格隆汇12月9日丨泰恩康(301263.SZ)公布，公司全资子公司安徽泰恩康制药有限公司于近日收到国家药 品监督管理局签发的吲哚布芬片境内生产药品注册上市许可申请《受理通知书》，国家药监局根据《中 华人民共和国行政许可法》第三十二条的规定，对上述药品的药品注册上市许可申请进行了审查，决定 予以受理。 吲哚布芬片是一种血小板聚集抑制剂，通过可逆性抑制环氧化酶及多种诱导剂，降低血栓风险，用于动 脉硬化引起的缺血性心血管病变、缺血性脑血管病变、静脉血栓形成。也可用于血液透析时预防血栓形 成。 ...

人民财讯12月9日电，泰恩康（301263）12月9日公告，全资子公司山东华铂凯盛生物科技有限公司近日 收到国家药监局签发的甲巯咪唑片《药品注册证书》，甲巯咪唑属于咪唑类抗甲状腺药物。另外，公司 全资子公司安徽泰恩康制药有限公司于近日收到国家药监局签发的吲哚布芬片境内生产药品注册上市许 可申请《受理通知书》。 ...

泰恩康12月9日公告，公司全资子公司安徽泰恩康制药有限公司于近日收到国家药监局签发的吲哚布芬 片境内生产药品注册上市许可申请《受理通知书》，国家药监局根据《中华人民共和国行政许可法》第 三十二条的规定，对上述药品的药品注册上市许可申请进行了审查，决定予以受理。吲哚布芬片是一种 血小板聚集抑制剂，通过可逆性抑制环氧化酶及多种诱导剂，降低血栓风险，用于动脉硬化引起的缺血 性心血管病变、缺血性脑血管病变、静脉血栓形成。也可用于血液透析时预防血栓形成。 ...

智通财经APP讯，泰恩康(301263.SZ)公告，公司全资子公司安徽泰恩康制药有限公司于近日收到国家药 品监督管理局签发的吲哚布芬片境内生产药品注册上市许可申请《受理通知书》，国家药监局对上述药 品的药品注册上市许可申请进行了审查，决定予以受理。 公告显示，吲哚布芬片是一种血小板聚集抑制剂，通过可逆性抑制环氧化酶及多种诱导剂，降低血栓风 险，用于动脉硬化引起的缺血性心血管病变、缺血性脑血管病变、静脉血栓形成。也可用于血液透析时 预防血栓形成。 ...

智通财经APP讯，泰恩康(301263.SZ)公告，公司全资子公司安徽泰恩康制药有限公司于近日收到国家药 品监督管理局签发的吲哚布芬片境内生产药品注册上市许可申请《受理通知书》，国家药监局对上述药 品的药品注册上市许可申请进行了审查，决定予以受理。 公告显示，吲哚布芬片是一种血小板聚集抑制剂，通过可逆性抑制环氧化酶及多种诱导剂，降低血栓风 险，用于动脉硬化引起的缺血性心血管病变、缺血性脑血管病变、静脉血栓形成。也可用于血液透析时 预防血栓形成。 ...

Core Viewpoint - 石四药集团 has received production registration approval from the National Medical Products Administration of China for Indobufene Tablets (0.2g), which is classified as a Class 3 chemical drug and is considered to have passed the consistency evaluation [1] Group 1: Company Developments - 石四药集团's stock rose nearly 3%, currently up 2.68% at HKD 3.06, with a trading volume of HKD 16.01 million [1] - The Indobufene Tablets are primarily used for treating ischemic cardiovascular diseases caused by arteriosclerosis, ischemic cerebrovascular diseases, and venous thrombosis, and can also be used to prevent thrombosis during hemodialysis [1] Group 2: Market Insights - Indobufene Tablets, developed by an Italian company, have become a substitute for aspirin for patients who are intolerant to it [1] - According to the MoShang Pharmaceutical Database, the total hospital sales of Indobufene Tablets exceeded 1 billion in 2022, showing a year-on-year growth over the past three years [1] - Sales are projected to exceed 1.9 billion in 2024, with a year-on-year increase of 37.47%, and over 1.1 billion in the first half of 2025, with a year-on-year increase of 28.07% [1] - The high sales figures have attracted attention from numerous pharmaceutical companies, intensifying market competition [1]

Core Viewpoint - Stone Four Pharmaceutical Group has seen a nearly 3% increase in stock price following the announcement of obtaining production registration for Indobufene tablets from the National Medical Products Administration of China, indicating a significant development in their product pipeline [1] Company Summary - Stone Four Pharmaceutical Group's stock rose by 2.68% to HKD 3.06, with a trading volume of HKD 16.01 million [1] - The company has received approval for Indobufene tablets (0.2g), classified as a Class 3 chemical drug, which is considered equivalent to passing the consistency evaluation [1] Product Summary - Indobufene tablets are primarily used for treating ischemic cardiovascular diseases caused by arteriosclerosis, ischemic cerebrovascular diseases, and venous thrombosis, and can also prevent thrombosis during hemodialysis [1] - Developed by an Italian company, Indobufene has become a substitute for aspirin in patients who are intolerant to it [1] Market Summary - According to the MoSheng Pharmaceutical Database, the total hospital sales of Indobufene tablets exceeded 1 billion in 2022, showing a year-on-year growth over the past three years [1] - Sales are projected to surpass 1.9 billion in 2024, reflecting a year-on-year increase of 37.47%, and exceed 1.1 billion in the first half of 2025, with a year-on-year growth of 28.07% [1] - The high sales figures have attracted attention from numerous pharmaceutical companies, intensifying market competition [1]

Core Viewpoint - The company Shijiazhuang Fourth Pharmaceutical Group has obtained the production registration approval from the National Medical Products Administration of China for Indobufene Tablets (0.2g), classified as a Class 3 chemical drug, which is considered equivalent to passing the consistency evaluation [1] Group 1 - Indobufene Tablets are primarily used for the treatment of ischemic cardiovascular diseases caused by arteriosclerosis, ischemic cerebrovascular diseases, and venous thrombosis, and can also be used to prevent thrombosis during hemodialysis [1]

每经AI快讯，11月14日，石四药集团有限公司港交所公告，本集团已取得中国国家药品监督管理局有 关吲哚布芬片(0.2g)的药品生产注册批件，属于化学药品第3类，视同通过一致性评价。吲哚布芬片主要 用于治疗动脉硬化引起的缺血性心血管病变、缺血性脑血管病变及静脉血栓形成，也可用于血液透析时 预防血栓形成。 ...

Policy Developments - Jiangxi Province is promoting the development of brain-computer interface medical devices, emphasizing the need for regulatory compliance and collaboration among industry players to seize opportunities in emerging technologies [1] - The market for brain-computer interface medical devices is noted to have significant potential, with a strong development momentum in Jiangxi Province [1] Medical Device Approvals - In October, the National Medical Products Administration approved 204 medical device products, including 173 domestic Class III devices, 10 imported Class III devices, and 21 imported Class II devices [2] Pharmaceutical Logistics - The Shanghai Municipal Drug Administration encourages the development of modern pharmaceutical logistics, advocating for improved storage and management systems to enhance operational efficiency and reduce costs [3] Drug Approvals - Fangsheng Pharmaceutical announced that its Indobufen tablets received a drug registration certificate from the National Medical Products Administration, allowing for production [4] - Saito Bio's application for the chemical raw material drug Mometasone Furoate has been approved, indicating its use in treating asthma and skin conditions [5] - Tianyao Pharmaceutical received a drug registration certificate for Metoclopramide injection, which is used for treating nausea and vomiting [6] Capital Market Activities - Yingsi Intelligent submitted a listing application to the Hong Kong Stock Exchange, aiming to raise funds for its AI-driven drug development initiatives [7][8] - Rejuve Bio plans to repurchase shares worth between 100 million and 200 million yuan to support employee stock ownership plans [9] Industry Developments - AstraZeneca's Baxdrostat demonstrated significant reductions in 24-hour average systolic blood pressure in treatment-resistant hypertension patients during the Bax24 Phase III trial, achieving a reduction of 14.0 mmHg compared to placebo [10][11] - The drug showed good overall tolerability and consistent safety profiles, with a notable percentage of patients achieving target blood pressure levels [11] - Maiwei Bio's IL-11 monoclonal antibody 9MW3811 received approval for Phase II clinical trials targeting pathological scars, marking it as the first IL-11 targeted drug to enter clinical trials for this indication [12] - Aiwei Technology's subsidiary obtained a medical institution practice license, enabling it to provide third-party medical testing services [13] - Anke Bio signed an exclusive agency framework agreement with Boshengji for the PA3-17 injection product, aimed at enhancing its product portfolio in the innovative drug market [14][15]