创新药及产业链 26 年展望 20251123 摘要 Q&A 2026 年创新药行业的医保政策有哪些重要变化？ 医保谈判持续深化，肿瘤药仍是重点，创新药获支持但降幅或较低。首 次设立商保创新药目录，为高价值创新药提供第二支付路径，利好 CAR-T、ADC 等高值创新药。 集采政策侧重稳临床、保质量，降幅趋稳，关注疗效而非仅低价。引入 锚点价和复活机制，提高 GMP 生产门槛，保障仿制药质量，生物类似 药集采或在 2026 年试点。 中国制药企业国际化进入 2.0 阶段，BD 交易活跃，总额同比增长 60%。企业需实现临床、研发和商业国际化，中美双报及国际多中心临 床成标配。 创新技术关注 ADC、I/O 及小核酸领域。ADC 方面，科伦博泰海外数据 及 BLA 递交受关注；I/O 领域，康方生物 AK112 及信达生物 PD-1/IL-2 数据值得期待；小核酸领域，诺华高血脂产品销售峰值预计可达 30 亿 美元。 GLP-1 市场前景广阔，礼来、罗氏、阿斯利康等公司将在心脑血管、糖 尿病及肥胖领域发布关键临床数据，推动行业发展。 2025 年的医保谈判已经完成，结果将在 12 月的第一个周末公布，并于 202 ...

立足于内：稳住国内根基，拥抱创新与整合。①政策展望：改革进入深水区，高质量增长成为常态。 2025年下半年我们重点关注的是药品和耗材集采政策优化、多元化支付及医疗服务价格改革。②制药产 业链：集采优化、积极创新转型，关注供应链安全。③器械：看好进口替代和并购整合机会，积极关注 AI和脑机接口等新技术方向。④关注中药、药店、流通、医疗服务及疫苗等行业经营触底回升节奏及 长期转型升级方向。 开拓于外：把握节奏与路径，积极开拓海外市场。①创新药：中国创新闪耀国际舞台，产业趋势持续强 化。②制药上游及生命科学：积极开拓海外市场，寻求第二增长曲线。③原料药：关税扰动短期有限， 关注行业转型机遇。④器械国际化：坚定看好出海趋势，关注部分创新器械自主销售和BD机会。⑤血 制品出海：静丙赋予血制品出海契机，血制品海外注册持续推进。⑥疫苗出海：模式趋于多元，进度有 望加速。 全球视角：外部挑战加剧，中国医药产业竞争力持续提升。从国际比较优势看，中国具备人口与内需优 势、制造与供应链优势，同时创新能力快速提升，中国资产出海数量也持续提升。美国在创新与早期研 发方面优势明显，同时具有高定价的内需市场。虽然外部挑战加大，但海外市场仍 ...

Group 1 - The report highlights the "engineer dividend" period for China's innovative drug industry, indicating that local innovations have gained full recognition from multinational corporations (MNCs) [4][5][53] - The report emphasizes the strong performance of various Chinese biotech stocks, with notable price increases observed in companies like Rongchang Biopharmaceutical (+199%) and Mawei Biopharmaceutical (+124%) in the A-share market [4][16] - The report identifies a significant increase in the number of first-in-class (FIC) drugs entering clinical trials in China, from only 9 in 2015 to an expected 120 in 2024, with China's global share of FIC drugs exceeding 30% [4][22] Group 2 - The report discusses the leading position of Chinese companies in the antibody-drug conjugate (ADC) sector, with over 50% global pipeline share in key targets such as HER2 and TROP2 [25][32] - It notes that two Chinese ADC drugs have entered the top ten global upfront payment rankings, indicating strong valuation potential for local innovations [30][31] - The report highlights the anticipated growth in bispecific antibodies (bsAbs), with Chinese companies dominating the top five global upfront payments for related assets [37][41] Group 3 - The report recommends several companies with significant global single product potential, including Kolon Biotech and Innovent Biologics, while also highlighting others like 3SBio and BeiGene as companies to watch [6][52] - It emphasizes the potential for substantial global pricing power for assets, particularly for companies like Rongchang Biopharmaceutical and Zai Lab, which are expected to see continued clinical data readouts [6][52] - The report suggests that companies like Innovent Biologics and Rongchang Biopharmaceutical are likely to turn profitable, with expectations of improved financial performance in the coming years [6][52]

Core Viewpoint - The overall revenue growth rate of the chemical pharmaceutical industry is projected to be -2.1% for Q1-Q3 2025, while the net profit margin (excluding non-recurring items) is expected to be 12.5%, indicating short-term revenue pressure but continuous improvement in profitability [1][2]. Group 1: Industry Performance - The pharmaceutical industry is experiencing a decline in revenue growth, with a rate of -2.1% for Q1-Q3 2025, but profitability is on the rise, as indicated by a net profit margin of 12.5% [1]. - Research and development (R&D) expenditure is increasing, with an R&D expense ratio of 9.6% for the first three quarters of 2025, up by 0.7 percentage points year-on-year [1]. - The financial data of 18 A-share biotech companies shows a revenue of 10 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 17.3%, while the net loss (excluding non-recurring items) has narrowed by 25.2% [1]. Group 2: Internationalization and Innovation - The internationalization of domestic pharmaceutical companies is crucial for innovation upgrades, with a total transaction amount of 93.7 billion USD for Q1-Q3 2025, matching the total amount of foreign transactions [2]. - The number of transactions reached 230, with upfront payments totaling 5 billion USD, both figures surpassing the total for the entire year of 2024, indicating a growing emphasis on independent R&D capabilities [2]. Group 3: Investment Opportunities - The domestic pharmaceutical industry is expected to benefit from a new product cycle driven by innovation and internationalization, presenting medium to long-term investment opportunities [3]. - The implementation of the "Full Chain Support for Innovative Drug Development" plan clarifies the industry's development direction, emphasizing continuous quality improvement in innovation [3]. Group 4: Recommended Stocks - Recommended stocks in the innovative drug sector include: 恒瑞医药 (600276.SH), 科伦博泰生物-B (06990), 百利天恒-U (688506.SH), and others [4]. - In the specialty drug sector, recommended stocks include: 人福医药 (600079.SH), 恩华药业 (002262.SZ), and 东诚药业 (002675.SZ) [4].

Group 1 - The National Medical Products Administration of China has approved 2 innovative drugs and 2 innovative medical devices for market entry since November, indicating a shift from being a "technology follower" to a "technology leader" with 4,804 innovative drugs in the pipeline, ranking second globally [1] - In 2025, negotiations for the national basic medical insurance drug catalog and commercial insurance innovative drug catalog pricing have been completed, with 120 companies participating, including 127 drugs for basic medical insurance and 24 for commercial insurance [1] Group 2 - The Hong Kong innovative drug ETF (SH520700) has shown a 2.13% increase, reflecting a clear trend of innovation going global, with ongoing benefits from drug review reforms and supportive policies [2] - The Chinese innovative drug industry has entered its 2.0 era, transitioning from "importing and imitating" to "innovative output," with various forms of internationalization such as license out and new co [2] - The ETF tracks the CSI Hong Kong Stock Connect Innovative Drug Index, which includes leading companies like BeiGene, Innovent Biologics, and WuXi AppTec, focusing on innovative drug development, production, and services in the Hong Kong market [2]

Market Overview - A-shares experienced a slight decline with the Shanghai Composite Index closing at 4000.14 points, down 0.07%, while the Shenzhen Component Index and the ChiNext Index fell by 0.36% and 0.39% respectively [1] - The Hong Kong market saw the Hang Seng Index rise over 1% during the session [1] Sector Performance Banking and Insurance - The banking and insurance sectors showed strength, with Agricultural Bank of China rising over 3% to reach a historical high, and major insurance stocks like China Life and New China Life also posting gains [9][10] - Analysts suggest that the economic recovery is injecting new growth momentum into the financial sector, with insurance products gaining traction due to low interest rates and regulatory guidance [9] Storage Chip Sector - The storage chip sector remained active, with companies like Xiangnan Chip and Demingli seeing significant gains of 10.47% and 6.06% respectively [5] - Global supply chain issues have led to a tight balance in the storage chip market, with SanDisk raising NAND flash contract prices by 50% [5][7] - Analysts predict that the storage chip price increase will continue through 2026, driven by a structural demand surge and limited supply [7] Pharmaceutical Sector - The pharmaceutical sector was notably active, with stocks like Kaineng Health and Sanmian Gene hitting the daily limit up of 20% and over 12% respectively [12] - The domestic innovative drug industry is showing long-term growth potential, with increased licensing deals expected to enhance global market commercialization [14] Solar Industry - The solar industry faced a significant downturn, with stocks like Aters falling over 14% and Longi Green Energy dropping more than 6% [16] - The China Photovoltaic Industry Association issued a statement refuting false information circulating online, emphasizing the need for careful decision-making [16]

Group 1 - The innovative drug sector has rebounded significantly, with the Kexin Innovative Drug ETF (589720) rising by 2.5% and trading volume increasing [1] - BeiGene's recent Q3 financial report shows total revenue of $1.4 billion, a 41% year-over-year increase, and a GAAP net profit of $125 million, marking a turnaround from a net loss of $121 million in the same quarter last year [2] - Market attention is shifting back to fundamentals as more multinational corporations (MNCs) disclose their investment and planning in collaboration pipelines, coinciding with the upcoming national medical insurance negotiations [2] Group 2 - There is a trend of funds buying on dips, with over $300 million invested in the Kexin Innovative Drug ETF (589720) in the past 10 days, indicating a rotation in market activity [3] - The focus is returning to the essence of the innovative drug industry, moving from speculative trading to validating the value of business development (BD) partnerships through tangible actions and investments by MNCs [4] - The Chinese innovative drug sector is entering a 2.0 era, transitioning from "importing and imitating" to "innovating and exporting," supported by favorable policies and abundant clinical resources [4] Group 3 - The Kexin Innovative Drug ETF (589720) is highlighted for its high growth potential and significant elasticity, focusing entirely on the innovative drug index with a 20% price fluctuation limit [5] - The top ten components of the Kexin Innovative Drug ETF include companies like BeiGene and Boli Tianheng, with BeiGene holding a weight of 10.45% [6]

Core Insights - The third Pujiang Biomedicine Source Innovation Conference was successfully held in Shanghai, focusing on cutting-edge technological innovation in China's pharmaceutical industry and global cooperation [1][2] - The conference emphasized the importance of source innovation and collaboration in accelerating the development of the biopharmaceutical sector, with a call for building an open and cooperative innovation ecosystem [1][3] Group 1: Industry Trends - China's innovative drug industry is transitioning from "catching up" to "keeping pace" and even "leading" in the global market, with a significant increase in the proportion of globally launched new drugs [2] - The development of innovative drugs in China has shown strong momentum, particularly in areas like antibody-drug conjugates (ADCs) and bispecific antibodies, with active overseas licensing transactions [2] Group 2: Strategic Directions - The need for a dual-integration development path was highlighted, focusing on establishing a multi-tiered payment system centered around commercial insurance and enhancing the pricing mechanism for innovative drugs [2] - Chinese pharmaceutical companies are encouraged to build independent global commercialization systems and actively seize international market opportunities, moving beyond mere licensing transactions [3] Group 3: Technological Integration - The integration of AI technology is seen as crucial for enhancing innovation capabilities, with a call for the industry to embrace the AI revolution and create a collaborative AI innovation ecosystem [3] - Companies like Fosun Pharma are actively pursuing innovation, internationalization, and AI integration, aiming to contribute to Shanghai's development as a world-class biopharmaceutical hub [3]

Core Insights - The continuous release of drug review reform dividends, supported by domestic engineer advantages, abundant clinical resources, and favorable policies, has led to the transition of domestic innovative drugs from following trends to FIC/BIC innovation [1][2] - Chinese innovative drugs are entering the international stage, marking a shift from "importing imitation" to "innovative output" [2] - The medical anti-corruption campaign that began in 2023 is expected to stabilize by 2025, with a gradual easing of its impact on the industry [1][8] Group 1: Industry Trends - The Chinese innovative drug industry has entered its 2.0 phase, with a significant increase in license-out transactions, reaching a total of $40.8 billion in the first half of 2025, a 96% year-on-year increase [2] - The focus on AI in healthcare is gaining momentum, with advancements in algorithm optimization and the widespread application of large models, indicating a promising future for AI+medical integration [10] - The medical device sector is also expected to see growth, with an increasing number of companies expanding internationally and establishing overseas sales teams [8] Group 2: Policy and Market Dynamics - The first batch of generic drug procurement price anchors has loosened, moving away from a strict low-price focus, reflecting a shift in procurement policies [8] - The development of commercial health insurance is being encouraged by the government, which is expected to alleviate payment conflicts and expand the domestic market [9] - The healthcare investment landscape is stabilizing, with 357 financing transactions in the domestic healthcare sector totaling approximately $3.5 billion in the first half of 2025 [3]

Market Review - The A-share market experienced a style switch with a mixed index performance, as technology stocks led the decline while small-cap stocks showed active performance. The Shanghai Composite Index broke through 4000 points before retreating, with an average daily trading volume of 2.33 trillion yuan, up from 1.80 trillion yuan the previous week [4][5]. Hard Technology - The global semiconductor expansion driven by AI continues, with Q2 2025 global semiconductor equipment sales reaching 33.1 billion USD, a 23% year-on-year increase. In September, Japan's semiconductor equipment sales reached 424.6 billion yen, up 14.9% year-on-year [14][15]. - Domestic semiconductor equipment manufacturers saw significant revenue growth in Q3 2025, with an average year-on-year increase of 35%. This reflects strong order fulfillment from last year's orders and progress in downstream wafer fabs [25][26]. Healthcare - Chinese innovative drug companies showcased significant achievements at the 2025 ESMO conference, with 33 companies presenting research results and 35 studies selected for oral presentations. Chinese companies accounted for 15.3% of the total abstracts presented [28][29]. - The value of patent licensing transactions for Chinese innovative drugs exceeded 100.7 billion USD in the first three quarters of 2025, marking a 170% year-on-year increase, indicating accelerated globalization of Chinese innovative drugs [32][33]. High-end Manufacturing - The tungsten price has significantly increased, reflecting supply-side policy tightening and recovering downstream demand. The average price of domestic black tungsten concentrate reached 299,000 yuan per ton, up 109.8% from the beginning of the year [38][39]. - The excavator industry in China has shown a continuous recovery, with sales reaching 174,000 units in the first nine months of 2025, a year-on-year increase of 18.1%. Both domestic and export markets experienced double-digit growth [42][43]. Consumer Sector - Cross-border e-commerce has emerged as a new highlight in China's foreign trade, with a rich midstream ecosystem involving merchants, platforms, and service providers. The development is driven by domestic "push" factors and overseas "pull" factors, leading to a comprehensive export era for platforms, factories, and sellers [5][6].