2026开年创新药板块迎来大幅上涨，沪指现14天阳线，港股创新药指数三天平均涨幅达12%，作为纯医药医疗领域二级市场私募基金，森瑞投资董事长林 存认为，这一行情的核心源于创新药作为新质生产力的核心地位获政策强力支撑，《全链条支持创新药发展》等政策为行业奠定巨大产业空间，且其重要 性与 AI 等领域同等优先。他强调，未来20年中国将迎来繁荣盛世，创新药板块的开门红预示各类创新领域将持续崛起，追随技术创新有望获得丰厚回 报。 森瑞投资董事长 林存 以下为全文： 背景介绍： 当2025年的日历翻至末页，生物医药产业正站在一个特殊的历史节点——这既是"十四五"的收官沉淀之年，更是"十五五"宏伟蓝图的启航之时。这一年， 技术狂飙与商业理性的碰撞、全球化布局与本土化深耕的平衡、"创新驱动"向"价值驱动"的范式转型，共同勾勒出2025年的行业主线。2026年，产业如何 跨越技术周期与资本周期的双重考验，在"健康中国"战略与全球创新格局双轨并行中，探寻可持续增长路径？思享启发思想，"生物医药大健康2026思享 汇：双轨并行・破局生长"重磅上线，与核心实践者、机构与权威专家一起同行，连接生物医药大健康领域内最强思想电波！ 20 ...

生物医药 2026 年度策略：十年创新，踏出海征程 20251217 摘要 2025 年 CXO 和化学制药板块表现突出，基金持仓集中度提升。诊疗端 需求稳定，医保基金结存率显著回升，控费效果明显。商保创新药目录 发布为医药行业带来新的支付增量。 2025 年前三季度 license out 交易金额达 920 亿美元，同比增长超一 倍，表明国内创新药受到海外认可。港股 IPO 回暖带动一级市场投融资 回升，多家医药企业上市。 2026 年医药行业关注创新，重点关注 IO 双抗和 GLP-1 两大主线。康方 生物 PD-1/VEGF 双抗 AK112 研发进度领先，多个关键临床数据将在明 年更新。 双抗领域备受关注，康方生物 AK112 等产品积极推进出海，并围绕非 小细胞肺癌等适应症开展全球三期临床试验，将成为明年的重要催化剂。 IO 加 ADC 是未来发展方向。科伦博泰 SKB264 在全球开展多项临床三 期试验，与默沙东 Keytruda 联合使用，有望重新定义 IO 加 ADC 治疗 格局。 Q&A 今年（2025 年）医药行业整体表现如何？有哪些重要的边际变化？ 今年（2025 年），医药行业整体估 ...

Investment Rating - The report maintains an "Outperform" rating for the industry [2]. Core Insights - The third-generation EGFR TKI has become the first-line standard therapy for advanced EGFR mutation NSCLC, significantly extending median progression-free survival (mPFS) to 18.9-22.1 months compared to earlier generations [4][24]. - The domestic EGFR TKI market is expected to exceed 20 billion CNY in 2024, with third-generation EGFR TKIs accounting for 88% of the market share [4][30]. - There is an urgent need to address resistance mechanisms following third-generation EGFR TKI treatment, with ongoing exploration of fourth-generation TKIs, bispecific antibodies, and antibody-drug conjugates (ADCs) [5][32]. Summary by Sections 1. High Incidence of Lung Cancer in China - Lung cancer is the most common malignant tumor globally, with approximately 2.6 million new cases expected in 2024, including about 1.15 million in China [8]. - Non-small cell lung cancer (NSCLC) accounts for around 85% of lung cancer cases, with adenocarcinoma and squamous cell carcinoma being the most prevalent subtypes [8]. 2. Third-Generation EGFR TKI as First-Line Therapy - The third-generation EGFR TKI has established itself as the first-line treatment for advanced EGFR mutation NSCLC, with significant improvements in mPFS compared to first and second generations [4][16][24]. - The report highlights the efficacy of third-generation TKIs in overcoming common mutations and their favorable safety profile [4][24]. 3. Exploration of Resistance Mechanisms - The report discusses the complexity of resistance mechanisms to third-generation EGFR TKIs, including both EGFR-dependent and independent pathways [5][32]. - Current research focuses on developing fourth-generation TKIs targeting specific mutations and exploring combination therapies with bispecific antibodies and ADCs [5][32][39]. 4. Investment Recommendations - The report emphasizes the growth potential of third-generation EGFR TKIs and suggests monitoring companies like Hansoh Pharma and Eli Lilly for market penetration and sales growth [51]. - It also highlights the progress of ADCs and bispecific antibodies in clinical trials, indicating a robust pipeline for future treatments [51][52].

Core Viewpoint - Kelong Pharmaceutical is a leading enterprise in the domestic large infusion industry, with strong R&D capabilities and a full industry chain advantage [1] Group 1: Business Performance - As of Q3 2025, Kelong Pharmaceutical reported revenue of 13.277 billion, ranking 5th in the industry, exceeding the industry average by 2.8 billion and the median by 0.838 billion, but lower than the top two competitors [2] - The net profit for the same period was 1.245 billion, ranking 9th in the industry, above the industry average of 299 million and the median of 78.29 million, but below the top two competitors [2] Group 2: Financial Ratios - Kelong Pharmaceutical's debt-to-asset ratio was 28.63% in Q3 2025, down from 31.68% year-on-year and below the industry average of 35.26%, indicating good solvency [3] - The gross profit margin for the same period was 47.89%, down from 52.51% year-on-year and below the industry average of 57.17%, suggesting a need for improvement in profitability [3] Group 3: Executive Compensation - Chairman Liu Gexin's salary decreased from 6.9 million in 2023 to 5.6 million in 2024, a reduction of 1.3 million [4] - General Manager Liu Sicong's salary remained stable at 4.8 million in 2024 [4] Group 4: Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 8.35% to 37,100, while the average number of shares held per shareholder decreased by 7.70% [5] Group 5: Future Outlook - Kelong Pharmaceutical's H1 2025 performance showed a decline, with revenue of 9.083 billion, down 23.2% year-on-year, and net profit of 1.001 billion, down 44.41% [6] - The company expects revenues for 2025-2027 to be 17.886 billion, 20.569 billion, and 22.626 billion, with respective year-on-year changes of -18.0%, +15.0%, and +10.0% [6] - Net profits for the same period are projected to be 2.022 billion, 2.801 billion, and 3.204 billion, with year-on-year changes of -31.1%, +38.5%, and +14.4% [6] Group 6: Innovation and R&D - Kelong Pharmaceutical's innovative drugs are showing rapid sales growth, with the newly approved product contributing to sales [6] - The company has over 30 items in its innovative R&D pipeline, primarily focused on cancer treatment [6][7]

Core Viewpoint - Kolon Biotech Inc. (06990) shares rose nearly 5%, currently up 3.42% at 436 HKD, with a trading volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference held in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 indicated that it surpassed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Core Viewpoint - Keren Biotechnology-B (06990) has seen a stock increase of nearly 5%, currently trading at 436 HKD with a transaction volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 was announced, showing that it outperformed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Group 1: Market Performance and Opportunities - The MSCI China Healthcare Index has increased by 58.6% year-to-date, outperforming the MSCI China Index which rose by 24.2% [1] - The recent slight pullback in the healthcare sector (10% decline in MSCI China Healthcare Index since October) presents a buying opportunity [1] - The recovery in capital market financing and the increase in overseas transactions for innovative drugs indicate a rebound in domestic innovative drug R&D demand [1] Group 2: Clinical Data and Drug Development - SKB264 is the only drug showing statistically significant overall survival (OS) in a Phase III trial for EGFR-TKI resistant NSCLC, with a hazard ratio (HR) of 0.56 compared to chemotherapy [2] - Ivonescimab demonstrated a median progression-free survival (mPFS) of 11.1 months in first-line sqNSCLC, outperforming the comparator at 6.9 months (HR=0.60) [2] - The uORR for drug 707 in first-line colorectal cancer reached 82.6%, with a cORR of 65.2%, indicating strong efficacy [2] Group 3: Strategic Collaborations and Future Outlook - The company suggests focusing on the clinical advancement of authorized pipelines overseas, as this has a higher certainty of success and can act as a catalyst for stock price increases [3] - The strategic collaboration between Innovent Biologics and Takeda for IBI363 involves shared global R&D costs and commercial rights, reflecting confidence in the drug and commitment to global strategy [3] - Pfizer is expected to announce overseas clinical plans for drug 707 within the year, with a focus on its combination with multiple ADC products [3]

Group 1 - The MSCI China Healthcare Index has increased by 58.6% since the beginning of 2025, outperforming the MSCI China Index by 24.2% [1] - The recent slight pullback in the healthcare sector (10% since October) presents a buying opportunity, driven by a recovery in capital market financing and an increase in the scale of innovative drug exports [1] - The CXO industry is expected to see performance recovery in the second half of 2025 due to the anticipated interest rate cuts in the U.S. [1] Group 2 - Significant clinical data was released at the ESMO conference, highlighting key drugs such as SKB264, which shows statistical significance in overall survival for NSCLC patients resistant to EGFR-TKI [2] - The mPFS for lvonescimab in first-line sqNSCLC was reported at 11.1 months, compared to 6.9 months for the control group [2] - The uORR for drug 707 from 三生制药 in first-line colorectal cancer reached 82.6%, indicating strong efficacy [2] Group 3 - The impact of business development (BD) on stock prices is diminishing, prompting a focus on the clinical advancement of authorized pipelines overseas [3] - 信达生物 has entered a global strategic partnership with Takeda for IBI363, sharing 40% of global R&D costs and U.S. commercial rights, reflecting confidence in the drug and commitment to globalization [3] - The company anticipates that clinical progress will serve as a catalyst for stock price increases, with most value realization dependent on successful commercialization rather than upfront payments from licensing deals [3]

Investment Rating - The report assigns a "Buy" rating to several companies in the pharmaceutical sector, indicating a potential upside of over 15% in their stock prices over the next 12 months [2][33]. Core Insights - The MSCI China Healthcare Index has increased by 58.6% from early 2025, outperforming the MSCI China Index by 24.2%. However, there has been a recent pullback of 10% in the healthcare sector, presenting a buying opportunity [1]. - The report highlights a recovery in the demand for domestic innovative drug research and development, driven by a resurgence in capital market financing and an increase in overseas clinical trials for authorized innovative drugs [1]. - The CXO industry is expected to see performance recovery in the second half of 2025, aided by the recent interest rate cuts in the U.S. [1]. - The report emphasizes the importance of monitoring the clinical progress of authorized innovative drug pipelines overseas, as this could serve as a catalyst for stock price increases [4]. Summary by Sections Industry Overview - The report discusses the recent clinical data released at the ESMO conference, focusing on several key drugs and their performance in clinical trials, such as SKB264 and ivonescimab, which show promising results in treating specific types of cancer [4]. - It notes that while business development (BD) activities for innovative drugs are ongoing, stock prices have not reflected this positively, primarily due to valuation concerns [4]. Company Ratings and Valuations - The report provides a detailed valuation table for several companies, including: - **Sangamo Therapeutics (1530 HK)**: Market cap of $8.76 billion, target price of $37.58, with a 34% upside potential [2]. - **Gusongtang (2273 HK)**: Market cap of $932.7 million, target price of $48.28, with a 62% upside potential [2]. - **Giant Biologics (2367 HK)**: Market cap of $5.74 billion, target price of $58.35, with a 40% upside potential [2]. - **WuXi AppTec (2268 HK)**: Market cap of $10.87 billion, target price of $74.00, with a 5% upside potential [2]. - **China National Pharmaceutical Group (1177 HK)**: Market cap of $16.80 billion, target price of $9.40, with a 35% upside potential [2]. - **Innovent Biologics (1801 HK)**: Market cap of $18.94 billion, target price of $110.62, with a 29% upside potential [2].

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]