近日，国家药监局公布的2025年我国新药批准上市的数据振奋人心。 亮眼的成绩单表明，我国医药产业从"跟跑"向"并跑"乃至"领跑"迈进，也标志着中国在全球医药创新格局中正扮演越来越重要的角色。 我国新药创新的含金量在不断提升。 看数量。国家医保局数据显示，2018至2024年，我国一类新药获批上市数量明显增加，2024年获批48种，是2018年的5倍以上。其中，国产新药占比也在 不断提升。前些年，我国批准上市的新药，进口药"唱主角"；近年来，国产药占比不断提升。2025年批准的76个新药中，国产新药为65个，占比超85%， 真正实现了国产药"唱主角"。 转自：人民日报客户端 新药对外授权交易总金额超过1300亿美元，交易笔数突破150笔，双双创下历史新高！ 76个新药获批上市，大幅超过2024年的48个，创历史新高！ "这款药比金子还珍贵！"中南大学湘雅医院病房，患有Ⅰ型神经纤维瘤病的聪聪终于等来了有效药物——芦沃美替尼片，聪聪妈妈非常激动。Ⅰ型神经纤 维瘤病是一种罕见病，此前无药可医，肿瘤会不断生长，直至威胁患者生命。2025年5月，芦沃美替尼片获批上市。该药通过抑制相关蛋白活性来抑制肿 瘤细胞增殖并诱导其凋 ...

Group 1 - The core viewpoint of the report is that the CSI Technology Advantage Growth 50 Strategy Index (referred to as Technology 50 Strategy) utilizes multiple factors such as growth, innovation, value, low volatility, and quality to select and weight stocks from the technology sector, aiming to provide investors with a multi-factor strategy investment target based on the technology industry [1][7][11] - As of December 31, 2025, the top ten constituent stocks of the Technology 50 Strategy Index are primarily leading companies across various technology sub-sectors, with the top five stocks accounting for 17.63% and the top ten stocks accounting for 30.93% of the index's total weight [1][10][11] - The index is biased towards large-cap stocks, with 31 constituents having a market capitalization exceeding 100 billion yuan, while only 2 constituents have a market capitalization below 10 billion yuan [1][11] Group 2 - The report compares the Technology 50 Strategy Index with other representative technology and innovation indices, noting that the Technology 50 Strategy Index achieved an annualized return of 11.96% from January 1, 2020, to December 31, 2025, ranking third among six technology and innovation indices [1][57][60] - The Technology 50 Strategy Index shows lower volatility in revenue growth compared to other indices, with a projected revenue growth rate of 33.65% for 2026, which is higher than that of the other five technology and innovation indices [1][61][62] - The selection of constituent stocks for the Technology 50 Strategy Index incorporates 11 factors, providing a more comprehensive evaluation compared to other indices that focus on fewer factors [1][67][68]

Core Insights - The "2025 Extraordinary Investment Value Company" award recognizes companies with strong core barriers and growth resilience, highlighting their exceptional investment value [6] Group 1: Award Overview - The "2025 Golden Jubilee Award" is divided into three categories: company, institution, and comprehensive, continuing a tradition established over the past seven years [5] - The award is based on extensive data analysis and comparisons of thousands of companies, with final selections made by a panel of media reporters and research teams [4] Group 2: Award Winners - Inner Mongolia Yili Industrial Group Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd., and New China Life Insurance Co., Ltd. were awarded the "2025 Extraordinary Investment Value Company" title [5][6] - These companies represent key sectors: Yili in consumer goods, Hengrui in pharmaceuticals, and New China Life in finance, demonstrating strong profitability and value creation capabilities [6] Group 3: Company Performance Highlights - Yili's milk powder business leads nationally, with a 18.73% increase in net profit excluding non-recurring items in the first three quarters, benefiting from low raw milk prices and policy support [6] - Hengrui has made significant progress in innovation, launching 24 first-class innovative drugs and expanding through international collaborations [6] - New China Life has optimized its asset and liability structure, showcasing industry-leading investment capabilities [6]

对恒瑞医药而言，瑞拉芙普-α（SHR-1701）的成功上市，是一场从Fast Follow到FIC的"幸运逆袭"。 当PD-L1/TGF-β双抗赛道的领头羊默克四次折戟，让这一领域的未来充满变数时，恒瑞却凭借这款药物顺利突围，不 仅成为全球首个该靶点获批上市的企业，更充分展现了传统大药企在临床设计与注册沟通上的深厚功底。 1月7日，瑞拉芙普-α如期而至。据NMPA官网，恒瑞医药的抗PD-L1/TGF-βRII双功能融合蛋白瑞拉芙普-α正式获批上 市，其适应症为联合氟尿嘧啶类和铂类药物，用于局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治 疗。 但争议也随之而来。瑞拉芙普-α的注册临床治疗组为瑞拉芙普-α联合化疗，对照组为安慰剂联合化疗——这一设计让 它的成功显得"似是而非"。 在当前胃癌一线治疗领域，免疫联合化疗已成为HER2阴性患者的标准方案，纳武利尤单抗、信迪利单抗等多款PD- （L）1抑制剂联合化疗的方案均已被全球指南推荐，且市场价格已降至"白菜价"水平。 尽管跨试验对比并不严谨，但从现有数据来看，瑞拉芙普-α并未展现出疗效和安全性优势。叠加PD-（L）1抑制剂成 熟的市场格局，让瑞拉芙普-α ...

Group 1 - Global capital markets are focusing on China, with strong confidence in its economic resilience and market potential from multiple foreign institutions [1][4] - Goldman Sachs predicts that the MSCI China Index and the CSI 300 Index will rise by 20% and 12% respectively in 2026, maintaining a high allocation to Chinese A-shares and Hong Kong stocks [1][4] - UBS expects a 14% profit growth for the MSCI China Index in 2026, driven mainly by internet platforms, high-end manufacturing, and companies with global expansion capabilities [1][5] Group 2 - There is a clear trend of capital returning to China, with international long-term funds continuing to flow in and a strong recovery in the Hong Kong IPO market [2] - UBS's China president noted that 2025 was a pivotal year for international investors' attitudes towards Chinese assets, shifting from passive observation to active participation [2] - Goldman Sachs forecasts that net buying from southbound funds could reach $200 billion in 2026, setting a new historical high [2] Group 3 - Global hedge funds currently have a net allocation of 7.6% and a total allocation of 6.5% to Chinese stocks, significantly below previous cycle peaks [3] - The MSCI China Index is expected to trade at a forward P/E ratio of 13 times by the end of 2026, indicating significant upside potential not yet reflected in current valuations [3] - The MSCI China Index currently trades at a discount of 38% compared to developed markets and 11% compared to other emerging markets, making it attractive for foreign investment [3] Group 4 - The positive outlook for Chinese assets is supported by fundamental improvements, reasonable valuations, and policy benefits [4][5] - Goldman Sachs emphasizes that the stock market's rise in 2026 will be driven by earnings growth, with expected profit growth of 14% for both the MSCI China Index and the CSI 300 Index [4][5] - The anticipated policy support will focus on accelerating investment in advanced technologies to enhance self-sufficiency and productivity [5] Group 5 - The technology innovation and AI sectors are identified as core growth areas attracting foreign investment [6] - China's AI technology companies have a total market value of approximately $5 trillion, which is only one-sixth of that of the U.S., indicating significant growth potential [6] Group 6 - Goldman Sachs recommends focusing on three core areas for investment: private enterprises benefiting from AI development, stocks supported by the "14th Five-Year Plan," and leading companies in export [7] - The top ten private leading enterprises in China, including Tencent and Alibaba, represent 40% of the MSCI China Index's weight and have a daily trading volume of $7.5 billion [7] - Companies with strong balance sheets and cash flows that are well-positioned for international market expansion are expected to perform well [7]

5 January 2026 China Pharma and Biotech China Pharma and Biotech 2026 Outlook: Off to the races Rebecca Liang, Ph.D. +852 2123 2656 rebecca.liang@bernsteinsg.com Ellie Li +852 2123 2621 ellie.li@bernsteinsg.com "The stock market is a device for transferring money from the impatient to the patient." Positive outlook at sector level: valuation-wise we're back in a more rational range than July - Aug, with most stocks dialing back 20-30%. The major healthcare and biotech indices are below the price levels of 2 ...

Core Insights - The core viewpoint of the article emphasizes that the surge in innovative drug licensing and BD transactions has significantly driven the stock price explosion in the pharmaceutical sector, with total transaction amounts reaching $135.655 billion in 2025, marking a 161% increase from 2024 [1][4]. Group 1: Market Performance - The Hong Kong biopharmaceutical sector has rebounded strongly in 2025, with the Hang Seng Healthcare Index (HSHCI) rising by 76%, outperforming the Hang Seng Index and the overall A-share biopharmaceutical sector, which saw a 25.64% increase [1]. - Southbound capital inflow reached a record high of HKD 1.4 trillion in 2025, with healthcare sector holdings increasing by 125.51% to HKD 540 billion, providing substantial liquidity to the market [1][3]. Group 2: Structural Differentiation - The structural differentiation within the biopharmaceutical sector is becoming more pronounced, with companies that have First-in-Class or Best-in-Class pipelines and stable BD revenue sources being favored, while those reliant on single core projects face valuation pressures [3]. - The CXO sector also performed well in 2025, benefiting from ongoing investments in innovative drugs, while the medical device and supplies sector showed solid performance due to stable cash flows [3]. Group 3: Policy and Regulatory Environment - The policy environment has been continuously optimized, with 76 innovative drugs approved for market entry by the National Medical Products Administration in 2025, significantly surpassing the 48 approvals in 2024 [5]. - The introduction of the first version of the innovative drug commercial insurance catalog marks a shift to a dual protection system of basic medical insurance and commercial health insurance, enhancing clinical medication standards and overall industry R&D returns [6]. Group 4: Future Outlook - The explosive growth in BD transactions and active IPOs is injecting strong cash flow and confidence into the biopharmaceutical industry, with expectations for leading companies like BeiGene to achieve profitability in 2026 [5]. - However, challenges remain, including potential market pressure from a wave of unlocks post-IPO lock-up periods and stricter regulatory scrutiny on IPO applications [7].

Core Insights - The new medical insurance directory has entered a substantial implementation phase, with several innovative drugs, including Tislelizumab and Fuzhengzhu, being prescribed under insurance in various hospitals, indicating a reduction in access barriers for patients [1] - The adjustment includes 114 new drugs and introduces a commercial health insurance directory for innovative drugs, marking a significant shift towards a multi-tiered insurance system [1][5] - The rapid inclusion of innovative drugs in the insurance directory reflects increased support for "true innovation" with high clinical value [5] Group 1: New Drug Inclusion - The new medical insurance directory has added 124 unique products, including Tislelizumab, the first targeted drug for thyroid eye disease, and Fuzhengzhu, a biological agent for psoriasis [5] - Heng Rui Medicine is a major beneficiary, with 20 products and indications adjusted, including 10 new drugs entering the directory for the first time [5][6] - Other biotech companies like BeiGene and Innovent Biologics have also benefited, with multiple products included in the new directory, enhancing their commercialization prospects [7] Group 2: Commercial Health Insurance Directory - The introduction of the commercial health insurance directory provides a secondary market for high-value innovative drugs, with price reductions ranging from 15% to 50%, which is less severe than the basic insurance cuts [9] - The directory aims to improve accessibility for high-priced drugs while ensuring adequate returns for pharmaceutical companies [9] - Notable CAR-T therapies have been included in the commercial directory, overcoming previous barriers to entry, with prices for these therapies exceeding 1 million yuan [8][10] Group 3: Market Dynamics and Drug Exits - The adjustment process has also seen the removal of 29 drugs from the insurance directory, including Benarutide, which faced competition from more effective alternatives [12][14] - The dynamic adjustment mechanism emphasizes the need for drugs to demonstrate clinical value, reinforcing a "can enter, can exit" policy [14] - Companies are encouraged to shift from "me-too" products to genuine innovations, focusing on high-value areas such as oncology and rare diseases [10][14]

Group 1: Market Outlook - Goldman Sachs predicts that Chinese stocks will be supported by artificial intelligence and policy measures, with the MSCI China Index expected to rise by 20% by the end of 2026, and the CSI 300 Index projected to increase by 12% to 5200 points [1] - As of the first trading day of 2026, the CSI 300 Index has already risen by 3.5%, reaching a four-year high, while the MSCI China Index has increased by approximately 3.6%, outperforming the S&P 500 [1] Group 2: Earnings-Driven Growth - The core argument of Goldman Sachs' report is that returns in 2026 will be primarily driven by earnings growth, supported by artificial intelligence, "going global" strategies, and anti-involution policies [2] - Five major capital flows are expected to support the market: net southbound capital inflows potentially reaching a record $200 billion; domestic asset reallocation bringing about 3 trillion RMB into the stock market; total dividends and buybacks nearing 4 trillion RMB; global active funds possibly increasing their allocation to Chinese stocks; and IPO financing exceeding $100 billion [2] Group 3: Investment Logic - On a macro level, Goldman Sachs has raised its forecast for China's real GDP growth in 2026, citing resilient exports as a key driver, with a trend towards diversification and quality improvement in export destinations [4] - The report indicates that the valuation of the MSCI China Index and CSI 300 has recovered to mid-cycle levels, with forward P/E ratios of 12.4x and 14.5x, respectively, around or slightly above the 10-year average [4] Group 4: Sector and Company Insights - Goldman Sachs expects the TMT sector (technology, media, and telecommunications) to have the highest earnings growth forecast at approximately 20%, driven by AI-related revenue growth and increased capital expenditures [5] - The firm holds an "overweight" view on several sectors, including technology hardware, media/entertainment, internet retail, materials, and insurance, benefiting from various supportive factors [5] - A list of ten leading Chinese companies comparable to the "Big Seven" in the U.S. stock market includes Tencent, Alibaba, CATL, Xiaomi, BYD, Meituan, NetEase, Hengrui Medicine, and Trip.com, with a total market capitalization of $1.7 trillion, accounting for 40% of the MSCI China Index [6]

这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 国家药监局：优化临床急需境外已上市药品审评审批 央视新闻消息显示，为加快临床急需境外已上市药品在境内上市，满足患者临床用药迫切需求，国家药 监局进一步优化这类药品审评审批。 国家药监局表示，坚持以临床价值为导向，鼓励申请人在中国开展全球同步研发、同步申报上市；鼓励 临床急需境外已上市的原研药及仿制药在境内申报，对于符合要求的可纳入优先审评审批范围。 药械审批 亿帆医药：全资子公司收到易黄汤颗粒境内生产药品注册受理通知书 1月7日，亿帆医药公告称，公司全资子公司宿州亿帆药业有限公司于2026年1月6日收到国家药品监督管 理局签发的易黄汤颗粒境内生产药品注册上市许可申请《受理通知书》。易黄汤颗粒是公司申报注册的 第一个经典名方品种，其功能主治为固肾止带，清热祛湿。 正海生物：公司获得医疗器械注册申请《受理通知书》 1月7日，微芯生物(688321.SH)公告称，近日，中华人民共和国澳门特别行政区药物监督管理局（简 称"ISAF"）官方网站公示，ISAF批准公司的西达本胺片上市。西达本胺是全球首个亚型选择性组蛋白 ...