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一粒药从实验室到临床应用有多远 十六条新措施助力创新药加速跑(政策解读)
Ren Min Ri Bao· 2025-07-01 21:53
Core Viewpoint - The article discusses the recent measures introduced by the National Healthcare Security Administration and the National Health Commission to support the high-quality development of innovative drugs in China, emphasizing the acceleration of innovative drugs from laboratories to hospitals and ensuring affordability for the public [1][2]. Group 1: Policy Measures - The new policy includes 16 measures aimed at invigorating the development of innovative drugs, marking a significant governmental push for the biopharmaceutical industry [1][2]. - The measures focus on encouraging "true innovation" in drug development and avoiding homogenization and insufficient clinical value in certain areas [2]. Group 2: Drug Approval and Market Dynamics - In 2024, the number of approved Class 1 innovative drugs reached 48, more than five times the number in 2018, indicating a significant increase in drug approvals [2]. - As of mid-2023, nearly 40 Class 1 innovative drugs were approved in the first half of the year alone, showcasing a clear "explosion effect" in the market [2]. Group 3: Affordability and Accessibility - The measures aim to enhance the multi-channel payment capabilities for innovative drugs, encouraging commercial health insurance and mutual medical assistance to include these drugs in their coverage [3][4]. - Since 2018, 149 innovative drugs have been included in the medical insurance directory, accounting for 17% of new drug approvals, with medical insurance fund expenditures reaching 4.1 trillion yuan, driving sales over 6 trillion yuan [3]. Group 4: Integration of Insurance Systems - The establishment of a commercial health insurance directory for innovative drugs is proposed to better align with basic medical insurance, enhancing overall coverage [4]. - The measures also suggest synchronizing settlements between basic medical insurance and commercial health insurance to streamline processes for patients [5]. Group 5: Drug Availability in Medical Institutions - The policy emphasizes the need to expedite the entry of innovative drugs into designated medical institutions and encourages timely meetings to address drug supply based on clinical needs [6]. - The ongoing reforms in medical insurance payment systems aim to support the reasonable use of innovative drugs, allowing medical institutions to apply for special cases when standard payment methods are not suitable [6]. Group 6: Global Market Expansion - The article highlights that Chinese pharmaceutical companies are increasingly engaging in overseas transactions, with over 90 deals completed in 2024, totaling more than 50 billion dollars [6]. - The measures propose to facilitate the global market development of innovative drugs by providing platforms and price support for companies looking to expand internationally [6].
人民同泰: 致同会计师事务所关于公司2024年年度报告的信息披露监管问询函的回复
Zheng Quan Zhi Xing· 2025-07-01 16:30
关于哈药集团人民同泰医药股份有限公司 回复 致同会计师事务所(特殊普通合伙) 致同会计师事务所(特殊普通合伙) 中国北京朝阳区建国门外大街 22 号 赛特广场 5 层邮编 100004 电话 +86 10 8566 5588 传真 +86 10 8566 5120 www.grantthornton.cn 关于哈药集团人民同泰医药股份有限公司 致同专字(2025)第 210A017071 号 上海证券交易所: 致同会计师事务所(特殊普通合伙)(以下简称"我们")接受委托对哈 药集团人民同泰医药股份有限公司(以下简称"公司"或"人民同泰公司") 合并及公司利润表、合并及公司现金流量表、合并及公司股东权益变动表以及相 关财务报表附注进行审计,并于 2025 年 4 月 11 日出具了致同审字(2025)第 我们于 2025 年 5 月 28 日收到了人民同泰公司转来的上贵所出具的《关于哈 药集团人民同泰医药股份有限公司 2024 年年度报告的信息披露监管问询函》 (上证公函【2025】0667 号)(以下简称"问询函")。按照该问询函的要求, 基于人民同泰公司对问询函相关问题的说明以及我们对人民同泰公司 2024 ...
创新药支付分水岭
Bei Jing Shang Bao· 2025-07-01 14:47
Group 1 - The establishment of a "Commercial Health Insurance Innovative Drug Directory" aims to address the payment challenges for high-priced innovative drugs outside of basic medical insurance [1][2][3] - The new policy signals a shift in the role of commercial insurance in supporting innovative drug payments, creating a multi-tiered medical security system [2][4] - The commercial health insurance sector is expected to develop specialized insurance products to support innovative drug payments, leveraging standardized drug lists and pricing mechanisms [3][4] Group 2 - The current basic medical insurance system has limitations in funding, particularly for high-cost treatments like CAR-T therapy, which can exceed one million yuan [4][5] - Commercial health insurance has a small market share in innovative drug payments, with only 7.7% of the innovative drug market being covered by commercial health insurance expenditures [5][6] - The "Hui Min Bao" program has made significant contributions to innovative drug payments, but its compensation for innovative drugs remains low compared to the overall market size [6][5] Group 3 - The implementation of the new policy presents challenges for insurance companies, including directory management, payment negotiations, cost impacts, risk control, and market education [7][8] - A robust evaluation system is necessary for assessing the clinical value and cost-effectiveness of innovative drugs, which poses a significant challenge for insurers [7][8] - The lack of historical data and the need for effective risk management strategies complicate the pricing and compensation models for innovative drugs [9][10] Group 4 - Data sharing between basic medical insurance and commercial health insurance is crucial for enhancing the effectiveness of innovative drug payment systems [11][13] - The development of specialized data interfaces and standardized coding for diseases and drugs is recommended to facilitate better collaboration between insurance sectors [14][13] - The focus on improving data collaboration can lead to more precise product development and risk management in the commercial health insurance market [13][14]
【新华解读】创新药产业迎支付准入两端重大利好
值得一提的是,文件还明确,商业健康保险保障范围内的创新药应用病例可以不纳入按病种付费范围,经审核评议程序后支付。 近年来,我国商业健康保险的市场快速增长,根据金融监管总局数据,2024年我国商业健康保险原保费收入达到9773亿元,同比增长8.2%。这已经基本 接近有10亿人参加的居民医保的总体筹资水平。 转自:新华财经 新华财经北京7月1日电(记者李唐宁、刘旭阳)国家医保局、国家卫生健康委日前印发《支持创新药高质量发展的若干措施》(以下简称《若干措 施》)。文件提出,增设商业健康保险创新药品目录,鼓励商业健康保险扩大创新药投资规模;推动创新药加快进入定点医药机构,探索为创新药研发提 供必要的医保数据服务。 业内人士认为,随着研发、准入和多元支付环节获得实际支持,创新药产业迎来新一轮利好。7月1日,创新药板块整体走强,涨幅3.28%,前沿生物、舒 泰神、微芯生物等个股涨幅居前。 推出商保创新药目录 培育支持"耐心资本" 对于商业保险这一重要支付方式,《若干措施》明确,增设商业健康保险创新药品目录,重点纳入创新程度高、临床价值大、患者获益显著且超出基本医 保保障范围的创新药。医保部门对符合条件的商业健康保险给予数 ...
四问创新药目录申报:哪些药品符合资质?价格谈判由谁主导?
Di Yi Cai Jing· 2025-07-01 11:51
根据工作方案,商保创新药目录的申报工作于7月正式启动,并将在本月内完成形式审查。通过形式审 查的创新药品将在此后两个月进入专家评审阶段。直到9-10月,商保创新药目录与基本医保目录同步开 展价格谈判。 创新药企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 整相比,商保创新药目录将充分尊重商业健康保险公司的市场主体地位。 按照工作规划,2025 年制定的第一版商保创新药目录主要纳入超出保基本定位、暂时无法纳入基本目 录,但创新程度高、临床价值大、患者获益显著的创新药,推荐商业健康保险、医疗互助等多层次医疗 保障体系参考使用。稳妥起步之后,后续该目录将根据医药技术发展、临床需求变化、商业健康保险发 展等因素实行动态调整。 针对医药企业在"国谈"申报时的主要关切,第一财经根据工作方案及国家医保局于同日召开的新闻发布 会内容,梳理了四问四答: 商保创新药目录将充分尊重商业健康保险公司的市场主体地位 2025年医保"国谈"将近。作为商保创新药目录与基本医保目录"同步申报、同步调整"的第一年,今 年"国谈"流程和创新药支付价格谈判机制将发生哪些改变? 7月1日,国家医保局就《2025 ...
两部门发布16条举措支持创新药,这些焦点问题与你我息息相关
Xin Jing Bao· 2025-07-01 11:20
Core Viewpoint - The National Healthcare Security Administration and the National Health Commission have issued measures to support the high-quality development of innovative drugs, focusing on enhancing R&D support, integrating innovative drugs into insurance directories, and encouraging clinical applications [1][2][3]. Group 1: Support for Innovative Drug R&D - The measures emphasize the organization and implementation of national major science and technology projects for innovative drug R&D, targeting major infectious diseases, chronic diseases, pediatric medications, and rare diseases [1][3]. - The proportion of innovative drugs among new drugs in the medical insurance directory is expected to rise significantly, from 32% in 2019 to 98% by 2024 [2]. Group 2: Integration into Insurance Systems - The policy allows for the inclusion of eligible innovative drugs into the medical insurance directory while maintaining a focus on basic coverage [3][4]. - Commercial health insurance and mutual medical assistance are encouraged to include innovative drugs in their coverage, with a notable growth in the commercial health insurance market, projected to reach 977.3 billion yuan in 2024, an 8.2% increase year-on-year [5][6]. Group 3: Clinical Application and Accessibility - The measures promote the rapid entry of innovative drugs into designated medical institutions, ensuring timely adjustments to drug availability based on clinical needs [4][11]. - Medical institutions are supported in autonomously applying for special cases for innovative drugs that do not fit standard payment models, enhancing the flexibility of drug usage [5][12]. Group 4: Global Market Development - The measures aim to facilitate the global development of innovative drugs, with over 90 overseas licensing transactions completed by Chinese pharmaceutical companies in 2024, totaling over 50 billion USD [9][10]. - The establishment of platforms to assist in expanding overseas markets and providing price support for innovative drugs is a key focus [10].
创新药目录申报在即,国家医保局:探索更严格的价格保密机制
Di Yi Cai Jing· 2025-07-01 10:12
商业保险公司将充分参与丙类目录的价格谈判等环节,商保专家对于一款药品能否进入该目录具有重要 决策权 今年以来,丙类目录的谈判和落地进展备受创新药业界关注。 根据国家医保局释放的最新消息:该目录将由国家医保局组织制定,丙类目录与医保目录同时申报,同 步调整,程序基本一致,商业保险公司将充分参与丙类目录的价格谈判等环节,商保专家对于一款药品 能否进入该目录具有重要的决策权。 7月1日,国家医保局和国家卫生健康委联合发布《支持创新药高质量发展的若干措施》(以下简称"若 干措施"),从支持创新药研发、多元支付、临床应用和药品"出海"等方面提出16条具体举措。 若干措施提出,支持创新药进入基本医保药品目录和商业健康保险创新药品目录,增设商业健康保险创 新药品目录(以下简称商保创新药目录)。商保创新药目录重点纳入创新程度高、临床价值大、患者获 益显著且超出基本医保保障范围的创新药,推荐商业健康保险和医疗互助等多层次医疗保障体系参考使 用。 第一财经了解到,这里的商保创新药目录,也即国家医保局曾在今年年初提到的"丙类目录"。 国家医保局医药管理司司长黄心宇在同日举办的新闻发布会上提出,对商保创新药目录实施"三除外支 持", ...
收评:沪指涨0.39%再创年内收盘新高 医药股领涨 数字货币股领跌
Xin Hua Cai Jing· 2025-07-01 07:33
巨丰投顾:周二市场震荡运行,中船系涨幅居前。历史数据显示,近20年上证指数在7月上涨概率为 60%。投资者可从三方面布局:节奏上,上旬防御为主,警惕外部冲击,配置公用事业等板块,下旬聚 焦中报业绩,关注超预期个股及政策动向;风格上,金融(政策刺激、低估值优势)与成长(科技政策 持续、产业趋势上行)占优;操作上,重点关注科技(半导体、人工智能核心企业)、军工(阅兵催 化、订单增长)及中报高增领域(TMT、中游制造等),规避业绩风险股。 沪深两市主要股指7月1日开盘涨跌不一,沪指微幅高开,深成指和创业板指小幅高开。沪指全日呈震荡 上扬态势;深成指和创业板指早盘期间震荡下行,深成指午间收盘前反弹,午后翻红并最终小幅收涨, 创业板指在接近回补缺口后有所回落,收盘时小幅下跌。指数表现方面,沪指7月1日的收盘点位高于6 月25日的收盘点位,再创年内收盘新高。 盘面上,医药股领涨,免疫治疗、创新药、重组蛋白、仿制药、减肥药、肝炎概念、毛发医疗等多个医 药医疗的细分领域指数均有较大幅度上涨。当日,船舶、工业气体、光刻机、银行、超导概念等板块亦 有显著上涨。数字货币股跌幅靠前,电子身份证、跨境支付、Web3概念等板块亦有较大幅 ...
IPO失败后海纳医药“卖身”又遇挫
Xin Lang Cai Jing· 2025-07-01 05:51
智通财经记者 | 陈杨 智通财经编辑 | 谢欣 6月29日,成都先导宣布终止收购海纳医药。 在此3个月前,成都先导曾发布重大资产重组事项公告,计划以现金方式受让海纳医药约65%的股权。交易完成后,前 者将成为后者控股股东。 而据本次公告,该交易终止的原因在于各方未能就交易方案、交易价格、交易对方范围、业绩承诺等核心条款达成一 致。 成都先导称,各方对终止本次重大资产重组无需承担任何违约责任,该事项也不会对公司业务开展、生产经营活动和财 务状况造成不利影响,亦不存在损害公司及股东特别是中小股东利益的情形。 6月30日,成都先导股价开盘低走,跌幅一度超7%,收盘价报16.08元/股,跌0.99%,当下市值64.43亿元。而与之可比 的是,公司公布该重大资产重组事项后一日,股价曾高涨超8%。 智通财经注意到,医药外包行业下行期,这类交易并非孤例。今年1月,"培养基第一股" 奥浦迈即宣布收购临床前CRO (医药研发外包)公司澎立生物100%股权。这两笔收购的相似点在于,买卖双方的体量都不算大,买方可以扩展业 务、增厚业绩,卖方也都经历了IPO失败,即缺少退出通道。 可以参考的是,据奥浦迈6月公布的交易方案,该交易对价 ...
国家医保局黄心宇:医保和商保将在保障范围、数据、结算、监管进行协同
news flash· 2025-07-01 02:41
Core Viewpoint - The National Healthcare Security Administration (NHSA) is promoting collaboration between basic medical insurance and commercial health insurance to address challenges faced by the latter, focusing on areas such as coverage, data, settlement, and regulation [1] Group 1: Coverage Collaboration - The NHSA aims to explore the support of commercial health insurance in conjunction with basic medical insurance, establishing a clear boundary for basic medical insurance coverage to allow room for the development of commercial health insurance [1] - The initiative includes the establishment of an innovative drug directory for commercial insurance as a starting point [1] Group 2: Data Collaboration - The NHSA emphasizes the importance of data collaboration, ensuring data security and privacy while promoting the application of medical insurance data in the commercial health insurance sector [1] - This collaboration aims to facilitate rapid underwriting and claims processing for commercial health insurance products [1] Group 3: Settlement Collaboration - The NHSA is exploring synchronized settlement processes between basic medical insurance and commercial health insurance, enabling patients to achieve simultaneous settlement at medical institutions when purchasing relevant commercial insurance [1] Group 4: Regulatory Collaboration - The NHSA plans to share its intelligent regulatory platform and capabilities to gradually achieve coordinated regulation between basic medical insurance and commercial health insurance [1] - This effort aims to ensure the reasonable use of funds in commercial health insurance and maintain its stable operation [1]