医药生物行业 行业研究 | 行业周报 短期波动，不改远期成长 ——创新药板块观点（2026 年第 1 期） 核心观点 投资建议与投资标的 | 自体 CAR-T 遇困，in vivo 风起：——医药 | 2026-02-23 | | --- | --- | | 行业专题报告 | | | 替尔泊肽加冕，减重热潮未平 | 2026-02-05 | | 小核酸破局：从"肝脏验证"迈向"多组 | 2026-02-03 | | 织扩展" | | 有关分析师的申明，见本报告最后部分。其他重要信息披露见分析师申明之后部分，或请与您的投资代表联系。并请阅读本证券研究报告最后一页的免责申明。 ⚫ 综合来看，创新药板块短期受外部因素冲击波动加剧，但是长期产业趋势明确。当 前回调已相对充分，等待市场波动企稳后，建议聚焦出海兑现、前沿技术突破、盈 利拐点三大主线，布局具备全球竞争力的优质创新药企业。相关标的如：科伦博泰 生物-B、三生制药、康方生物、前沿生物-U、瑞博生物-B、石药集团、百济神州- U、信达生物、艾力斯等。 风险提示 | 伍云飞 | 执业证书编号：S0860524020001 | | --- | --- | | | 香 ...

Core Viewpoint - The strategic collaboration between Innovent Biologics and Eli Lilly marks their seventh partnership, focusing on the development of innovative drugs in oncology and immunology, with significant financial implications for Innovent [2][5]. Financial Aspects - Innovent will receive an upfront payment of $350 million and may earn up to approximately $8.5 billion in milestone payments related to research, regulatory, and commercialization achievements [2]. - The company’s stock price rose by 7.42% to HKD 85.4 per share, with a market capitalization nearing HKD 150 billion as of February 9 [3]. Historical Context - The partnership dates back to 2015, yielding successful products such as the PD-1 antibody, Sintilimab, and the GLP-1 receptor agonist, MaShidu [4]. - Sintilimab has been a cornerstone of Innovent's commercialization strategy, rapidly entering the domestic market and becoming a key product in their portfolio [4]. Strategic Development - The collaboration emphasizes a new model of business development, focusing on entirely new targets and molecules rather than existing products [2][5]. - Innovent will lead the projects from drug discovery to clinical validation in China, while Eli Lilly retains global rights outside of Greater China [5]. Industry Trends - The partnership reflects a broader trend where multinational pharmaceutical companies are increasingly interested in early-stage innovative assets from Chinese firms, moving away from established clinical pipelines [6]. - This shift is seen as a necessary evolution in the research paradigm, allowing for systematic validation of technologies across multiple targets while managing costs [6]. Future Outlook - Innovent's product revenue is projected to reach approximately CNY 11.9 billion in 2025, marking a 45% year-on-year increase, with significant contributions from its oncology and chronic disease product lines [8]. - The company has three core assets expected to enter or are already in international Phase III clinical trials, with a combined market potential exceeding $60 billion [8][9]. Product Pipeline - The new generation IO therapy, IBI363, is anticipated to have a market potential exceeding $40 billion, while IBI343 and IBI324 are also expected to contribute significantly to revenue, with market potentials of over $8 billion and $15 billion, respectively [9][10].

Core Insights - The collaboration between Innovent Biologics and Eli Lilly is valued at over $8.8 billion, marking a significant milestone in the pharmaceutical industry [1][2] - Innovent will receive an upfront payment of $350 million and has the potential to earn up to approximately $8.5 billion in milestone payments related to research, regulatory, and commercialization achievements [1][2] - This partnership represents a shift from traditional licensing agreements to a more integrated model involving deep collaboration on technology platforms and research systems [1][2] Group 1 - Innovent will lead the research and development from drug discovery to clinical concept validation in China, while Eli Lilly will have exclusive global development and commercialization rights outside Greater China [3][4] - The collaboration aims to combine Innovent's efficient drug discovery capabilities with Eli Lilly's extensive global reach, creating a synergistic innovation ecosystem [3][4] - The specific number of projects involved in this collaboration has not been disclosed, but it is indicated to be fewer than similar recent partnerships [3][4] Group 2 - Previous collaborations between Chinese pharmaceutical companies and multinational firms have involved a larger number of projects, such as the partnership between CSPC and AstraZeneca, which included eight projects [4] - Innovent's CEO noted that the success of such technology platform collaborations depends on the uniqueness and validation of the platform technology, as well as the contributions to intellectual property from both parties [4] - This marks the seventh collaboration between Innovent and Eli Lilly, indicating a strong existing relationship and mutual understanding [4][5] Group 3 - The trend of multinational companies shifting early-stage research work to China reflects their recognition of the research efficiency and capabilities of Chinese pharmaceutical firms [5] - Innovent achieved product revenues of 11.9 billion yuan in 2025, marking its first time surpassing 10 billion yuan, with a target of reaching 20 billion yuan by 2027 [5]

Core Viewpoint - The National Medical Products Administration (NMPA) has approved the launch of the anti-CTLA-4 monoclonal antibody, Ipilimumab N01 injection (brand name: Daberxin), developed by Innovent Biologics, for neoadjuvant treatment in patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer, marking it as China's first domestically approved anti-CTLA-4 monoclonal antibody and the first globally for this indication [1][5]. Group 1 - The approval is based on the results of a randomized, controlled, multi-center Phase III registration study (NeoShot-III, NCT05890742) conducted in China, which aimed to evaluate the efficacy and safety of Ipilimumab N01 in combination with Sintilimab compared to direct radical surgery [3][7]. - The primary endpoints of the study included pathological complete response (pCR) and event-free survival (EFS) [3][7]. - The interim analysis of the NeoShot-III study showed that the predefined primary endpoints were met, as assessed by the Independent Data Monitoring Committee (iDMC) [3][7]. Group 2 - As of November 28, 2024, among the first 50 patients in the trial group, 41 achieved pathological complete response after neoadjuvant treatment, resulting in a pCR rate of 82% [4][8]. - In terms of safety, the combination of Ipilimumab N01 and Sintilimab did not significantly increase additional safety risks compared to the direct surgery group [4][8]. - The Chief R&D Officer of Innovent Biologics, Dr. Zhou Hui, emphasized the significant unmet clinical need for neoadjuvant treatment in resectable MSI-H/dMMR colorectal cancer, highlighting the importance of the NeoShot-III study's interim analysis for this treatment area [4][8].

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The company achieved a revenue of 5.953 billion yuan in H1 2025, representing a year-on-year increase of 50.6%. Product sales revenue was 5.234 billion yuan, up 37.3% year-on-year, and net profit reached 834 million yuan, a turnaround from a net loss of 393 million yuan in the same period last year [3][4] - The company has a strong and diverse product matrix, with 16 products approved for market, including 12 oncology products and 4 from its comprehensive pipeline. Two additional products are expected to be approved by the end of 2025, which will provide long-term growth momentum [4] - The company is expanding its global footprint through partnerships and market access initiatives, including a global collaboration with Roche for IBI3009 [5] - Significant milestones have been achieved in late-stage clinical projects, with R&D expenses of 1.009 billion yuan in H1 2025, indicating high investment efficiency and strong execution in R&D [6] Financial Performance and Forecast - The company has revised its net profit forecasts for 2025 and 2026 to 846 million yuan and 1.572 billion yuan, respectively, reflecting an increase of 176% and 18% from previous estimates. A new forecast for 2027 projects a net profit of 2.736 billion yuan [8] - The revenue forecast for 2025 is set at 12.084 billion yuan, with a growth rate of 28.26% [10] - The company is expected to maintain strong sales performance from its core products, with multiple blockbuster products entering late-stage clinical trials [8]

Core Viewpoint - The National Medical Products Administration (NMPA) has announced a new policy to expedite the clinical trial approval process for innovative drugs, reducing the review time to 30 working days, which represents a 50% acceleration in the approval process [1][2]. Group 1: Policy Changes and Impacts - The new policy aims to prioritize resources for innovative drugs that have significant clinical value, ensuring that only those meeting specific criteria can access the expedited review process [2][4]. - In 2024, the NMPA approved 48 Class 1 innovative drugs, a 20% increase year-on-year, marking the highest number in five years, with over 70% of these approvals achieved through accelerated pathways [2][3]. - The approval of 39 global new drugs in China from January to May 2024, with 34 being domestic innovations, highlights the vibrant growth of China's pharmaceutical innovation [3]. Group 2: Historical Context and Future Outlook - Prior to 2015, the domestic pharmaceutical market primarily followed a model of imitative innovation, with new drugs typically taking 5-7 years longer to launch in China compared to overseas [4]. - The establishment of rapid review channels and the acceleration of key national research projects are expected to enhance China's competitiveness in global pharmaceutical innovation [4][5]. - The recent establishment of review centers in regions like the Yangtze River Delta and the Greater Bay Area aims to improve regulatory efficiency and support the rapid approval of innovative drugs [5]. Group 3: Global Trends - The FDA has also introduced a new priority review program, reducing its approval timeline from approximately 10-12 months to 1-2 months, indicating a global trend towards faster clinical review processes [5].