21世纪经济报道记者季媛媛 上海报道 2025年初，迪哲医药研发的肺癌靶向药舒沃哲 （舒沃替尼片）向美国FDA递交新药上市申请并获得优 先审评资格，这一消息在医药行业引起了广泛关注。就在7月3日，该药正式获得FDA批准上市，用于经 治EGFR Exon20ins晚期非小细胞肺癌（NSCLC）患者，成为中国首款独立研发在美获批的全球首创 （First-in-Class）新药。 美国是全球最主要的医药市场，FDA 获批不仅是对药物本身的认可，其商业化天花板也将更高，如百 济神州泽布替尼在2024年的全球销售额达到了188.59亿元（约26亿美元），同比增长106.4%。其中，美 国市场的销售额表现突出，达到了138.90亿元（约20亿美元）。截至2024年12月底，共有8款国产创新 药获FDA批准上市，包括泽布替尼、呋喹替尼、西达基奥仑赛、特瑞普利单抗等。 不过，本土创新药国际化路径究竟该如何走得更稳？从临床试验到FDA审评，从生产质量到商业布局， 中国药企能否实现一场全方位的国际化蜕变？ 此外，FDA关注对照组设计的合理性，例如是否采用标准疗法作为对照，以及长期安全性数据的收集， 特别是在针对肿瘤等慢性疾病的研 ...

Group 1 - The core viewpoint of the news is the release of the "Several Measures to Support the High-Quality Development of Innovative Drugs" by the National Medical Insurance Administration and the National Health Commission, which includes 16 initiatives aimed at supporting the entire chain of innovative drug development, access, and payment [1][2] - The measures emphasize the importance of supporting innovative drugs to go global, encouraging regions to explore building global trading platforms for innovative drugs, particularly targeting Southeast Asia, Central Asia, and other Belt and Road countries [1][5] - The new "1+" drug approval mechanism in Hong Kong, effective from November 2023, aims to streamline the registration process for innovative drugs, allowing for faster market entry and enhancing Hong Kong's role as a bridge for innovative drugs to reach global markets [7][8] Group 2 - The establishment of a commercial health insurance innovative drug directory is a significant highlight of the measures, which will include innovative drugs that exceed basic insurance coverage and have high clinical value [3][4] - The commercial health insurance innovative drug directory will be developed by the National Medical Insurance Administration, allowing companies to apply for inclusion in either the insurance directory or the basic medical insurance directory [3][4] - The measures also aim to enhance the multi-layered payment capabilities for innovative drugs, addressing the challenges of price expectations from innovative drug companies and the payment capabilities of insurance [2][3] Group 3 - The measures propose to support the expansion of investment in innovative drugs by commercial health insurance, fostering a patient capital environment for innovative drug companies [5][6] - The collaboration between Hong Kong and Shenzhen aims to establish a "Real-World Research and Application Center" to promote data sharing and expedite drug approval processes [6][8] - The National Medical Insurance Administration plans to implement more effective measures to support the pricing of innovative drugs going abroad, including exploring stricter price confidentiality mechanisms for drugs in the commercial health insurance directory [10]

Core Insights - The article discusses the recent measures introduced by the National Healthcare Security Administration (NHSA) and the National Health Commission (NHC) to support the development of innovative drugs in China, focusing on policy support and pricing guarantees for companies while ensuring accessibility and safety for the public [1][2]. Group 1: Policy Measures - The "Several Measures to Support the High-Quality Development of Innovative Drugs" includes 16 measures across five areas, addressing the entire chain of innovative drug development, approval, hospital use, and multi-channel payment [1]. - The NHSA has made significant progress in the approval of innovative drugs, with the number of Class 1 innovative drugs approved reaching 48 in 2024, over five times the number in 2018, and nearly 40 already in the first half of this year [1]. Group 2: Multi-Payment System - The NHSA is establishing a multi-payment system for innovative drugs, which includes regular adjustments to the medical insurance drug list and the introduction of a commercial health insurance innovative drug list [2][3]. - The commercial health insurance innovative drug list will focus on highly innovative drugs with significant clinical value that exceed the basic medical insurance coverage, enhancing the multi-layered medical security system [2]. Group 3: Market Dynamics - The commercial health insurance market in China has been growing rapidly, with the original insurance premium income for commercial health insurance reaching 977.3 billion yuan in 2024, a year-on-year increase of 8.2% [3]. - The NHSA aims to streamline the application process for innovative drugs to be included in both the medical insurance and commercial health insurance lists, reducing the administrative burden on companies [3][4]. Group 4: Support for Global Expansion - The measures also aim to support the global market development of Chinese innovative drugs, with over 90 overseas licensing transactions completed by Chinese pharmaceutical companies in 2024, totaling over 50 billion USD [6]. - The NHSA will facilitate the entry of domestic drugs into ASEAN countries and support innovative drugs in overseas markets, including the implementation of price confidentiality for certain drugs [6][7].

【大河财立方 记者 王鑫】7月1日，创新药板块高开高走。 招商证券表示，中国创新药登上全球竞争舞台，技术创新+市场扩容引领创新药产业趋势行情，持续看好后续催 化与兑现。该券商指出，创新药出海，是供给与需求方相互成就的产业逻辑。截至目前，2025年国内创新药项 目已经完成BD项目数量超过80项，分子形式多样广泛。从MNCs引进交易数量及交易金额情况来看，中国成为 增长最快的国家。国内创新药企从2020～2024年首付款金额从5亿美元增长至41亿美元，也侧面印证了国内药企 的全球竞争力。 国联民生证券认为，创新药或将逐步进入兑现期。2025年预计是国内创新药授权出海的重要年份，自2018 年"4+7"集采以后，国内企业纷纷开始从仿制药向创新药转型，至今7年时间，已经陆续进入兑现期。部分先驱 创新药企业有望陆续实现盈亏平衡，利润端转正。 责编:史健 | 审校:张翼鹏 | 审核:李震 | 监审:古筝 截至收盘，Wind创新药指数上涨3.46%。从个股来看，前沿生物涨停，舒泰神、科兴制药涨逾15%，荣昌生物、 微芯生物涨超10%，华纳药厂、泽璟制药、千红制药等涨幅居前。 | 序号 名称 | | 现价 | 涨跌幅 ▼ | ...

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"， ...

消息面上，2025年6月30日生物医药产业资本对接会成功举办，促进产融合作。此外，6月24日，市药品 监督管理局在宝山高新区举办第三期生物医药产品"注册讲堂"，聚焦无源/有源器械及体外诊断试剂检 测与临床评价要点，为80余家医疗器械企业提供政策指导。 注：如提及个股仅供参考，不代表投资建议。指数/基金短期涨跌幅及历史表现仅供分析参考，不预示 未来表现。市场观点随市场环境变化而变动，不构成任何投资建议或承诺。文中提及指数仅供参考，不 构成任何投资建议，也不构成对基金业绩的预测和保证。如需购买相关基金产品，请选择与风险等级相 匹配的产品。基金有风险，投资需谨慎。 （文章来源：每日经济新闻） 东莞证券指出，医药生物板块近期迎来回调，此前涨幅较大的创新药相关产业链和减肥药板块跌幅居 前。目前国内创新药公司经过多年研发投入，陆续进入收获期，创新药领域近期利好频出，新药出海授 权金额不断创新高，创新药业务开始为创新药企业贡献业绩。SW医药生物行业近期下跌5.05%，跑输 同期沪深300指数约6.43个百分点，三级细分板块全部录得负收益，其中医疗耗材和医院板块跌幅较 少，化学制剂和线下药店板块跌幅居前。行业估值有所下降，目 ...

创新药板块，迎来重磅利好！ 7月1日最新消息，国家医保局、国家卫生健康委印发《支持创新药高质量发展的若干措施》（以下简称《若干 措施》）。其中提出，支持医保数据用于创新药研发，鼓励商业健康保险扩大创新药投资规模，有针对性地加 强创新药在药品目录准入方面的政策指导。 组织实施创新药物研发国家科技重大专项，聚焦重大传染病、高发重大慢性病、儿童用药、罕见病等重点领 域，推动药物研发相关任务落地实施并完善多部门联动的支持机制。发挥国家医学中心和国家临床医学研究中 心作用，依托国家科技重大专项、重点研发计划等，支持医药企业、科研院所、医疗机构等开展以创新药研发 为导向的科研攻关。 在上述消息的刺激下，7月1日早盘，创新药概念股集体拉升，塞力医疗、贵州百灵涨停，舒泰神涨近12%，热 景生物涨近10%。 有券商指出，2025年预计是国内创新药授权出海的重要年份，技术创新+市场扩容引领创新药产业趋势行情， 持续看好后续催化与兑现。 创新药板块迎来重磅利好 自今年5月中旬以来，创新药概念股持续走强，虽然中途曾出现高位调整，但最近几个交易日又再度活跃起 来。7月1日早间，创新药板块再度拉升，截至中午收盘，塞力医疗、贵州百灵涨停， ...

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index (000683) increased by 0.93% as of July 1, 2025, with notable gains from stocks such as Rongchang Biopharmaceutical (688331) up 7.21% and Shanghai Yizhong (688091) up 3.61% [1] - Starting July 1, 2025, a new policy mandates that all drug sales must include a verification code for medical insurance reimbursement, with full traceability of drug codes required by January 1, 2026, which is expected to enhance drug circulation regulation and impact the entire pharmaceutical industry chain [1] - The current bull market in innovative drugs is driven by the improvement of China's pharmaceutical innovation capabilities, with a trend towards international collaboration in new drug development expected to enhance profitability and market potential for Chinese pharmaceutical companies [2] Group 2 - As of June 30, 2025, the top ten weighted stocks in the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index accounted for 50.3% of the index, including companies like United Imaging Healthcare (688271) and BeiGene (688235) [3] - The Sci-Tech Biopharmaceutical ETF closely tracks the performance of the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index, which includes 50 large-cap companies in various biopharmaceutical sectors [2]

Group 1 - The Chinese capital market is expected to show a "stable index, structural bull" trend in the second half of the year, indicating significant potential for A-shares [2] - Long-term funds are anticipated to become an important incremental capital source for the market, suggesting a structural bull market for A-shares [2][3] - The capital market is projected to exhibit a "dual bull" trend in stocks and bonds by the second half of 2025 [3] Group 2 - The stock market is expected to respond more quickly to policy easing, potentially leading to an upward turning point among major asset classes [3] - A-shares may experience a volatile trend due to a combination of declining profits and credit conditions in the second half of the year [4] - The profit bottom for A-shares may not arrive until at least the third quarter, indicating weakening elasticity in the profit cycle [5] Group 3 - Key sectors attracting institutional interest include banking, which offers safety and yield certainty amid external uncertainties and low interest rates [6] - The new consumption sector is seen as a growth area, driven by changing consumption concepts among Generation Z [7] - The innovative pharmaceutical sector is expected to see significant licensing opportunities in 2025, with potential catalysts for market performance in the second half of the year [7] Group 4 - The technology sector, having adjusted valuations to reasonable levels, may present new investment opportunities in the second half of the year [7] - The smart driving sector is poised for growth, with new vehicle launches focusing on intelligence and currently low valuations of related companies [7] - The new energy vehicle sector typically experiences two market cycles: the first driven by expectations and the second by actual performance [8] Group 5 - The A-share market is anticipated to experience a phase of volatility followed by an upward trend in the second half of the year [9] - The market is expected to continue a pattern of oscillation and gradual ascent [9]

以下文章来源于东方财富网 ，作者辣笔小强 东方财富网 . 东方财富网，中国财经门户，提供7*24小时财经资讯及全球金融市场报价，汇聚全方位的综合财经新闻 和金融市场资讯。 在海外大额BD交易、以及基本面向好预期下，年内创新药板块成为市场"香饽饽"之一。东方财富 Choice数据显示，年内创新药涨幅达17.67%，排在概念涨幅榜第17位。若是看成分个股超100的大板块 的话，创新药可以排在第4位，仅次于微盘股、人形机器人和ST股。 | 序号 | 概念简称 | 年内涨幅(%) | 成分个股 | | --- | --- | --- | --- | | 1 | 重组蛋白 | 44.69 | 18 | | 2 | 微盘股 | 40.18 | 400 | | 3 | 发电机概念 | 31.41 | 21 | | 4 | 数字货币 | 26.01 | 80 | | 5 | 減速器 | 25.42 | 70 | | 6 | 同步磁阻电机 | 24.60 | 6 | | 7 | 噪声防治 | 24.01 | 8 | | 8 | 富士康 | 23.69 | 37 | | 9 | РСВ | 22.90 | ਰੇਤੇ | | 10 ...