仿制药一致性评价

Search documents
浙江康恩贝制药股份有限公司 关于子公司氨甲环酸片获得药品注册证书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-07-31 23:15
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。 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求, 批准注册,发给药品注册证书。 近日,浙江康恩贝制药股份有限公司(以下简称"公司""本公司")全资子公司杭州康恩贝制药有限公司 (以下简称"杭州康恩贝")收到国家药品监督管理局(以下简称"国家药监局")核准签发的规格为 0.25g的氨甲环酸片《药品注册证书》,现将相关情况公告如下: 一、药品注册证书的主要内容 药品名称:氨甲环酸片 剂型:片剂 规格:0.25g 注册分类:化学药品4类 上市许可持有人:杭州康恩贝 批准文号:国药准字H20255025 证书编号:2025S02376 根据国家相关政策,境内申请人仿制已在境内上市原研药品的药品,应与原研药品的质量和疗效一致。 杭州康恩贝氨甲环酸片以化学药品4类获批,视同通过仿制药一致性评价。公司将积极安排该品种的生 产上市,预计将对公司业绩产生积极影响。 公司高度重视药品研发,并严格控制药品研发、生产、销售环节的质量和安全。但因受国家政策、市场 ...
津药药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
Shang Hai Zheng Quan Bao· 2025-07-29 17:34
证券代码:600488 证券简称:津药药业 编号:2025-048 三、同类药品市场情况 根据米内网全国放大版的医院数据(含城市公立医院、县级公立医院、城市药店、网上药店、城市社区 医院、乡镇卫生院)显示,2023年、2024年腹膜透析液(乳酸盐-G1.5%)国内销售额为15.48亿元、 16.89亿元。2023年、2024年腹膜透析液(乳酸盐-G2.5%)国内销售额为7.43亿元、8.40亿元。 四、影响及风险提示 根据国家相关政策规定,对于通过一致性评价的药品品种,在医保支付方面予以适当支持,医疗机构应 优先采购并在临床中优先选用。津药和平腹膜透析液(乳酸盐)通过一致性评价,有利于提升该药品的 市场竞争力。由于药品研发、生产和销售容易受到国家政策、市场环境等因素影响,具有较大不确定 性,敬请广大投资者谨慎决策,注意防范投资风险。 津药药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个别及连带责任。 近日,津药药业股份有限公司(以下简称"公司")子公司津药和平(天津)制药有限公司 ...
津药药业: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· 2025-07-29 13:14
证券日报网讯 7月29日晚间,津药药业发布公告称,近日,公司子公司津药和平(天津)制药有限公司 收到国家药品监督管理局核准签发的腹膜透析液(乳酸盐)(以下简称"本品")的《药品补充申请批准 通知书》,批准本品通过仿制药质量和疗效一致性评价(简称"一致性评价")。 (编辑 楚丽君) ...
主力资金近三日都在买这些概念股
Zheng Quan Shi Bao Wang· 2025-07-29 08:54
| 概念板块 | 板块涨跌 | 相对大盘涨跌 | 板块主力资金 | 领涨股 | 涨跌幅 | 主力资金(万 | | --- | --- | --- | --- | --- | --- | --- | | | (%) | (%) | (亿元) | | (%) | 元) | | 共封装光学 | 5.30 | 5.19 | 31.77 | 仕佳光 | 24.59 | 21301.22 | | (CPO) | | | | 子 | | | | AI PC | 5.31 | 5.20 | 26.24 | 景旺电 子 | 24.40 | 19367.88 | | 中国AI 50 | 2.64 | 2.53 | 26.11 | 寒武纪 | 18.42 | 78499.66 | | 先进封装 | 5.30 | 5.19 | 21.70 | 方邦股 份 | 46.86 | 7583.98 | | 仿制药一致性 评价 | 3.70 | 3.59 | 19.99 | 亚太药 业 | 28.98 | 41461.29 | | 5G | 3.45 | 3.34 | 19.48 | 方邦股 份 | 46.86 | 7583.98 | | F ...
12.24亿主力资金净流入,仿制药一致性评价概念涨2.30%
Zheng Quan Shi Bao Wang· 2025-07-29 08:48
今日涨跌幅居前的概念板块 | 概念 | 今日涨跌幅(%) | 概念 | 今日涨跌幅(%) | | --- | --- | --- | --- | | CRO概念 | 4.00 | 猪肉 | -1.35 | | 重组蛋白 | 2.90 | 养鸡 | -1.12 | | 创新药 | 2.79 | 草甘膦 | -1.10 | | 减肥药 | 2.76 | 粮食概念 | -1.00 | | F5G概念 | 2.43 | 芬太尼 | -0.88 | | 细胞免疫治疗 | 2.42 | PEEK材料 | -0.85 | | 仿制药一致性评价 | 2.30 | 预制菜 | -0.85 | | 共封装光学(CPO) | 2.23 | 生态农业 | -0.78 | | 特钢概念 | 2.08 | C2M概念 | -0.78 | | 先进封装 | 1.91 | 人造肉 | -0.76 | 截至7月29日收盘,仿制药一致性评价概念上涨2.30%,位居概念板块涨幅第7,板块内,104股上涨, 亚太药业、九洲药业、辰欣药业等涨停,南新制药、苑东生物、海特生物等涨幅居前,分别上涨 17.01%、15.45%、15.28%。跌幅居前的有昂 ...
亚太药业:公司阿替洛尔片通过仿制药一致性评价
news flash· 2025-07-20 07:49
Core Viewpoint - Asia-Pacific Pharmaceutical (002370.SZ) announced that its Atenolol tablets have passed the consistency evaluation of generic drug quality and efficacy, which will enhance the company's product pipeline and market competitiveness [1] Group 1: Product Development - The Atenolol tablets are primarily used for treating hypertension, angina pectoris, and myocardial infarction [1] - Passing the consistency evaluation will further enrich the company's product line and improve its market position [1] Group 2: Future Prospects - The successful evaluation will provide valuable experience for the company in conducting consistency evaluations for other products in the future [1] - The production and sales of pharmaceuticals are subject to policy and market environment influences, which introduces uncertainty [1]
海南自贸区概念涨2.21%,主力资金净流入23股
Zheng Quan Shi Bao Wang· 2025-07-16 09:00
Group 1 - The Hainan Free Trade Zone concept rose by 2.21% as of the market close on July 16, ranking 6th among concept sectors, with 27 stocks increasing in value, including Haide Co., Hainan Ruize, and Jingliang Holdings, which rose by 5.79%, 4.70%, and 4.59% respectively [1] - The top gainers in the Hainan Free Trade Zone concept included Haide Co. with a net inflow of 92.2 million yuan, followed by Hainan Ruize with 61.9 million yuan, and Hainan Haiyao with 43.7 million yuan [1][2] - The concept sector saw a net inflow of 219 million yuan from main funds, with 23 stocks experiencing net inflows, and 16 stocks receiving over 10 million yuan in net inflows [1] Group 2 - The leading stocks by net inflow ratio included ST Huluwa, Haide Co., and *ST Yedao, with net inflow ratios of 16.55%, 15.77%, and 13.49% respectively [2] - The top stocks in the Hainan Free Trade Zone concept by main fund flow included Haide Co. with a main fund flow of 92.2 million yuan and a turnover rate of 4.66%, and Hainan Ruize with a flow of 61.9 million yuan and a turnover rate of 11.86% [2][3] - Other notable stocks included Hainan Haiyao with a 3.49% increase and a main fund flow of 43.7 million yuan, and HNA Holding with a 1.45% increase and a flow of 30.2 million yuan [3]
21.02亿主力资金净流入,仿制药一致性评价概念涨2.67%
Zheng Quan Shi Bao Wang· 2025-07-16 08:56
Core Viewpoint - The generic drug consistency evaluation concept has shown a significant increase, with a rise of 2.67%, making it the second-highest gaining sector on the market as of July 16 [1][2]. Market Performance - The generic drug consistency evaluation sector saw 119 stocks increase in value, with notable performers including: - Guangsheng Tang, which rose by 16.55% - Lai Mei Pharmaceutical, which increased by 8.48% - Han Yu Pharmaceutical, which gained 6.41% [1][2]. - Conversely, the sector also experienced declines, with *ST Su Wu dropping by 5.02%, Nanxin Pharmaceutical by 3.17%, and Kelun Pharmaceutical by 0.95% [1]. Capital Flow - The sector attracted a net inflow of 2.102 billion yuan from major funds, with 77 stocks receiving net inflows. Five stocks had net inflows exceeding 100 million yuan, led by Qianhong Pharmaceutical with 227 million yuan [2][3]. - Other significant net inflows were observed in: - Han Yu Pharmaceutical with 166 million yuan - Ha San Lian with 155 million yuan - Run Du Shares with 145 million yuan [2]. Stock Performance Metrics - The top stocks in terms of net inflow ratio included: - Run Du Shares at 42.20% - Ha San Lian at 34.99% - Zhejiang Zhen Yuan at 29.25% [3]. - The performance of stocks within the sector varied, with Qianhong Pharmaceutical showing a daily increase of 9.98% and a turnover rate of 14.39% [3][4].
海南海药:子公司注射用头孢唑肟钠通过一致性评价
news flash· 2025-07-09 10:17
Core Viewpoint - Hainan Haiyao's subsidiary has received approval for the injectable drug Cefoperazone Sodium, which is expected to enhance market competitiveness and positively impact the company's performance [1] Company Summary - Hainan Haiyao's wholly-owned subsidiary, Haikou Pharmaceutical Factory, has been granted a drug supplement approval notice by the National Medical Products Administration for the injectable drug Cefoperazone Sodium [1] - The drug has passed the consistency evaluation of quality and efficacy for generic drugs, which is beneficial for the company's market position [1] Industry Summary - Cefoperazone Sodium is a third-generation broad-spectrum semi-synthetic cephalosporin antibiotic, effective against various infections including lower respiratory tract infections, urinary tract infections, and sepsis [1] - The approval of this drug aligns with the industry's trend towards enhancing the quality and efficacy of generic medications, which is crucial for maintaining competitiveness in the pharmaceutical market [1]
浙江震元: 浙江震元股份有限公司2024年向特定对象发行股票募集说明书(修订稿)
Zheng Quan Zhi Xing· 2025-07-02 16:36
Group 1 - The company plans to issue A-shares to specific investors, pending approval from the Shenzhen Stock Exchange and the China Securities Regulatory Commission (CSRC) [2][3][4] - The final issuance price will be no less than 85% of the average trading price of the company's shares over the 20 trading days prior to the pricing date [3][4][5] - The total number of shares to be issued will not exceed 25% of the company's total share capital, amounting to a maximum of 83,530,821 shares [5][6] Group 2 - The funds raised will be allocated to specific projects, including the construction of a production base for amino acids and an enhancement project for raw materials [6][7] - The company may adjust the investment priorities and amounts based on the actual net amount raised and project urgency if the net proceeds are less than planned [6][7] - The company has committed to using the raised funds in compliance with relevant regulations and will replace any pre-invested funds once the raised funds are available [6][7] Group 3 - The company operates in the pharmaceutical industry, which is subject to strict regulatory oversight from various government bodies, including the National Medical Products Administration and the National Healthcare Security Administration [19][20] - The pharmaceutical industry is characterized by significant competition and regulatory challenges, including drug approval processes and pricing regulations [19][20][21] - The company’s business encompasses pharmaceutical distribution, manufacturing, and health services, with a focus on both commercial and industrial sectors [19][20]