2024年8月，常乐制药首次递交美阿沙坦钾片(40mg/80mg)注册申请并获受理，近日常乐制药收到国家药 监局核准签发的美阿沙坦钾片(40mg/80mg)《药品注册证书》。常乐制药美阿沙坦钾片(40mg/80mg)按照 化学药品4类进行申报，根据国家相关政策，本次获得《药品注册证书》视同通过仿制药质量和疗效一 致性评价。 截至本公告披露日，常乐制药美阿沙坦钾片(40mg/80mg)研发投入约为人民币1099.00万元(未经审计)。 截至本公告披露日，常乐制药已经获得10个生产批件。 格隆汇12月26日丨联环药业(600513.SH)公布，公司控股子公司新乡市常乐制药有限责任公司于近日收 到国家药品监督管理局核准签发的《药品注册证书》。 美阿沙坦钾片可用于治疗成人原发性高血压。2024 年度全国样本医院美阿沙坦钾片销售额达5873.19万 元(数据来源于摩熵·医药数据库)。 本次常乐制药获得美阿沙坦钾片(40mg/80mg)《药品注册证书》，进一步丰富了公司及子公司的产品 线，有助于提升公司及子公司产品的市场竞争力。上述《药品注册证书》的取得预计不会对公司及子公 司近期经营业绩产生重大影响。 财经频道更多独家 ...

北陆药业12月12日公告，公司近日收到国家药品监督管理局核准签发的吡格列酮二甲双胍片 （15mg/500mg）《药品注册证书》。吡格列酮二甲双胍片（15mg/500mg）按照化学药品3类获批，视 同通过仿制药质量和疗效一致性评价，进一步丰富了公司降糖药产品管线，有助于提升公司产品的市场 竞争力。公司将积极开展新产品上市的各项准备工作，并尽快将产品推向市场，但其生产和销售可能会 受到一些不确定性因素的影响。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002332 证券简称：仙琚制药 公告编号：2025-056 浙江仙琚制药股份有限公司 关于盐酸尼卡地平注射液通过一致性评价的公告 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。 浙江仙琚制药股份有限公司（以下简称"公司"）于近日收到国家药品监督管理局核准签发的关于盐酸尼 卡地平注射液的《药品补充申请批准通知书》（通知书编号：2025B05803和2025B05804），公司盐酸 尼卡地平注射液通过仿制药质量和疗效一致性评价。现将相关情况公告如下： 一、药品基本信息 ■ 申请内容：申报仿制药质量和疗效一致性评价。 2025年12月10日 二、药品的其他相关情况 盐酸尼卡地平注射液是一种钙离子拮抗剂药物，主要用于快速降低血压和处理急性高血压情况，如手术 中或急诊环境。它通过扩张血管来促进血流，保护心、脑、肾等重要器官，效果迅速但需在医生监控下 使用。 本公司盐酸尼卡地平注射液已批准上市的规格为10ml:10mg（药品批准文号为国药准字H20258264）和 5ml:5mg（药品批准文号为国药准字H202 ...

普洛药业公告，全资子公司浙江普洛巨泰药业有限公司近日收到国家药品监督管理局签发的阿莫西林克 拉维酸钾片《药品注册证书》。该药品用于治疗上呼吸道感染、下呼吸道感染、泌尿系统感染、皮肤和 软组织感染及口腔感染。根据相关数据，2024年度中国院内市场规模为7.6亿片，销售金额为6.2亿元。 截至公告披露日，累计研发投入为1082.45万元。该药品视同通过仿制药质量和疗效一致性评价，将具 备参加国家药品集中采购续约资格，有利于扩大市场销售，提高市场竞争力。 ...

Core Viewpoint - The announcement highlights that the company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration of China for its injectable Cefoperazone Sodium and Sulbactam Sodium (2.0g), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Specifications - The injectable Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic with broad-spectrum antibacterial activity, suitable for monotherapy or combination therapy [1] - It is indicated for the treatment of infections caused by sensitive bacteria, including respiratory, urinary, intra-abdominal, septicemia, meningitis, skin and soft tissue, bone and joint, and reproductive tract infections [1] Group 2: Market Position and Future Prospects - The product is listed as a Class B drug in the National Medical Insurance Directory (2024 edition), which may enhance its market accessibility [1] - The approval is expected to help the company strengthen its competitive position in the anti-infection field and contribute to greater returns for the company and its shareholders through ongoing product development and consistency evaluations [1]

Group 1 - The company has elected Mr. Zheng Fangwei as the employee director of the fifth board of directors, with a term starting from November 24, 2025 [1][3] - The election of the employee director complies with relevant laws and regulations, ensuring that the number of employee representatives does not exceed half of the total board members [1] Group 2 - The company's wholly-owned subsidiary, Shanghai Sitaili Pharmaceutical Co., Ltd., has received a drug registration certificate for Gadopentetate Dimeglumine Injection from the National Medical Products Administration [4][5] - The drug is classified as a Class 4 chemical drug and is primarily used for magnetic resonance imaging of various organs and tissues [5][7] - The total R&D investment for this drug has reached approximately 7.07 million yuan [6] - The market data indicates that the sales of Gadopentetate Dimeglumine Injection in Chinese public medical institutions are expected to exceed 700 million yuan in 2024 [8]

□ 本报记者杨易臻 一种药物从最初的靶点确认到最后的成功上市，要经历漫长的研发过程。在当今精细化的医药分工中， CRO(合同研究组织)企业为医药企业、科研机构的药物研发提供专业外包服务。假若把一家创新药企比 作一家"大饭店"，那么CRO企业的任务就是根据饭店老板的需求协助研发"新菜品"。 成立于2020年6月的南京科默生物医药有限公司(简称"科默医药")，正是一家CRO企业。短短5年，科默 医药迅速扩张至500余人，完成数亿元融资。该公司2023年成为"江苏潜在独角兽企业"，今年进入"科创 未来之星"企业行列。近日，记者走进科默医药，了解其在全链条新药研发赛道上的发展路径。 把握"风口"努力消除行业弊端 记者走进科默医药的实验室，第一印象是"满"。600多台高端分析仪器日夜运转，数百名身穿白大褂的 研发人员在实验台前忙碌。 企业创始人张孝清博士，毕业于南京医科大学，此后留校任教，在管理医药研发平台、开发候选药物研 究、建立新药研发合作等方面具有20余年的丰富经验。他曾创立南京华威医药科技集团有限公司，在华 威医药与新疆百花村股份有限公司进行重大资产重组上市后，又创办科默医药。 这个二次创业项目，既在于把握政策 ...

Core Viewpoint - The company has received approval for its cephalosporin product, marking a significant milestone in its market strategy and potential for growth [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhejiang Pro Pharmaceutical Co., Ltd., has been granted a drug registration certificate for its cephalosporin dry suspension (1.5g; 3.0g) by the National Medical Products Administration [1] - This product is the first generic drug in China to be approved and deemed to have passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2: Market Implications - The approval allows the product to qualify for participation in national medical insurance negotiations, which is expected to enhance its market sales and competitiveness [1] - The company may face uncertainties in production and sales due to potential changes in policies, regulations, and market conditions [1]

Core Viewpoint - The company held a Q3 2025 earnings presentation on November 19, 2025, to discuss its financial status, market expansion, R&D projects, and future strategies with investors [1][2]. Group 1: Earnings Presentation Overview - The earnings presentation was conducted via the Shanghai Stock Exchange's online platform, with key executives including the chairman and CFO in attendance [2]. - The company disclosed its Q3 2025 report on October 29, 2025, prior to the earnings presentation [1]. Group 2: Investor Questions and Company Responses - The company is focusing on expanding its sales channels to include outpatient markets and grassroots medical institutions, aiming to integrate resources across different healthcare settings [3]. - The market demand for steroid hormones and amino acids is competitive, prompting the company to concentrate on core areas such as dermatology and respiratory health while enhancing its product pipeline [3]. - The company anticipates challenges in achieving its 2025 annual performance targets due to price reductions from centralized procurement and intensified competition, but it plans to adapt its sales strategies and enhance market operations [3]. - Recent product developments include two products passing the consistency evaluation for generic drug quality and efficacy, and several products receiving registration certificates [4]. - The company reported that the market prospects for butorphanol tartrate injection are promising, with projected sales of CNY 1.965 billion in 2023 and CNY 1.899 billion in 2024 [4]. - The company emphasizes its commitment to returning value to investors, maintaining a cash dividend ratio exceeding 80% since 2023, and focusing on sustainable growth [4]. - The company is enhancing its compliance management systems and conducting regular training to foster a strong compliance culture [4].

海南海药11月14日公告，公司全资子公司海口市制药厂有限公司近日获得国家药品监督管理局核准签发 的化学药品注射用美罗培南的《药品补充申请批准通知书》。注射用美罗培南主要适用于成人和儿童由 单一或多种对美罗培南敏感的细菌引起的感染：肺炎（包括院内获得性肺炎）、尿路感染、腹腔内感 染、妇科感染（如子宫内膜炎和盆腔炎）、皮肤软组织感染、脑膜炎、败血症。 ...