26H1 催化丰富、CDK4 抑制剂重点转向一线 Bcl2 抑制剂索托克拉：预计26H1 启动ZS 固定剂量方案对比AV方案的III 期试验，ASH 数据来看有望成 为BIC；BTK CDAC/BGB-16673：预计26H1 读出用于后线CLL 的II 期潜在关键试验数据； CDK4 抑制剂/BGB-43395：预计26H1 启动用于1L BC 的III 期试验（不再开发2L）； 事件 公司公布2025 年三季报，25Q1-Q3 收入为276.0 亿元（+44.2%），归母净利润为11.4 亿元（去年同期 为-36.9 亿元），扣非归母净利润为9.7 亿元（去年同期为-39.9 亿元）。25Q3 收入为100.8 亿元 （+41.1%），归母净利润为6.9 亿元（去年同期为-8.1 亿元），扣非归母净利润为7.1 亿元（去年同期 为-8.7 亿元）。公司同时将全年收入指引从此前的50-53 亿美元调整至51-53 亿美元、全年GAAP 经营利 润为正的指引不变。 核心观点 25Q3 泽布替尼突破10 亿美元， 费用环比稳中略降前三季度拆分来看，泽布替尼全球收入达27.8 亿美元 （+53.2%），其中美国1 ...

Core Viewpoint - BeiGene's Q3 2025 performance exceeded expectations with product revenue of $1.395 billion (up 7% quarter-over-quarter) and a GAAP net profit of $125 million, marking a year-on-year turnaround [1] Group 1: Financial Performance - Product revenue reached $1.395 billion, reflecting a 7% increase compared to the previous quarter [1] - GAAP net profit was $125 million, indicating a year-on-year turnaround from losses [1] Group 2: Future Guidance and Clinical Developments - The company raised its full-year guidance while actively advancing its next-generation self-developed pipeline products globally [1] - In H2 2025, BeiGene plans to submit an accelerated approval application for the Phase II data of Sotigalimab targeting R/R MCL in the US and EU [1] - In H1 2026, the company will initiate a Phase III clinical trial for CDK4 targeting HR+/HER2- BC [1] - Additional clinical pipeline POC data readouts are anticipated [1] Group 3: Market Opportunities - The overseas expansion of BTK has exceeded expectations, contributing to revenue growth [1] - The commercialization of PD-1 in the EU, Japan, and other countries is expected to further enhance revenue [1] - Continued realization of significant pipeline products such as BCL-2, BTK CDAC, and CDK4 is anticipated to drive further commercialization [1]

Core Viewpoint - BeiGene's Q3 2025 performance exceeded expectations, with product revenue reaching $1.395 billion, a 7% quarter-over-quarter increase, and a GAAP net profit of $125 million, marking a year-on-year turnaround [1] Group 1: Financial Performance - Product revenue for Q3 2025 was $1.395 billion, reflecting a 7% increase compared to the previous quarter [1] - The company achieved a GAAP net profit of $125 million, indicating a year-on-year turnaround [1] - The annual guidance has been raised due to strong performance [1] Group 2: Clinical Development Pipeline - The company is advancing its next-generation self-developed pipeline with a focus on global clinical layouts and progress [1] - In H2 2025, BeiGene plans to submit an accelerated approval application for the Phase II data of Sotigalimab targeting R/R MCL in the US and EU [1] - In H1 2026, the company will initiate a Phase III clinical trial for CDK4 targeting HR+/HER2- BC [1] - Additional clinical pipeline POC data readouts are anticipated [1] Group 3: Market Opportunities - The overseas volume of BTK has exceeded expectations, contributing to growth [1] - The PD-1 product is experiencing volume growth in the EU, Japan, and other countries [1] - Continued commercialization of key pipelines such as BCL-2, BTK CDAC, and CDK4 is expected to drive further revenue realization [1] - The company maintains a "Buy" rating based on these developments [1]

Core Viewpoint - The article highlights the significant financial performance of BeiGene, showcasing its successful global business strategy and marking a milestone in the profitability of Chinese innovative pharmaceutical companies in the oncology sector [2]. Financial Performance - In Q3 2025, BeiGene reported total revenue of $1.4 billion, a 41% increase year-over-year, achieving a historical high for the same period. The net profit was 689 million yuan, marking a turnaround from losses [1]. - For the first three quarters of 2025, revenue reached 27.595 billion yuan, up 44.2% year-over-year, with a net profit of 1.139 billion yuan, also a turnaround from losses [1]. Product Performance - The BTK inhibitor, Zanubrutinib, achieved global sales of $1.039 billion in the quarter, a 51% increase year-over-year, entering the "blockbuster" drug category and becoming the highest-grossing product in its class [2]. - In the U.S. market, Zanubrutinib sales reached $739 million, a 47% increase year-over-year, with a growing market share and a leading position in new patient acquisition [2]. - In Europe, Zanubrutinib's sales surged to $163 million, a 68% increase year-over-year, with full inclusion in health insurance in major countries like Germany, Italy, and France [2]. Regulatory Approvals and Clinical Trials - Zanubrutinib is approved for five indications, including chronic lymphocytic leukemia and mantle cell lymphoma, with ongoing expansion into new indications such as primary membranous nephropathy [3][4]. - The company has also made significant progress with its PD-1 product, Tislelizumab, which received EU approval for use in non-small cell lung cancer [4]. Future Outlook - BeiGene has raised its revenue guidance for the year from $5-5.3 billion to $5.1-5.3 billion, driven by the continued growth of Zanubrutinib and its expansion in Europe and other regions [7]. - The company anticipates several important developments in 2026, including potential orphan drug designation for Zanubrutinib in Japan and further clinical trials for its other products [7][8]. - The revenue potential for BeiGene remains substantial, with upcoming data readouts expected to drive future growth [9].

Core Viewpoint - Haitong International has raised its revenue forecasts for BeiGene (06160) for FY25-27 to $5.3 billion, $6.4 billion, and $7.1 billion respectively, reflecting a three-year revenue CAGR of 23% due to stronger-than-expected market performance of Zebrutinib in the US and Europe [1] Group 1: Financial Performance - In Q3 2025, BeiGene achieved revenue of $1.41 billion, representing a year-on-year increase of 41% and a quarter-on-quarter increase of 7.7%, with product revenue at $1.40 billion [1] - The company reported a gross margin of 86.1%, an increase of 3.1 percentage points year-on-year [1] - R&D expenses were $520 million, reflecting a year-on-year increase of 5.5% [1] Group 2: Product Performance - Zebrutinib's global revenue is expected to approach $3.9 billion in 2025, with Q3 2025 global revenue at $1.04 billion, a year-on-year increase of 50.8% and a quarter-on-quarter increase of 9.6% [1] - In the US, Zebrutinib generated $740 million, a year-on-year increase of 46.7% and a quarter-on-quarter increase of 8.0% [1] - In Europe, Zebrutinib's revenue was $160 million, a year-on-year increase of 67.5% [1] Group 3: Pipeline Developments - In the hematological malignancies area, the focus is on BCL-2 inhibitors and BTK CDAC [1] - Management anticipates data for Sotigalimab (BCL-2 inhibitor) in R/R MCL to be released at the 2025 ASH meeting, with plans to submit a US marketing application for R/R MCL [1] - For BTK CDAC, phase II clinical data for R/R CLL is expected in 1H26, and a phase III trial has been initiated [1] Group 4: Solid Tumor Developments - The company is focusing on CDK4 inhibitors, with ongoing phase II clinical trials exploring two dosage levels, showing high response rates that support the initiation of phase III trials [2] - The B7-H4 ADC (BG-C9074) has completed dose escalation and is currently undergoing dose optimization studies in ovarian cancer, endometrial cancer, and breast cancer [2] - The PRMT5i (BGB-58067) has shown good safety and efficacy data, while the GPC3-targeting T-cell activator has demonstrated effectiveness in previously treated liver cancer patients [2]

事件 2025年三季度，百济神州实现收入14.1亿美元(同比+41%，环比+7.7%)，其中公司产品收入14.0亿美元。公司实现毛利率86.1%(同比+3.1ppts)。公司研发费用 5.2亿美元(同比+5.5%)，销售费用5.3亿美元(同比+16.2%)，经营利润为1.6亿美元。三季度公司实现净利润1.2亿美元，管理层上调2025全年总收入指引至51- 53亿美元(前值50-53亿美元)，略微下调经营费用至41-43亿美元(前值41-44亿美元)。 智通财经APP获悉，海通国际发布研报称，考虑到百济神州(06160)泽布替尼在美国和欧洲市场放量超过该行此前预期，上调公司FY25-27营收分别至53亿/64 亿/71亿美元，对应三年收入CAGR为23%;此外该行上调FY25-27归母净利润分别至3.6亿/6.6亿/10.5亿美元，以反映公司销售费用和研发费用增长好于该行预 期。该行使用现金流折现(DCF)模型及FY26-FY34的现金流进行估值。基于WACC9%，永续增长率4.0%(均不变)，对应目标价213.10港元，维持"优于大 市"评级。 海通国际主要观点如下： 血液瘤方面，重点关注BCL-2抑制剂和B ...

2025年三季度，百济神州实现收入14.1亿美元(同比+41%，环比+7.7%)，其中公司产品收入14.0亿美 元。公司实现毛利率86.1%(同比+3.1ppts)。公司研发费用5.2亿美元(同比+5.5%)，销售费用5.3亿美元(同 比+16.2%)，经营利润为1.6亿美元。三季度公司实现净利润1.2亿美元，管理层上调2025全年总收入指引 至51-53亿美元(前值50-53亿美元)，略微下调经营费用至41-43亿美元(前值41-44亿美元)。 智通财经APP获悉，海通国际发布研报称，考虑到百济神州(06160)泽布替尼在美国和欧洲市场放量超过 该行此前预期，上调公司FY25-27营收分别至53亿/64亿/71亿美元，对应三年收入CAGR为23%;此外该 行上调FY25-27归母净利润分别至3.6亿/6.6亿/10.5亿美元，以反映公司销售费用和研发费用增长好于该 行预期。该行使用现金流折现(DCF)模型及FY26-FY34的现金流进行估值。基于WACC9%，永续增长率 4.0%(均不变)，对应目标价213.10港元，维持"优于大市"评级。 海通国际主要观点如下： 事件 CDK4抑制剂临床进展：1.公司目前 ...

Investment Rating - The report maintains an "Outperform" rating for BeiGene with a target price of HKD 213.10, reflecting a positive outlook on the company's performance [2][17]. Core Insights - In Q3 2025, BeiGene reported revenue of USD 1.41 billion, representing a year-on-year increase of 41% and a quarter-on-quarter increase of 7.7%. The gross profit margin was 86.1%, up by 3.1 percentage points year-on-year. The company achieved a net profit of USD 120 million for the quarter [3][13]. - Management has raised the full-year 2025 revenue guidance to USD 5.1–5.3 billion, slightly lowering the operating expenses guidance to USD 4.1–4.3 billion [3][13]. Revenue and Profit Forecasts - Revenue projections for FY25, FY26, and FY27 have been increased to USD 5.3 billion, USD 6.4 billion, and USD 7.1 billion, respectively, indicating a three-year compound annual growth rate (CAGR) of 23% [16][17]. - Net profit attributable to shareholders is forecasted to be USD 360 million, USD 660 million, and USD 1.05 billion for FY25, FY26, and FY27, respectively [16][17]. Product Performance - Zanubrutinib (BRUKINSA) generated global revenue of USD 1.04 billion in Q3 2025, with significant contributions from the U.S. (USD 740 million), Europe (USD 160 million), and China (USD 90 million). The global revenue for Zanubrutinib is expected to exceed USD 3.9 billion in 2025 [4][15]. - Tislelizumab (PD-1) reported global revenue of USD 190 million, reflecting a year-on-year increase of 16.7% [15]. Clinical Development Focus - The report highlights the importance of clinical progress in the hematologic oncology portfolio, particularly the BCL-2 inhibitor and BTK CDAC. Management plans to submit a new drug application for the R/R MCL indication and initiate a head-to-head trial in treatment-naïve chronic lymphocytic leukemia patients [14][15]. - In the solid tumor space, the focus is on the CDK4 inhibitor and B7-H4 ADC, with ongoing clinical trials and dose optimization efforts [15][16]. Valuation Methodology - The company is valued using a Discounted Cash Flow (DCF) model, with a WACC of 9% and a perpetual growth rate of 4%. The target price of HKD 213.10 reflects the company's growth potential and market position [17].

Core Insights - The company reported a total revenue of $1.4 billion in Q3 2025, representing a year-on-year increase of 41%, and achieved a GAAP net profit of $125 million, marking a turnaround from losses [1] - Zebutinib continues to show rapid growth, becoming the global leader in the BTKi market with Q3 sales of $1.04 billion, up 51% year-on-year and 10% quarter-on-quarter [1][2] - The company has raised its full-year guidance, projecting total revenue between $5.1 billion and $5.3 billion, with GAAP net profit expected to be positive for the year [1] Revenue and Profit Analysis - Zebutinib's sales in the U.S. reached $739 million, a 47% increase year-on-year, while European sales grew by 68% to $163 million [1] - The sales of another product, Tislelizumab, amounted to $191 million in Q3, reflecting a 17% year-on-year increase [1] R&D Pipeline and Future Prospects - The company anticipates significant upcoming milestones in its R&D pipeline, including clinical trials for various products scheduled for 2025 and 2026 [2] - The company has adjusted its net profit forecasts for 2025-2027 to $312 million, $795 million, and $1.222 billion, respectively, indicating a positive outlook for profitability [2] - The company maintains a "buy" rating due to its leading position in the domestic biopharma sector and successful international expansion [2]

Core Viewpoint - Guojin Securities maintains a "Buy" rating for BeiGene (06160), highlighting its leadership in the domestic biopharma sector and significant global expansion, with both commercialization and R&D reaching critical turning points [1] Financial Performance - In Q3 2025, the company achieved total revenue of $1.4 billion, a year-on-year increase of 41%, and a GAAP net profit of $125 million [1] - The updated guidance for 2025 includes total revenue of $5.1-5.3 billion, GAAP operating expenses of $4.1-4.3 billion, and a gross margin in the high 80-90% range, with positive GAAP net profit and free cash flow for the year [1] Product Sales - In Q3 2025, the sales of Zanubrutinib reached $1.04 billion, showing a year-on-year growth of 51% and a quarter-on-quarter increase of 10%, establishing it as a leader in the global BTKi market [1] - The U.S. market contributed significantly, with sales of $739 million, a year-on-year increase of 47% and a quarter-on-quarter increase of 8%, while the European market saw a sales increase of 68% year-on-year, reaching $163 million [1] - Sales of Tislelizumab in Q3 2025 amounted to $191 million, reflecting a year-on-year growth of 17% [1] R&D Milestones - Upcoming R&D milestones include the submission of Sotigalimab in H2 2025 in the U.S., initiation of head-to-head clinical trials for Zanubrutinib and Acalabrutinib in H1 2026, and the start of Phase III trials for MM in H2 2026 [2] - The company plans to read out potential registration clinical data for BTKCDAC in H1 2026 and will not pursue second-line development for CDK4 inhibitors, instead focusing on first-line HR+HER2- breast cancer trials [2] - POC data readouts are expected in H1 2026 for FGFR2b ADC, pan-KRASi, EGFRCDAC, and CDK2i, with additional data readouts in H2 2026 for PRMT5i+MAT2Ai and EGFR/MET/MET tri-antibodies [2]