Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary, Yantai Lannacheng Biotechnology Co., Ltd. (referred to as "Lannacheng"), has received the acceptance notice from the National Medical Products Administration for the marketing authorization application of the investigational drug Fluorine-18 [18F] PSMA peptide injection [1] Group 1 - Lannacheng's Fluorine-18 [18F] PSMA peptide injection is a targeted radioactive diagnostic drug for in vivo imaging of prostate cancer patients with positive prostate-specific membrane antigen (PSMA) lesions [1] - The drug is intended for two specific patient groups: (1) prostate cancer patients suspected of having metastatic lesions who are about to undergo initial radical treatment; (2) prostate cancer patients with elevated serum prostate-specific antigen (PSA) levels suspected of biochemical recurrence [1]

Core Viewpoint - Dongcheng Pharmaceutical's subsidiary, Lanacheng, has received approval from the National Medical Products Administration for the marketing application of the investigational drug Fluorine-18 [18F] PSMA peptide injection, which targets PSMA for PET imaging in prostate cancer patients [1] Group 1: Product Information - Fluorine-18 [18F] PSMA peptide injection is a radiopharmaceutical used for in vivo diagnostic imaging targeting prostate-specific membrane antigen (PSMA) in prostate cancer patients [1] - There are currently no similar products available in the domestic market, while similar products are already available internationally [1] Group 2: Market Context - Lantheus Holdings reported that its product, 18F-PSMA diagnostic agent PYLARIFY, is expected to generate sales revenue of $1.1 billion in 2024 [1]

Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) has received a notice from the National Medical Products Administration regarding the acceptance of its application for the marketing authorization of Fluorine-18 PSMA peptide injection, a targeted radioactive diagnostic drug for prostate cancer patients [2] Group 1: Product Development - The drug is designed for PET imaging in prostate cancer patients and is the first of its kind to be approved for marketing in China, with similar products already available and performing well in international markets [2] - The company acknowledges the inherent uncertainties in new drug development and commits to actively advancing the subsequent processes while ensuring timely information disclosure [2]

Core Viewpoint - The company is making steady progress on its key products before the IPO, with specific timelines for NDA submissions for its investigational drugs [2] Group 1: Product Development Progress - The impurity supplement study for 18F-APN-1607 is ongoing, with no specific completion date mentioned [2] - The NDA for fluorine-18 labeled somatostatin analog (氟[18F]思睿肽) is expected to be submitted in the first half of 2026, while the NDA for fluorine-18 labeled alpha peptide (氟[18F]阿法肽) is anticipated in 2027 [2] - The pre-NDA communication for 99mTc-GSA is in progress, although specific details were not provided [2] Group 2: Market Strategy - The company is committed to actively promoting the research and development progress to expedite the market launch of its products [2]

Core Viewpoint - The company is actively preparing for the NDA submission of Fluorine-18 labeled Somatostatin Injection, with an expected submission in the first half of 2026, although the approval timeline remains uncertain [1] Group 1 - The company is currently working on the NDA submission preparations for the Fluorine-18 Somatostatin Injection [1] - The expected timeline for NDA submission is the first half of 2026 [1] - The approval timeline is uncertain and will depend on regulatory requirements [1]

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002675证券简称：东诚药业公告编号：2025-069 烟台东诚药业集团股份有限公司 注册地址：山东省烟台市牟平区东兴大街9号21号楼 法定代表人：罗志刚 企业负责人：吴晓明 质量负责人：周洪涛 关于控股子公司获得放射性药品 生产许可证的公告 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。 近日，烟台东诚药业集团股份有限公司（以下简称"公司"）收到控股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"）的通知，通知其收到山东省药品监督管理局下发的《放射性药品生产许可 证》。相关信息如下： 一、基本情况 企业名称：烟台蓝纳成生物技术股份有限公司 统一社会信用代码：91310000MA1H3FYU34 由于医药产品具有高技术、高风险、高附加值等特点，药品销售易受行业政策、市场环境变化等因素影 响，敬请广大投资者理性投资，注意投资风险。 三、备查文件 《放射性药品生产许可证》 特此公告。 烟台东诚药业集团股份有限公司 许可证编号：鲁RS202502 分类码：Br1 生产地址和生产范围：南京江原安迪 ...

Policy Developments - The National Healthcare Security Administration announced five typical cases of fraud involving maternity insurance funds, urging insured units and individuals to participate legally and provide accurate application materials to safeguard the fund [1] Drug and Device Approvals - Dongcheng Pharmaceutical's subsidiary received a production license for radioactive drugs, with expectations that it will not significantly impact current performance until commercial production is approved [1] - Jianyou Co., Ltd. received FDA approval for its propofol emulsion injection, with an investment of approximately RMB 73.66 million in R&D, and plans to launch the product in the U.S. soon [2] - Aihong Pharmaceutical presented clinical trial data for APL-1401 at the European Colorectal Congress, focusing on treating moderate to severe ulcerative colitis [6] - Fosun Pharma's subsidiary received approval for clinical trials of FXS887, an innovative drug for treating advanced malignant solid tumors [7] - Xinlitai received approval for clinical trials of SAL0140, a novel drug for chronic kidney disease, which could provide new treatment options if successful [8] Capital Market Activities - Lexin Medical announced that its controlling shareholder, Pan Weichao, has released the pledge on 18.71 million shares, which is 28.01% of his holdings and 8.56% of the total share capital [3] - Berry Genomics reported a decrease in the shareholding ratio of its controlling shareholder, Gao Yang, to 6.90% due to stock pledge defaults, with no significant adverse impact on the company's operations [4] - Tailong Pharmaceutical is planning a major matter that may lead to a change in control, with stock suspension expected to last no more than three trading days [5] Strategic Collaborations - JD Health and Boehringer Ingelheim Animal Health signed a strategic cooperation agreement to enhance the quality development of the domestic pet health industry through resource integration and complementary advantages [10] Regulatory Actions - Guizhou Bai Ling's actual controller, Jiang Wei, is under investigation by the China Securities Regulatory Commission for insider trading and other violations, which does not affect the company's daily operations [11]

人民财讯12月3日电，东诚药业（002675）12月3日公告，控股子公司蓝纳成收到山东省药监督管理局下 发的《放射性药品生产许可证》。此次蓝纳成取得药品生产许可证，预期不会对公司当前业绩产生重大 影响，氟[18F]思睿肽注射液待获得药品上市批准文号后可进行商业化生产。 ...

东诚药业（002675）(002675.SZ)发布公告，近日，公司收到控股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")的通知，通知其收到山东省药品监督管理局下发的《放射性药品生产许可 证》。本次蓝纳成取得《药品生产许可证》，预期不会对公司当前业绩产生重大影响，氟[18F]思睿肽 注射液待获得药品上市批准文号后可进行商业化生产。 ...

智通财经APP讯， 东诚药业(002675.SZ)发布公告，近日，公司收到控股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")的通知，通知其收到山东省药品监督管理局下发的《放射性药品生产许 可证》。本次蓝纳成取得《药品生产许可证》，预期不会对公司当前业绩产生重大影响，氟[18F]思睿 肽注射液待获得药品上市批准文号后可进行商业化生产。 ...