ac-LNC1011 注射液相关情况公告如下： | 药物名称 | 注射液 225Ac-LNC1011 | | --- | --- | | 剂型 | 注射剂 | | 申请事项 | 临床试验 | | IND 号 | 175370 | | 审批结论 | 已完成对 注射液申请的安全性审核， FDA 225Ac-LNC1011 | | | 并认为可以继续进行拟议的前列腺癌临床研究。 | 一、药物的基本情况 二、药物的其他情况 烟台东诚药业集团股份有限公司 关于下属公司获得药物临床试验批准通知书的公告 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。 2025 年 8 月 22 日，烟台东诚药业集团股份有限公司（以下简称"公司"） 下属公司 LNC PHARMA PTE. LTD. （以下简称"蓝纳成药业"）收到美国食品 药品监督管理局（以下简称"FDA"）核准签发的关于 225Ac-LNC1011 注射液的 药品临床试验批准通知书 (Study May Proceed Letter，以下简 ...

Group 1 - The actual controller of Yantai Dongcheng Pharmaceutical Group Co., Ltd., Mr. You Shouyi, has notified the company about the extension of the pledge of part of his shares [1] - As of August 21, 2025, Mr. You holds 103,305,678 shares of Dongcheng Pharmaceutical, with a total of 28,578,000 shares pledged, accounting for 27.66% of his total holdings [1] - The overall risk of share pledge is controllable, and there is currently no risk of forced liquidation [1][4] Group 2 - The actual controller and his concerted actors have a good credit status and possess the financial capability to repay, thus there is no risk of forced liquidation or transfer of control [4] - The company will continue to monitor the pledge situation and will disclose relevant information in a timely manner as required [4]

Group 1 - The core business of Dongcheng Pharmaceutical is entirely focused on the biopharmaceutical industry, with a revenue composition of 100% from this sector for the first half of 2025 [1] Group 2 - Dongcheng Pharmaceutical announced on August 21 that its actual controller, Mr. You Shouyi, has pledged part of his shares for extension. As of August 21, 2025, he holds approximately 103 million shares of Dongcheng Pharmaceutical, with a total of about 28.58 million shares pledged, accounting for 27.66% of his total holdings. The overall risk of share pledge is manageable, and there is currently no risk of forced liquidation [3]