仿制药质量和疗效一致性评价
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在新药研发“风口”加速奔跑
Xin Hua Ri Bao· 2025-11-25 21:46
□ 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 ...
普洛药业:子公司头孢地尼干混悬剂获得药品注册证书
Sou Hu Cai Jing· 2025-11-24 08:04
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]
津药药业股份有限公司 关于2025年第三季度业绩说明会召开情况的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-11-20 02:22
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:子公司注射用美罗培南通过仿制药质量和疗效一致性评价
Xin Lang Cai Jing· 2025-11-14 11:19
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。 ...
津药药业:子公司盐酸甲氧氯普胺注射液获得药品注册证书
Xin Lang Cai Jing· 2025-11-11 07:48
Core Viewpoint - The company announced that its subsidiary, Hubei Jinyao Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the registration certificate of Methoclopramide Hydrochloride Injection, which is expected to positively impact the company's performance and market expansion in the domestic formulation sector [1] Group 1 - The approved drug is classified as a Class 3 chemical drug and has passed the consistency evaluation of quality and efficacy for generic drugs [1] - The approval enhances the company's formulation product portfolio, which is anticipated to contribute positively to the company's performance [1] - The development, production, and sales of pharmaceuticals are subject to significant uncertainties due to national policies and market conditions [1]
北陆药业:碘美普尔注射液获得药品注册证书
Xin Lang Cai Jing· 2025-11-10 08:21
北陆药业11月10日公告,公司近日收到国家药品监督管理局核准签发的碘美普尔注射液《药品注册证 书》。碘美普尔注射液按照化学药品4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 公司碘类对比剂产品的布局,对比剂产品线更加多元化。公司控股子公司浙江海昌药业股份有限公司碘 美普尔原料药于2025年8月获批上市,碘美普尔注射液"原料药+制剂"的经营模式已成型。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。 ...
南京健友生化制药股份有限公司关于那屈肝素钙注射液通过仿制药质量和疗效一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-11-06 19:10
Core Viewpoint - Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its enoxaparin sodium injection to pass the consistency evaluation of generic drug quality and efficacy [1][2]. Drug Basic Information - Drug Name: Enoxaparin Sodium Injection - Indications: Used in surgical procedures to prevent venous thromboembolism in moderate to high-risk situations, treat existing deep vein thrombosis, and in combination with aspirin for unstable angina and non-Q wave myocardial infarction. It is also used to prevent clot formation during hemodialysis [1][2]. - Dosage Forms: Injection (pre-filled syringe products) [2]. - Specifications: 0.3ml: 3075AXaIU and 0.6ml: 6150AXaIU [2]. - Original Drug Approval Numbers: National Drug Approval Number H20194077 and H20191005 [2]. Other Relevant Information - The company has invested approximately RMB 23.56 million in research and development for the consistency evaluation of the enoxaparin sodium injection [3]. - Currently, there are eight companies, including Jianyou, that have launched generic versions of enoxaparin sodium injection in China [3]. Impact on the Company - The approval of the consistency evaluation will provide greater support for the drug in terms of medical insurance payments and procurement by medical institutions. It also qualifies the product for participation in national drug centralized procurement [4]. - The successful evaluation is expected to enhance the market sales and competitiveness of the enoxaparin sodium injection [5].
石四药集团:维生素B6注射液(1ml:0.1g)已取得国家药监局批准通过仿制药质量和疗效一致性评价
Zhi Tong Cai Jing· 2025-11-03 00:06
Core Viewpoint - The company Shijiazhuang Four Medicines Group has received approval from the National Medical Products Administration of China for its Vitamin B6 injection (1ml:0.1g) to pass the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The Vitamin B6 injection is primarily used for the prevention and treatment of Vitamin B6 deficiency [1] - It can also be utilized in cases of pregnancy, radiation sickness, and vomiting caused by anticancer drugs, as well as seborrheic dermatitis and hereditary Vitamin B6 dependency syndrome in newborns [1]
北京中关村科技发展(控股)股份有限公司关于下属公司北京华素盐酸纳曲酮片通过一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-10-31 19:20
Core Viewpoint - Beijing Zhongguancun Science and Technology Development (Holding) Co., Ltd. announced that its subsidiary, Beijing Huasu Pharmaceutical Co., Ltd., has successfully passed the consistency evaluation for the drug "Naltrexone Hydrochloride Tablets" [1][2] Group 1: Drug Approval and Details - The drug "Naltrexone Hydrochloride Tablets" (specification: 50mg) has received approval from the National Medical Products Administration, confirming its quality and efficacy consistency evaluation [1][2] - The original manufacturer of Naltrexone is TEVA WOMENS, which received approval in the United States in 1984 under the brand name REVIA [2] - Currently, there are no original or imported generic versions of this drug available in China, making Beijing Huasu the sole provider of this product in the market [2] Group 2: Financial and R&D Investment - The total research and development investment for the consistency evaluation project of Naltrexone Hydrochloride Tablets has reached 11.7389 million yuan [3] Group 3: Market Impact and Competitive Advantage - The approval of the consistency evaluation is expected to enhance the company's market competitiveness and positively impact its operating performance [4] - The drug will receive support in terms of medical insurance payments, and medical institutions are encouraged to prioritize its procurement and clinical use [4] - The successful evaluation provides valuable experience for the company in conducting future consistency evaluations for other generic drugs [4]
国药现代:法莫替丁注射液通过仿制药质量和疗效一致性评价
Zhi Tong Cai Jing· 2025-10-17 11:32
Core Viewpoint - The company Guoyao Modern (600420.SH) announced that its wholly-owned subsidiary, Guoyao Group Rongsheng Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplementary application of Famotidine injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - Guoyao Modern's subsidiary has been granted a supplementary application approval for Famotidine injection [1] - Famotidine is an H2 receptor antagonist used for treating upper gastrointestinal bleeding caused by various factors, excluding tumors and esophageal or gastric varices [1] - The approval indicates the company's capability to produce a drug that meets regulatory standards for quality and efficacy [1]