仿制药一致性评价

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地拉罗司分散片国内市场竞争加剧,石家庄四药成功入局
Ge Long Hui· 2025-05-26 01:18
Core Viewpoint - Shijiazhuang Four Pharmaceutical has received approval for its generic drug, Deferasirox dispersible tablets (125mg), marking it as the third domestic company to pass the consistency evaluation for this product in China [1][8]. Group 1: Product Information - Deferasirox, developed by Novartis, is primarily used to treat chronic iron overload due to blood transfusions in patients aged 2 and above, as well as in non-transfusion-dependent thalassemia (NTDT) patients aged 10 and above [3]. - It is the first FDA-approved oral iron chelator that is routinely used, and it has been approved in over 80 countries globally [3]. - In 2022, the global sales of Deferasirox exceeded $300 million [3]. Group 2: Market Performance - In the domestic market, Deferasirox dispersible tablets were included in the national medical insurance directory in 2019 and entered the regular medical insurance directory in 2021 [5]. - In 2023, the total sales of Deferasirox dispersible tablets in hospitals across China reached 168 million yuan, representing a year-on-year growth of 15.03% [5]. - Original drug manufacturers hold a dominant market share of 96.76% in the hospital sales sector [5]. Group 3: Competitive Landscape - The first generic version of Deferasirox dispersible tablets was approved by Aosaikang in June 2021, followed by the second approval from China Medical Huashitong Biopharmaceutical in August 2024 [8]. - Shijiazhuang Four Pharmaceutical is now the third domestic company to pass the evaluation for Deferasirox dispersible tablets [8]. Group 4: Company Strategy - Shijiazhuang Four Pharmaceutical emphasizes a "combination of innovation and generics," supported by a strong innovation team and mechanisms, leading to a robust product pipeline and enhanced research outcomes [11]. - As of now, the company has had 112 products approved or deemed to have passed the consistency evaluation [11]. - In 2024, Shijiazhuang Four Pharmaceutical has already had 45 products approved, with six being the first to pass the evaluation [12].
首仿药获批热潮:2024年896款过评,齐鲁制药霸榜,技术门槛提升成趋势
Ge Long Hui· 2025-05-26 01:18
Core Insights - The balance between innovation and generics is crucial for the healthy development of the pharmaceutical industry. Recently, the first generic drugs have become a focus for domestic pharmaceutical companies, with over 170 first generics approved from 2022 to 2023, and the number of approvals increasing year by year. In 2024, despite fierce competition from ten rounds of centralized procurement, 896 drugs have passed or are deemed to have passed consistency evaluations, with 254 being first approvals and 107 being significant first generics. Qilu Pharmaceutical topped the annual list with 7 first generics [1][2][4]. Industry Overview - The domestic generic drug market has become increasingly competitive due to market opening and reform of drug approval systems. The tenth round of national centralized procurement has intensified competition, leading to extreme pricing situations, with some injectable drugs priced lower than bottled water. This has put significant pressure on B-class enterprises, with some industry insiders claiming that generic drug projects are becoming unsustainable [2][4]. Company Performance - Leading companies in the domestic generic drug sector, such as Qilu Pharmaceutical, Kelun Pharmaceutical, and Heng Rui Medicine, have maintained strong competitive positions. In 2022, Heng Rui and Kelun each achieved 7 first generics, while in 2023, Kelun led with 6 first generics. In 2024, Qilu Pharmaceutical excelled with 7 first generics, solidifying its leading position in the generic drug field [4][5][6]. Market Dynamics - In 2024, a total of 896 generic drugs passed or were deemed to have passed consistency evaluations, with 254 being first approvals, accounting for 28.34%. The competition for first generics remains fierce, with Qilu Pharmaceutical achieving the highest number of first generics [2][4][5]. Emerging Competitors - Other companies, such as Zhengda Tianqing, also demonstrated strong R&D capabilities, achieving 5 first generics in both 2023 and 2024, maintaining a solid position in the market. Companies like Shanghai Xuantai and Wuhu Daorun have made significant gains, with Xuantai achieving 4 first generics in 2024, marking a notable improvement from 2023 [5][9][12]. Future Outlook - The generic drug market in China is expected to continue evolving, with a focus on high-quality first generics and innovative drugs. The success of first generics is concentrated in high-tech niche areas, highlighting the progress made by pharmaceutical companies in overcoming technical challenges. The competitive landscape will likely shift further as policies and market conditions change [14].
仿制药一致性评价概念涨1.31%,主力资金净流入这些股
Zheng Quan Shi Bao Wang· 2025-05-23 10:18
| 300705 | 九典制 | 0.44 | 3.37 | 660.10 | 3.35 | | --- | --- | --- | --- | --- | --- | | | 药 | | | | | | 600572 | 康恩贝 | 0.68 | 1.45 | 627.79 | 3.76 | | 002349 | 精华制 | 0.81 | 2.27 | 571.95 | 4.13 | | | 药 | | | | | | 002004 | 华邦健 | 0.25 | 0.80 | 571.40 | 9.29 | | | 康 | | | | | | 688553 | 汇宇制 | 1.93 | 1.88 | 555.55 | 5.80 | | | 药 | | | | | | 300086 | 康芝药 | -0.39 | 3.88 | 517.25 | 5.87 | | | 业 | | | | | | 002907 | 华森制 | 3.77 | 5.14 | 493.67 | 2.10 | | | 药 | | | | | | 000908 | *ST景峰 | 1.19 | 2.66 | 475.12 | 3.98 | ...
中韩自贸区概念下跌3.07%,主力资金净流出13股
Zheng Quan Shi Bao Wang· 2025-05-23 10:16
Group 1 - The core viewpoint of the news is that the China-South Korea Free Trade Zone concept has experienced a significant decline, with a drop of 3.07%, placing it among the top losers in the concept sector [1][2] - Within the China-South Korea Free Trade Zone concept, stocks such as Lianyungang and *ST Jinguang hit the daily limit down, while Qingdao King, Qingdao Port, and Rizhao Port saw notable declines [1][2] Group 2 - The China-South Korea Free Trade Zone concept faced a net outflow of 454 million yuan from major funds today, with 13 stocks experiencing net outflows, and 6 stocks seeing outflows exceeding 10 million yuan [2] - The stock with the highest net outflow was Qingdao King, which saw a net outflow of 260 million yuan, followed by Lianyungang and Rizhao Port with net outflows of 115 million yuan and 29 million yuan, respectively [2]
仁和药业(000650) - 000650仁和药业投资者关系管理信息20250522
2025-05-22 08:00
Group 1: Business Strategy and Product Development - The company plans to continue expanding its OBM (Original Brand Manufacturer) business while ensuring product quality control, which is crucial for brand reputation [1] - Recent initiatives include enhancing production capacity and optimizing product categories to improve overall gross margin, laying a solid foundation for sustainable development [2] - The company has successfully passed consistency evaluations for several generic drugs and obtained registration certificates for various products, indicating a strong focus on R&D [2] Group 2: Financial Performance and Shareholder Returns - The cash dividend for the year is set at 210 million yuan, representing 43.57% of the company's net profit, with a dividend yield of 3%-4% [2] - The company achieved an investment return of over 70 million yuan through self-owned funds, ensuring capital safety [3] - Management has expressed confidence in meeting performance targets for the 2024 employee stock ownership plan, focusing on revenue and net profit [3] Group 3: Corporate Governance and Market Position - The management team has actively supported the company's long-term development by purchasing shares, demonstrating confidence in the company's future [3] - The company has maintained a high cash dividend ratio over the past two years, reinforcing its commitment to shareholder returns [3] - Concerns regarding the quality of products from a subsidiary were addressed, emphasizing compliance with national regulations and standards [3]
亚宝药业:盐酸普萘洛尔片通过仿制药一致性评价
news flash· 2025-05-16 11:18
Core Viewpoint - The announcement indicates that the company's subsidiary, Taiyuan Pharmaceutical, has received approval from the National Medical Products Administration for the supplement application of Propranolol Hydrochloride Tablets, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Market Impact - The approved drug, Propranolol Hydrochloride Tablets, is expected to contribute to the company's revenue, as the domestic sales amount for this drug in 2023 is approximately 82.18 million RMB [1] - The public medical market accounts for about 57.76 million RMB of the total sales, while retail pharmacies contribute approximately 24.42 million RMB [1] - Currently, six other companies have also passed the consistency evaluation for this drug in the domestic market [1] Group 2: R&D Investment - The company has invested approximately 2.6005 million RMB in the research and development of this product [1]
哈三联:药品氯化钾氯化钠注射液通过一致性评价
news flash· 2025-05-09 07:49
Group 1 - The company Harsanlian (002900) announced that its drug Potassium Chloride and Sodium Chloride Injection has passed the consistency evaluation of generic drug quality and efficacy [1] - This drug is used to treat hypokalemia caused by various reasons, prevent hypokalemia, and address arrhythmias caused by digitalis poisoning [1] - The company is the first in China to pass the consistency evaluation for all three specifications of Potassium Chloride and Sodium Chloride Injection, which will enhance the product's technical level and market competitiveness [1]
多瑞医药2025年Q1实现营收4,944.34万元,原料药+制剂双轮驱动战略转型
Xin Lang Cai Jing· 2025-04-25 06:27
财报显示,公司一季度业绩下滑,主要系主要产品醋酸钠林格注射液收入下降,新收购主体四川多瑞、 鑫承达等研发费用增加以及理财收入减少、利息增加等因素所致。 近三年研发投入8,745.20万元,探索多元增长与转型并进路径 据了解,多瑞医药主要从事化学药品制剂及中间体、原料药的研发、生产和销售。公司主要有自产产品 醋酸钠林格注射液、代理产品注射用阿莫西林钠克拉维酸钾等。 资料显示,公司核心产品醋酸钠林格注射液,是国内首仿的新一代晶体液,市场占有率长期超80%,具 有显著的市场主导地位,且2024年12月成功入选第十批国家组织药品集中采购目录并中选,进一步巩固 了市场优势。 2024年,多瑞医药营业收入2.41亿元,其中醋酸钠林格注射液等制剂的营业收入为人民币1.87亿元,占 营业收入的77.63%,单一产品占比逐年下降。与此同时,公司正在加快新产品开发进度,以培育新的 盈利增长点。 近年来,受"仿制药一致性评价"和"集中带量采购"等政策影响,原料药市场规范性和壁垒提升,行业集 中度增强。多瑞医药为控制成本、保障原料药供应稳定与质量,以及提升产业链话语权,开始向上游布 局,并购原料药企业,打造"原料药+制剂"一体化布局 ...
葵花药业布洛芬混悬液上市:品质对标国际标准 国产儿童退热药迈入新阶段
新浪财经· 2025-04-21 00:37
仿制药入局易对标难 儿童退热市场等待"中国答案" 据《 2016 中国儿童用药安全白皮书》,我国约有五成儿童用药不规范,每年因用药不当 导致失聪的儿童病例超 3 万例,致死案例超 7000 例。 数据显示,我国 2400 种儿童化学药中,专用化药不足 5% ,儿童依从性更好的口服溶液 剂、混悬剂不足 10% 。在退热药市场,"美林"长期占据国内线下药店终端超 90% 份额, 其缺货期间 3000 元每瓶的黄牛价更暴露市场畸形现状。 同时需要指出的是,仿制药入局易,对标却难。据 CDE 数据,国内目前已有 28 个布洛芬 混悬液生产批件,但由于家长普遍认为原研药质量更好、疗效更为稳定,因而给儿童选择药 物时更倾向于选择品牌知名度高的原研药,导致仿制药难以进入市场,实际生产规模十分有 限,强生制药的原研药物"美林"依旧一家独大。 近年来,患者对于仿制药质量问题的疑虑似乎从未真正消失过。从医生反应"麻药不 麻"、"泻药不泻",到仿制药一致性评价数据雷同,再到 FDA 对多家中国药品检测公司发 出检测数据警告,仿制药的信任危机不断发酵,甚至愈发强烈。 高品质国药崛起正当时 近日,葵花药业宣布旗下重庆小葵花儿童制药有限 ...
完全不要脸了
猫笔刀· 2025-01-24 14:13
今天有一件和a股没有直接关系,但有不小间接关系的事传的沸沸扬扬,起初是源于一位医生博主发文质疑,药监局公布的药物一致性评价的数据里出现 了不合理的雷同。 我给个超链接,想看原文的点击下面: 《仿制药一致性评价大量数据雷同》 事情发酵后引起了《经济观察报》的注意,记者找上门的时候雷同数据已经被修改,但文档有编辑记录,记录了最新一次编辑就是今天。面对舆情质疑, 药监局向记者承认问题是由于编辑工作失误导致。 以上就是客观事实部分,我确实对仿制药的一致性评价不了解,所以不评论。但通过看阅读信息知道了一件事,就是仿制药的一致性评价是要花钱的,不 便宜,要上千万,而且有失败没通过的情况,重新再做需要继续花钱。 …… 今天柯洁(中国一流围棋选手)回国后,把自己微博简介改成了世界围棋九冠王,这可太有梗了。柯洁年少成名,2015-2020先后拿下8个世界冠军,但在 此之后状态起伏,迟迟拿不到第九个世界冠军。 就在前几天结束的LG杯,柯洁奋力杀入决赛,并在三局两胜的比赛中拿下第一局。 1月22日进行的第二局比赛,柯洁在提子后没有放入盒盖,被对手卞相壹举报,第一次被罚2目,第二次被判负。比分来到1:1。 1月23日进行的第三局决胜 ...