2025年，是中国创新药在技术、市场、国际化领域破釜沉舟的一年，药企"走出去"迈出了关键一 步。对外授权交易（BD）爆发是最佳证明，全年对外授权总金额突破1000亿美元，首付款达81亿美 元，超九成跨国药企已经与中国药企达成合作，模式已不再局限于单纯技术转让，而是向"授权+联合 开发+商业化参与"多层次合作迈进。总体看，中国正加速从医药大国向医药强国转型。 "十四五"收官，我国生物医药市场规模稳居全球第二，在研创新药约占全球的30%，标志着我国医 药产业实现了从跟跑到并跑的关键跨越。"十四五"期间，我国共批准上市创新药220个、创新医疗器械 282个，分别达到"十三五"期间的6.2倍、3.1倍。批准415个儿童药品、155个罕见病药品上市，批准上市 中药创新药28个，新批准注册和备案公示化妆品新原料344件，医药产业创新发展活力不断增强。 国际化：从跟跑到领跑 医药行业国际化势头在2025年彻底爆发，一方面表现在BD交易激增，另一方面是"A+H"布局火 热。 数据显示，2025年中国创新药对外授权出海总金额已突破1000亿美元，较2024年同期飙升约75%， 从"卖产品"到"卖技术"，从"被动授权"到"主动布 ...

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The number of innovative drugs listed in China continues to grow, with domestic products accounting for approximately half of the total market share. The R&D capabilities for innovative drugs in China are also increasing, attracting global attention. Notably, the number and value of domestic innovative drug business development (BD) transactions have reached new highs, with ADC, bispecific antibodies, small nucleic acids, and CAR-T being the four key R&D directions to watch in 2026 [15][21][22] - The Chinese innovative drug market has seen a significant increase in the number of new drug applications (NDA), with domestic products making up a growing proportion. From 2017 to 2024, the number of innovative drugs listed in China rose from 41 to 92, with domestic products accounting for 50% of the total by 2024 [17][21] - The report highlights that the license-out transaction volume and total amount for Chinese companies reached $92.03 billion in the first three quarters of 2025, a 77% increase compared to the total for 2024. The upfront payment for license-out transactions has also surpassed the total financing amount in the primary market for the same period [22][25] Summary by Sections Industry Trends - The A-share pharmaceutical index has shown a year-to-date increase of 14.29%, while the Hang Seng Healthcare Index has surged by 62.29% [3][8] - The report notes that the pharmaceutical sector has experienced fluctuations, with raw materials and medical devices showing positive growth [8] R&D Progress and Company Dynamics - The report provides an overview of the R&D progress for innovative and modified drugs, including approvals and clinical applications [5] - It lists key companies to watch in various sub-sectors, including innovative drugs, research services, and medical devices, with specific recommendations for companies like Innovent Biologics, Hengrui Medicine, and WuXi AppTec [11][12] Market Insights and Regulatory Observations - The report tracks the price-to-earnings ratio of the pharmaceutical index, noting that it is currently lower than historical averages [5] - It emphasizes the importance of the regulatory environment and market dynamics in shaping the future of the pharmaceutical industry [5]

12.5亿美元首付款，60亿美元总交易额，三生制药与辉瑞的一纸协议，在今年5月点燃了资本市场的热 情，也映照出中国创新药的"DeepSeek时刻"。在本轮行情中，百济神州、百利天恒、诺诚健华等一批企 业凭借技术实力和出海策略脱颖而出，它们可以作为观察行业趋势的典型样本。它们是当下的典型，未 来却绝不是"全部"。 资本市场敏锐地嗅到了变化。今年以来，二级市场上创新药板块成为明星。港股创新药指数一度飙升逾 100%，A股创新药板块亦亮点频现。水涨船高之下，A股和港股千亿市值创新药企已达8家。 与此同时，港交所迎来药企扎堆申报，仅11月就有近10家创新药企递表，其中不乏多轮融资但仍未盈利 的创新药企。资本的热浪席卷着二级市场，而在这背后，中国创新药企正用实实在在的临床数据和商业 价值实现价值重估。 /二级市场狂欢/ 资本市场总是先知先觉。经历近四年的深度调整后，创新药在2025年迎来强势反弹。 东方财富显示，自4月9日阶段性探底后，港股创新药板块发起猛攻，截至11月19日收盘，港股创新药指 数累计涨幅达到110.75%，期间一度涨超100%。A股创新药板块同样大涨。4月9日至11月19日，A股创 新药板块累计上涨4 ...

Investment Rating - The report rates the pharmaceutical and biotechnology industry as "Outperforming the Market" [1][8]. Core Insights - The report highlights a significant increase in the success rate of negotiations for high-value innovative drugs, with the 2025 National Medical Insurance Directory adding 114 new drugs, including 50 innovative drugs, and achieving a negotiation success rate of 88%, up from 76% in 2024 [3]. - The introduction of a commercial insurance drug directory marks a new phase in healthcare, aiming to create a multi-layered insurance system that complements basic medical insurance, with 19 innovative drugs included in the first version [3]. - The report emphasizes the potential for Chinese innovative drugs to expand internationally, with a focus on ADCs, bispecific antibodies, small nucleic acids, and weight-loss drugs as key investment opportunities [3]. Summary by Sections Industry Performance - The SW Pharmaceutical and Biotechnology Index decreased by 0.74% in the week of December 1-7, underperforming the Shanghai and Shenzhen 300 Index, which increased by 1.28% [2]. - Within the pharmaceutical sector, the drug distribution (+6.48%) and offline pharmacy (+1.85%) segments performed relatively well, while raw materials (-2.54%), vaccines (-1.62%), and CXO (-1.29%) segments showed weaker performance [2]. National Medical Insurance Directory - The 2025 version of the National Medical Insurance Directory will officially implement on January 1, 2026, with a total of 3,253 drugs included, enhancing coverage for critical areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [3]. - Notably, 105 of the newly added drugs are exclusive products, including 98 Western medicines and 7 traditional Chinese medicines [3]. Commercial Insurance Drug Directory - The first version of the commercial insurance innovative drug directory includes 19 drugs, focusing on high clinical value and significant patient benefits, which are beyond the scope of basic medical insurance [5]. - This directory includes treatments for rare diseases, cancer therapies, and Alzheimer's disease, establishing a foundation for the development of a multi-tiered medical insurance system [3][5]. Investment Recommendations - The report suggests a positive outlook for the international expansion of Chinese innovative drugs and recommends monitoring ADCs, bispecific antibodies, small nucleic acids, and weight-loss drugs for investment opportunities [3]. - Key companies to watch include Yiming Biotechnology-B, WuXi AppTec, Maiwei Biotechnology-U, Kelun-Biotech, and Kangfang Biotech [3].

Core Insights - Junshi Bioscience has transformed from a small laboratory in Zhangjiang, Shanghai, to a leading player in the global biopharmaceutical industry, with over 50 innovative drug pipelines in just 13 years [1][2] - The company's core product, the PD-1 monoclonal antibody Toripalimab, has gained global recognition, becoming the first self-developed innovative biopharmaceutical from China to receive FDA approval [1][2] R&D and Innovation - Junshi Bioscience shifted from "single-point breakthroughs" to "platform innovation," focusing on multiple therapeutic areas and developing a robust pipeline of over 50 new drugs [4][5] - The company has successfully developed Toripalimab, which addresses local high-incidence cancers and has broken the monopoly of imported drugs in China [2][4] - The company plans to advance several innovative drugs, including JS212 and JS213, into clinical trials by 2025, aiming for a comprehensive drug pipeline [5][6] Global Expansion and Commercialization - Junshi Bioscience is transitioning from a "R&D-focused company" to a "full-chain operator," with a strong emphasis on internationalization as a key highlight for the next five years [6] - The company has established a commercial network covering over 80 countries through partnerships and self-built teams, aiming to penetrate emerging markets in Southeast Asia [6][7] - The production capabilities at the Shanghai Lingang base support the company's ambition for global commercialization, with a fully autonomous production process [6] Market Position and Future Outlook - The success of Toripalimab marks a significant shift in the landscape of Chinese innovative drugs, moving from "importing" to "exporting" [1][2] - The company aims to redefine treatment boundaries with next-generation therapies, including bispecific antibodies and antibody-drug conjugates, supported by AI-assisted research [5][6] - Junshi Bioscience is committed to pushing more products into late-stage clinical trials and registration phases during the 14th Five-Year Plan period [5][6]

Core Viewpoint - The article highlights a significant global strategic collaboration between Innovent Biologics and Takeda Pharmaceutical, focusing on the development of innovative cancer therapies, particularly in the fields of tumor immunology and antibody-drug conjugates, with a total deal value potentially reaching $11.4 billion [1][5][19]. Summary by Sections Collaboration Details - Innovent Biologics and Takeda will co-develop the next-generation IO cornerstone therapy IBI363 and will commercialize it in the U.S. under a shared governance model, with Takeda leading the development efforts [1][9]. - Innovent will grant Takeda commercialization rights for IBI363 outside of Greater China and the U.S., while Takeda will have exclusive rights for IBI343 in regions outside Greater China [1][9][12]. Financial Aspects - Innovent will receive an upfront payment of $1.2 billion, including a $100 million premium strategic equity investment, with potential milestone payments bringing the total deal value to $11.4 billion [1][5]. - The agreement includes a revenue-sharing model, where both companies will share profits or losses from the U.S. market at a 40/60 ratio [9]. Market Context - The global oncology drug market is projected to exceed $200 billion, driven by unmet clinical needs and technological advancements, with a compound annual growth rate (CAGR) of over 20% expected for next-generation technologies like bispecific antibodies and ADCs over the next five years [5][15]. - The shift from the "PD-1 dividend period" to a "next-generation technology-driven period" is emphasized, indicating a transition in market dynamics [5][13]. Product Pipeline - IBI363 is a globally innovative PD-1/IL-2α-bias bispecific antibody that has shown promising clinical results in various cancer types, including immune-resistant lung cancer and melanoma [7][8]. - IBI343 is a novel CLDN18.2-targeting ADC that is currently undergoing Phase III clinical trials in China and Japan for gastric cancer [11][12]. - IBI3001, a first-in-class ADC targeting B7-H3 and EGFR, is in Phase I clinical trials and demonstrates multiple anti-tumor mechanisms [11][12]. Industry Trends - The article notes that multinational pharmaceutical companies are increasingly seeking partnerships with Chinese biotech firms to access innovative therapies, particularly in oncology, as they face pressures from patent expirations and competition from biosimilars [15][16]. - The trend of cross-border collaborations is on the rise, with a significant increase in the number of deals involving Chinese companies, particularly in the oncology sector [17][19].

Core Viewpoint - Cinda Biologics has entered a significant global strategic partnership with Takeda Pharmaceutical to accelerate the global development of two late-stage investigational drugs, leveraging Cinda's innovation in tumor immunology and antibody-drug conjugates (ADC) alongside Takeda's extensive experience in global oncology drug development [1] Group 1: Partnership Details - The collaboration will focus on the joint development of the next-generation IO cornerstone therapy IBI363 (PD-1/IL-2α-bias) and its commercialization in the U.S., with Takeda leading the efforts [1][6] - Cinda will receive an upfront payment of $1.2 billion, including a $100 million premium strategic equity investment, with potential milestone payments bringing the total deal value to up to $11.4 billion [1] - Cinda will grant Takeda exclusive commercialization rights for IBI363 outside Greater China and the U.S., as well as exclusive rights for IBI343 (CLDN18.2 ADC) outside Greater China [1][9] Group 2: Market Context - The global oncology drug market is experiencing a shift from the "PD-1 dividend period" to a "next-generation technology-driven period," with a focus on unmet clinical needs and technological iterations such as dual antibodies and ADCs [4][11] - The oncology market has surpassed $200 billion, with a projected compound annual growth rate (CAGR) exceeding 20% over the next five years, driven by the penetration of next-generation technologies [2] Group 3: Product Insights - IBI363 is a globally innovative PD-1/IL-2α-bias dual-specific antibody fusion protein, showing promising results in various cancers, including immune-resistant lung cancer and melanoma [5][10] - IBI343 is an innovative CLDN18.2-targeting ADC, currently in Phase III clinical trials for gastric and gastroesophageal junction cancers, having received breakthrough therapy designation from the NMPA and FDA [8] - IBI3001, a first-in-class dual-targeting ADC, is in Phase I clinical trials and demonstrates multiple anti-tumor mechanisms [8][9] Group 4: Strategic Implications - The partnership reflects a broader trend where multinational pharmaceutical companies are seeking to mitigate patent cliff pressures by acquiring innovative pipelines from biotech firms, particularly in the oncology sector [12] - The collaboration is seen as a typical case of Chinese biotech firms leveraging technological differentiation to penetrate global mainstream markets, potentially reshaping the valuation framework for Chinese innovative drugs [12][15]

Core Viewpoint - The report from Shenwan Hongyuan indicates that Zai Lab (09688) is expected to achieve non-GAAP operating profit by Q4 2025, driven by the commercialization of products and localized production [1] Financial Projections - Revenue projections for Zai Lab from 2025 to 2027 are estimated at $553 million, $802 million, and $1.203 billion respectively, with net profit attributable to the parent company expected to be -$134 million, $15 million, and $173 million for the same years [1] - The target price set at HKD 35.2 implies a 39% upside potential, reflecting confidence in the company's innovative pipeline [1] Product Portfolio and Commercialization - Zai Lab is a global biopharmaceutical company in the commercialization stage, with seven products approved in China, including four oncology products and one immunology product [2] - Since the approval of its first commercial product, Niraparib, in 2019, Zai Lab has seen significant sales growth, with total revenue projected to reach $399 million in 2024, a 50% increase year-on-year [3] New Product Development - The company has submitted applications for new products, including KarXT and TF ADC, to the NMPA, with plans to submit for Bemarituzumab for 1L gastric cancer in the second half of the year [3] - Zai Lab anticipates revenue could reach $2 billion by 2028, supported by the sales of existing products and the approval of new products [3] Expansion of Indications - Efgartigimod, the first FcRn antagonist globally, has received approvals for multiple indications, with sales expected to reach $94 million in 2024, reflecting an 835% year-on-year growth [4] - The company is exploring additional indications for Efgartigimod, which could broaden its market reach across various medical fields [4] Global Pipeline Development - Zai Lab is actively expanding its global pipeline, focusing on ADCs and bispecific antibodies, with several products showing potential for first-in-class (FIC) or best-in-class (BIC) status [5] - The company plans to initiate global pivotal studies for ZL-1310, which has shown promising clinical activity and safety [5]

Investment Rating - The industry investment rating is "Outperform" [1] Core Viewpoints - The global market for Inflammatory Bowel Disease (IBD) drugs is expected to reach $37 billion by 2030, with major pharmaceutical companies investing in this area [4][26] - There is a significant unmet clinical need for new therapies due to the complexity of IBD mechanisms and the high percentage of patients who do not respond to initial treatments [4][18] - The report emphasizes the importance of new targets and mechanisms in drug development, particularly focusing on TL1A, which has garnered interest from multiple multinational corporations (MNCs) [4][32] Summary by Sections IBD Treatment Overview - IBD includes Ulcerative Colitis (UC) and Crohn's Disease (CD), affecting over 3 million patients in the US and Europe, with no current cure available [4][10] - The market for IBD drugs is projected to grow at a compound annual growth rate (CAGR) of 5.88% from $23.26 billion in 2022 to $37 billion by 2030 [26][29] Market Dynamics - The sales proportion of TNF inhibitors is declining, while IL-23 inhibitors and JAK inhibitors are increasing in sales [4][29] - Ustekinumab is expected to contribute approximately $7.8 billion to the market by 2024, while Vedolizumab is projected to reach $6.107 billion [4][29] Clinical Needs and Drug Development - There is a pressing need for new therapies as up to 30% of patients do not respond to initial treatments, and 40% lose response over time [4][18] - The report suggests focusing on new targets and mechanisms, including companies like Abivax, Chenxin Pharmaceutical, and others for potential investment opportunities [4][32] Long-term Investment Strategy - The report recommends a strategic focus on leading innovative drug companies and those involved in the development of new therapies for IBD, highlighting companies such as Innovent Biologics, BeiGene, and others [4][32] - The report also notes the potential for significant market transactions in the IBD space, with several deals exceeding $5 billion in value [4][30]

Core Insights - China's innovative drug development has achieved significant milestones, with over 20% of global new drug research and development, ranking second globally [1] - The number of approved innovative drugs has accelerated, with 43 new drugs approved in the first half of 2025, marking a historical high for the same period [3][4] - The trend of "innovation + internationalization" in the pharmaceutical industry remains strong, with Chinese companies showing competitive advantages in various therapeutic areas [1][2] Industry Development - During the "14th Five-Year Plan" period, China approved 210 innovative drugs and 269 innovative medical devices, indicating a sustained growth trend [1] - The total amount of foreign licensing for innovative drugs reached nearly $66 billion in the first half of 2025, reflecting increasing global recognition of Chinese innovative drugs [1] - The biopharmaceutical industry is experiencing a resurgence, with significant growth potential remaining, driven by technological advancements and improved global competitiveness [2] Company Performance - Leading innovative pharmaceutical companies have reported strong revenue growth, with Hengrui Medicine achieving a revenue of 15.76 billion yuan, a year-on-year increase of 15.88% [3] - Innovent Biologics turned a profit in the first half of 2025, with a net profit of 1.21 billion yuan, compared to a loss of 160 million yuan in the same period last year [5] - The sales of innovative drugs are becoming a prominent feature of the industry, with companies like BeiGene and Fosun Pharma also reporting significant revenue increases [3][5] Regulatory Environment - The National Medical Products Administration (NMPA) has optimized the clinical trial review and approval process, reducing the review time from 60 days to 30 days [6] - Continuous improvements in the drug approval process are expected to further stimulate innovative drug development [6] R&D Investment - R&D investment among leading pharmaceutical companies has increased, with a total of 17.64 billion yuan spent on R&D in the first half of 2025, a year-on-year increase of 12.66% [7] - Companies like BeiGene and Hengrui Medicine are leading in R&D expenditures, emphasizing the importance of innovation in their growth strategies [7] Market Trends - The oncology drug segment remains the dominant area for innovative drugs, accounting for approximately 40% of the approved drugs [5] - The rapid commercialization of innovative drugs is driving performance breakthroughs for pharmaceutical companies [5][8] - ADC (antibody-drug conjugates) and other advanced therapies are gaining traction, with several companies making significant progress in these areas [9][10]