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中国医药健康产业股份有限公司 关于子公司药品通过仿制药一致性评价的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-24 04:21
Core Viewpoint - The company announced that its subsidiary, Tianfang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the injection of Lincomycin Hydrochloride, which has passed the consistency evaluation of generic drug quality and efficacy [1][6]. Group 1: Drug Approval Information - The drug name is Lincomycin Hydrochloride Injection, with an acceptance number of CYHB2450368 and a notification number of 2025B04301 [1]. - The drug is classified as a chemical drug and is in injection form with a specification of 2ml:0.6g [1]. - The approval is based on various regulations, including the Drug Administration Law of the People's Republic of China and relevant announcements regarding the consistency evaluation of generic drugs [1]. Group 2: Drug Usage and Market Context - Lincomycin Hydrochloride Injection is primarily used to treat severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus [2]. - The original product was developed by Pharmacia & Upjohn and was approved by the FDA in December 1964, marketed under the name Lincocin [2]. - As of the announcement date, the project has incurred a cumulative investment of approximately 6.08 million RMB (unaudited) [4]. Group 3: Market Competition and Sales Data - More than ten companies, including Ruiyang Pharmaceutical Co., Ltd. and Hainan Puli Pharmaceutical Co., Ltd., have passed or are deemed to have passed the consistency evaluation for this drug [5]. - The estimated sales revenue for the drug in public hospitals and grassroots medical terminals in China for 2024 is approximately 77 million RMB, with the company's projected sales for the drug being around 15.32 million RMB [5].
聚焦产业提质升级 北上协《股东来了》系列活动走进三家生物医药企业
Zheng Quan Ri Bao· 2025-09-23 16:33
Group 1 - The "Shareholders Are Coming" series of events organized by the Beijing Listed Companies Association aims to protect investor rights and facilitate communication between investors and listed companies [1][4] - The events featured three listed companies in the biopharmaceutical sector: Sanyuan Gene, China Pharmaceutical, and Ganli Pharmaceutical, showcasing their strengths in technological innovation and industry upgrades [2][3] Group 2 - Sanyuan Gene is a leading enterprise in the field of gene engineering drugs, with its main product being human interferon α1b, which is China's first gene engineering drug with independent intellectual property rights [2][5] - China Pharmaceutical has become an important platform for the China General Technology Group, focusing on an integrated development model in the pharmaceutical and medical device sectors, covering the entire industry chain from cultivation to international trade [3][5] - Ganli Pharmaceutical has achieved significant market competitiveness, ranking first in the procurement agreement volume for insulin analogs in 2024, and is actively expanding into the medical device sector [3][5] Group 3 - The series of events provided a platform for investors to engage with company management on key topics such as the development prospects of the biopharmaceutical industry and corporate strategies [4][5] - Company executives shared insights on their operational data, business models, and the challenges faced, emphasizing the importance of transparent communication with investors [5]
中国医药:关于子公司药品通过仿制药一致性评价的公告
Zheng Quan Ri Bao Zhi Sheng· 2025-09-23 11:15
Core Viewpoint - China Medical announced that its wholly-owned subsidiary, Tianfang Pharmaceutical, received approval from the National Medical Products Administration for the supplement application of Lincomycin Hydrochloride Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1]. Group 1 - The approval signifies a regulatory milestone for the company, enhancing its product portfolio in the pharmaceutical market [1]. - The drug's successful consistency evaluation indicates that it meets the required standards for quality and efficacy, which is crucial for market competitiveness [1].
中国医药(600056.SH):子公司药品通过仿制药一致性评价
Ge Long Hui A P P· 2025-09-23 09:00
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary Tianfang Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration for the supplemental application of Lincomycin Hydrochloride Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved drug, Lincomycin Hydrochloride Injection, is primarily used to treat severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus [1]
中国医药(600056) - 关于子公司药品通过仿制药一致性评价的公告
2025-09-23 08:30
近日,中国医药健康产业股份有限公司(以下简称"公司")下属全资子公 司天方药业有限公司(以下简称"天方药业")收到国家药品监督管理局(以下 简称"国家药监局")核准签发的盐酸林可霉素注射液(以下简称"该药品") 《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。现将 有关情况公告如下: 一、通知书基本信息 证券代码:600056 证券简称:中国医药 公告编号:临 2025-077 号 中国医药健康产业股份有限公司 关于子公司药品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法律责任。 批准在美国上市,商品名 Lincocin®,规格 2ml:0.6g 与 10ml:3g。目前原研产品 未在国内进口上市。 药品名称:盐酸林可霉素注射液 受理号:CYHB2450368 通知书编号:2025B04301 剂型:注射剂 规格:2ml:0.6g(按 C18H34N2O6S 计) 注册分类:化学药品 上市许可持有人:天方药业有限公司 审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药品医 疗器 ...
中国医药子公司盐酸林可霉素注射液通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-09-23 08:18
Core Viewpoint - China Pharmaceutical (600056.SH) announced that its wholly-owned subsidiary Tianfang Pharmaceutical (600253) received approval from the National Medical Products Administration for the supplement application of Lincomycin Hydrochloride Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Market Impact - Tianfang Pharmaceutical's Lincomycin Hydrochloride Injection is primarily used to treat severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus [1] - The approval of the drug through the consistency evaluation will enhance its market competitiveness and further expand its market share [1] - Drugs that pass the consistency evaluation will receive greater support in areas such as medical insurance payments and procurement by medical institutions according to national policies [1]
中国医药(600056.SH)子公司盐酸林可霉素注射液通过仿制药一致性评价
智通财经网· 2025-09-23 08:18
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary Tianfang Pharmaceutical has received approval from the National Medical Products Administration for the supplement application of Lincomycin Hydrochloride Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval - Tianfang Pharmaceutical's Lincomycin Hydrochloride Injection is now approved for use, which is primarily indicated for severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus [1] - The approval includes a supplement application notification, enhancing the product's regulatory standing [1] Group 2: Market Impact - The drug's passage through the consistency evaluation will provide greater support in areas such as medical insurance payments and procurement by medical institutions, according to national policies [1] - This approval is expected to enhance the market competitiveness of Lincomycin Hydrochloride Injection and further expand its market share [1]
中国医药:盐酸林可霉素注射液通过一致性评价
Di Yi Cai Jing· 2025-09-23 08:12
Core Viewpoint - The announcement highlights that Tianfang Pharmaceutical, a subsidiary of China Pharmaceutical, has successfully passed the consistency evaluation for the quality and efficacy of its Lincomycin Hydrochloride Injection, which is expected to enhance its market competitiveness and expand market share [1] Group 1: Product Development - Tianfang Pharmaceutical's Lincomycin Hydrochloride Injection received acceptance for consistency evaluation by the National Medical Products Administration in July 2024 [1] - The company has invested approximately 6.08 million RMB (about 0.608 million) in the development of this product as of the announcement date [1] Group 2: Market Potential - The domestic sales revenue for public hospitals and grassroots medical terminals in 2024 is projected to be around 77 million RMB (approximately 0.77 billion) [1] - Tianfang Pharmaceutical's sales revenue for this product is approximately 15.32 million RMB (about 1.532 million) [1] Group 3: Competitive Advantage - Passing the consistency evaluation is expected to improve the market competitiveness of the Lincomycin Hydrochloride Injection, allowing for further market share expansion [1]
中国医药:子公司盐酸林可霉素注射液通过仿制药一致性评价
Xin Lang Cai Jing· 2025-09-23 08:08
中国医药9月23日公告,公司下属全资子公司天方药业有限公司近日收到国家药品监督管理局核准签发 的盐酸林可霉素注射液《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。盐酸 林可霉素注射液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。 ...
2025年7月中国医药材及药品进出口数量分别为3.31万吨和15万吨
Chan Ye Xin Xi Wang· 2025-09-23 03:26
近一年中国医药材及药品出口情况统计图 根据中国海关数据显示:2025年7月中国医药材及药品进口数量为3.31万吨,同比下降9.7%,进口金额 为45.98亿美元,同比增长5.1%,2025年7月中国医药材及药品出口数量为15万吨,同比增长10.8%,出 口金额为22.57亿美元,同比增长9.9%。 近一年中国医药材及药品进口情况统计图 数据来源:中国海关,智研咨询整理 相关报告:智研咨询发布的《2025-2031年中国医药制造行业市场发展态势及前景战略研判报告》 数据来源:中国海关,智研咨询整理 知前沿,问智研。智研咨询是中国一流产业咨询机构,十数年持续深耕产业研究领域,提供深度产业研 究报告、商业计划书、可行性研究报告及定制服务等一站式产业咨询服务。专业的角度、品质化的服 务、敏锐的市场洞察力,专注于提供完善的产业解决方案,为您的投资决策赋能。 ...