本次申请的企业主要集中在上海、江苏、广东等省市。申请的产品涉及到11个产品器械分类，主要集中在有源手术器械、无源植入器械，无源手术器械等 类别中。 资料来源：药监局官网、药智医械数据 2025年11月，国家药监局和地方药监局共公示了26款器械进入创新医疗器械特别审查通道。其中国家局发布了10款产品，地方药监局发布了16款产品。 资料来源：药监局官网、药智医械数据 资料来源：药监局官网、药智医械数据 下附26款进入创新通道的器械名单。 2025年11月进入创新器械审批通道的器械 | 创新器械名称 | 申请企业 | 发布日期 | 审核机构 | | --- | --- | --- | --- | | 肾动脉超声消融系统 | 深圳迈微医疗科技有限公司 | 2025/11/28 | 国家药品监督管理局 | | 双极高频超声双输出手术设备 | 上海益超医疗器械有限公司 | 2025/11/28 | 国家药品监督管理局 | | 肾部穿刺手术导航定位系统 | 深圳惟德精准医疗科技有限公司 | 2025/11/11 | 国家药品监督管理局 | | 经导管主动脉瓣 置换手术辅助系统 | 智程医疗科技(嘉兴)有限公司 | 2025 ...

Market Overview - The A-share pharmaceutical and biotechnology index fell by 1.17%, underperforming the CSI 300 index by 2.44 percentage points and the ChiNext index by 1.89 percentage points, ranking 17th among 31 sub-industries [4] - The H-share Hang Seng Healthcare Index also declined by 0.71%, lagging behind the Hang Seng Index by 1.45 percentage points [4] R&D Progress - Recent IND applications include Yifang Biotech's D-0502 tablets and Hengrui Medicine's HRS-6257 tablets; clinical applications include BeiGene's BG-C137 injection and Hengrui's HRS-4642 [5] - Shijiazhuang Pharmaceutical's SYS6002 and Zai Lab's Epcoritamab are in Phase III clinical trials; Maiwei Biotech's 9MW3811 is in Phase II; and 3SBio's SSGJ-709 is in Phase I [5] Policy and Market Developments - On December 7, the National Healthcare Security Administration released the new National Basic Medical Insurance Drug Directory and the Commercial Health Insurance Innovative Drug Directory for 2025, with 127 products participating in negotiations, of which 114 were successfully included, achieving a success rate of 88%, the highest in seven years [6] - The first commercial insurance directory included 24 drugs, with 19 successfully negotiated, including CAR-T therapies and treatments for rare diseases such as neuroblastoma and Gaucher disease, as well as Alzheimer's disease [6] - The implementation of the commercial insurance innovative drug directory is expected to open broader market opportunities for innovative drugs in the context of a growing number of "global new" drugs emerging in China [6] Investment Strategy - The investment strategy for the pharmaceutical sector is shifting towards emphasizing the clinical value of drugs, addressing clinical needs of patients, influenced by domestic healthcare policies and global expansion [7] - The focus is on the innovative drug supply chain and innovative medical devices, reflecting a clinical value-based investment approach [7]

新华财经上海12月7日电（记者杜康）中国正在跻身全球医疗器械创新的中心。如今，全球医疗器械 TOP 100的名单中，开始出现越来越多中国企业的身影，且排名多呈上升态势。以创新产品叩开海外中 高端市场，一些国内头部企业的海外利润占比总利润已经过半。 在行业人士看来，医疗器械创新始于临床，终于临床。产业、医院、科研机构之间的密切合作，成为中 国医疗器械领域的"创新密码"。前不久，位于上海浦东的医疗器械明星企业上海英诺伟医疗器械股份有 限公司（以下简称"英诺伟"）与复旦大学附属中山医院共同协作研发的一款消化介入领域的低温等离子 设备正式获批，成为"医工结合"推动医疗器械创新的又一典型案例。据悉，这是目前在全球公开已知范 围内，首个获批应用于消化介入领域的低温等离子设备。 "医疗器械创新活力源于 '临床需求牵引 + 平台支撑 + 全周期协作'的生态体系。医工转化不是简单的'技 术买卖'，而是临床与工程的深度融合共创。"英诺伟董事长严航表示。 从临床痛点到行业前列：低温等离子技术在消化内镜领域实现新突破 "我们这款应用于消化内镜领域的等离子产品，是一个典型的医工交叉案例，也是一个从临床需求起 始，成功完成商业化的案例。 ...

Core Insights - The pharmaceutical sector is experiencing a rise, with the Shanghai Stock Exchange Sci-Tech Innovation Board Biomedicine Index increasing by 1.03% as of December 4, 2025, with notable gains from companies like Zai Lab (up 4.47%) and Rongchang Bio (up 4.14%) [1] Industry Overview - The pharmaceutical industry has undergone eleven rounds of national drug centralized procurement and multiple rounds of medical insurance negotiations, leading to an inevitable decline in the generic drug sector, which impacts the overall pharmaceutical industry [1] - From January to September 2025, the pharmaceutical manufacturing industry's revenue remained relatively stable, but the outlook for generic drugs is bleak, indicating a need for innovative drugs to drive future growth [1] Investment Perspective - According to Everbright Securities, future investments in the pharmaceutical sector should focus on the clinical value of drugs, addressing clinical needs of patients, as both domestic medical insurance policies and global expansion strategies increasingly emphasize clinical value [1] - The innovative drug industry chain and innovative medical devices are viewed positively based on the clinical value framework [1] Market Data - As of November 28, 2025, the top ten weighted stocks in the Shanghai Stock Exchange Sci-Tech Innovation Board Biomedicine Index include companies like United Imaging Healthcare and BeiGene, collectively accounting for 49.75% of the index [1]

Core Viewpoint - Fosun Pharma announced that its subsidiary received approval from the National Medical Products Administration for clinical trials of the innovative oral small molecule drug FXS887 for advanced malignant solid tumors, with no approved therapies targeting the same pathway expected until December 3, 2025 [2] Group 1: Company Developments - Fosun Pharma's FXS887 is aimed at treating advanced malignant solid tumors and is notable for being the first of its kind in its target pathway [2] - The approval for clinical trials marks a significant step in the development of innovative therapies within the company [2] Group 2: Market Activity - The pharmaceutical and biotechnology sector saw increased activity, with the STAR Market pharmaceutical ETF (588130) rising by 0.99%, and several holdings such as Yirui Technology, Zai Lab, Rongchang Bio, Dize Pharmaceutical, and Yifang Bio each increasing by over 3% [2] Group 3: Industry Insights - Everbright Securities suggests that investment in the pharmaceutical sector should increasingly focus on the clinical value of drugs, addressing the needs of patients and healthcare providers [2] - The report emphasizes that both domestic healthcare policies and global expansion strategies are placing higher premiums on clinical value, indicating a positive outlook for the innovative drug and medical device industries [2]

Core Insights - The article highlights a significant inflow of 12 million units into the medical ETF (159865), indicating strong investor interest in medical assets [1] - Beijing has issued measures to promote the high-quality development of the medical device industry, focusing on various aspects such as clinical research support, application promotion, and international expansion [1] Industry Summary - The new policies aim to provide robust support for innovative medical device companies, addressing previous barriers to hospital access for new products and fostering a positive cycle between research and market [1] - The measures include financial support for qualifying innovative device enterprises, which is expected to enhance the innovation and development of medical consumables [1] - Policies related to international expansion are designed to reduce the cost burden of overseas registration for companies, particularly benefiting those seeking new market opportunities amid domestic procurement pressures [1] Company Summary - The medical ETF (159828) tracks the CSI Medical Index (399989), which selects listed companies in the pharmaceutical and healthcare sectors from the Shanghai and Shenzhen markets [1] - The index primarily covers areas such as medical devices, medical services, and medical research outsourcing, reflecting the overall performance of related listed companies [1] - The constituent stocks of the index tend to be small to mid-cap companies, characterized by high growth potential and volatility [1]

Group 1 - The small nucleic acid industry is expected to enter its first explosive growth cycle in 2025, with commercialization progress and new platform validations exceeding market expectations [1] - Alnylam's drug AMVUTTRA for treating ATTR is projected to become the first small nucleic acid drug with sales exceeding $2 billion this year [1] - Ionis's drug for treating sHTG saw a 35% stock price increase after positive data was released in September, with key phase 3 data and commercialization progress in 2026 being noteworthy [1] Group 2 - Arrowhead is focusing on weight loss and CNS projects leveraging its leading liver-external Trim platform, with the first commercial product for treating FCS, Plozasiran, expected in November [1] - The acceleration of small nucleic acid drug commercialization is driving continuous growth in demand for related raw materials and outsourced R&D [1] - The sentiment in the pharmaceutical sector is currently low, but upcoming data releases from the ASH conference, new medical insurance catalogs, and the first version of the commercial health insurance innovative drug catalog are expected to improve the outlook for innovative drugs, CXO, and the medical device industry [1] Group 3 - The vaccine ETF (159643) tracks the vaccine biotech index (980015), which selects listed companies involved in vaccine development, production, and sales, reflecting the overall performance of the vaccine sector within the biopharmaceutical industry [1] - This index exhibits high growth potential and strong specialization characteristics [1]

Market Overview - The pharmaceutical and technology sectors experienced a strong rally, with all three major A-share indices rising [2] - The Shanghai Composite Index rose by 0.14%, the Shenzhen Component Index increased by 1.61%, and the ChiNext Index surged by 2.76% [3] Pharmaceutical Sector - The pharmaceutical sector saw significant gains, with sub-sectors such as pharmaceutical commerce, chemical pharmaceuticals, medical services, and innovative drugs leading the way [2][7] - Notable stocks included Guangdong Wanyanqing and Huaren Health, both hitting the 20% daily limit up, while leading companies like Baijie Shenzhou and Hengrui Medicine also saw increases [7][9] Technology Sector - The computing power industry chain showed strong performance, particularly in the optical module sector, with stocks like Zhongji Xuchuang rising by 13.89% to reach a market capitalization of 606.99 billion [2][3] - Other leading stocks in the computing power sector, such as Xinyi Technology and Hushen Technology, also experienced significant increases [3] Catalysts for Pharmaceutical Sector Growth - The rapid rise in flu activity since November has driven demand for antiviral medications, with sales of Oseltamivir increasing by 237% and other flu treatments also seeing substantial growth [9] - Recent policy support measures from Beijing and Shanghai aimed at promoting the high-quality development of the medical device and pharmaceutical industries have further boosted investor sentiment [10] Investment Outlook - Analysts suggest that the pharmaceutical sector remains fundamentally strong, with a gradual improvement expected. The sector is currently viewed as being at a valuation bottom, presenting opportunities for investment in innovative drugs and medical devices [10]

Core Viewpoint - The pharmaceutical sector experienced a strong rally on the 26th, particularly in innovative drugs and vaccine concepts, with several companies seeing significant stock price increases [1] Industry Summary - Recent advancements in the small nucleic acid drug field have garnered significant attention from both the industry and investors, marking a transition from concept validation to the brink of industrial rise [1] - By 2025, breakthroughs in delivery technology are expected to expand indications from the liver to cardiovascular and CNS areas, coupled with the commercialization of major products and substantial mergers by multinational pharmaceutical giants, indicating a golden development period driven by "technological breakthroughs + commercial realization" [1] - According to Everbright Securities, domestic pharmaceutical companies are accelerating their R&D progress, with many entering clinical research phases since 2025. The focus should be on leading innovative drug companies with advanced technology platforms and differentiated pipelines, as well as innovative industry chain companies likely to benefit from the overall industry upturn [1] - The investment approach in the pharmaceutical sector should increasingly emphasize the clinical value logic, addressing clinical needs of patients and doctors, influenced by domestic medical insurance policies and global expansion strategies, which are assigning higher premiums to clinical value [1] - From the perspective of clinical value, the innovative drug industry chain and innovative medical devices are viewed positively [1]

Group 1 - The A-share market is experiencing an upward trend, with the medical device sector remaining active, as evidenced by the medical device ETF (562600) increasing by 0.8% and reaching a historical high of 322 million yuan [1] - Shanghai has introduced new policies to promote innovation and acceleration in the medical device industry, including prioritizing innovative review procedures for second-class innovative medical devices with significant clinical value and reducing the average registration cycle to under 6 months [1] - CITIC Securities believes that long-term investment opportunities in the medical device sector stem from innovation, international expansion, and mergers and acquisitions, with the sector's innovation and international capabilities being recognized and valuations being reassessed [1] Group 2 - The medical device industry is rapidly developing, and investors can leverage the medical device ETF (562600) to capture growth opportunities, as it tracks the CSI All Index Medical Device Index, which includes 100 representative companies with a high industry concentration of 89.3% [2] - For off-market users, there are options to invest in the Huaxia CSI All Index Medical Device ETF Initiated Link A (021250) and Link C (021251) for convenient exposure [2]