Policy Developments - The 2025 Pharmaceutical Digital Development Conference was held in Beijing on September 17-18, focusing on the modernization of drug regulation through information technology and digital collaboration [1] Drug and Device Approvals - Hengrui Medicine's SHR-1501 has been included in the list of proposed breakthrough therapy varieties by the National Medical Products Administration, aimed at treating non-muscle invasive bladder cancer [2] - Kehua Bio's ferritin assay kit received a medical device registration certificate, valid from September 17, 2025, to September 16, 2030, for the quantitative measurement of ferritin in human serum and plasma [3] - Shanghai Pharmaceuticals' Nicorandil tablets passed the consistency evaluation for generic drugs, with approximately 5.5352 million yuan invested in R&D [4] Capital Market - Roche announced a definitive agreement to acquire biopharmaceutical company 89bio for up to nearly $3.5 billion, focusing on innovative therapies for liver and heart metabolic diseases [5] Industry Events - The first national group standard for "Non-Clinical Safety Technical Guidelines for Oligonucleotide Drugs" was released during the 9th China (Tianjin) Nucleic Acid Drug Conference [6] Research and Development - Chinese researchers developed a new generation of brain-machine interface electrodes, marking a shift towards dynamic and intelligent detection in bioelectronic interfaces [7] - A new blood testing tool, "HPV-DeepSeek," can identify HPV-related head and neck cancers up to 10 years before symptoms appear, potentially improving patient outcomes [9] Corporate Governance - The independent director of Buchang Pharma, Cheng Hua, resigned due to personal reasons, leading to a temporary reduction in the number of independent directors on the board [10] Strategic Collaborations - Siemens Healthineers and Stryker announced a strategic partnership to develop a new robotic system for neurovascular interventions [8]

证券代码：601607 证券简称：上海医药 编号：临2025-084 上海医药集团股份有限公司 关于尼可地尔片通过仿制药一致性评价的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"公司"）下属山东信谊制药有限公司（以下简称"山东信 谊"）的尼可地尔片（以下简称"该药品"）收到国家药品监督管理局（以下简称"国家药监局"）颁发的 《药品补充申请批准通知书》（通知书编号：2025B04288），该药品通过仿制药质量和疗效一致性评 价。 一、该药品基本情况 尼可地尔片用于治疗心绞痛，最早由日本中外制药株式会社研发，于1983年在日本上市。2024年11月， 山东信谊就该药品仿制药一致性评价向国家药监局提出申请并获受理。截至本公告日，公司针对该药品 已投入的研发费用约人民币553.52万元。 截至本公告日，中国境内该药品的主要生产厂家有中外制药株式会社、西安汉丰药业有限责任公司、天 方药业有限公司、山西鑫煜制药股份有限公司等。 IQVIA数据库显示，2024年中国大陆医院采购尼可地尔 ...

Major Events - Jinfang Pharmaceutical-B (02595) received a subscription rate of 2662.79 times for its public offering in Hong Kong, raising approximately HKD 1.67 billion from the global offering [1] - Heng Rui Pharmaceutical (01276) announced that its SHR-1501 injection has been included in the list of proposed breakthrough therapy products [1] - Shanghai Pharmaceuticals (02607) successfully passed the consistency evaluation for the generic drug Nicorandil tablets [1] - Qutech Technology (01478) plans to sell 51.08% of its stake in India for INR 5.53 billion [1] - Boleton (01333) signed a procurement contract for energy storage system equipment with Guoxia Technology [1] - Hongye Futures (03678) shareholders Suhao Huihong and Hongye Logistics collectively reduced their holdings by 5.9482 million shares [1] - Shangu Holdings (00412) responded to concerns about concentrated shareholding, stating that the company can comply with public shareholding regulations [1] - Changfei Optical Fiber and Cable (06869) experienced unusual stock price fluctuations, with its hollow core fiber business not yet significantly impacting financial data [1] - Sanhua Intelligent Control (02050) reported abnormal trading fluctuations in A-shares, confirming no undisclosed significant matters or ongoing major planning [1] Operating Performance - China Pacific Insurance (02601) reported that its life insurance premium income for the first eight months reached CNY 217.05 billion, a year-on-year increase of 13.2% [1] - Datang Renewable (01798) completed a power generation volume of 2.1691 million MWh in August, representing a year-on-year increase of 27.5% [1]

（文章来源：证券日报） 证券日报网讯 9月18日晚间，上海医药发布公告称，近日，公司下属山东信谊制药有限公司的尼可地尔 片收到国家药品监督管理局颁发的《药品补充申请批准通知书》（通知书编号：2025B04288），该药 品通过仿制药质量和疗效一致性评价。 ...

据悉，尼可地尔片用于治疗心绞痛，最早由日本中外制药株式会社研发，于1983年在日本上市。2024年 11月，山东信谊就该药品仿制药一致性评价向国家药监局提出申请并获受理。截至本公告日，公司针对 该药品已投入的研发费用约人民币553.52万元。 截至公告日，中国境内该药品的主要生产厂家有中外制药株式会社、西安汉丰药业有限责任公司、天方 药业有限公司、山西鑫煜制药股份有限公司等。IQVIA数据库显示，2024年中国大陆医院采购尼可地尔 片(5mg)金额为人民币72,682万元。 格隆汇9月18日丨上海医药(02607.HK)公布，近日，公司下属山东信谊制药有限公司(以下简称"山东信 谊")的尼可地尔片(以下简称"该药品")收到国家药品监督管理局(以下简称"国家药监局")颁发的《药品补 充申请批准通知书》(通知书编号：2025B04288)，该药品通过仿制药质量和疗效一致性评价。 ...

IQVIA 数据库显示，2024年中国大陆医院采购尼可地尔片(5mg)金额为人民币7.27亿元。 根据国家相关政策，通过一致性评价的品种在医保支付及医疗机构采购等领域将获得更大的支持力度。 因此山东信谊的尼可地尔片通过仿制药一致性评价，有利于扩大该药品的市场份额，提升市场竞争力， 同时为公司后续产品开展一致性评价工作积累了宝贵的经验。 截至本公告日，中国境内该药品的主要生产厂家有中外制药株式会社、西安汉丰药业有限责任公司、天 方药业有限公司、山西鑫煜制药股份有限公司等。 智通财经APP讯，上海医药(02607)发布公告，近日，该公司下属山东信谊制药有限公司(以下简称"山东 信谊")的尼可地尔片(以下简称"该药品")收到国家药品监督管理局(以下简称"国家药监局")颁发的《药品 补充申请批准通知书》(通知书编号：2025B04288)，该药品通过仿制药质量和疗效一致性评价。 尼可地尔片用于治疗心绞痛，最早由日本中外制药株式会社研发，于1983年在日本上市。2024年11月， 山东信谊就该药品仿制药一致性评价向国家药监局提出申请并获受理。截至本公告日，公司针对该药品 已投入的研发费用约人民币553.52万元。 ...

北京商报讯（记者 王寅浩 实习记者 宋雨盈）9月18日，上海医药发布公告称，公司下属山东信谊制药 有限公司的尼可地尔片收到国家药品监督管理局颁发的《药品补充申请批准通知书》，该药品通过仿制 药质量和疗效一致性评价。 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary Shandong Xinyi Pharmaceutical Co., Ltd. received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, indicating that the drug Nicorandil tablets have passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The drug Nicorandil tablets are used for the treatment of angina pectoris [1]

智通财经APP讯，上海医药(601607.SH)公告，公司下属山东信谊制药有限公司(简称"山东信谊")的尼可 地尔片收到国家药品监督管理局颁发的《药品补充申请批准通知书》，该药品通过仿制药质量和疗效一 致性评价。尼可地尔片用于治疗心绞痛。 ...

格隆汇9月18日丨上海医药(601607.SH)公布，公司下属山东信谊制药有限公司(简称"山东信谊")的尼可 地尔片(称"该药品")收到国家药品监督管理局颁发的《药品补充申请批准通知书》(通知书编号： 2025B04288)，该药品通过仿制药质量和疗效一致性评价。尼可地尔片用于治疗心绞痛。 ...