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中国仿制药行业市场竞争加剧
Di Yi Cai Jing Zi Xun· 2025-11-24 04:15
2025.11.24 本文字数:2412,阅读时长大约4分钟 作者 |第一财经 吴斯旻 近年来,"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时,随着"国谈"中生 物药占比增加,"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网入院 及院内推广提供便利。 双重趋势下,中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升,却 也面临"品种同质化"和"生产拼成本"等发展困境。 近日,中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中 国仿制药发展报告(2025)》(下称"报告")显示,中国仿制药市场规模多年维持在9000亿元水平,企 业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现,在化学仿制药领域,2024年,通过一致性评价或视同过评的品种数较三年前增 加了超过2/3,但当年增长主要由少数企业和既往过评品种的持续获批推动;而在生物类似药领域,截 至2024年,我国已有41家制药企业的87款生物类似药(包含胰岛素)获批上市,但仅涉及23个药品通用 名。 此外,有业界观点认为,在中国仿制药行业市场集 ...
华润双鹤董事长陆文超:全链筑基 双轮驱动开辟增长新空间
● 本报记者 傅苏颖 在医药行业转型升级的关键期,华润双鹤正以清晰的战略布局书写高质量发展答卷。华润双鹤董事长陆 文超日前在接受中国证券报记者专访时表示,华润双鹤的发展始终与国家战略、民众需求同频共振,通 过深耕集采锤炼全价值链硬实力,以"处方药龙头打造+合成生物突破"双轮驱动构建核心竞争力,更依 托国际化布局拓宽发展边界,为企业长远发展注入强劲动能。 构建全价值链硬实力 "华润双鹤的发展轨迹,始终与国家战略部署、民众健康需求紧密相连。"陆文超表示,从地方药企到全 国性集团,从规模扩张到高质量发展,公司每一次转型都紧扣时代脉搏,在顺应变革中实现可持续发 展。"如今华润双鹤已构建起覆盖抗感染、慢病、专科等多个领域的产品体系,既在市场变化中保持稳 健活力,也为守护国民健康持续发力。" 国家药品集中带量采购政策的落地,成为华润双鹤锤炼核心能力的重要契机。陆文超表示,政策推出以 来,公司便确立了积极拥抱的战略方向,旨在通过深度参与集采获取政策红利。截至目前,公司累计有 近60个产品在国家集采中中标,超过70%的产品在省级及联盟集采中中选。 "参与集采,是我们构建全价值链低成本能力的'牛鼻子'和核心纽带。"陆文超说,参 ...
石药集团绩后跌超6% 集采降价拖累业绩 前三季度成药业务收入下滑17%
Zhi Tong Cai Jing· 2025-11-21 02:07
Core Viewpoint - The stock price of CSPC Pharmaceutical Group (01093) dropped over 6% following the release of its third-quarter results, reflecting market concerns over declining revenue and profit margins [1] Financial Performance - For the first three quarters, the company reported revenue of 19.891 billion RMB, a year-on-year decrease of 12.32% [1] - The profit attributable to the company's owners was 3.511 billion RMB, down 7.06% compared to the previous year [1] Business Segment Analysis - The prescription drug business generated revenue of 15.450 billion RMB, representing a year-on-year decline of 17.2% [1] - The decline in revenue is primarily attributed to the ongoing impact of centralized drug procurement and price adjustments in the national medical insurance drug list [1]
港股异动 | 石药集团(01093)绩后跌超6% 集采降价拖累业绩 前三季度成药业务收入下滑17%
智通财经网· 2025-11-21 02:07
Core Viewpoint - The stock price of CSPC Pharmaceutical Group (01093) dropped over 6% following the release of its Q3 earnings report, reflecting ongoing challenges in the pharmaceutical industry due to policy impacts on drug pricing and procurement [1] Financial Performance - For the first three quarters, the company reported a revenue of 19.891 billion RMB, a year-on-year decrease of 12.32% [1] - The profit attributable to shareholders was 3.511 billion RMB, down 7.06% compared to the previous year [1] - The revenue from the prescription drug business was 15.450 billion RMB, which represents a year-on-year decline of 17.2% [1] Industry Impact - The decline in revenue is primarily attributed to the ongoing effects of centralized drug procurement and adjustments in the National Medical Insurance drug list pricing policies [1]
第11批集采结果公布:从降价导向转向质量导向
21世纪经济报道记者 闫硕 日前,第11批国家组织药品集中带量采购(简称"集采")结果正式公布,将于2026年2月实施。 据了解,此次集采共纳入55种药品,覆盖抗感染、抗过敏、抗肿瘤、降血糖、降血压、降血脂、消炎镇 痛等领域常用药品,全部采购成功。全国共4.6万家医药机构参加报量,445家企业的794个产品参与投 标,其中272家企业的453个产品中选。 第11批集采总体实现了"稳临床、保质量、反内卷、防围标"预期目标。比如,复活环节的设置,进一步 提高了厂牌与临床实际需求的匹配度,也有利于引导企业科学研判、理性报价。 在业内专家看来,新增未入围复活机制及锚点价后,企业报价整体趋稳,既为维护市场竞争秩序提供有 力支撑,也彰显了医保部门在平衡药品降价与履约保障方面的积极探索。总体来看,本次集采更注重可 持续性与执行效能平衡,彰显政策正从"降价导向"向"质量导向"稳步转型。 截至目前,国家医保局共开展11批国家组织药品集采,成功采购490种药品,集采惠民覆盖面持续扩 大。"十五五"规划建议明确部署"优化药品集采",国家医保局后续将加强评估、总结经验、补齐短板, 持续推动集采工作规范化、制度化、常态化开展。 以竞争 ...
更“阳光”更惠民!国家“团购”药品为就医减负 健康保障更加“可及+可靠”
Yang Shi Wang· 2025-11-06 13:56
央视网消息:近日,第十一批国家组织药品集中带量采购和国家医保谈判先后结束,55种药品纳入集采,越来越多的质量优良、价格适宜的药 品中选,国家医保局首次制定商保创新药目录,给商业健康保险发展以充分空间。本次药品集采规则调整更"阳光"更惠民,引导市场良性竞 争,为医药产业健康发展营造良好环境。 国家医保谈判3日结束,120家内外资企业现场参与,为更好地满足人民群众多层次、多元化用药需求,今年目录调整中增设了商保创新药目 录,共有121个高值药品通过商保创新药目录形式审查。 国家医保局医药服务管理司司长黄心宇称:"商保创新药目录由国家医保局组织制定,我们考虑与医保目录同时申报、同步调整。企业可以自 主申报纳入医保药品目录或者商保创新药目录,也可以同时申报两者。与医保目录调整的不同点在于,商保创新药目录将充分尊重商业保险公 司的市场主体地位。" 10月底,第十一批国家组织药品集中带量采购公布中选结果,55种药品纳入集采,覆盖多种常用药品,全国患者预计将于2026年2月用上新一 批质量优良、价格适宜的中选药。 南京大学卫生政策与管理研究中心主任顾海称:"我们这次一共超过了4.6万家医疗机构来进行报量,77%是按照厂牌来 ...
浏阳经开区4家药企8个药品拟纳入第十一批国家集采
Chang Sha Wan Bao· 2025-10-31 12:11
Core Insights - The 11th batch of national organized drug centralized procurement results has been announced, with 55 drugs selected, covering various therapeutic areas such as anti-infection, anti-allergy, anti-tumor, and more [1][2] - A total of 272 companies with 453 products have been proposed for selection, indicating a significant participation from the pharmaceutical industry [1] - The procurement aims to stabilize clinical use, ensure quality, counteract price wars, and prevent collusion in bidding processes [1] Group 1: Selected Companies and Products - Hunan Jiutian Pharmaceutical Co., Ltd. has 11 products selected in total, including Dapagliflozin tablets and Nicorandil tablets [1] - Hunan Warner Pharmaceutical Co., Ltd. has 22 products selected for national or regional procurement, including Benidipine Hydrochloride tablets [2] - Hunan Xianshi Pharmaceutical Co., Ltd. has three drugs selected, including inhalation solutions and capsules for treating various conditions [2] Group 2: Pricing and Market Impact - The centralized procurement process has significantly reduced drug prices, alleviating the financial burden on patients [2] - For instance, the price of imported Malatoparib tablets was previously between 4000 to 5000 yuan, while the locally produced version is priced under 40 yuan [2] - This pricing strategy aims to break the monopoly of imported drugs and enhance patient accessibility [2] Group 3: Company Innovations and Investments - Mingrui Pharmaceutical has invested over 400 million yuan in new drug research and development, successfully launching numerous new products [3] - The company’s selected product, Rosasthit capsules, is aimed at treating anemia caused by chronic kidney disease [3] - Mingrui's commitment to innovation is evident through its continuous product development and market introduction [3]
第十一批国家药品集采开标,华纳药厂盐酸贝尼地平片拟中选
Chang Sha Wan Bao· 2025-10-31 10:25
Group 1 - The core point of the article is the successful selection of Hunan Warner Pharmaceutical Co., Ltd.'s Benidipine Hydrochloride Tablets in the 11th batch of national centralized drug procurement, highlighting the company's competitive edge in the pharmaceutical market [1][2] - The centralized procurement included 55 types of commonly used drugs across various therapeutic areas, with participation from 4.6 million medical institutions and 445 companies submitting bids [1] - Benidipine Hydrochloride Tablets are a long-acting third-generation dihydropyridine calcium antagonist used for treating primary hypertension and angina, addressing a significant health concern in China where cardiovascular diseases affect 330 million people [2] Group 2 - The national procurement emphasizes "stabilizing clinical use and ensuring quality," raising the quality control standards for participating companies [3] - Warner Pharmaceutical has maintained a 100% pass rate in national quality inspections for its procurement products, establishing a strong quality brand [3] - The company has actively embraced centralized procurement policies, with 22 products selected in national or regional procurements, demonstrating its adaptability to policy changes [3]
第十一批集采拟中选结果公示:445家企业竞逐55种药品
Mei Ri Jing Ji Xin Wen· 2025-10-30 15:16
Core Insights - The eleventh round of national organized drug procurement has been completed, involving 55 types of commonly used medications across various therapeutic areas, with 4.6 million medical institutions participating and 272 companies winning bids for 453 products [1][3][8] Group 1: Procurement Results - A total of 445 companies participated in the bidding, marking the largest scale in the history of drug procurement [5] - The average selection rate for products was approximately 57%, with about 60% of participating companies winning bids [8][11] - The procurement aims to ensure that selected products meet clinical needs, with 75% of medical institutions' procurement requests being satisfied [7] Group 2: Quality and Competition - The procurement process has set higher qualification thresholds for bidding companies to ensure quality, requiring production experience and compliance with quality management standards [7][8] - Measures have been implemented to prevent extreme low pricing and promote rational bidding, including the introduction of a "reference price" and a revival mechanism [7][8] - The competitive landscape remains intense, with companies needing to adjust their strategies to focus on product quality and brand building rather than solely on cost-cutting [9][10] Group 3: Regulatory Changes - New regulations require companies bidding below the "reference price" to provide a justification for their pricing, detailing cost structures [11] - Companies that fail to submit the required justification during the public announcement period risk losing their selection status and being placed on a "violation list" [11] - The procurement process is expected to positively impact the market presence and operational performance of selected companies, as medical institutions will prioritize the use of selected drugs [11]
复星医药前3季营收扣非净利双降 靠出售资产拉升净利
Zhong Guo Jing Ji Wang· 2025-10-30 03:01
Core Viewpoint - Fosun Pharma plans to spin off its subsidiary Fosun Antigen (Chengdu) Biopharmaceutical Co., Ltd. for a listing on the Hong Kong Stock Exchange to enhance corporate governance and sustainable development, aiming to maximize shareholder value [1] Group 1: Company Overview - Fosun Antigen was established in July 2012 and is primarily focused on the research, production, and sales of human vaccines, with a technology platform for both bacterial and viral vaccines [1] - Fosun Pharma holds approximately 70.08% of Fosun Antigen, while 17 other shareholders collectively own about 29.92% [1] Group 2: Financial Performance - In 2024, Fosun Antigen reported a revenue of RMB 97.42 million and a net loss of RMB 123.39 million; for the first half of 2025, revenue was RMB 153.16 million with a net loss of RMB 58.45 million [1] - For the third quarter of 2025, Fosun Pharma's revenue was RMB 9.879 billion, a year-on-year decrease of 5.46%, while net profit increased by 4.52% to RMB 821 million [1] - For the first three quarters of 2025, the company reported revenue of RMB 29.393 billion, a year-on-year decline of 4.91%, but net profit increased by 25.5% to RMB 2.523 billion [2]