一场原本被寄予厚望、持续仅数月的跨国"联姻"，却迅速走向了终点。在两家公司的会议室里，曾经摆放着的战略规划图已被 合作终止协议所取代。 1月6日，宜明昂科发布公告宣布与美国Axion Bio,Inc.（简称"Axion"）终止授权合作协议，重新收回两款核心抗癌新药IMM2510 （珀维拉芙普α）及IMM27M（泰泽苏拜单抗）的全球开发与商业化权利，已收取的3500万美元首付款及里程碑付款不受影响。 宜明昂科与Axion Bio的合作始于2024年8月，当时双方签署授权合作协议，将两款核心抗癌新药在大中华地区以外的全球独家开 发、商业化权利授予Axion。2025年5月，宜明昂科曾公告收到来自Axion Bio的500万美元第二期近期付款，累计已收到2000万美 元的首付款及近期付款。 仅仅几个月后，原本看似稳固的合作关系却急转直下。对于此次"分手"的原因，21世纪经济报道记者采访了宜明昂科相关负责 人，该人士无奈地表示："对方海外临床推进速度实在太慢了。" 至于后续的海外临床布局情况，宜明昂科方面对记者表示，"我们先把海外已获得的数据转过来，然后继续谈合作伙伴，目前的 现金流情况，纯靠自己开海外有一定挑战的。 ...

Core Viewpoint - The article highlights the unprecedented surge in business development (BD) activities in China's biotech sector, with the total amount of domestic innovative drug licensing exceeding $100 billion by November 18, 2025, marking a doubling compared to 2024. This trend reflects the increasing global competitiveness and value of Chinese pharmaceutical assets, while also prompting a deeper examination of transaction quality and product value realization post-agreement [1][2]. Summary by Sections BD Market Dynamics - The BD market in China is experiencing a significant boom, with a projected compound annual growth rate (CAGR) for external BD activities expected to remain in double digits over the next five years, despite a forecasted decline in growth rate [2]. - Key characteristics of future transactions include an increase in late-stage pipeline contributions and a shift from pure technology transfer to models involving "licensing + co-development + commercialization" [2]. Major Transactions - Notable transactions in 2025 include: - Hengrui Medicine's collaboration with GSK, involving a total potential amount of approximately $120 billion, with an upfront payment of $500 million [3]. - Innovent Biologics' agreement with Takeda, with a potential total of $114 billion and an upfront payment of $1.2 billion [3]. - A record-setting deal between 3SBio and Pfizer, with an upfront payment of $12.5 billion and potential milestone payments reaching $48 billion [5][6]. Global Interest in Chinese Biotech - Chinese innovative drugs are gaining significant traction in global markets, with multinational corporations increasingly sourcing early-stage innovation pipelines from China due to cost-effectiveness and potential efficacy [7][8]. - The trend indicates a shift where Chinese biotech firms are evolving from technology providers to value co-creators in the global pharmaceutical landscape [7]. Transaction Models - The dominant transaction model remains "License-out," which accounted for 91% of upfront payments and 99% of total amounts in related transactions in the first half of the year [10]. - NewCo models are gaining popularity, allowing companies to inject parts of their product pipelines into newly formed entities with foreign capital, reflecting a flexible asset operation strategy [10][11]. Future Outlook - The BD market is expected to continue thriving, driven by the need for multinational companies to replenish their pipelines as many blockbuster drugs face patent expirations, creating a significant market opportunity [15]. - Emerging technologies, particularly in ADCs and bispecific antibodies, are anticipated to dominate future BD transactions, with a notable interest in metabolic and autoimmune products [16][17]. Challenges and Considerations - Despite the growth, challenges remain in ensuring compliance with international standards and protecting intellectual property during global collaborations [13]. - The market is expected to stabilize, with a rational return to expectations regarding BD transactions, as the industry matures and the focus shifts from explosive growth to sustainable value creation [17].

兴业证券主要观点如下： TCE在血液瘤中的疗效与商业化能力已充分验证，实现实体瘤中的广泛应用仍需解决诸多挑战 当前全球已获批的TCE疗法共有12款(美国获批10款，中国获批6款)，其中9款用于血液瘤，仅3款用于 实体瘤。TCE在实体瘤中的应用需要解决以下问题：(1)靶向肿瘤外毒性，避免TCE分子对健康组织中表 达TAA的组织进行杀伤;(2)解决肿瘤微环境中T细胞浸润的缺乏;(3)调节性T细胞等免疫抑制性细胞及其 产生的细胞因子引起的抑制性肿瘤微环境，导致效应T细胞耗竭等问题。 非全长双抗、2+1格式设计、TCR、前药、共刺激靶点与选择性T细胞靶点等设计进一步增强TCE在实 体瘤的适用性 (1)Amgen与MSD非全长双抗设计在DLL3靶点中表现出突出的抗肿瘤活性：Amgen基于HLE-BiTE平台 开发的DLL3/CD3双抗塔拉妥单抗已成功实现铂化疗进展SCLC的获批上市;MSD的Gocatamig高剂量组在 后线SCLC患者中实现较高比例的肿瘤应答，且对脑转移患者表现出差异化疗效。 (2)"2+1"格式设计有望实现对CD3亲和力的精准调控：Xencor公司XmAb平台的("2+1"格式设计有效调控 CD3靶 ...

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an IPO application to the Hong Kong Stock Exchange, aiming to capitalize on the growing T cell engager (TCE) therapy market, which is experiencing rapid development and increasing interest from major international pharmaceutical companies [1][6]. Company Overview - Founded in 2017, Shimai Pharmaceutical is a pioneer in next-generation TCE therapies, focusing on utilizing the human immune system to combat cancer [1]. - The company has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors [1]. Financial Performance - Shimai Pharmaceutical is currently in the clinical research phase with no commercialized products. The company reported revenues of 14.649 million, 6.618 million, and 2.278 million RMB for 2023, 2024, and the first half of 2025, respectively [2]. - The company has incurred losses of 74.943 million, 59.899 million, and 25.42 million RMB over the same periods, showing a trend of narrowing losses [2]. - Research and development expenses were 76.109 million, 53.382 million, and 22.389 million RMB for the same periods, with employee costs being a significant component [2]. Product Pipeline - Shimai Pharmaceutical has four innovative drug candidates in clinical stages and two additional candidates in preclinical stages targeting solid tumors [2][5]. - The lead candidate, DNV3, targets LAG3 and has shown promising clinical data, including a 44.4% objective response rate in melanoma patients previously treated with PD-(L)1 inhibitors [3][4]. - SMET12, another candidate, is a potential first-in-class intravenous TCE for EGFR-positive advanced solid tumors and is currently in Phase IIa clinical trials [5]. Market Potential - The global TCE market is projected to grow from $400 million in 2020 to $3 billion by 2024, with a compound annual growth rate of 67.6%, and could reach $47.5 billion by 2030 and over $120 billion by 2035 [9][11]. - The TCE therapy offers advantages over CAR-T therapies and antibody-drug conjugates (ADCs), making it a promising direction for next-generation cancer immunotherapy [6][9]. Competitive Landscape - The TCE field is witnessing significant interest, with over $8.5 billion in transactions in 2024 alone, as major pharmaceutical companies enter the market [8]. - Currently, only two TCE drugs for solid tumors have been globally approved, indicating a substantial market opportunity for companies like Shimai Pharmaceutical that focus on this area [11][13]. Strategic Positioning - Shimai Pharmaceutical's focus on solid tumor TCE therapies positions it well in a market with limited competition, as most domestic players are still concentrated on hematological malignancies [13][14]. - The company’s innovative drug candidates are developed through specialized platforms, creating a competitive barrier in the TCE space [5].

Core Insights - The Chinese innovative drug sector is experiencing strong growth driven by accelerated new drug approvals and increased business development (BD) activities [1][13] - In the first half of 2025, the total transaction amount in China reached $60.8 billion, a significant year-on-year increase of 129%, while the cumulative transaction amount for the first three quarters reached $93.7 billion, up 64% year-on-year [1][13] - The commercialization of innovative drugs is boosting overall revenue recovery and improving corporate profitability, indicating a transition to a new phase of high-quality development in the industry [1][13] Company Performance Highlights 1. BeiGene - In Q3 2025, BeiGene's revenue exceeded 10 billion yuan for the first time, with a year-on-year growth of 41.1%, and adjusted net profit increased by 489% [2][14] - The gross margin for global product revenue under GAAP was 85.9%, up 3.1 percentage points from the same period in 2024, primarily due to increased sales of Zanubrutinib [2][14] 2. HengRui Medicine - HengRui Medicine achieved revenue of 7.427 billion yuan in Q3 2025, a year-on-year increase of 12.72%, with net profit growing by 9.53% [4][15] - The company has made significant strides in international BD transactions, with over $800 million in upfront payments from innovative drug licensing agreements in the first three quarters of the year [5][15] 3. WuXi AppTec - WuXi AppTec reported total revenue of 12.057 billion yuan in Q3 2025, a year-on-year increase of 15.26%, with net profit rising by 53.27% [6][17] - The company has adjusted its full-year revenue guidance upward, expecting sustained double-digit growth in its core business [7][17] Industry Future Trends - The Chinese innovative drug industry is undergoing a paradigm shift from "domestic substitution" to "global value creation" and "international ecological collaboration," marking the entry into an international 2.0 era [8][18] - The focus on internationalization is becoming more pronounced, with strategic collaborations extending beyond late-stage assets to include early-stage technology platforms [8][18] Strategic Recommendations for Companies - Companies should build globally-oriented differentiated R&D pipelines, shifting focus from filling domestic gaps to addressing unmet clinical needs globally [9][19] - Developing dual-capacity international BD capabilities is essential, treating international expansion as a core strategic capability rather than a one-time transaction [10][20] - Establishing a lean and efficient global operational system is crucial for maintaining cost and efficiency advantages in the competitive international market [10][20]

Core Viewpoint - The innovative drug sector has regained market attention after a two-month adjustment period, driven by macroeconomic liquidity easing and strong Q3 earnings reports from key companies [1][3]. Group 1: Performance and Financials - The Hang Seng Innovative Drug ETF (159316) rose by 2.52%, while the low-fee Innovative Drug ETF from E Fund (516080) increased by 31% year-to-date [2]. - BeiGene reported Q3 revenue of 27.595 billion yuan, a 44.21% year-on-year increase, with a net profit of 1.562 billion yuan, reversing previous losses [3]. - Innovent Biologics announced over 3.3 billion yuan in product revenue for Q3 2025, maintaining approximately 40% growth [3]. - Other leading companies like WuXi AppTec, Hengrui Medicine, Shanghai Pharmaceuticals, and Fosun Pharma reported revenues of 32.857 billion yuan, 23.188 billion yuan, 21.507 billion yuan, and 2.939 billion yuan respectively, with net profits of 12.076 billion yuan, 5.751 billion yuan, 5.147 billion yuan, and 2.523 billion yuan [3]. Group 2: Industry Trends - A total of 81 innovative drug companies reported a 13.84% year-on-year increase in net profit, with 9 companies turning losses into profits, indicating a shift towards commercialization in the sector [4]. - The total value of outbound licensing transactions for Chinese innovative drugs exceeded 101.24 billion USD, significantly surpassing the projected 51.9 billion USD for 2024 [5]. - Notable licensing deals include Hengrui's collaboration with GSK valued at up to 12 billion USD and a deal between 3SBio and Pfizer worth over 1 billion USD [6]. Group 3: Market Dynamics - The innovative drug sector has experienced a 17% correction since early September, suggesting it may be nearing a bottom [8]. - Historical data indicates that corrections of 15%-20% often signify deep pullbacks, but current macroeconomic conditions are not as extreme as in previous downturns [11]. - The likelihood of a significant market drop exceeding 20-30% is low, given the improving macroeconomic environment and corporate earnings recovery [12]. Group 4: Future Growth Drivers - The domestic policy environment has shifted to a more stable and supportive framework for innovative drug development, with recent healthcare negotiations enhancing commercial prospects [18]. - China's biotech sector ranks second globally in clinical pipelines, with over 20% of global clinical projects, indicating strong future product launches [20]. - Chinese companies are transitioning from "me-too" drugs to "First-in-Class" and "Best-in-Class" innovations, leveraging lower costs and faster clinical trial processes [23]. Group 5: Conclusion - The innovative drug sector is entering a favorable phase characterized by policy improvements, international expansion, and strong earnings, suggesting a potential market rebound [25]. - The increasing interest in innovative drug ETFs reflects the challenges of direct stock investment in this complex sector, with products like the Hang Seng Innovative Drug ETF providing a focused investment vehicle [25].

Core Viewpoint - The recent surge in the stock prices of Chinese innovative drug companies, particularly BeiGene and Hengrui Medicine, reflects a significant shift in the market's perception of the innovative drug sector, driven by successful product commercialization and strategic business development deals [2][4][10]. Group 1: Company Performance - BeiGene achieved its first half-year profit with a net profit of approximately 4.50 billion yuan, surpassing its goal of achieving operational profitability for the year [3]. - The company's stock price reached a new high of 346 yuan per share, leading to a market capitalization exceeding 500 billion yuan [2][5]. - Hengrui Medicine's market capitalization has decreased significantly from a peak of 600 billion yuan in early 2021 to around 477.74 billion yuan, indicating a widening gap in market performance between the two companies [2][6]. Group 2: Market Dynamics - The innovative drug sector in China is experiencing a resurgence, with a notable increase in licensing deals, totaling 72 transactions in the first half of 2025, amounting to 60 billion USD, a 16% increase from the previous year [4]. - The Hang Seng Hong Kong Stock Connect Innovative Drug Index has risen from a low of 1774.67 points to 4170.13 points, reflecting a cumulative increase of 134.98% [4]. Group 3: Strategic Developments - BeiGene's recent business development deal with Royalty Pharma, involving an upfront payment of 885 million USD for rights to a monoclonal antibody, has been a key driver of its stock price increase [5]. - The company retains rights to a portion of the sales revenue from the drug, which has not yet been launched in China, thereby alleviating financial pressure from R&D investments [5]. Group 4: International Expansion - BeiGene's revenue from international markets accounted for over 63% of its total revenue in 2024, compared to Hengrui Medicine's overseas revenue of only 2.56% [10]. - In the first half of the year, BeiGene's revenue distribution was 51.86% from the US, 34.22% from China, and 11.14% from Europe, showcasing its strong international presence [11]. Group 5: R&D and Future Prospects - BeiGene is focusing on developing its pipeline for solid tumors, with key products expected to enter late-stage clinical trials by 2026 [15]. - The company has a robust global R&D team of over 3,700 people, enabling it to conduct trials across six continents and collaborate with regulatory bodies in over 45 countries [18]. - The strategic emphasis on rapid clinical data generation and a data-driven approach to R&D is expected to enhance the company's ability to replicate its success in other therapeutic areas [17].

Core Viewpoint - The recent surge in the stock prices of Chinese innovative drug companies, particularly BeiGene and Hengrui Medicine, reflects a significant shift in the market dynamics and investor confidence in the innovative drug sector in China [1][2][10]. Group 1: Company Performance - BeiGene's stock price reached a new high of 346 CNY per share on September 2, 2023, with a market capitalization exceeding 500 billion CNY, marking a significant milestone for the company [2][7]. - In the first half of the year, BeiGene achieved a net profit of approximately 450 million CNY, marking its first half-year profitability [2][6]. - Hengrui Medicine's market capitalization has decreased from a peak of 600 billion CNY in early 2021 to around 477.7 billion CNY, indicating a widening gap in market performance between the two companies [2][8]. Group 2: Market Dynamics - The innovative drug sector in China is experiencing a transformation, with a notable increase in licensing transactions, which reached 72 deals in the first half of 2025, totaling 60 billion USD, a 16% increase from the previous year [3][10]. - The Hang Seng Hong Kong Stock Connect Innovative Drug Index has seen a significant rise of 134.98% from its lowest point, reflecting renewed investor confidence in the sector [3]. Group 3: Strategic Developments - BeiGene's recent business development (BD) deal with Royalty Pharma, involving an upfront payment of 885 million USD for rights to a monoclonal antibody, has been a key driver of its stock price increase [6][10]. - The company has strategically focused on international markets, with over 63% of its revenue coming from outside China, compared to Hengrui's 2.56% [10][19]. Group 4: R&D and Future Prospects - BeiGene is advancing its pipeline with a focus on blood cancers and solid tumors, with several products expected to enter late-stage clinical trials by 2026 [15][16]. - The company has established a robust global R&D team of over 3,700 personnel, enabling it to conduct trials across six continents [16][17]. Group 5: Competitive Landscape - Hengrui Medicine remains a strong player in the market, with a recent deal with GSK worth up to 120 billion USD, highlighting its established brand and extensive R&D capabilities [8][10]. - Despite Hengrui's strong pipeline, BeiGene's focus on innovative drugs and internationalization has attracted more investor interest in recent years [10][19].

Core Viewpoint - The Hong Kong stock market's innovative pharmaceuticals sector continues to lead, with the Hong Kong Stock Connect Innovative Drug ETF (520880) showing strong performance and significant trading activity [1][4]. Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (520880) has seen a price increase of 1.53%, marking its fourth consecutive day of gains, with a trading volume of 260 million CNY [1]. - The index tracked by the ETF has achieved a year-to-date increase of 115.87%, outperforming other innovative drug indices [4]. - Major pharmaceutical companies such as CSPC Pharmaceutical Group and China Biologic Products have also shown strong stock performance, with increases of approximately 5% and over 2% respectively [1][2]. Group 2: Industry Developments - BeiGene, a leading innovative drug company, has signed a significant agreement with Royalty Pharma, receiving an upfront payment of 885 million USD and the potential for an additional 65 million USD [3]. - Since the beginning of the year, there have been 83 licensing agreements for domestic innovative drugs, reflecting a 57% year-on-year increase, with total amounts reaching 84.531 billion USD, a 185% increase compared to the previous year [3]. - The upcoming major conferences in the second half of the year are expected to showcase key clinical data from Chinese innovative drugs, potentially leading to a favorable market environment similar to the one seen during the American Society of Clinical Oncology (ASCO) meeting in May [3]. Group 3: Index Adjustments - The Hang Seng Index has announced revisions to the Hang Seng Stock Connect Innovative Drug Select Index, removing companies primarily engaged in CXO services to focus on innovative drug research and development firms [4][7]. - This adjustment is expected to enhance the index's performance by eliminating disturbances caused by CXO companies, reflecting the maturation of China's innovative drug development [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 increased by 0.39% during the reporting period, ranking 26th among 31 primary industries, underperforming the CSI 300 index which rose by 7.01% [4][14] - The industry shows resilience despite a slight decline in overall revenue and net profit for A-share pharmaceutical companies in the first half of the year, with stable gross profit margins [6] - The CXO sector has returned to high prosperity with significant growth in performance, while the chemical preparation sector shows a mixed performance [6] - The report highlights the approval of several innovative drugs, including Novartis' "Acrux" for IgA nephropathy and the first oral HER2 inhibitor "Zongertinib" by Boehringer Ingelheim [5][41] Industry Review - The pharmaceutical and biotechnology industry PE (TTM, excluding negative values) is at 31.41x, slightly down from 31.38x in the previous period, indicating a valuation below the average [20] - The top three sub-industries by PE are vaccines (56.18x), hospitals (42.24x), and medical devices (40.66x), while pharmaceutical circulation has the lowest valuation at 14.06x [20] - In the reporting period, 29 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 1 billion CNY [4] Important Industry News - The CDE released a draft guideline for single-arm clinical trials to support the regular approval of anti-tumor drugs [25] - Novartis' IgA nephropathy drug "Acrux" received NMPA approval, marking it as the first of its kind in China [28] - The approval of the new generation ALK inhibitor "Dirocitinib" by Xuan Bamboo Biotech for treating ALK-positive non-small cell lung cancer [36] - The approval of the ADC "Datopotamab deruxtecan" for treating HR-positive, HER2-negative breast cancer [39] Investment Recommendations - The report suggests focusing on investment opportunities in the chemical preparation sector, particularly innovative drugs, and the CXO sector due to their clear long-term growth logic [6]