9月20日，A股百济神州收跌4%，主力资金净流出逾3000万元。港股百济神州亦收跌4.7%。 消息面上，百济神州自主研发的百泽安（替雷利珠单抗）遭诺华制药"退货"。诺华将拥有的该药在美 国、欧盟成员国等国家/地区的全球化开发、生产和商业化权益退还给百济神州。这为该药的市场前景 带来更多不确定性，也将更考验百济神州的全球商业化能力。 百济神州是国内创新药出海的先行者，目前有多款药物正在进行全球化推广。不久前，其研发的欧司珀 利单抗，商业化等权利也回到了自己手中。这对百济神州来说，是机遇，也是挑战。 9月19日晚间，百济神州宣布其自主研发的抗PD-1抗体百泽安（替雷利珠单抗）获得欧盟批准，作为单 药用于治疗既往接受过含铂化疗的不可切除、局部晚期或转移性食管鳞状细胞癌（ESCC）的成人患 者。 同一天，百济神州宣布与诺华制药集团达成协议，重新获得开发、生产和商业化替雷利珠单抗的全部全 球权利。 除欧盟之外，百济神州还在全球多个市场递交替雷利珠单抗的新药上市申请。其中，在美国，FDA正在 审评对替雷利珠单抗用于二线治疗食管鳞状细胞癌（ESCC）的新药上市许可申请，已于第二季度完成 此项申请获批前的生产基地现场核查。 ...

Core Insights - The global pharmaceutical sales ranking for the first half of 2025 has been released, highlighting the dominance of GLP-1 drugs in the market, with the top three drugs surpassing $10 billion in sales, driving industry growth [2][5] - The competition among pharmaceutical giants is intensifying, particularly in the GLP-1 category, with Novo Nordisk and Eli Lilly leading the charge [5][6] Group 1: GLP-1 Drug Market - GLP-1 drugs are the main drivers of market growth, contributing nearly 30% to the global biopharmaceutical market [3][5] - Semaglutide from Novo Nordisk topped the sales chart with $16.632 billion, while Eli Lilly's tirzepatide followed closely with $14.734 billion, marking a significant year-on-year growth of 121.3% [5][6] - The competitive landscape is shifting, with semaglutide's various formulations (injection, oral, and weight loss) ending Keytruda's long-standing dominance [5][6] Group 2: Emerging Therapies - New therapies such as bispecific antibodies, antibody-drug conjugates (ADC), and fusion proteins are gaining traction, accounting for over 15% of the top-selling drugs [3][10] - ADC drug Enhertu made its debut in the top rankings with $3.9 billion in sales, indicating a growing interest in innovative therapies [3][10] Group 3: CDK4/6 Inhibitors - The CDK4/6 inhibitor market is experiencing a reshuffle, with Eli Lilly's Abemaciclib leading at $2.648 billion, while Novartis' Ribociclib showed a remarkable growth rate of 58.7% [10] - Pfizer's Palbociclib, once a market leader, has seen a decline, dropping to $2.026 billion in sales [10] Group 4: BTK Inhibitors - The BTK inhibitor market is projected to reach approximately $12.5 billion by 2024, with Ibrutinib, Zebrutinib, and Acalabrutinib dominating the market [11][12] - Zebrutinib from BeiGene has entered the global top 50 list with $1.742 billion in sales, marking a significant achievement for Chinese innovation in the pharmaceutical sector [12][13]

Investment Rating - The report maintains a positive outlook on the innovative drug sector, recommending it as a "Buy" due to its potential for long-term growth despite short-term pressures [1]. Core Insights - The pharmaceutical sector experienced a decline of 0.8% this week, ranking last among 31 sub-industries, while the overall market indices showed positive performance [3][6]. - Innovative drug companies have shown strong revenue growth and significant business development (BD) transactions, indicating a trend of expanding market interest [1]. - Major companies like BeiGene and others have reported strong earnings, with BeiGene's revenue for H1 2025 reaching 17.52 billion yuan, a 46% year-on-year increase [1][12]. Market Performance - The overall pharmaceutical index fell by 0.8%, while the Shanghai Composite Index rose by 2.1% [3][5]. - The current valuation of the pharmaceutical sector stands at 32.2 times PE for 2025E, ranking it 6th among 31 primary industries [6][9]. Key Company Updates - BeiGene's H1 2025 revenue was 17.52 billion yuan, with a net profit of 450 million yuan, marking a turnaround from losses [1]. - Other companies like HeYue and Zai Lab also reported positive earnings growth, with HeYue's revenue increasing by 21.5% year-on-year [1][12]. Investment Analysis - The report emphasizes the importance of focusing on innovative drug companies with significant product launches and BD expectations, highlighting companies such as Hengrui Medicine, Betta Pharmaceuticals, and WuXi AppTec [1][12].

Core Insights - The global pharmaceutical sales ranking for the first half of 2025 has been released, highlighting the dominance of GLP-1 drugs, with the top three drugs surpassing $10 billion in sales, marking them as key growth drivers in the industry [1][2][3] - The competition among global pharmaceutical giants is intensifying, particularly in the metabolic drug sector, with companies like Novo Nordisk and Eli Lilly expected to further strengthen their market positions [2][3] GLP-1 Drug Market Dynamics - Novo Nordisk's GLP-1 family, particularly semaglutide, achieved sales of $16.632 billion, securing the top position, while Eli Lilly's tirzepatide followed closely with $14.734 billion, reflecting a year-on-year growth of 121.3% [3][4] - The sales of GLP-1 drugs are reshaping the "king of drugs" competition, with semaglutide and tirzepatide leading the market, and the latter's rapid growth could potentially position it as the top-selling drug for the year [3][4] Emerging Drug Categories - New therapeutic modalities, including bispecific antibodies, antibody-drug conjugates (ADC), and fusion proteins, are gaining traction, accounting for over 15% of the top-selling drugs, with ADC drug Enhertu entering the list with $3.9 billion in sales [1][8] - The mRNA vaccine category also contributed significantly, with three vaccines generating a total of $9.4 billion in sales [1] CDK4/6 Inhibitor Market - The CDK4/6 inhibitor market is experiencing a reshuffle, with Eli Lilly's Abemaciclib leading at $2.648 billion, followed by Novartis' Ribociclib, which saw a remarkable growth rate of 58.7% [6] - Pfizer's Palbociclib, once a market leader, has seen a decline, with sales dropping to $2.026 billion, marking a significant shift in market dynamics [6] BTK Inhibitor Landscape - The global BTK inhibitor market is projected to reach approximately $12.5 billion by 2024, with Ibrutinib, Acalabrutinib, and Zanubrutinib dominating over 97% of the market share [7] - Chinese innovation is making strides, with BeiGene's Zanubrutinib entering the global top 50 list for the first time, achieving sales of $1.742 billion [7][8] Future Outlook - The GLP-1 market is expected to maintain high growth, potentially securing two of the top three positions in the overall sales ranking for 2025, indicating a significant shift in the weight loss drug market [8] - The rise of new molecular entities such as bispecific antibodies and ADCs suggests that the next wave of major innovations will stem from modality innovations, further transforming the pharmaceutical landscape [8]

报告表示，百济神州2025年次季及上半年业绩均超预期，同时，集团将2025年毛利率与现金流指引上 调。该行认为，集团临床发展前景更为光明，因此将集团2025-2027年盈测分别上调14%、2%、2%，至 5.56亿美元、8.60亿美元和25亿美元。 建银国际发布研报称，基于SOTP估值及新的业务进展，上调百济神州(06160)目标价24%，由186港元升 至230港元。随着盈测上调及Bcl-2抑制剂成功概率的提高，该行对集团的估值或进一步上调，维持"跑 赢大市"评级。 ...

报告表示，百济神州2025年次季及上半年业绩均超预期，同时，集团将2025年毛利率与现金流指引上 调。该行认为，集团临床发展前景更为光明，因此将集团2025-2027年盈测分别上调14%、2%、2%，至 5.56亿美元、8.60亿美元和25亿美元。 智通财经APP获悉，建银国际发布研报称，基于SOTP估值及新的业务进展，上调百济神州(06160)目标 价24%，由186港元升至230港元。随着盈测上调及Bcl-2抑制剂成功概率的提高，该行对集团的估值或 进一步上调，维持"跑赢大市"评级。 ...

Summary of the Conference Call for BeiGene Company Overview - **Company**: BeiGene - **Industry**: Innovative Pharmaceuticals - **Date of Call**: August 10, 2025 Key Points Company Strategy and Market Position - BeiGene is a leading innovative pharmaceutical company in China, accelerating its international strategy through independent global clinical development and commercialization [2][4] - The company has a strong pipeline with high clinical enrollment speed and quality, particularly in ADC and CDECK platform development, laying a foundation for future new molecular entities [2][4] Core Products and Financial Performance - **Zebutinib**: The core product has shown strong performance in the U.S. market, with second-quarter results exceeding expectations. Year-over-year and quarter-over-quarter growth is robust, especially in the treatment of chronic lymphocytic leukemia (CLL) [2][3] - Projected revenue for 2025 is expected to reach between $5 billion and $5.3 billion, indicating significant growth [3] - Zebutinib's peak sales potential is anticipated to exceed current levels, with a global sales figure of over $2 billion last year [13] New Product Development - In addition to Zebutinib, BeiGene is developing BCL-2 inhibitor Sotorasib and BTK inhibitor CDECK, which are expected to significantly enhance revenue [2][6] - The company is actively expanding into solid tumor areas with approved products like PD-1 and early-stage products such as CDK4, PAN-KRAS, and EGFR-CDECK, which are expected to enter clinical trials in the coming years [2][6][9] Clinical Development and Regulatory Progress - Sotorasib is expected to be approved by 2026, and the progress of BTK-CDECK in Phase III clinical trials is noteworthy [8] - Multiple catalysts for development are anticipated in the second half of the year, including the approval of Sotorasib and updates on various clinical trials [10] Market Dynamics and Competitive Landscape - BeiGene's unique position as the only domestic company conducting independent global clinical development allows it to maintain a competitive edge [4] - The company is well-positioned to navigate U.S. policy changes, including drug price negotiations and Medicare reforms, with minimal impact on its core products [7][27] Financial Projections and Valuation - Future peak sales projections include $7 to $8 billion for Zebutinib, $2.5 billion for Sotorasib, and $2 billion for BTK CDECK, with a total valuation estimate of 350 billion RMB [29] - The company is rated as a "buy" due to its potential for excess returns as a leader in Chinese innovation [29] Additional Insights - The market for chronic lymphocytic leukemia is evolving, with a shift towards targeted therapies like BTK inhibitors, which have a long treatment duration and high patient numbers [12] - Fixed-duration therapies are raising concerns about market size, but real-world studies suggest that overall healthcare costs may decrease, potentially benefiting BeiGene's sales [21] Conclusion - BeiGene is positioned for significant growth with a strong pipeline and strategic international expansion, while navigating market challenges effectively. The company's innovative approach and robust product development are expected to drive future revenue and valuation increases.

根据市场公开信息及8月8日披露的机构调研信息，知名私募重阳投资近期对2家上市公司进行了调研，相关名单如下： 1）塔牌集团 （上海重阳投资管理股份有限公司参与公司电话会议） 相关ETF 科创100ETF华夏 (产品代码: 588800) 调研纪要：塔牌集团表示，7月进入传统淡季，需求端维持疲软态势，销量环比6月有所下降，9月将进入销售旺季。上半年销量逆市增长，得益于 气候适宜施工和粤东低价水泥减少，填补市场空间。煤炭采购周期1.5个月，成本影响滞后2-3个月，6月初采购的煤炭将在三季度体现，预计对成 本下降有贡献。粤东严格执行全省统一错峰生产政策，未采取更严格地方性措施。现有产能能满足市场需求，除产能置换外暂无补产能计划。金 融资产配置合理，投资风险可控，收益稳定可持续。珠三角水泥价格接近成本线，预计随销售旺季到来将企稳回升。管理费用下降主要因去年同 期辞退福利较大。资本开支主要用于环保改造、固废处置、光伏发电、智能化和绿色矿山等项目。公司建立弹性薪酬机制，员工薪酬与企业效益 挂钩，持续降本增效。受益于政策红利、需求降幅收窄、煤炭价格下降等因素，预计今年效益好于去年。 2）百济神州 （重阳投资参与公司业绩说明会 ...

Core Viewpoint - The Chinese innovative pharmaceutical industry is transitioning from imitation-based innovation to original innovation, and there is a strong emphasis on expanding into emerging overseas markets to achieve high-quality development [1][2]. Group 1: Industry Insights - Since the reform of the drug review and approval system in 2015, China's innovative drugs have entered a rapid development phase [1]. - Experts at the "Future Path of Chinese New Drugs (T20+)" conference suggested that collaboration among various stakeholders is essential to accelerate the internationalization of innovative drugs [1]. - The potential market in developing countries is significant due to their large populations, and China's innovative drugs are seen as high-quality and affordable alternatives [1]. Group 2: Company Initiatives - Companies like BeiGene, China Biologic Products, and CanSino Biologics are taking proactive steps to promote their innovative drugs in developing countries, contributing to global health challenges such as infectious diseases and chronic illnesses [1]. - A new alliance called the "Emerging Market New Drug Product Export Alliance" was established to facilitate experience sharing and collaborative efforts in promoting products to more countries [2].

Investment Rating - The report maintains an investment rating of "Outperform" with a target price set for leading stocks [3][4]. Core Insights - The innovative drug sector is experiencing fluctuations, but several catalysts are anticipated, including academic conferences, business development achievements, and negotiations for medical insurance [2]. - The National Medical Insurance Administration has updated the data on innovative drugs included in the medical insurance directory, showing rapid hospital admissions for several newly included domestic innovative drugs [2][22]. Summary by Sections Weekly New Drug Market Review - From August 4 to August 10, 2025, the top five companies in the new drug sector by stock price increase were: Beihai Kangcheng (+73.1%), Jiahe Biotech (+39.0%), Gilead Sciences (+30.3%), Heyu Biotech (+21.1%), and Hengrui Medicine (+15.3%). The top five companies with the largest declines were: Hutchison China MediTech (-13.8%), Frontier Biotech (-13.4%), Yifang Biotech (-11.7%), Haichuang Pharma (-9.9%), and Maiwei Biotech (-9.2%) [1][16]. Recommended Stocks to Watch - The report suggests focusing on potential overseas licensing opportunities for significant products, including differentiated GLP-1 assets from companies like Zhongsheng Pharma, Kangyuan Pharma, and Gilead Sciences. Additionally, upgraded PD-1 products from Kangfang Biotech and others are highlighted [2][22]. Key Analysis of the New Drug Industry - The report notes that several innovative drugs newly included in the medical insurance directory are rapidly entering hospitals, with notable growth in hospital admissions for drugs such as Zaiqiang Pharma's recombinant thrombin and Hengrui Medicine's Tazemetostat [2][22][23]. New Drug Approval and Acceptance Status - This week, three new drug applications were approved, including Adalimumab injection from Wuhan Biological Products Research Institute, Dulaglutide injection from Shandong Boan Biotech, and Evinacumab injection from Xi'an Janssen [28][29]. Additionally, four new drug applications were accepted, including Trastuzumab injection from Amgen and others [28][30]. Clinical Application Approval and Acceptance Status - A total of 55 new drug clinical applications were approved this week, while 31 new drug clinical applications were accepted [10][31].