坚定出海方向，把握结构性机遇 - 医药行业 2026 年策略 20260108 摘要 2025 年创新药企凭借对外授权交易（BD）取得突破，全球前十大创新 交易中八项来自中国企业，提升市场信心，但 BD 首付款仅为部分价值 兑现，临床数据验证仍是关键。 中国创新药发展加速，从 me-too/fast follow 向 best-in-class/first- in-class 升级，出海成关键驱动力。ADC、双抗等技术积累领域已突破， 小核酸、基因治疗等新兴领域展现潜力。 医疗器械领域各细分市场表现分化：低值耗材（如丁腈手套）已具产业 话语权；IVD 疫情期间出口良好；高端医疗设备和高值耗材出海初期， 高值耗材被认为更具突破性。 医疗器械出海成绩显著，心血管支架、人工关节、心脏起搏器等增速可 观，本土企业在关节和内镜检查耗材方面实现出口突破，进入发达国家 市场，定价和利润回报可期。 高值耗材与药品差异在于其独立知识产权和创新性，可进行 license out。通过合作或自建渠道建立发达国家销售网络，有望抵消国内集采 影响，推动医疗器械板块增速回升。 Q&A 2025 年医药行业的整体表现如何？创新药在其中扮演 ...

港股创新药ETF（159567）紧密跟踪国证港股通创新药指数，前十大成份股包含百济神州、信达生物、 三生制药等港股创新药板块龙头，锐度鲜明，其中包含多只AI制药龙头，具有较高的创新制药企业占 比，在AI赋能创新药行情全面来临时有望展现高弹性。 消息面上，医药魔方NextPharma数据库显示，截至2025年12月31日，中国创新药商务拓展（BD）出海 授权全年交易总金额达到1356.55亿美元（约9483亿元人民币），首付款70亿美元，交易总数量达到157 笔，远超2024年全年519亿美元和94笔，各个维度的数据统计均达到了历史新高。 西南证券判断，2025年5月随着PD1/VEGR双抗首付款12.5亿美金BD落地，创新药迎来加速上涨行情。 随着三季度结束，创新药迎来高位调整。2026年创新药板块将从普涨进入精选个股行情。看好医药出 海、脑机接口、AI医疗三大方向。 市场1月5日消息，今日港股市场午后，盘面上生物医药板块涨幅居前。ETF方面，截至13:18，港股创 新药ETF（159567）涨5.21%，盘中成交额超13亿元，换手率超16%，交投活跃。 热门个股方面，映恩生物-B涨超10%，科伦博泰生物科技 ...

西南证券认为，2025年初，港股企业陆续达成BD，港股创新药领先上涨；3月，《政府工作报告》提 出"健全药品价格形成机制，制定创新药目录，支持创新药和医疗器械发展，A股创新药跟涨。5月随着 PD1/VEGR双抗首付款12.5亿美金BD落地，创新药迎来加速上涨行情。随着三季度结束，创新药迎来高 位调整。该行判断，2026年创新药板块将从普涨进入精选个股行情。2026年，该行看好医药出海、脑机 接口、AI医疗三大方向。 2026年1月5日，恒生医药ETF(159892)大涨5.1%，持仓股映恩生物-B涨超10%，微创医疗涨超6%，科伦 博泰生物-B涨超5%。 数据统计，中国创新药licenseout交易总额突破1300亿美元，同比激增超150%，全球占比首超50%。BD 爆发带来的现金流、IPO热潮筹集的研发资金，为行业接下来的发展提供了充足弹药；而商业化兑现、 临床数据验证、支付体系完善，将成为2026年推动行业向上的三大核心动力，共同推开一个"价值兑 现"的美好新时代大门。 恒生医药ETF(159892)聚焦创新药、CXO及相关产业，港交所18A制度优势下覆盖众多创新标的(百济神 州、信达生物等)，在创新药出 ...

智通财经APP获悉，西南证券发布研报称，2025年初，港股企业陆续达成BD;港股创新药领先上涨;3 月，《政府工作报告》提出"健全药品价格形成机制，制定创新药目录，支持创新药和医疗器械发展， A股创新药跟涨。5月随着PD1/VEGR双抗首付款12.5亿美金BD落地，创新药迎来加速上涨行情。随着 三季度结束，创新药迎来高位调整。该行判断，2026年创新药板块将从普涨进入精选个股行情。2026 年，该行看好医药出海、脑机接口、AI医疗三大方向。 西南证券主要观点如下： 出海方面 2025年中国创新药出海节奏显著提速，截至12月5日，BD出海项目数量已达166项，较2024年全年增加 54项;首付款已达63.0亿美元，较2024年全年增长超199%;总金额已达1419.7亿美元，较2024年全年增长 超136.8%。超52%的分子在出海时处于I期临床及临床前的早期阶段，ADC和双抗等仍是出海热点、 GLP-1R靶点新药在长效化/口服化/多靶点激动/减脂保肌等方向上仍具出海潜力。器械出海方面：2025 年7月赛诺医疗冠脉支架获批FDAPMA进展高度提振市场信心，未来关注国内企业器械产品在美国实现 PMA注册进展。 脑 ...

Core Insights - The report indicates that the innovative drug sector is entering a phase of selective stock picking in 2026, following a beta market in 2025. The A-share pharmaceutical industry has risen by 15.9% since the beginning of 2025, underperforming the CSI 300 index by 0.65 percentage points, ranking 17th among industries [2][14]. - The report highlights three key investment directions for 2026: overseas expansion of pharmaceuticals, brain-computer interfaces, and AI in healthcare [2]. Investment Strategy Overview - The innovative drug sector is expected to shift from a broad market rally to a focus on selective stocks in 2026. The average increase for 75 innovative drug sample indices in A-shares reached 54.8%, with Hong Kong's indices doubling [2]. - The report notes that as of December 5, 2025, there were 166 overseas business development (BD) projects, a significant increase from the previous year, with upfront payments reaching $6.3 billion, a growth of over 199% compared to 2024 [2]. Key Investment Directions Overseas Expansion - The report emphasizes the acceleration of Chinese innovative drugs entering international markets, with ADCs and bispecific antibodies being hot topics. The potential for GLP-1R target new drugs remains strong in areas such as long-acting formulations and oral medications [2]. Brain-Computer Interfaces - The report outlines the government's strategic push for brain-computer interfaces as a new economic growth point, with applications in medical rehabilitation for conditions like stroke and spinal cord injuries [2]. AI in Healthcare - The report discusses the establishment of clear short-term and long-term goals for AI in healthcare, covering various applications such as AI health management and clinical decision support systems [2]. Recommended Stocks - The report recommends several companies for investment, including Heng Rui Medicine (600276), BeiGene (688235), Mindray Medical (300760), and others, indicating a diversified approach across the innovative drug and medical device sectors [2].

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]

Core Viewpoint - The company has completed the technical design for the overseas expansion of Canalin and has entered the preclinical animal testing phase [1] Group 1: Company Developments - The company has conducted substantial equivalent scheme research and small-scale process work related to the overseas expansion of Canalin [1] - The company plans to advance its overseas market expansion in phases based on actual business planning and product conditions [1]

Core Viewpoint - InnoCare Pharma Inc., a wholly-owned subsidiary of Innovent Biologics, has signed a licensing agreement with Zenas BioPharma, granting Zenas rights to develop, produce, and commercialize the drug Orelabrutinib and two preclinical assets, with total payments exceeding $2 billion [1][2][4]. Group 1: Licensing Agreement Details - The agreement includes global exclusive rights for Orelabrutinib in multiple sclerosis (MS) and other non-MS indications outside Greater China and Southeast Asia, as well as exclusive rights for a preclinical IL-17 inhibitor and a preclinical oral TYK2 inhibitor [2][3]. - Zenas will pay an upfront fee of $100 million, milestone payments, and grant 7 million common shares to Innovent, with total potential payments exceeding $2 billion [2][4]. Group 2: Strategic Importance - This licensing deal marks the second business development (BD) initiative for Innovent in 2023, emphasizing the company's focus on international expansion and product commercialization over the next three years [1][7]. - The management has indicated that BD will be a priority, aiming to accelerate the global development and commercialization of Orelabrutinib and other pipeline products [4][7]. Group 3: Market Reaction - Following the announcement, Innovent's stock price fell by 6.24% on October 9 and continued to decline by 9.16% on October 10, indicating market skepticism regarding the licensing of non-core indications for Orelabrutinib [3][4]. Group 4: Previous Collaborations - Innovent has a history of international collaborations, including a previous agreement with BeiGene for Orelabrutinib, which was terminated in June 2023, but the company remains committed to exploring the drug's potential in various B-cell lymphomas [5][6][7].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index experienced a decline of 2.72%, ranking 23rd among 31 primary industries, underperforming the CSI 300 index which declined by 2.62% [4][16] - The industry valuation as of September 30, 2025, is a PE (TTM overall method, excluding negative values) of 31.23x, down from 31.79x in the previous period, indicating a downward trend and below the average [21] - The top three sub-industries in terms of PE (TTM overall method, excluding negative values) are vaccines (55.74x), medical devices (41.29x), and hospitals (39.51x), with the median at 33.19x, while pharmaceutical circulation has the lowest valuation at 14.34x [21] Industry Review - The report highlights that during the reporting period, 51 listed companies in the pharmaceutical and biotechnology sector had a net reduction in shareholders amounting to 2.435 billion yuan, with 14 companies increasing their holdings by 681 million yuan and 37 companies reducing their holdings by 3.116 billion yuan [4] - The report emphasizes the importance of upcoming clinical data and the strong fundamentals of companies ahead of the ESMO 2025 conference, which is expected to showcase significant clinical research results from various domestic pharmaceutical companies [7][8] Important Industry News - AstraZeneca plans to list on the New York Stock Exchange [6] - The report mentions the approval of a new oral SERD drug by Eli Lilly, marking it as the second such drug approved globally [8][45] - The approval of the first domestic quadrivalent HPV vaccine in China is expected to expand the coverage population and potentially be priced lower than imported versions [8][50][52]

Summary of Key Points from the Conference Call Industry Overview - The pharmaceutical industry in China is experiencing enhanced innovation capabilities, with leading companies showing growth rates surpassing the global average, indicating an increase in global competitiveness [1][2] - Despite recent market fluctuations, the fundamentals of the pharmaceutical industry remain robust, with reasonable valuations and no signs of bubbles [1][3][4] Core Insights and Arguments - The overall valuation of the pharmaceutical sector is deemed reasonable, with potential growth for innovative drug companies projected at 50-100% over the next three years [1][4] - The medical device, CRO (Contract Research Organization), consumer healthcare, and traditional Chinese medicine sectors also show relatively low valuations, indicating manageable risks [1][4] - The current allocation in the pharmaceutical sector is at a historical low, suggesting room for improvement in future investments [5] - The innovative drug sector's logic remains unchanged, with active business development (BD) activities expected, particularly in areas like PD-L1 Plus, ADC, and dual antibodies [1][7] Market Performance and Trends - The pharmaceutical sector has shown significant performance this year, with the Hong Kong stock index rising nearly 100% and the A-share market increasing by approximately 40-50% [3][5] - The recovery of the innovative drug sector is expected to lead to nonlinear growth, with many companies in the sector having a PEG ratio of less than 1, indicating accelerated earnings growth [6][7] - The medical device sector is in a mild recovery phase, with procurement pressures easing and opportunities for domestic companies to gain market share through competitive pricing [3][24][25] Investment Opportunities - Innovative drugs are highlighted as the primary investment focus due to their potential for significant earnings growth and market interest following recent interest rate cuts [6][7] - The medical device sector is also seen as a stable investment opportunity, with leading companies showing signs of recovery in their financial performance [6][7] - Consumer healthcare and traditional Chinese medicine are currently more focused on individual stock selection, with potential for recovery in the latter half of the year [6][35] Company-Specific Insights - Key companies with strong growth potential include Heng Rui, BeiGene, and Innovent Biologics, with expectations of exceeding profit forecasts [7][10] - The performance of companies like WuXi AppTec and WuXi Biologics is also noted, with a focus on their recovery and growth potential in the coming years [19][20] Policy and Regulatory Environment - Recent policy changes, such as the optimization of centralized procurement, are expected to positively impact the pharmaceutical sector, providing better financial and profit margins for innovative drug companies [9][24] - The adjustment of the essential drug list is anticipated to have significant implications for the traditional Chinese medicine sector, with expectations for clearer guidelines in the near future [45] Risks and Challenges - While there are no significant risks currently identified in the industry, geopolitical factors, particularly U.S.-China relations, could introduce uncertainties [23] - The medical device sector faces ongoing pricing pressures, particularly in the context of centralized procurement, which could impact profitability [25][29] Conclusion - The pharmaceutical industry in China is positioned for growth, with innovative drugs and medical devices leading the way. The current market environment presents numerous investment opportunities, particularly for companies demonstrating strong fundamentals and growth potential.