医药产业创新
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国务院常务会议解读|国务院常务会议审议通过药品管理法实施条例修订草案
Xin Hua She· 2025-12-31 15:11
会议指出,根据形势变化及时修订药品管理监督法律法规,对于保障人民群众用药安全、促进医药 产业健康有序发展具有重要意义。要完善药品研制和注册制度,加快突破性治疗药物审评审批,不断激 发产业创新发展活力。要保持药品监管高压态势,加强全链条全流程质量监管,严厉打击药品领域违法 违规行为。 新华社北京12月31日电(记者 戴小河)12月31日召开的国务院常务会议,审议通过《中华人民共 和国药品管理法实施条例(修订草案)》。 中央党校(国家行政学院)经济学教研部教授蔡之兵表示,审议通过药品管理法实施条例修订草案 对百姓用药安全及产业发展具有重要意义。首先,条例强调全链条全流程监管,从研发到使用严管药品 质量,直接保障百姓用药安全。其次,激活产业发展动能,完善研审制度和突破性治疗药物加快审评审 批,可以加快创新药上市,既鼓励药企敢投敢研,也能让创新药更快落地,促进医药产业从"仿 制"向"创新"升级,做强国产医药产业。再次,夯实法治根基,紧随形势修订法规,把药品监管的"严要 求"固化成"硬制度",让监管有法可依、执法更硬。 ...
“十四五”期间 我国基本医保参保率稳定在95% 跨省异地就医直接结算超6亿人次
Yang Guang Wang· 2025-12-14 01:23
5年来,国家医保局加大基金使用监管力度,通过大数据模型和智能监管挽回基金损失95亿元。目 前药品追溯码已累计归集超1000亿条,有力地打击了违法违规行为。 明年,国家医保局将通过医保基金预付、即时结算等支付改革赋能医药机构高质量发展,同时持续 加大对医药产业创新发展的支持力度。 国家医保局数据显示,"十四五"期间,医保基金累计支出超13万亿元,惠及近200亿就诊人次;全 国生育保险的参保人数达到2.55亿人,近95%的统筹区将生育津贴直接发放给个人。国家医保局局长章 轲透露,5年来,国家组织药品和高值医用耗材集采已经覆盖糖尿病、肿瘤、感染等常见病用药和人工 关节、人工晶体、人工耳蜗等高值医用耗材。与此同时,跨省直接结算范围扩大,职工医保个人账户共 济范围拓宽至近亲属等举措落地。 章轲:5年来跨省异地就医直接结算服务超6亿人次,减少了群众的垫付超6600亿元。医保信息平台 接入了超100万家定点医药机构,日均结算超过了2800万人次,累计12.5亿人激活了医保码,并实现了 刷码就医购药。 央广网北京12月14日消息(记者杜希萌 孙永)据中央广播电视总台中国之声《新闻和报纸摘要》 报道,国家医保局13日透露,"十 ...
医疗服务行业周报 12.8-12.12:经济工作会议:优化集采、支付变革、长护险破题-20251213
Xiangcai Securities· 2025-12-13 13:22
Investment Rating - The report maintains a "Buy" rating for the medical services industry [7] Core Insights - The medical and biological sector experienced a decline of 1.04% this week, ranking 17th among 31 primary industries [15] - The medical services sub-sector reported a closing value of 6239.94 points, with an increase of 1.67% [28] - The report highlights a shift in policy focus from cost control to quality and efficiency in the medical sector, emphasizing the need for innovation and sustainable practices [4][70] Summary by Sections Industry Performance - The medical services sector's PE (ttm) is 31.74X, with a PB (lf) of 3.20X, showing a slight decrease from the previous week [3][36] - The top-performing companies in the medical services sector include Zhaoyan New Drug (+23.4%) and MediWest (+12.5%), while the underperformers include Guangzheng Eye Hospital (-9.4%) and Lanwei Medical (-8.7%) [2][34] Economic Policy Developments - The Central Economic Work Conference emphasized optimizing drug procurement and deepening medical insurance payment reforms, aiming to enhance the quality and efficiency of the medical industry [4][70] - The introduction of a long-term care insurance system is expected to stimulate the rehabilitation care industry and address aging population needs [11][72] Investment Recommendations - The report suggests focusing on high-growth areas such as ADC CDMO and the weight-loss drug supply chain, with specific companies like WuXi AppTec and Haoyuan Pharmaceutical highlighted [13][74] - It also points to potential recovery in profitability for third-party medical testing laboratories and consumer healthcare sectors, particularly in ophthalmology and dentistry [13][75]
国家医保局最新会议透露关键信号
21世纪经济报道· 2025-12-13 07:44
Core Viewpoint - The National Medical Insurance Administration summarized the achievements of the "14th Five-Year Plan" period and outlined key tasks for 2026, emphasizing the importance of healthcare reform and innovation to support public health and economic development [1][2]. Achievements of the "14th Five-Year Plan" - Standardized and unified the medical insurance system, enhancing the mutual assistance and protection functions of medical insurance [5]. - Strengthened the foundation for universal coverage, improving the quality and scope of insurance for flexible employment workers and migrant workers [6]. - Expanded the scope of benefits, with over 90% reimbursement for rural low-income individuals and the inclusion of assisted reproductive projects in insurance coverage [6]. - Optimized the payment mechanism, with 949 new drugs added to the insurance directory, totaling 3,253 drugs [6][7]. - Deepened drug price governance, promoting a unified national market for pharmaceuticals and medical supplies [7]. - Enhanced fund management, recovering approximately 120 billion yuan in misused funds over five years [8]. - Promoted digital empowerment in medical insurance, achieving over 600 million cross-province direct settlements [8]. - Emphasized the importance of party leadership in ensuring the stability and development of the medical insurance sector [8]. Key Tasks for 2026 - Consolidate the achievements of universal coverage and improve the basic medical insurance system [11]. - Support the development of commercial health insurance to create a multi-tiered medical security system [11]. - Strengthen fund management to ensure the safety and rational use of medical insurance funds [12]. - Adapt to population development strategies, promoting maternity and long-term care insurance [12]. - Optimize payment and settlement mechanisms to support the healthy development of the healthcare sector [13]. - Leverage strategic purchasing to support innovation in the pharmaceutical industry [13]. - Promote scientific approaches to medical insurance, enhancing the digital platform for universal coverage [14]. - Continuously improve service management to enhance the quality and efficiency of medical insurance services [14].
国家药监局局长最新发声
财联社· 2025-12-10 14:31
Core Viewpoint - The article emphasizes the importance of strict regulation in promoting the development of innovative drugs and medical devices, highlighting the balance between ensuring drug safety and fostering industry innovation [1] Group 1: Achievements in Drug Regulation - Since the 14th Five-Year Plan, China's drug regulatory system has adhered to the "four strictest" requirements, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2] - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2] Group 2: Promoting Industry Innovation - A total of 220 innovative drugs and 282 innovative medical devices were approved since the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3] - The approval of 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines, indicates a growing vitality in pharmaceutical innovation [3] Group 3: Future Measures for Drug Safety - The regulatory focus will shift from "passive defense" to "active prevention," enhancing the drug safety responsibility system and improving risk management capabilities [4] - A comprehensive dynamic safety supervision system will be established, covering the entire lifecycle of drugs, from research and development to production and use [5] Group 4: Supporting Innovation in Pharmaceuticals - The regulatory body will support enterprises in enhancing their innovative drug and medical device research and development, emphasizing policy guidance and resource allocation for original products [6] - Efforts will be made to accelerate the market entry of innovative drugs and medical devices by optimizing registration processes and reducing costs [7] Group 5: Enhancing Public Welfare - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that regulatory reforms benefit all citizens and meet their health needs [8] - Measures will be taken to expedite the approval of urgently needed drugs, including those for rare diseases and children, while maintaining high standards [9] Group 6: Interdepartmental Collaboration - Strengthening coordination with health and insurance departments will be crucial for improving clinical trial oversight and drug traceability systems [10] - Public awareness campaigns will be conducted to enhance understanding of drug regulations and promote a supportive environment for innovative drug and device development [11]
步长制药双获殊荣:创新研发与公益担当引领大健康产业发展新标杆
21世纪经济报道· 2025-12-10 08:29
近日,2025年第九届21世纪大健康产业竞争力研究「阳光」案例正式揭晓,步长制药凭借在药物 研发领域的持续突破与在社会公益事业的深耕践行,一举斩获"年度药物研发创新企业"与"年度优 秀公益企业"两项重磅荣誉。 作为大健康产业极具权威性的年度评选,「阳光」案例由数字化智库型财经媒体领跑者《2 1 世 纪 经 济 报 道 》 与 2 1 世 纪 新 健 康 研 究 院 发 起 , 历 经 九 年 沉 淀 已 成 为 行 业 高 质 量 发 展 的 " 风 向 标"。步长制药的双奖加冕,既印证了其在产业创新与社会责任领域的双重领先地位,也为医 药企业可持续发展提供了生动范本。 第 九 届 2 1 世 纪 大健康产业竞争力 ing t 研究 | 阳光 | 案例 DIE ESG实践 典 范 类 「阳光」年度优秀 必要要亦 * 步长制药 这一战略调整并非简单的业务扩张,而是基于医药产业发展趋势的精准预判。彼时,中国医 药行业正从"仿制药主导"向"创新药突破"跨越,在政策、技术、资本的推动下,创新药实现 快速发展。在这一进程中,步长制药始终与产业发展同频共振。 持 续 的 研 发 投 入 是 创 新 的 关 键 。 2 0 ...
医药生物行业:艾迪药业核心原料药获批,国产抗艾产业链竞争力提升
Jianghai Securities· 2025-10-31 08:29
Investment Rating - The industry investment rating is "Overweight" (maintained) [5] Core Insights - The approval of Aidi Pharmaceutical's core product, Dolutegravir Sodium, marks a significant breakthrough in the vertical integration of the anti-HIV drug supply chain, enhancing the company's competitiveness and cost control in the domestic market [5][7] - The approval aligns with national policies encouraging innovation in the pharmaceutical industry and supports the high-quality development of the biopharmaceutical sector, showcasing the increasing R&D capabilities of domestic pharmaceutical companies [7] Summary by Sections Recent Industry Performance - Over the past 12 months, the industry has shown a relative return of -7.19% compared to the CSI 300 index, with absolute returns of 13.9% [3] Key Events - Aidi Pharmaceutical announced the approval of its core product, Dolutegravir Sodium, by the National Medical Products Administration (NMPA), which is a key drug in the WHO's first-line treatment for HIV [5][6] Investment Recommendations - The report suggests focusing on other antiviral companies, particularly those with existing products or strong R&D capabilities in chronic viral diseases like HIV and hepatitis B [7] - It also recommends investing in specialty raw material and CDMO companies, highlighting the value of firms with high-quality standards and technological barriers [7]
医保局明确下半年重点:创新药、长护险新政来了
Di Yi Cai Jing· 2025-08-19 08:43
Group 1: Healthcare Policy Focus - The core focus of healthcare policy in the second half of the year includes the development of medical institutions, innovation in the pharmaceutical industry, comprehensive implementation of long-term care insurance, and expansion of maternity insurance [1] - The meeting emphasized a shift in the healthcare system from "passive payment" to "active empowerment" and from "disease compensation" to "health investment" [1] - A series of new healthcare policies will be initiated or implemented, including the establishment of a commercial insurance innovative drug directory and the launch of the 3.0 version of the disease-based payment grouping scheme [1] Group 2: Drug Pricing and Innovation - The National Healthcare Security Administration announced a list of 534 drugs that passed the basic medical insurance directory review and 121 drugs that passed the commercial insurance innovative drug directory review [2] - The establishment of the commercial insurance innovative drug directory allows for the inclusion of high-innovation drugs that meet unmet needs and have confirmed clinical value, facilitating their entry into hospitals [2] - The policy aims to improve drug accessibility by not including these drugs in the basic medical insurance self-payment rate indicators and the monitoring scope of alternative drugs in centralized procurement [2] Group 3: Payment and Care Models - The meeting called for the initiation of the 3.0 version of the disease-based payment grouping scheme to enhance the quality and efficiency of medical institutions [3] - As of June, over 90% of coordinated areas in the country achieved instant settlement for medical insurance, with payment timelines reduced to within 20 working days after application [3] - The long-term care insurance, referred to as the "sixth insurance," will be fully implemented in the second half of the year, with a focus on planning and supporting long-term care service institutions [3] Group 4: Maternity Insurance Expansion - The maternity insurance system will undergo upgrades and expansions, encouraging the inclusion of flexible employment personnel, migrant workers, and new employment forms into the coverage [4] - As of now, the number of people covered by maternity insurance has reached 253 million, with maternity insurance benefit expenditures amounting to 67.832 billion yuan in the first half of the year [4] - Five provinces have achieved full coverage of hospitalization costs for childbirth within the policy scope, and 18 provinces have fully implemented direct payment of maternity allowances to insured individuals [4]
医保工作年中座谈会要求:赋能医药产业创新 完善生育保险制度
Zhong Guo Zheng Quan Bao· 2025-08-18 23:39
Group 1: Medical Insurance Development - The National Medical Security Administration emphasizes empowering the pharmaceutical industry and implementing measures to support high-quality development of innovative drugs [1][2] - By mid-2025, significant progress is expected in medical security, including an increase in the number of people covered by maternity insurance to 253 million and maternity insurance benefit expenditures reaching 67.832 billion yuan in the first half of the year [1] - The meeting highlights the need for a comprehensive adjustment of the national medical insurance drug catalog and the establishment of a commercial health insurance innovative drug catalog [2] Group 2: Maternity Insurance and Long-term Care - The meeting encourages regions to include flexible employment workers, migrant workers, and new employment forms in maternity insurance coverage, while also exploring basic service packages for prenatal check-ups [3] - Long-term care insurance will be fully implemented, with a focus on planning and configuring designated long-term care service institutions and encouraging commercial insurance products that align with long-term care services [3] Group 3: Digital Transformation in Medical Insurance - The meeting calls for a shift in medical insurance from passive payment to active empowerment, focusing on health investment rather than disease compensation [3] - There is an emphasis on integrating medical insurance with technology to promote new medical services, AI health management, and smart elderly care [3]
医药产业创新获政策加码,关注恒生创新药ETF(159316)、医药ETF(512010)等投资价值
Sou Hu Cai Jing· 2025-08-07 13:12
Group 1 - The Hang Seng Hong Kong Stock Connect Innovative Drug Index fell by 3.7%, while the CSI Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index decreased by 3.1% [1] - The CSI Innovative Drug Industry Index declined by 2%, and the CSI Biotechnology Theme Index dropped by 1.3% [1] - The CSI 300 Pharmaceutical and Health Index saw a decrease of 0.8% [1] Group 2 - As of yesterday, the Hang Seng Innovative Drug ETF (159316) experienced a net inflow of over 500 million yuan in the past month, reaching a record high of 1.08 billion yuan [1] - A joint initiative by seven departments in Shanghai was announced to promote the high-quality development of commercial health insurance, which includes 18 measures aimed at enhancing the insurance industry's ability to serve public health needs and improving the accessibility and affordability of innovative drugs and medical devices [1]