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“破壁者”宋瑞霖:乐意为医药创新鼓与呼 | 我们的四分之一世纪
Jing Ji Guan Cha Wang· 2025-12-29 05:49
编者按: 2025 年,经济观察报以 " 我们的四分之一世纪 " 为年终特刊主题,旨在通过数十位时代亲历者的故事,共绘一幅属于这段岁月的集体记忆图谱。 0:00 在医药圈,宋瑞霖被一部分人视为异类,又被产业界看作是顶流。 过去四分之一世纪:他从朝堂之上,走入社会之中;他以法学背景跨界执掌医药协会,把一个没人愿交会费的边缘协会带成中国医药创新的代言人;他常对 政策提出批评建议,也积极参与官方文件的起草;他多次前往欧美考察学习,回国传递医改药改经验,为中国药企搭建出海桥梁。 如果用一个词来形容他,最贴切的或许是"破壁者"。 宋瑞霖,1962年出生在北京胡同,曾在国务院法制办工作,2007年离开体制,后长期领导中国医药创新促进会(下称"药促会"),担任执行会长16年,直至 2025年6月卸任。 2016年,宋瑞霖向国家药监局系统分享了他此前考察美国制药业时的发现——支撑美国医药产业创新的是三大法案:《拜杜法案》解决从实验室到市场的转 化问题;《哈奇-韦克斯曼法案》延长创新药的专利保护期,补偿因FDA审批占用的时间,不再要求仿制药进行临床试验,同时引入专利链接制度;《处方 药申报者付费法案》允许FDA收取申请费,FD ...
约印医疗基金顾问委员会主席姒亭佑:医疗投资需要保持耐心
Sou Hu Cai Jing· 2025-12-27 02:50
医药投资需前瞻布局 回归需求为本的核心逻辑 姒亭佑表示,医疗行业的发展是一个持续演变的过程,并不存在所谓的"最好机遇"。当下市场上的生物医药BD交易,其布局往往始于七八年前,这意味着 行业发展具有极强的前瞻性,若在风口显现后再盲目入局,极易陷入同质化竞争的困局。 回顾行业发展历程,姒亭佑谈到,二十年前国内医药市场以仿制药为主,这与当时缺医少药的市场需求高度契合。随着行业发展进入快速跟随阶段,政策导 向曾推动企业聚焦"中美双报"和"一致性评价",但政策的动态调整让部分跟风布局的企业遭遇发展瓶颈。"这也印证了医药投资不能单纯追逐政策热点,更 要回归核心——是否真正解决市场未被满足的需求。"姒亭佑强调。 在姒亭佑看来,科技创新并非医药投资的唯一考量标准,市场需求的体量同样关键。不少创业项目虽拥有先进技术,但因瞄准的市场空间狭窄,最终难以实 现规模化发展。基于此,项目立项阶段的研判尤为重要,从立项方向便能窥见企业的成立时间与行业风口的关联度。 对于医药行业的下一阶段发展方向,姒亭佑给出了明确的方向指引。他认为,抗药性药物研发、提升药物有效性、增强用药安全性以及提高患者用药依从 性,将成为行业未来的核心发力点。他强调, ...
广西造“良药好械美妆”不断走向市场
Guang Xi Ri Bao· 2025-12-26 03:16
药品安全监管方面,广西推动监管机制更好适应医药创新发展需求。政策加持下,2025年广西获国 家药监局批准上市药品10个,其中1个为全球首个仿制药,仿制药品种从"十三五"末的1个增长至42个; 109个第二类医疗器械填补广西空白;3个化妆品新原料通过国家药监局备案,实现零的突破。广西 造"良药好械美妆"正在不断走向市场。 通过综合运用监督检查、抽检监测等强化监管,"十四五"期间,全区实现药品安全事件"零发生", 药品评价性抽检合格率稳定在99%以上。 医药产业促进有力——自治区医疗器械检测中心检测能力覆盖区内生产90%的第二、三类医疗器 械;十米法电磁兼容实验室填补全区大型高端医疗器械检测能力的空白。《广西海洋中药材标准》完成 编制。药物临床试验机构数量从12家增长至54家。2025年,38家区外医药企业入驻重点园区,全区新增 第二类医疗器械注册证472张、普通化妆品备案2266个,分别同比增长11.06%和19.8%。 2025年前三季度,广西还为88个药品、136个医疗器械产品出具出口销售证明,销售额分别同比增 长27.23%和16.25%,更多广西产品首次走出"国门"。(刘冬莲) 12月25日,自治区政府 ...
“十四五”创新药上市交出惠民答卷
Xin Lang Cai Jing· 2025-12-25 01:02
核心阅读 (来源:中国医药报) 转自:中国医药报 这些产品的获批上市,极大地满足了临床治疗需求,在填补我国多个治疗领域用药空白的同时,丰富了 患者的用药选择,为广大患者带来了新的希望 □ 魏利军 除了肺癌,乳腺癌和血液肿瘤的治疗也获得显著突破。国家癌症中心数据显示,乳腺癌是除肺癌外,目 前我国女性发病率最高的癌症。相关创新药的获批,丰富了激素受体阳性乳腺癌、人表皮生长因子受体 2阴性乳腺癌的治疗选择,为PIK3CA突变乳腺癌患者带来了靶向药物治疗的新方案,还为临床需求亟待 满足的三阴乳腺癌患者带来了全新疗法——靶向TROP2的抗体药物偶联物。血液肿瘤方面,得益于免 疫检查点抑制剂和CAR-T疗法的快速发展,患者有了更多治疗选择,其预后也进一步改善。CAR-T疗法 是我国医药行业具备全球竞争力的主要赛道之一。过去五年,我国有多款CAR-T细胞治疗产品相继获批 上市。另外,甲状腺癌、胆管癌、宫颈癌等适应证也首次出现靶向药物,鼻咽癌、胃癌、前列腺癌、结 直肠癌等适应证的治疗方案数量大幅提升,患者整体治疗获益明显。 在免疫调节剂领域,创新药的上市带来了显著的临床进步:不仅为系统性红斑狼疮、移植物抗宿主病和 斑秃等疾病 ...
2026年医药行业投资策略:聚焦创新、出海与确定性
Chengtong Securities· 2025-12-24 12:41
Group 1: Overview of the Pharmaceutical Industry - The pharmaceutical industry maintained stable revenue around 2.45 trillion yuan from 2023 to 2025, with quarterly revenue stabilizing at approximately 600 billion yuan [1][15] - The biotech sector is expected to achieve over 100 billion yuan in sales by 2025, marking it as a significant growth segment within the pharmaceutical industry [2] - The overall revenue for the pharmaceutical industry in the first three quarters of 2025 was 1.83 trillion yuan, reflecting a year-on-year decline of 1.5% [15][19] Group 2: Innovation in Pharmaceuticals - The innovation drug sector has shown remarkable performance, with biotech companies experiencing over 70% revenue growth in 2023 and 2024, and maintaining around 42% growth in the first three quarters of 2025 [20][21] - The CXO industry is the fastest-growing sub-sector in terms of profit, with a year-on-year increase of 33.4% [20] - The total transaction value for license-out deals in the innovation drug sector reached 920 billion USD in the first three quarters of 2025, providing significant cash flow for domestic innovation drug companies [3][20] Group 3: International Expansion - The global market for innovative drugs is expanding, with license-out transactions expected to exceed 100 billion USD in 2025, capturing nearly half of the global pharmaceutical business development transaction volume [2] - The export of medical devices from China has shown a recovery trend, with a total export value of 355.3 billion yuan in 2024, marking a year-on-year growth of 9.8% [4][7] Group 4: Blood Products Sector - The blood products industry is characterized by high barriers to entry and a stable pricing structure, with the top six companies accounting for 80% of domestic plasma collection [8] - Despite short-term supply-demand disturbances, the blood products sector remains a stable segment within the pharmaceutical industry [8][22] - The industry is currently experiencing a wave of mergers and acquisitions, leading to increased market concentration [8] Group 5: Medical Devices - The domestic medical device bidding market showed a significant recovery, with a total market size exceeding 80 billion yuan in the first half of 2025, reflecting a year-on-year growth of 62.75% [4] - The recovery in international markets has also contributed to the growth of medical device exports, which are expected to continue their upward trend [4][7]
AI重塑医药创新范式 专家:区域协同与国际合作释放新机遇
Zhong Guo Xin Wen Wang· 2025-12-23 17:14
此外,中国已从仿制药大国加速迈向创新药重要策源地,临床试验数量和国际合作水平持续提升,创新 药"走出去"的步伐明显加快。数据显示,2025年前10月,中国创新药海外授权超过100笔,金额突破 1000亿美元。 "面向未来,AI在医药创新领域还有诸多可应用的场景。"田佑中表示,推动医药创新需要同时关注区域 协同和国际合作。 中新网杭州12月23日电(钱晨菲)"在人工智能(下称,AI)加速重塑医药研发和产业体系的背景下,区域协 同与国际合作正成为推动医药创新的重要变量。"12月23日,2025长三角产业创新发展大会在浙江杭州 举行,中非医院联盟健康丝路AI发展联合工作组组长田佑中作主旨演讲时如是说。 随着AI加速赋能实体经济,医药创新正迎来深刻变革。但与此同时,"看病难、看病贵"仍是各国医疗体 系绕不开的结构性难题。田佑中指出,其背后既有优质资源分布不均、基层承接能力不足的问题,也有 医患信息不对称、创新成本持续攀升等深层原因。在此背景下,通过技术创新提升医疗体系运行效率至 关重要。 具体来看,聚焦政策环境,从将健康优先发展战略和AI深度赋能结合,到推动"三医协同"并将"医疗"置 于首位,再到明确提出"深入实施' ...
益诺思荣获“2025上市公司最具社会责任奖”,以责任与专业铸就CRO领域新标杆
Sou Hu Wang· 2025-12-16 09:15
Core Viewpoint - Shanghai Yinos Biotechnology Co., Ltd. has been awarded the "2025 Most Socially Responsible Listed Company Award" for its outstanding practices in social responsibility and professional service capabilities, highlighting its deep accumulation and core value in the CRO professional segment [1][3] Company Overview - Yinos is a comprehensive R&D service (CRO) company specializing in non-clinical research services for biomedicine, adhering to the core values of "science-led, quality-first, integrity, and win-win cooperation" [3] - The company focuses on major national biomedicine development needs and plays a significant role in drug evaluation services, contributing to the high-quality development of the biomedicine industry [3] Business Performance - In Q3 2025, Yinos achieved operating revenue of 195 million yuan, a quarter-on-quarter increase of 17.71%, maintaining a steady growth trend [4] - The company saw a 29.37% year-on-year increase in new order amounts, with significant growth in new drug clinical trial applications (IND) and new drug marketing applications (NDA), which rose by 30.71% and 23.06% respectively [4] Market Position and Strategy - Yinos is positioned as a leading enterprise in the CRO industry, benefiting from a high-growth cycle and possessing technical advantages that meet high-end demand across the entire service chain [4] - The company has established a non-clinical drug metabolism platform compliant with ICH, FDA, and NMPA standards, enhancing its capabilities in radiolabeled isotopes and imaging evaluation research [4] Innovation and International Expansion - Yinos is continuously advancing frontier technologies, particularly in small nucleic acid drugs and CAR-T cell therapy, establishing a comprehensive technical service matrix [5][6] - The company has expanded its international market presence, with significant growth in new order amounts from overseas, enhancing its brand influence and recognition [6] Future Outlook - The award received is not only a recognition of past achievements but also an expectation for future development, as CRO companies play an increasingly important role in new drug development [6] - Yinos aims to leverage this award to strengthen its professional advantages while actively fulfilling social responsibilities, contributing to the high-quality development of China's biomedicine industry [6]
流感创新药亮“中国方案”!创新药替代进口加速?
Xin Lang Cai Jing· 2025-12-15 09:07
百亿市场待重构,替代空间广阔 今年,多款国产抗流感创新药密集获批上市,引发市场高度关注,2025年甚至被称为"国产流感创新药 元年"。有业内人士表示,国产流感创新药密集取得进展,是我国医药创新能力持续提升的必然结果。 这背后蕴藏着什么投资机遇?(资料参考:证券日报《国产创新药破局 为应对流感提供"中国方 案"》,2025.11.12) 国产流感创新药商业化提速 2025年3月至7月,我国有三款抗流感创新药(玛舒拉沙韦片、昂拉地韦片、玛硒洛沙韦片)获批上市, 另有两款药物(玛氘诺沙韦、玛帕西沙韦)完成临床试验,已经提出了上市申请,预计不久将加入市场 竞争。专业人士分析称,目前国产创新药上市以后,销量在稳步提升,反映出这些产品在疗效、安全性 方面获得了认可。(资料参考:央广网《全国整体进入流感流行季 多款国产流感创新药密集上市》, 2025.11.21;36氪《围剿"流感神药"奥司他韦,药厂卷起"一次治疗"新战场》,2025.11.14) 突破进口药局限,实现多重优化 国产新药与进口流感药玛巴洛沙韦作用机制相同,都是通过抑制流感病毒的CAP帽子结构依赖性内切 酶,从而阻断病毒复制。值得关注的是,这批国产新药并非简 ...
全国医保会议16次提“创新”,明年医药产业迎来哪些利好
第一财经· 2025-12-13 14:44
2025.12. 13 2026年,国家医保局将继续用真金白银、价格立项、医保数据等医保的资源和政策来支持我国医药 产业的创新发展。 12月13日,全国医疗保障工作会议在北京召开。国家医保局公众号发布的会议内容中,多达16次提 到"创新"。此次会议释放出明确信号:医保不仅是民生工作也是经济工作,不仅要为民众提供医疗保 障,更是引导医药产业转型升级、支持新质生产力发展的重要战略购买方。 本次会议部署了明年全国医保工作的八大重要任务: 一是巩固全民参保成果,完善基本医疗保障制度; 二是支持商业健康保险发展,健全多层次医疗保障体系; 三是加强医保基金运行管理,守牢医保基金安全底线; 四是积极适应人口发展战略,推动生育保险和长期护理保险发展; 五是优化医保支付结算机制,促进医疗事业健康发展; 本文字数:2008,阅读时长大约3分钟 作者 | 第一财经 郭晋晖 今年印发的《关于支持创新药高质量发展的若干措施》,首次制定商业健康保险创新药品目录,纳入 19种临床价值大、创新程度高、患者受益显著的药品。 医保基金作为中国医药领域最大的购买方,"十四五"期间累计支出约13万亿元,并保持了年均10%左 右的较高增速,为创新提供 ...
全国医保会议16次提“创新”,明年医药产业迎来哪些利好
Di Yi Cai Jing· 2025-12-13 14:22
Core Insights - The National Medical Insurance Administration (NMIA) will utilize its resources and policies to support the innovation and development of China's pharmaceutical industry by 2026 [1][2][3] - The recent national medical insurance work conference emphasized the dual role of medical insurance as both a social welfare tool and an economic driver, aiming to guide the transformation and upgrading of the pharmaceutical industry [1][2] Summary by Categories National Medical Insurance Strategy - The NMIA plans to consolidate the achievements of universal insurance coverage and improve the basic medical insurance system [1] - There will be a focus on supporting the development of commercial health insurance to create a multi-tiered medical security system [1][4] - The NMIA aims to enhance the management of insurance funds to ensure their safety and sustainability [1] Support for Pharmaceutical Innovation - The NMIA will play a strategic purchasing role to foster innovation in the pharmaceutical industry, encouraging healthy competition and differentiated development [2][5] - A total of 949 new drugs have been added to the medical insurance catalog since the establishment of the NMIA, with the latest version including 114 new drugs, marking a record high for innovative drugs [3] - The NMIA has committed approximately 13 trillion yuan in insurance fund expenditures during the 14th Five-Year Plan period, maintaining an annual growth rate of around 10% to provide stable funding for innovation [3] Commercial Health Insurance Development - The NMIA encourages commercial health insurance to complement basic medical insurance and expand coverage for reasonable medical expenses not included in the basic insurance catalog [4][5] - The introduction of a commercial health insurance innovative drug catalog aims to include more high-value, innovative drugs, benefiting a larger patient population [3][5] Technological Innovation and AI Integration - The NMIA is promoting the integration of artificial intelligence in the healthcare sector, encouraging participation from medical institutions, pharmaceutical companies, and research organizations [5][6] - Efforts are being made to create a comprehensive personal health profile for insured individuals, facilitating the application of AI in healthcare services [6] - The NMIA is actively working on a progressive industrial upgrade and payment system for new technologies and products in the healthcare sector [6]