中国医药晚间公告，子公司天方药业的盐酸林可霉素注射液通过仿制药质量和疗效一致性评价。国家药 监局于2024年7月受理该药品的一致性评价申请，截至公告披露日，已累计投入约608万元人民币（未经 审计）。该药品主要用于治疗由链球菌、肺炎球菌和葡萄球菌等敏感菌株引起的严重感染。2024年国内 公立医院及公立基层医疗终端销售额约为0.77亿元，天方药业该药品销售额约为1532万元。通过一致性 评价有助于提升该药品的市场竞争力，进一步拓展市场份额。 ...

证券代码：600200 证券简称：*ST苏吴 公告编号：临2025-112 江苏吴中医药发展股份有限公司 关于盐酸林可霉素注射液通过仿制药一致性评价的公告 本公司董事会及董事会全体成员保证公告内容不存在虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实、准确和完整承担个别及连带责任。 近日，江苏吴中医药发展股份有限公司（以下简称"公司"）全资子公司江苏吴中医药集团有限公司下属 分支机构江苏吴中医药集团有限公司苏州制药厂（以下简称"苏州制药厂"）收到了国家药品监督管理局 （以下简称"国家药监局"）核准签发的关于"盐酸林可霉素注射液"（以下简称"该药品"或"本品"）的 《药品补充申请批准通知书》（通知书编号：2025B04321），该药品通过仿制药质量和疗效一致性评 价（以下简称"仿制药一致性评价"）。现将相关情况公告如下： 一、药品基本情况 二、药品的其他相关情况 药品名称：盐酸林可霉素注射液 剂型：注射剂 规格：2ml：0.6g（按C18H34N2O6S计） 药品批准文号：国药准字H32021365 注册分类：化学药品 上市许可持有人：江苏吴中医药集团有限公司苏州制药厂 药品生产企业：江苏吴中医药集团有限公 ...

Group 1 - The core viewpoint of the article highlights the recent developments in HaiXin Co., Ltd.'s pharmaceutical sector, particularly in the area of oncology drug research and development [1] - The chairman of HaiXin Co., Ltd., Deng Haibin, stated that the company's pharmaceutical subsidiaries are primarily traditional generic drug companies, focusing on post-marketing clinical trial evaluations of existing key products and promoting the consistency evaluation of generic drugs [1] - Regarding the clinical trial progress of HaiXin Biotech's APDC, it was mentioned that the design of the Phase III clinical trial was established a long time ago, leading to difficulties in patient enrollment, and the company is currently exploring solutions to this issue [1]

以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 国药现代(600420.SH)公告称，公司收到国家药品监督管理局核准签发的《药品补充申请批准通知 书》，批准马来酸依那普利片（5mg）通过仿制药质量和疗效一致性评价。马来酸依那普利片为一种血 管紧张素转移酶抑制药，主要用于治疗原发性高血压、肾血管性高血压及症状性心力衰竭等病症。根据 米内网数据库显示，马来酸依那普利片2024年全国公立医疗机构及城市药店销售额为人民币1.64亿元。 公司用于该项目的累计研发投入约人民币1,536.57万元（未经审计）。本次5mg过评，将有利于该产品 未来的市场拓展和销售。上述事项对公司目前经营业绩不会产生重大影响。 ...

Group 1 - The company held its third extraordinary general meeting of shareholders on September 12, 2025, with no resolutions being rejected [1][2][6] - A total of 100 shareholders participated in the meeting, representing 113,225,082 shares, which is 35.6054% of the total voting shares [7] - The meeting approved several resolutions, including amendments to the company's articles of association and governance systems, with significant support from shareholders [11][12][14][16][18][20] Group 2 - The company received an administrative penalty notice from the China Securities Regulatory Commission (CSRC) regarding violations of information disclosure laws, specifically for inflating profits in 2017 and 2018 [24][25] - The inflated profits amounted to 92,204,254.47 yuan in 2017 and 28,823,001.51 yuan in 2018, representing 30.21% and 20.61% of the reported profits for those years, respectively [25][27] - The company and several executives face fines and potential market bans due to their involvement in these violations, with the actual controller facing a lifetime ban from the securities market [31][34] Group 3 - The company's stock will be subject to additional risk warnings starting September 15, 2025, due to the identified violations, although it will not be suspended from trading [38][40] - The company plans to enhance its internal controls and compliance measures to prevent future violations and improve governance [42]

Core Viewpoint - The company, China National Pharmaceutical Group Modern (600420.SH), announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a supplemental application regarding sodium bicarbonate injection, which includes an increase in specifications and has passed the consistency evaluation for generic drug quality and efficacy [1]. Group 1 - The sodium bicarbonate injection is classified as an antacid [1]. - Indications for sodium bicarbonate injection include: (1) treatment of metabolic acidosis; (2) prevention of uric acid kidney stones, reduction of nephrotoxicity from sulfonamides, and prevention of hemoglobin deposition in renal tubules during acute hemolysis; (3) intravenous infusion for non-specific treatment of certain drug poisonings, such as barbiturates, salicylates, and methanol [1].

根据国家相关政策，通过仿制药质量和疗效一致性评价的药品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。本次三精明水的拉西地平片（4mg）通过仿制药质量和疗效一致性评价，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仿制药质量和疗效一致性评价工作 积累了有益的经验。 格隆汇9月11日丨哈药股份(600664.SH)公布，公司所属企业哈药集团三精明水药业有限公司（称"三精 明水"）收到国家药品监督管理局颁发的关于拉西地平片的《药品补充申请批准通知书》【编号： 2025B04172】，本品通过仿制药质量和疗效一致性评价。 拉西地平为特异性高效钙离子拮抗剂，对于血管平滑肌的钙通道具有高度选择性。其主要作用为扩张外 周小动脉，减少外周血管阻力和降低血压。单独使用或与其他抗高血压的药物，如β-阻滞剂、利尿药和 血管紧张素转化酶抑制剂合用，治疗高血压。 ...

Group 1 - The company Shanghai Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration approving the supplementary application for the drug Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1][2] - The drug Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, wheezing bronchitis, and obstructive pulmonary emphysema, and it was developed by Eisai Co., Ltd. and launched in Japan in October 1952 [2] - As of the announcement date, the company has invested approximately RMB 3.05 million in research and development for this drug [2] Group 2 - The approval of the drug's consistency evaluation is expected to enhance its market share and competitiveness, as products that pass this evaluation will receive greater support in medical insurance payments and procurement by medical institutions [2] - The total procurement amount for Dihydroxypropyl Theophylline Injection (2ml:0.3g) in hospitals in mainland China for 2024 is reported to be RMB 9.737 million [2]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a "Drug Supplement Application Approval Notice" from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - Dihydroxypropyl Theophylline Injection was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and combined consistency evaluation of the generic drug, which was accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a Supplementary Application Approval Notice from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - The drug was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and consistency evaluation of the generic drug, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]