Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary Yantai Lannacheng Biotechnology Co., Ltd. received approval from the National Medical Products Administration of China for clinical trials of the drug 177Lu-LNC1009, which will commence shortly [1] Group 1 - The product 177Lu-LNC1009 is a dual-target radioactive internal therapy drug that targets fibroblast activation protein (FAP) and integrin αvβ3, intended for the treatment of patients with advanced malignant solid tumors that are positive for FAP and integrin αvβ3 [1] - There are currently no similar products available in the domestic or international markets, nor are there any related sales data [1]

Core Viewpoint - Dongcheng Pharmaceutical has received approval from the National Medical Products Administration of China for clinical trials of its drug 177Lu-LNC1009, indicating a significant step forward in its product development pipeline [1] Group 1 - Dongcheng Pharmaceutical's subsidiary, Yantai Lannacheng Biotechnology Co., Ltd., is the entity that received the clinical trial approval [1] - The clinical trials for 177Lu-LNC1009 are set to commence shortly, which may enhance the company's market position in the biopharmaceutical sector [1]

东诚药业公告称，其全资子公司安迪科的锝替曲膦注射液被纳入《国家基本医疗保险、生育保险和工伤 保险药品目录（2025年）》。该产品仅用于诊断，可用于药物负荷和静息状态下心肌灌注显像。产品属 乙类注射剂，分类为心血管系统的诊断用放射性药物。《医保目录（2025年）》于2026年1月1日起执 行，暂不会对公司经营业绩构成重大影响。 ...

Core Viewpoint - Dongcheng Pharmaceutical announced that its subsidiary, Lannacheng, received approval from the National Medical Products Administration for clinical trials of the 177Lu - LNC1009 injection, which is a dual-target radioactive internal therapy drug aimed at treating patients with advanced malignant solid tumors that are FAP positive and integrin αvβ positive [1] Group 1 - The clinical trial for the injection will commence soon, marking a significant step in the drug's development process [1] - The 177Lu - LNC1009 injection is currently the only product of its kind in both domestic and international markets [1] - The total research and development expenses incurred for this project amount to approximately 13.579 million yuan [1] Group 2 - The drug development process from research to market launch is lengthy and involves multiple stages, which introduces uncertainties [1]

锝[ 99mTc]替曲膦注射液被纳入《医保目录（2025年）》，提高患者对SPECT-MPI 检查的可及性，促进冠状动脉疾病诊疗精准化，将有利于该产品的市场推广及未 来销售。因《医保目录（2025 年）》将于 2026 年 1 月 1 日起正式执行，暂不会 证券代码：002675 证券简称：东诚药业 公告编号：2025-071 烟台东诚药业集团股份有限公司 关于锝[99mTc]替曲膦注射液纳入医保目录的公告 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。 二、对公司的影响及风险提示 药品名称 适应症 药品分 类代码 药品分类 编号 剂型 医保分类 锝[ 99mTc] 替曲膦注 射液 锝[ 99mTc]替曲膦注射液仅用 于诊断。在患有或疑似冠状 动脉疾病的成人中两次注射 液给药条件下，可用于药物 负荷和静息状态下心肌灌注 显像，以反映心肌血流灌注 变化。 XV09G 心血管系 统的诊断 用放射性 药物 399 注射剂 乙类 一、本次纳入《医保目录（2025 年）》产品信息 根据国家医疗保障局、人力资源社会保障部于 2025 年 12 月 7 日发布的《国 家基本 ...

证券代码：002675 证券简称：东诚药业 公告编号：2025-070 烟台东诚药业集团股份有限公司 关于控股子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。 | 药物名称 | 177Lu-LNC1009 注射液 | | --- | --- | | 剂型 | 注射剂 | | 申请事项 | 临床试验 | | 号 IND | CXHL2501029 | | 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 注射液临床试验申请符合药 177Lu-LNC1009 | | | 品注册的有关要求，同意本品开展晚期实体瘤的临床试验。 | 一、药物的基本情况 二、药物的其他情况 1、公司在研产品 177Lu-LNC1009 注射液是一种靶向结合成纤维细胞激活蛋 白（FAP）与整合素αvβ3的双靶点放射性体内治疗药物，拟用于 FAP 阳性和整合 素αvβ3阳性的晚期恶性实体瘤患者的治疗。 2、FAP 为 II 型跨膜丝氨酸蛋白酶，高表达于许多上皮肿瘤相关成纤维细胞 (Cancer-Associat ...

Group 1 - The company, Yantai Dongcheng Pharmaceutical Group Co., Ltd., has received a production license for radioactive drugs for its subsidiary, Yantai Lanacheng Biotechnology Co., Ltd. [1] - The production license is specifically for the radiopharmaceutical fluorine-18 labeled peptide injection, which is intended for product registration application use only [1] - The license is valid until November 25, 2030, and the production will take place at Nanjing Jiangyuan Andike Positron Research and Development Co., Ltd. [1] Group 2 - The company anticipates that the acquisition of the production license will not have a significant impact on its current performance, as commercial production can only commence after obtaining the drug marketing approval number [1] - The pharmaceutical industry is characterized by high technology, high risk, and high added value, making drug sales susceptible to changes in industry policies and market conditions [2]

Core Viewpoint - Dongcheng Pharmaceutical (002675) announced that its subsidiary, Lanacheng, has received a production license for radioactive drugs from the Shandong Provincial Drug Administration, which is expected to have no significant impact on the company's current performance [1] Group 1 - Lanacheng has obtained the production license for radioactive drugs, allowing it to proceed with commercial production once it receives the marketing approval for Fluorine-18 labeled somatostatin analog injection [1]

Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary, Yantai Lanacheng Biotechnology Co., Ltd. (referred to as "Lanacheng"), has received the "Production License for Radioactive Drugs" from the Shandong Provincial Drug Administration. This license is expected to have no significant impact on the company's current performance, and the fluorine-18 labeled peptide injection will be commercially produced after obtaining the drug listing approval number [1]. Group 1 - Dongcheng Pharmaceutical's subsidiary Lanacheng has received a production license for radioactive drugs [1] - The production license is anticipated to not significantly affect the current performance of Dongcheng Pharmaceutical [1] - The fluorine-18 labeled peptide injection will be available for commercial production following the drug listing approval [1]

Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary, Yantai Lanacheng Biotechnology Co., Ltd. (referred to as "Lanacheng"), has received the "Radioactive Drug Production License" from the Shandong Provincial Drug Administration. This license is expected to have no significant impact on the company's current performance, and the commercial production of Fluorine-18 labeled somatostatin injection will commence after obtaining the drug marketing approval number [1]. Group 1 - Dongcheng Pharmaceutical's subsidiary, Lanacheng, has received a production license for radioactive drugs [1] - The company anticipates that this development will not significantly affect its current performance [1] - Commercial production of Fluorine-18 labeled somatostatin injection is contingent upon obtaining the necessary marketing approval [1]