仿制药一致性评价

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广州白云山医药集团股份有限公司 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· 2025-09-03 22:59
Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of injectable Cefotaxime [1][2] Drug Basic Information - The drug is injectable Cefotaxime with specifications of 0.5g and 1.0g, classified as a chemical drug [1] - The approval notification numbers are 2025B04013 and 2025B04015, with acceptance numbers CYHB2350966 and CYHB2350965 [1] - The drug is produced by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., located at 808 Binhai East Road, Haizhu District, Guangzhou [1] Drug Related Information - Tianxin Pharmaceutical obtained the registration certificate for injectable Cefotaxime in September 2002 and submitted the consistency evaluation application in December 2023 [3] - Injectable Cefotaxime is a third-generation cephalosporin antibiotic used for treating various infections, including severe systemic infections and respiratory tract infections [3] - The sales revenue for injectable Cefotaxime in 2024 is projected to be RMB 1,431.78 million, with total sales in China expected to reach RMB 185,877 million [3] R&D Investment - As of the announcement date, Tianxin Pharmaceutical has invested approximately RMB 1,036 million in the R&D project for injectable Cefotaxime [4]
*ST双成:注射用胸腺法新、注射用生长抑素、奥曲肽注射液、注射用硼替佐米等均通过一致性评价
Mei Ri Jing Ji Xin Wen· 2025-09-02 05:18
Group 1 - The company *ST Shuangcheng (002693.SZ)* confirmed that several of its products have passed the consistency evaluation for generic drugs [2] - The products that have achieved this include Thymosin injection, Somatostatin injection, Octreotide injection, and Bortezomib injection [2]
广州白云山医药集团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
Shang Hai Zheng Quan Bao· 2025-09-01 21:11
证券代码:600332 证券简称:白云山 公告编号:2025-066 (一)注射用头孢哌酮钠舒巴坦钠 药品通用名称:注射用头孢哌酮钠舒巴坦钠 通知书编号:2025B03888、2025B03891、2025B03893 受理号:CYHB2350978、CYHB2350964、CYHB2350979 广州白云山医药集团股份有限公司 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。 近日,广州白云山医药集团股份有限公司(以下简称"本公司")控股子公司广州白云山天心制药股份有 限公司(以下简称"天心制药")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》,注 射用头孢哌酮钠舒巴坦钠(1.0g、1.5g、2.0g)、克林霉素磷酸酯注射液(2ml:0.3g、4ml:0.6g)已通 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、药品的基本情况 剂型:注射剂 规格:1.0g(C25H27N9O8S2 0.5g与C8H11NO5S 0.5g)、1.5g(C25H27N9O8S2 1 ...
上海医药集团股份有限公司关于盐酸维拉帕米注射液通过仿制药一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-09-01 19:48
证券代码:601607 证券简称:上海医药 编号:临2025-080 上海医药集团股份有限公司 关于盐酸维拉帕米注射液通过仿制药一致性评价的公告 注册分类:化学药品 申请人:上海禾丰制药有限公司 药品批准文号:国药准字H31021343 审批结论:本品通过仿制药质量和疗效一致性评价。 二、该药品相关的信息 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")下属上海禾丰制药有限公司(以下简称"上药禾 丰")的盐酸维拉帕米注射液(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:2025B03892),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 药品名称:盐酸维拉帕米注射液 剂型:注射剂 规格:2ml:5mg 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。 因此上药禾丰的盐酸维拉帕米注射液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 ...
股市必读:白云山(600332)9月1日主力资金净流出2759.11万元,占总成交额4.24%
Sou Hu Cai Jing· 2025-09-01 18:01
Trading Information Summary - On September 1, 2025, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (600332) closed at 26.61 yuan, up 0.23%, with a turnover rate of 1.73% and a trading volume of 243,300 shares, amounting to a transaction value of 651 million yuan [1] - On the same day, the net outflow of main funds was 27.59 million yuan, accounting for 4.24% of the total transaction value; the net outflow of retail funds was 25.91 million yuan, accounting for 3.98% of the total transaction value; while retail investors saw a net inflow of 53.50 million yuan, accounting for 8.22% of the total transaction value [1][3] Company Announcements Summary - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of generic drugs for two products: injectable cefoperazone sodium and sulbactam sodium (1.0g, 1.5g, 2.0g) and clindamycin phosphate injection (2ml: 0.3g, 4ml: 0.6g) [2] - The domestic sales revenue for injectable cefoperazone sodium and sulbactam sodium is projected to be 688.93 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 15.90 million yuan and R&D expenses around 7.92 million yuan [2] - The domestic sales revenue for clindamycin phosphate injection is expected to be 13.51 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 7.51 million yuan and R&D expenses approximately 2.73 million yuan [2]
上海医药: 上海医药集团股份有限公司关于盐酸维拉帕米注射液通过仿制药一致性评价的公告
Zheng Quan Zhi Xing· 2025-09-01 16:10
Group 1 - Shanghai Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of Verapamil Hydrochloride Injection [1][2] - The drug is primarily used for the rapid conversion of paroxysmal supraventricular tachycardia and for temporary control of ventricular rate in atrial flutter or atrial fibrillation [1][2] - The company has invested approximately RMB 3.29 million in research and development for this drug's consistency evaluation [1] Group 2 - As of the announcement date, there is one other company, Sichuan Meida Kangjiale Pharmaceutical Co., Ltd., that has also been deemed to have passed the consistency evaluation for this drug in China [2] - The IQVIA database indicates that the total procurement amount for Verapamil Hydrochloride Injection in hospitals in mainland China for 2024 is RMB 148.51 million [2] - The approval for consistency evaluation is expected to enhance the market share and competitiveness of Shanghai Hefeng's Verapamil Hydrochloride Injection, while also providing valuable experience for future product evaluations [2]
白云山:天心制药收到国家药监局核准签发的《药品补充申请批准通知书》
Zhi Tong Cai Jing· 2025-09-01 10:16
Core Viewpoint - Baiyunshan (00874) announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. ("Tianxin Pharmaceutical"), has received approval from the National Medical Products Administration for its supplementary drug application, indicating that its injectable formulations of Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g) have passed the consistency evaluation for generic drug quality and efficacy [1] Group 1 - Tianxin Pharmaceutical's injectable formulations have successfully passed the consistency evaluation, which will enhance the market competitiveness of these products [1]
华润双鹤药业股份有限公司关于全资子公司安徽双鹤药业有限责任公司氯化钾注射液获得药品补充申请批准通知书的公告
Shang Hai Zheng Quan Bao· 2025-08-31 20:10
证券代码:600062 证券简称:华润双鹤 公告编号:临2025-077 氯化钾注射液获得药品补充申请批准通知书的公告 华润双鹤药业股份有限公司 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。 关于全资子公司安徽双鹤药业有限责任公司 近日,华润双鹤药业股份有限公司(以下简称"公司")全资子公司安徽双鹤药业有限责任公司(以下简 称"安徽双鹤")收到了国家药品监督管理局(以下简称"国家药监局")颁发的氯化钾注射液(以下简称"该药 品")《药品补充申请批准通知书》。现将相关情况公告如下: 一、通知书主要内容 ■ 二、药品相关情况 国内市场,根据国家药监局网站信息显示,中国大陆境内已批准上市的氯化钾注射液(10ml:1.5g)生产企 业有44家(含安徽双鹤),其中通过或视同通过一致性评价的生产企业有26家(含安徽双鹤)。根据米内网 数据显示,2024年国内医疗市场和零售市场氯化钾注射液销售总额(终端价)为6.17亿元人民币,其中排 名前5名的企业及其市场份额分别为大冢制药43.44%,湖北科伦药业17.87%,山西诺成制药9.99%, ...
亚太药业: 2025年半年度报告
Zheng Quan Zhi Xing· 2025-08-29 09:09
Core Viewpoint - Zhejiang Yatai Pharmaceutical Co., Ltd. reported a significant decline in revenue and net profit for the first half of 2025, primarily due to intensified market competition and the impact of centralized drug procurement policies [5][10]. Company Overview and Financial Indicators - The company’s total revenue for the reporting period was approximately CNY 152.07 million, a decrease of 31.48% compared to the same period last year [5][10]. - The net profit attributable to shareholders was approximately CNY -48.86 million, reflecting a decline of 524.31% year-on-year [5][10]. - The company plans not to distribute cash dividends or issue bonus shares [1]. Industry Analysis - The pharmaceutical industry is characterized by weak cyclicality, high investment, high risk, and strict regulation, making it a strategic emerging industry crucial for national health and safety [6][7]. - The industry is experiencing profound changes due to ongoing healthcare reforms, which have significantly altered the competitive landscape, particularly in terms of drug quality and pricing strategies [6][7]. - The demand for pharmaceuticals is expected to continue growing due to factors such as an aging population, rising chronic disease rates, and increased health awareness among residents [6][7]. Business Operations - The company focuses on the manufacturing of pharmaceuticals, including both antibiotic and non-antibiotic products, with a total of 114 approved formulations [8][9]. - The sales strategy includes establishing a comprehensive marketing network that extends to various healthcare institutions and pharmacies, transitioning from traditional marketing to more specialized academic marketing [9][10]. Performance Drivers - The decline in revenue is attributed to intensified competition and the effects of centralized procurement policies, which have pressured sales [10][11]. - The company’s financial expenses increased significantly due to the redemption of convertible bonds, which were due in April 2025 [10][11]. - Investment income surged by 923.49% due to the sale of a subsidiary, indicating a shift in profit sources [10][12].
永太科技上半年营收净利润同比双位数增长 永太新能源电解液净利润同比大增389.45%成增长引擎
Quan Jing Wang· 2025-08-28 09:00
Core Insights - Zhejiang Yongtai Technology Co., Ltd. reported a significant increase in revenue and net profit for the first half of 2025, with revenue reaching 2.609 billion yuan, a year-on-year growth of 21.97%, and net profit attributable to shareholders at 58.8002 million yuan, up 56.17% [1] - The company's subsidiary, Yongtai New Energy, saw substantial growth in both revenue and net profit, with increases of 131.19% and 389.45% respectively, driven by the gradual release of production capacity [1] - The company has established an integrated industrial chain covering lithium salt raw materials, lithium salts, additives, and electrolytes, enhancing cost control and market responsiveness, which are key drivers of performance growth [1] Financial Performance - The net cash flow from operating activities turned positive, reaching 221 million yuan, a significant improvement of 219.23% year-on-year, primarily due to increased sales collections and the unfreezing of litigated funds [1] - As of the end of the reporting period, total assets amounted to 11.040 billion yuan, with net assets attributable to shareholders at 2.747 billion yuan, indicating a stable overall financial condition [1] Business Segments - The company operates in three main sectors: pharmaceuticals, plant protection, and lithium battery materials. The pharmaceutical segment experienced a decline in revenue due to patent expirations and increased competition, but the company is taking measures to optimize its cost structure and enhance its product offerings [2][4] - The lithium battery materials sector is in a growth phase, with significant increases in sales volumes, particularly in lithium and other materials, which saw a revenue increase of 105.74% year-on-year [3] - The plant protection segment also showed strong performance, with a revenue increase of 63.67% year-on-year, supported by the company's complete industrial chain from intermediates to formulations [3] Strategic Initiatives - The company is focusing on innovation and internationalization in its pharmaceutical business, aiming to enhance profitability and expand its market presence [2] - In the liquid cooling industry, the company is seizing opportunities presented by technological upgrades and market expansion, particularly in high-density cooling applications driven by AI and high-performance computing [2] - The company has established long-term partnerships with major international chemical companies and domestic leaders, enhancing its market position and operational efficiency [5] Research and Development - The company has invested in multiple innovation platforms, including a national-level enterprise technology center and a post-doctoral workstation, with R&D expenditure increasing by 21.92% year-on-year [4] - Collaboration with Fudan University on lithium battery technology development further strengthens the company's technological positioning in the new energy materials sector [4] Market Position - Yongtai Technology's deep engagement in fluorine fine chemicals positions it advantageously in high-growth sectors such as lithium batteries, pharmaceuticals, and plant protection, supporting its role in the global supply chain [6] - The ongoing development of strategic emerging industries like new energy and new pharmaceuticals is expected to continuously unlock growth potential for the company, creating long-term value for investors [6]