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东诚药业(002675.SZ):氟[18F]思睿肽注射液上市申请获国家药品监督管理局受理
Ge Long Hui A P P· 2026-01-09 12:26
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]
东诚药业:氟[18F]思睿肽注射液上市申请获受理
Ge Long Hui A P P· 2026-01-09 12:17
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]
东诚药业:氟思睿肽注射液上市申请获受理
Xin Lang Cai Jing· 2026-01-09 12:17
Core Viewpoint - Dongcheng Pharmaceutical's subsidiary, Lanacheng, has received the acceptance notice from the National Medical Products Administration for the marketing authorization application of the investigational drug, Fluorine-18 PSMA injection, which is a targeted radiopharmaceutical for PET imaging in prostate cancer patients [1] Group 1: Product Information - Fluorine-18 PSMA injection is designed for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions 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 Comparison - Lantheus Holdings' product, 18F-PSMA diagnostic agent PYLARIFY, reported sales revenue of $1.1 billion in its 2024 annual report [1]
东诚药业(002675) - 关于氟[18F]思睿肽注射液上市申请获国家药品监督管理局受理的公告
2026-01-09 12:15
证券代码:002675 证券简称:东诚药业 公告编号:2026-006 烟台东诚药业集团股份有限公司 关于氟[ 18F]思睿肽注射液上市申请 获国家药品监督管理局受理的公告 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。 2026 年 1 月 9 日,烟台东诚药业集团股份有限公司(以下简称"公司") 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")收到国家 药品监督管理局核准签发的关于蓝纳成在研药品氟[ 18F]思睿肽注射液上市许可 申请的《受理通知书》。现将相关情况公告如下: 一、药品基本情况 名称:氟[ 18F]思睿肽注射液 二、药品的其他情况 1、氟[ 18F]思睿肽注射液是一种靶向 PSMA 的放射性体内诊断药物,适用于 下述前列腺癌患者前列腺特异性膜抗原(PSMA)阳性病灶的正电子发射断层扫 描(PET)成像: (1)拟接受初始根治性治疗,怀疑存在转移灶的前列腺癌患者; (2)血清前列腺特异性抗原(PSA)水平升高,怀疑生化复发的前列腺癌 患者。 2、氟[ 18F]思睿肽与 PSMA 蛋白具有较高的特异性和亲和力,可在 PSMA 高 1 ...
东诚药业:氟[18F]思睿肽注射液上市申请获受理 目前国内未有同类产品上市
Mei Ri Jing Ji Xin Wen· 2026-01-09 12:13
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]
烟台东诚药业集团股份有限公司 关于取得金融机构股票回购专项贷款承诺函的公告
Group 1 - The company approved a share repurchase plan using its own and self-raised funds, with a maximum repurchase price of RMB 18.00 per share and a total repurchase amount between RMB 100 million and RMB 200 million, to be completed within 12 months [1] - The company received a loan commitment letter from China Merchants Bank Yantai Branch, promising a loan of up to RMB 170 million, which cannot exceed 90% of the actual repurchase amount, with a term of no more than 36 months [1] - The total amount of the repurchase, including the loan and self-funds, will not exceed the upper limit of the repurchase amount, and the actual total will be determined at the end of the repurchase period [1] Group 2 - The share repurchase plan is in response to national policies supporting stock buybacks, aimed at improving the efficiency of the company's capital use, and it does not constitute a related party transaction or significantly impact the company's operations and performance [2] - The company will implement the repurchase plan based on market conditions within the specified period and will fulfill its information disclosure obligations according to relevant laws and regulations [2]
1月8日增减持汇总:东诚药业等2股增持 中微公司等11股减持(表)
Xin Lang Cai Jing· 2026-01-08 13:45
Group 1 - Dongcheng Pharmaceutical announced a commitment to a stock repurchase loan of up to 170 million yuan [2][4] - Xin Kaiyuan plans to repurchase shares worth between 40 million to 50 million yuan for cancellation [2][4] Group 2 - Zhongwei Company’s major shareholder, Xunxin Investment and Chairman Yin Zhiyao, intends to reduce their holdings by up to 2.05% [5] - *ST Jianyi's shareholder Sun Yun plans to reduce holdings by up to 1.23% [5] - Hongrun Construction's shareholder Zhou Meizhen plans to reduce holdings by up to 0.12% [5] - ST Yigou's shareholder Hangzhou Haoyue reduced holdings by 20.22 million shares from January 5 to 8 [5] - Huafeng Measurement and Control's financial director plans to reduce holdings by up to 0.0021% [5] - Zhukebo Design's shareholder intends to reduce company shares [5] - Taifengquan's shareholders Hongtai Investment and Yitai Investment plan to reduce holdings by up to 0.54% [5] - Lai Yifen's controlling shareholder Aiwuqi Management plans to reduce holdings by up to 3% [5] - Jialitu's shareholder Anle Group plans to reduce holdings by up to 3% [5] - Hu Silicon Industry's largest shareholder, the National Integrated Circuit Industry Investment Fund, reduced holdings by 0.2% from January 7 to 8 [5] - Yuguang Jinchang's shareholder Investment Group plans to reduce holdings by up to 1.71% [5]
东诚药业:取得不超1.7亿元金融机构股票回购专项贷款承诺函
Mei Ri Jing Ji Xin Wen· 2026-01-08 10:01
每经AI快讯,1月8日,东诚药业(002675.SZ)公告称,公司近日取得招商银行烟台分行出具的《贷款承 诺函》,承诺为公司本次回购股份专项贷款融资提供支持,贷款金额不超过人民币17,000万元(且贷款 金额不得超过实际回购金额的90%),期限不超过36个月,承诺函有效期自出具之日起至2027年1月5日 止。该事项不构成关联交易,不会对公司经营及业绩产生重大影响。 ...
东诚药业(002675.SZ):取得金融机构股票回购专项贷款承诺函
Ge Long Hui A P P· 2026-01-08 10:01
Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) has received a loan commitment letter from China Merchants Bank Yantai Branch to support its share repurchase financing, with specific terms outlined [1] Group 1: Loan Details - The loan amount is capped at RMB 170 million, which cannot exceed 90% of the actual repurchase amount [1] - The loan term is set for a maximum of 36 months [1] - The validity period of the commitment letter is from the date of issuance until January 5, 2027 [1]
东诚药业:取得不超1.7亿元回购股份专项贷款融资支持
人民财讯1月8日电,东诚药业(002675)1月8日公告,近日,公司取得招商银行股份有限公司烟台分行 出具的《贷款承诺函》,承诺为公司本次回购股份专项贷款融资提供支持,贷款金额不超过1.7亿元 (且贷款金额不得超过实际回购金额的90%)期限不超过36个月。 ...