Adagene FY Conference Summary Company Overview - **Company**: Adagene (NasdaqGM:ADAG) - **Focus**: Development of immuno-oncology drugs, specifically targeting microsatellite stable colorectal cancer (MSS-CRC) with low response rates to current therapies [2][3] Key Points and Arguments Drug Development and Efficacy - **Lead Compound**: ADG126, a masked anti-CTLA-4 antibody, is being developed in combination with KEYTRUDA (pembrolizumab) for late-line MSS-CRC without liver metastases [3][4] - **Response Rates**: ADG126 has shown a response rate between 15% and 30% depending on dosage, with a median overall survival of 20 months in the lowest dose cohort [3][5] - **Safety Profile**: The discontinuation rate is less than 10%, with no grade 4 or 5 adverse events reported, indicating a favorable safety margin [5][15] Market Opportunity - **Target Population**: Approximately 10,000 patients in the U.S. represent the MSS-CRC without liver metastases, a challenging tumor type for immuno-oncology agents [12] - **Historical Context**: Current standard of care has a median overall survival of 10-14 months, highlighting the need for more effective treatments [2][11] Collaboration and Funding - **Sanofi Investment**: Sanofi committed to an equity investment of up to $25 million, with the first tranche of $17 million received at $2 per share. This funding supports the ongoing phase 2 trial of ADG126 [6][7] - **Trial Collaboration**: Sanofi will evaluate ADG126 in combination with their bispecific PD-1 IL-15 in over 100 patients with solid tumors [6][7] Competitive Landscape - **CTLA-4 Mechanism**: CTLA-4 therapies like Yervoy (ipilimumab) and Imjudo (tremelimumab) generate close to $4 billion in revenues, indicating a robust market for effective CTLA-4 inhibitors [8][9] - **Differentiation**: ADG126 is positioned as a safer alternative with a better safety margin compared to existing CTLA-4 therapies, which have shown high toxicity [10][76] Future Developments - **Upcoming Data**: Updates on ADG126's efficacy and safety are expected in the coming months, including data from triplet combinations and a phase 2 trial in neoadjuvant colorectal cancer patients [20][23] - **Regulatory Pathway**: Plans for a randomized phase 3 trial focusing on overall survival as the primary endpoint are in discussion with the FDA [62][73] Additional Important Insights - **Combination Potential**: ADG126 is seen as a versatile partner for various combinations beyond PD-1, including potential combinations with VEGF and TGF inhibitors [36][38] - **Strategic Partnerships**: The company aims to pursue more licensing deals and trial collaborations to expand its market reach and evaluate novel regimens [23][24] This summary encapsulates the critical insights from the Adagene FY Conference, highlighting the company's strategic direction, drug development progress, and market potential in the oncology space.

抗凝药物升级窗口已至，下一代药物箭在弦上 国泰海通发布研报称，人口老龄化与心血管疾病患病率攀升推动抗血栓药物市场持续扩容，其中抗凝药 物作为核心品类，市场需求稳步增长，中国市场增速尤为显著，为新型抗凝药物研发与商业化奠定了广 阔的市场基础。凭借"精准抗凝、低出血风险"的独特优势，FXI成为下一代抗凝药的理想靶点，目前全 球有多款FXI/FXIa抑制剂进入注册性临床阶段，涵盖小分子、大分子单抗、siRNA等多种技术路线，覆 盖房颤、卒中预防、静脉血栓栓塞等多个适应症。 国泰海通主要观点如下： 抗血栓药物市场需求扩容，格局待新 血栓性疾病成为全球主要死亡原因之一，人口老龄化与心血管疾病患病率攀升推动抗血栓药物市场持续 扩容，2023年全球市场规模已达529亿美元，预计2033年将突破1100亿美元。其中抗凝药物作为核心品 类，市场需求稳步增长，中国市场增速尤为显著，为新型抗凝药物研发与商业化奠定了广阔的市场基 础。 2)大分子FXI单抗中，诺华的Abelacimab已获得FDA两项快速通道资格，分别针对房颤卒中预防及肿瘤 相关血栓，目前正在推进III期临床；再生元双管线布局FXI单抗，直接阻断FXI的催化结构域的 ...

从靶点到管线，FXI 引领抗凝产业新变革 [Table_Industry] 医药 FXI/FXIa 抑制剂行业研究报告 | [Table_Invest] | | | --- | --- | | 评级： | 增持 | | | | | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 彭娉(分析师) | 021-23185619 | pengping@gtht.com | S0880525040080 | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | 本报告导读： 靶向 FXI 的药物可在不显著增加出血风险的前提下防治血栓，有望为患者提供更安 全的抗凝选择。当前该领域的研发活跃，2026 年起预计有多个药物进入关键数据读 出的阶段，静待抗凝领域新一代"大药"的诞生。 投资要点： [Table_Report] 相关报告 医药《医疗设备招采规模高基数影响部分回落， 关注手术机器人市场机遇》2026.02.09 医药《高景气延续，持续推荐创新药械产业链》 2 ...

Summary of Tango Therapeutics Conference Call Company Overview - **Company**: Tango Therapeutics (NasdaqGM:TNGX) - **New CEO**: Malte Peters, who has been a board member since 2018 and emphasizes continuity in strategy following the transition from former CEO Barbara. Key Priorities and Strategic Focus - **Regulatory Approval**: The primary focus is to achieve regulatory approval for vopimetostat, either as a monotherapy or in combination with RAS inhibitors [4][5]. - **Clinical Development**: Transitioning Tango into a late-phase drug development company is a key priority, with a pivotal trial protocol developed for second-line pancreatic cancer [4][6]. Clinical Trials and Data - **Pivotal Trial for Pancreatic Cancer**: A pivotal trial protocol for second-line pancreatic cancer has been developed, with positive feedback from the FDA regarding trial design and statistical analysis [6][11]. - **Combination Trials**: A combination trial of vopimetostat with RevMed's RAS inhibitors (daraxonrasib and zoldonrasib) has been initiated, showing early signs of clinical activity [6][16]. - **Monotherapy Study**: A 300-patient study is planned, focusing on progression-free survival (PFS) and overall survival [9][12]. - **Promising Data**: Previous monotherapy data indicated a 25% overall response rate (ORR) and approximately 7 months PFS in pancreatic cancer [12]. Market and Competitive Landscape - **Global Trial Design**: The study will be conducted globally, including the USA, Europe, and Asia Pacific, to enhance patient recruitment [11]. - **Chemo-Free Regimen**: There is significant interest in developing a chemotherapy-free regimen for pancreatic cancer, which could greatly benefit patients [37][41]. - **Comparison with Competitors**: Tango is pursuing a different strategy than competitors like BMS, focusing on non-chemotherapy combinations due to scientific and financial considerations [40][41]. Future Directions and Opportunities - **Expansion into Other Tumor Types**: The company is exploring opportunities in other tumor types with MTAP deletions, showing promising signals in head and neck cancer [45][46]. - **TNG456 Development**: The TNG456 clinical trial is in dose escalation, with plans to explore its potential in glioblastoma and non-small cell lung cancer [42][43]. - **Combination with Abemaciclib**: There are plans to pursue a combination with abemaciclib based on preclinical data suggesting potential benefits [49]. Upcoming Updates - **Data Releases**: Updates on pancreatic cancer monotherapy data, combination data with Revolution Medicines, and TNG456 dose escalation data are expected later this year [51][56]. Conclusion - **Exciting Year Ahead**: The company anticipates a year filled with significant developments and data releases, positioning itself for potential breakthroughs in cancer treatment [56].

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The pharmaceutical index in A-shares has shown a slight increase of 0.14% this week and 3.28% year-to-date, outperforming the CSI 300 by 1.41% and 0.85% respectively [3][8] - The report highlights the emergence of molecular glue as a significant trend in the industry, with several successful stocks like RVMD, GLU, and KYMR, and substantial business development (BD) activities [3][15] - The report suggests that molecular glue has the potential to create new blockbuster drugs in oncology and autoimmune diseases, urging investors to focus on domestic companies involved in this area [3][11] Summary by Sections 1. Market Performance - The A-share pharmaceutical index has outperformed the CSI 300 index, with notable gains in traditional Chinese medicine (2.56%), medical services (1.31%), and raw materials (0.64%) [3][8] - The report lists top-performing stocks, including Guangsheng Tang (+29.83%) and HaiXiang Pharmaceutical (+18.64%), while noting declines in stocks like Changshan Pharmaceutical (-15.78%) [8] 2. Molecular Glue - Molecular glue is defined as a class of small molecule drugs that facilitate the binding of E3 ubiquitin ligases to previously unrecognized pathogenic target proteins, leading to their degradation [15] - The report mentions that BMS has two marketed molecular glues with peak sales exceeding $16 billion, and ongoing research into new iterations [3][15] - Domestic companies such as Yuan Dong Biology and Jin Fang Pharmaceutical are noted for their potential in molecular glue development [3][11] 3. R&D Progress and Corporate Developments - The report highlights significant clinical research milestones, including Pfizer's initiation of a Phase II/III trial for its PD-1/VEGF bispecific antibody SSGJ-707 [3] - It also notes that Novartis has submitted its BAFF-R monoclonal antibody for approval in China, and AbbVie has started a Phase II trial for its Bcl-2 inhibitor Venetoclax [3] 4. Recommended Stocks - The report provides a list of recommended stocks across various sectors, including: - CXO and upstream research services: WuXi AppTec, Hao Yuan Pharmaceutical, and Aopumai [11] - Traditional Chinese medicine: Zuo Li Pharmaceutical and Fang Sheng Pharmaceutical [11] - PD-1 PLUS: 3SBio, KANGFANG Biologics, and Innovent Biologics [11] - ADC: Ying En Biologics and Kelong Biotechnology [11] - AI drug development: Jing Tai Holdings [11]

Core Viewpoint - The company, Baillie Tianheng, is expected to report a net profit of -1.1 billion CNY for 2025, marking a significant decline of 129.67% year-on-year, reflecting the challenges faced by Chinese innovative pharmaceutical companies in balancing R&D investment and commercialization [2][29]. Financial Performance - Baillie Tianheng's revenue for 2025 is projected to be approximately 2.5 billion CNY, a decrease of 33.23 billion CNY or 57.06% compared to the previous year [2][29]. - The company has reported consecutive losses from 2021 to 2023, accumulating losses of 1.3 billion CNY [5][31]. - In 2024, the company achieved a revenue of 5.823 billion CNY and a net profit of 3.708 billion CNY, a staggering increase of 575.02% year-on-year, primarily driven by an 800 million USD upfront payment from BMS [5][31]. R&D Investment - The company has significantly increased its R&D investment, with a reported expenditure of 1.772 billion CNY in the first three quarters of 2025, a 90.23% increase year-on-year, accounting for 85.79% of its operating revenue [5][31]. - The company has 17 innovative drugs in clinical trials, with over 100 ongoing clinical trials globally, including more than 90 in China [21][48]. IPO and Market Performance - Baillie Tianheng's plans for an IPO in Hong Kong have faced delays, with the company announcing a postponement of its global offering due to current market conditions [9][36]. - The company had initially planned to issue 8.6343 million H-shares, aiming to raise approximately 3.359 billion HKD [10][37]. Product Pipeline and Commercialization - The core product, BL-B01D1, is a dual-target ADC drug that has completed Phase III clinical trials and aims to treat various cancers [17][44]. - The potential annual peak sales for BL-B01D1 are estimated to reach 20 billion USD, but the product has yet to achieve commercialization [23][50]. - The company is currently facing challenges in its commercialization capabilities, as it has no marketed innovative drug products and its traditional business continues to decline [24][50]. Conclusion - The performance fluctuations of Baillie Tianheng highlight the pitfalls of relying on one-time revenue models in the innovative pharmaceutical sector, emphasizing the need for effective commercialization of R&D investments [25][51]. - The company's future success will depend on its ability to balance R&D investments with sustainable revenue generation and the successful commercialization of its core products [52].

Core Viewpoint - Pfizer has unveiled a significant R&D plan for 707/PF'4404 (PD-1/VEGF) in collaboration with 3SBio, with an accelerated pace and breadth beyond expectations, aiming to initiate four global Phase III clinical trials by 2026 across five major first-line indications [1][2] Group 1: Clinical Development - Pfizer plans to launch four Phase III clinical trials in 2026 targeting first-line squamous/non-squamous NSCLC, mCRC, endometrial cancer, and urothelial carcinoma [2] - The company has already completed the first patient enrollment for Phase III trials targeting first-line NSCLC and mCRC, as well as Phase II/III trials for first-line ES-SCLC [2] - Pfizer will also initiate Phase III clinical studies combining 707 with various ADCs, such as Padcev for first-line treatment of urothelial carcinoma [2] Group 2: Competitive Landscape - Four multinational corporations (MNCs) are competing in the PD-(L)1/VEGF space, including Pfizer, BMS, Merck, and AbbVie, with Pfizer expected to stand out due to its "speed, breadth, and depth" advantages [2] - BMS and BioNTech have announced extensive clinical plans, but their progress in core indications like first-line NSCLC and mCRC lags behind Pfizer [2] Group 3: Pipeline and Financials - 3SBio is increasing R&D investments with multiple pipelines expected to yield clinical data, including 705 (PD-1/HER2) and 706 (PD-1/PD-L1) in Phase II trials in China [3] - The core business fundamentals of 3SBio remain robust, with projected revenue of approximately 4.2 billion yuan in 2025, including 2.89 billion yuan from the upfront payment for 707 licensing [3] - Excluding the upfront payment, the internal business revenue of 3SBio is estimated to grow by about 9% year-on-year [3] Group 4: Investment Rating - The company maintains a "Buy" rating with a target price of 37.43 HKD, supported by an estimated net cash position of approximately 13 billion yuan [4] - Confidence in 707 becoming a global blockbuster is reaffirmed due to Pfizer's unexpected clinical advancement [4]

Investment Rating - The report maintains a "Positive" outlook for the pharmaceutical and biotechnology industry in China [6] Core Insights - The focus remains on the combination of IO (Immuno-Oncology) and ADC (Antibody-Drug Conjugates), with significant advancements expected in their joint application [10][11] - The year 2026 is identified as a critical year for the combination of IO and ADC, with expectations for increased demand for ADCs, particularly in the context of various cancer treatments [11][41] Summary by Sections Section 1: Focus on Second-Generation IO and ADC - Merck's sac-TMT is a strategic focus, with 16 ongoing Phase III clinical trials, particularly in gynecological cancers [14][15] - AstraZeneca has 8 ADCs in clinical stages, with significant data readouts expected in 2026 [19][20] - Pfizer is advancing 4 Phase III clinical trials for its PD-1/VEGF dual antibody SSGJ-707, highlighting its strategic importance in oncology [26][27] - Johnson & Johnson aims to become the leading oncology company by 2030, focusing on multiple myeloma and various cancers [30] - Bristol-Myers Squibb (BMS) is advancing its PD-L1/VEGF dual antibody and oral CELMoD therapies, with significant data catalysts expected in 2026 [32][33] - Roche is focusing on breast cancer, with its oral SERD Giredestrant expected to be approved soon [37][38] Section 2: The Year of IO+ADC Combination - The combination of IO and ADC is seen as a key development direction, with various clinical trials underway [41] - The first-generation IO+ADC combinations are competitive, with sac-TMT emerging as a significant player [42] - The second-generation IO combined with chemotherapy is led by AK112, with multiple milestones expected in the coming years [47] - The second-generation IO combined with ADC is still in early exploration, with AstraZeneca leading the way [49] Section 3: Investment Recommendations and Targets - The report identifies several investment targets, including Kangfang Biotech, 3SBio, and others, highlighting their potential in the oncology sector [11][56]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 37.43, representing a potential upside of 55.5% from the current price of HKD 24.08 [2][8]. Core Insights - Pfizer is rapidly advancing the global clinical development of 707/PF'4404 (PD-1/VEGF), with plans to initiate four Phase III trials in 2026 targeting five major indications. This development is expected to position Pfizer favorably in the competitive landscape of next-generation cancer immunotherapy [1][8]. - The collaboration between Pfizer and the company is anticipated to unlock significant global value for 707/PF'4404, serving as a key catalyst for the company's upward trajectory [1][8]. - The company is also increasing its R&D investments, with multiple pipelines expected to yield clinical data soon, enhancing the potential for external licensing opportunities [8][12]. Financial Summary - For FY23A, the company reported sales revenue of RMB 7,816 million, with a year-on-year growth of 13.8%. Projections for FY24A and FY25E are RMB 9,108 million and RMB 17,972 million, respectively, indicating a significant growth trajectory [2][15]. - The net profit attributable to shareholders for FY23A was RMB 1,549 million, reflecting a decline of 19.1% year-on-year, but is expected to rebound to RMB 2,090 million in FY24A and surge to RMB 9,741 million in FY25E, marking a growth of 366.0% [2][15]. - The earnings per share (EPS) for FY25E is projected at RMB 3.84, with a price-to-earnings (P/E) ratio of 5.6, indicating a strong valuation relative to earnings [2][15]. Market Position and Shareholder Structure - The company's market capitalization stands at HKD 61,115.2 million, with a 52-week stock price range of HKD 35.90 to HKD 6.01 [3][4]. - Major shareholders include TMF (Cayman) Ltd. with 22.8% and Decade Sunshine with 19.6%, indicating a concentrated ownership structure [4]. Clinical Development and Pipeline - The report highlights the competitive landscape for PD-(L)1/VEGF therapies, with Pfizer's strategy of combining IO with ADCs (antibody-drug conjugates) as a unique advantage [1][8]. - The company has several promising candidates in its pipeline, including 705 (PD-1/HER2) and 706 (PD-1/PD-L1), which are currently in Phase II trials in China [8][12]. Valuation and Forecast Adjustments - The report adjusts the financial forecasts for FY25E and FY26E, reflecting a slight increase in revenue expectations due to the anticipated success of the 707 program [12][13]. - The DCF valuation analysis estimates a per-share value of HKD 37.43, based on a weighted average cost of capital (WACC) of 10.11% and a perpetual growth rate of 2.0% [13][14].

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 [29]. Core Insights - The MSCI China Healthcare Index has increased by 9.2% since the beginning of 2026, outperforming the MSCI China Index, which rose by 5.6% [1]. - The pharmaceutical industry has seen significant growth, driven by strong institutional investor interest and the ongoing trend of innovative drugs going global [1]. - The report emphasizes the importance of clinical progress and data validation for pipelines that have already gone overseas, suggesting that this trend will continue in the long term [1]. Summary by Sections Industry Overview - The report highlights a robust trend in the outbound licensing of innovative drugs, with multiple business development (BD) transactions occurring at the start of 2026, reflecting a high level of activity in the sector [4]. - Key transactions include significant upfront and milestone payments for various drugs, indicating strong market interest and potential for future growth [4]. Company Ratings and Valuations - The report provides detailed valuations for several companies, including: - **Sangfor Technologies (1530 HK)**: Market cap of $7,598.4 million, target price of $37.58, with a 54% upside potential [2]. - **Gusongtang (2273 HK)**: Market cap of $963.3 million, target price of $44.95, with a 46% upside potential [2]. - **WuXi AppTec (2268 HK)**: Market cap of $10,551.0 million, target price of $88.00, with a 28% upside potential [2]. - **China National Pharmaceutical Group (1177 HK)**: Market cap of $15,951.4 million, target price of $9.40, with a 42% upside potential [2]. Market Trends - The report notes that the competition in the PD-(L)1/VEGF space is intensifying, with several companies advancing their clinical trials and aiming for first-line indications [4]. - The report suggests that the efficiency and breadth of clinical trials, as well as the richness of combination therapies, will be critical factors in determining success in this competitive landscape [4].