Financial Performance - BeOne reported Q2 2025 revenue of $1.3 billion, a 42% year-over-year increase[13] - BRUKINSA U S revenue reached $684 million, representing a 43% year-over-year growth[16] - TEVIMBRA revenue increased by 22% year-over-year[45] - GAAP earnings per ADS were $0.84, while non-GAAP earnings per ADS were $2.25[13] - GAAP operating cash flow was $264 million, and free cash flow was $220 million[13] BRUKINSA Highlights - BRUKINSA is the U S revenue leader among BTK inhibitors and the fastest-growing brand[15] - BRUKINSA demonstrated an overall response rate (ORR) ranging from 76.3% to 88.4% across different follow-up periods in the ALPINE trial[23] - In the ALPINE trial, BRUKINSA showed progression-free survival (PFS) superiority over ibrutinib in relapsed/refractory CLL patients, with a hazard ratio of 0.66 (95% CI: 0.52, 0.84)[26] Pipeline Development - Registrational filings for Sonro in China for R/R CLL and R/R MCL have been submitted[13] - Phase 3 trials have been initiated for Sonro in combination with CD20 antibody[13] - Global registrational filings for Sonro in R/R MCL are expected in the second half of 2025[13]

Core Viewpoint - In the first half of 2025, BeiGene achieved a net profit of 450 million yuan, marking its first profit driven by product sales rather than external licensing, primarily due to the sales growth of its self-developed products, Brukinsa (Zebutinib) and Tislelizumab, as well as Amgen's licensed products [1][2]. Financial Performance - In the first half of 2025, BeiGene reported total revenue of 17.518 billion yuan, a year-on-year increase of 46% [1]. - The global sales of Brukinsa reached 12.527 billion yuan, up 56.2% year-on-year, with U.S. sales contributing 8.958 billion yuan, reflecting a 51.7% increase [3]. - Tislelizumab's sales totaled 2.643 billion yuan, growing by 20.6% year-on-year, driven by new patient demand from its inclusion in the Chinese medical insurance [3]. Revenue Guidance and Profitability - BeiGene updated its revenue guidance for 2025, now expecting total revenue between 35.8 billion and 38.1 billion yuan, with a gross margin forecasted to be in the mid-to-high range of 80% to 90% [3]. - The company anticipates positive net cash flow from operating activities after capital expenditures for the year [3]. Product Development and Pipeline - BeiGene plans to conduct multiple concept validation data readouts across a broad product portfolio, with over 20 milestone advancements expected in the next 18 months in both hematological and solid tumor pipelines [3][4]. - The company is advancing its two blood cancer products, BCL2 inhibitor Sotorasib and BTK chimeric degradation-activated compound BGB-16673, which are in Phase 3 clinical trials [4]. Clinical Trials and Regulatory Progress - Sotorasib is being evaluated in global clinical trials, with a focus on its use in combination with Brukinsa for treating relapsed or refractory chronic lymphocytic leukemia and mantle cell lymphoma [5]. - The application for Sotorasib's marketing in China has been accepted and is under priority review, with plans for data readout from Phase 2 trials expected in the second half of 2025 [5].

报告期内，百济神州营业利润达7.99亿元，归属于母公司所有者的净利润达4.5亿元，较去年同期均实现 扭亏为盈。这也是百济神州今年以来首次在营业利润和归母净利润上实现全面盈利。公告显示，此次实 现盈利主要由于产品收入的大幅增长，同时费用管理推动了经营效率的提升。 北京商报讯（记者 王寅浩 实习记者 宋雨盈）8月6日，百济神州披露2025年上半年主要财务数据。2025 年上半年，百济神州实现营业总收入175.18亿元，同比增长46%。产品收入达173.6亿元，同比增长 45.8%。 ...

Core Insights - The company reported a significant increase in product revenue for the first half of 2025, reaching 17.36 billion yuan, a year-on-year growth of 45.8% [1] - Total operating revenue for the same period was 17.52 billion yuan, reflecting a 46.0% increase compared to the previous year [1] - The net profit attributable to the parent company was 450 million yuan, with total assets amounting to 44.87 billion yuan, an increase of 4.8% from the beginning of the period [1] Product Performance - The growth in product revenue was primarily driven by the sales of self-developed products such as Baiyueze® (Zebutinib capsules) and licensed products from Amgen, as well as Baizean® (Tislelizumab injection) [2] - Baiyueze® achieved global sales of 12.53 billion yuan, a year-on-year increase of 56.2%, with U.S. sales reaching 8.96 billion yuan, up 51.7% [2] - European sales of Baiyueze® totaled 1.92 billion yuan, marking an 81.4% increase, while sales in China reached 1.19 billion yuan, a growth of 36.5% [2] Market Position and Clinical Development - Baizean® recorded sales of 2.64 billion yuan, a 20.6% increase, driven by new indications approved for reimbursement in China [3] - Baiyueze® is noted for having the broadest range of approved indications among BTK inhibitors globally, with ongoing clinical trials in over 30 countries involving approximately 7,100 patients [3] - The company is advancing its pipeline of next-generation self-developed products, emphasizing rapid generation of early clinical validation data through a cost-effective global development model [4] Research and Development Strategy - The company has a global R&D team of over 3,700 people, conducting trials across six continents and collaborating with regulatory agencies and researchers in over 45 countries [4] - The strategic R&D model is data-driven, allowing the company to allocate resources to the most promising projects while adjusting priorities for others [4] - The company anticipates over 20 milestone advancements in its hematological and solid tumor pipelines within the next 18 months [4]

美国证券交易委员会 Washington, D.C. 20549 ___________________________________________________________ 表格 10-Q ___________________________________________________________ （选择一项） 根据 1934 年证券交易法第 13 条或第 15（d）条编制的季度报告 截至 2025 年 6 月 30 日的季度期间 或 根据 1934 年证券交易法第 13 条或第 15（d）条编制的过渡报告 过渡期从 至 交易委员会档案编号：001-37686 百济神州有限公司 （注册人章程中载明的准确名称） 瑞士 98-1209416 （注册成立或组织所在的州或其他司法管辖区） （美国国家税务局雇主身份识别号码） c/o BeOne Medicines I GmbH Aeschengraben 27 巴塞尔，瑞士 4051 （主要行政办事处地址） （邮政编码） +41 61 685 19 00 （注册人的电话号码，包括地区编码） 根据本法案第 12（b）条注册的证券： 各类别名称 交易 ...

Core Viewpoint - BeOne Medicines Ltd. (formerly known as 百濟神州有限公司) reported strong financial performance for the second quarter of 2025, highlighting significant revenue growth and key business developments in the oncology sector [3][4]. Financial Performance - Total revenue for Q2 2025 reached $1.315 billion, a 42% increase year-over-year from $929 million [3][4]. - Product revenue for Q2 2025 was $1.302 billion, up from $921 million in the same period last year, driven primarily by the sales of 百悅澤 (Zebutinib) [3][4]. - The diluted earnings per American Depositary Share (ADS) were $0.84 under GAAP and $2.25 under non-GAAP, compared to a loss of $1.15 in the previous year [3][4][5]. - Free cash flow for Q2 2025 was $220 million, an increase of $425 million year-over-year [5]. Key Business Highlights - 百悅澤 (Zebutinib) generated global revenue of $950 million in Q2 2025, reflecting a 49% year-over-year growth [3][4]. - The company anticipates over 20 milestone developments in its blood cancer and solid tumor pipelines within the next 18 months [3][4]. - The company has received regulatory approvals for new formulations and expanded indications for its key products, enhancing its market presence [5][6]. Operational Insights - The gross margin for Q2 2025 was 87.4%, up from 85.4% in the previous year, benefiting from improved production efficiency [3][4]. - Research and development (R&D) expenses increased due to advancements in clinical projects, with total operating expenses for Q2 2025 amounting to $1.063 billion, an 18% increase from the previous year [3][4][8]. - The company maintains its full-year revenue guidance for 2025 at $5 billion to $5.3 billion, reflecting strong growth expectations [5][6]. Future Outlook - The company plans to initiate several clinical trials and expects to achieve significant regulatory milestones in the coming months [6][7]. - BeOne Medicines Ltd. aims to expand its product pipeline and enhance drug accessibility for cancer patients globally [6][7].

8月6日晚间，百济神州(688235)发布2025年半年度主要财务数据显示，上半年公司产品收入为173.6亿 元，较上年同比上升45.8%；营业总收入175.18亿元，较上年同比上升46%；归属净利润4.5亿元，同比 扭亏为盈。 百济神州表示，产品收入的增长主要得益于自主研发产品百悦泽 （泽布替尼胶囊） 和安进授权产品以 及百泽安（替雷利珠单抗注射液）的销售增长。 （文章来源：北京商报） ...

8月6日，百济神州(纳斯达克代码：ONC；香港联交所代码：06160.HK；上交所代码：688235.SH)公布 2025年第二季度美股业绩报告，以及A股半年度主要财务数据公告。2025年上半年，百济神州实现营业 总收入175.18亿元，同比增长46.0%。产品收入达173.60亿元，同比增长45.8%。 基于此，百济神州更新收入指引，预计2025年全年营收将从人民币352亿元至381亿元之间，调整为人民 币358亿元至381亿元之间。此外，毛利率更新为80%至90%的中高位区间。现金流方面，经营活动产生 的现金流量扣除购建固定资产等资本性支出后的净额预计全年为正。 百济神州联合创始人、董事长兼首席执行官欧雷强(John V. Oyler)表示："第二季度强劲的表现，进一步 巩固了公司在全球肿瘤治疗领域的领先地位，并充分证明了我们实现可持续、长期增长的能力。我们目 标明确，正在不断朝着使命前进，致力于为全球更多患者带来突破性药物。百悦泽 作为公司血液肿瘤 领域的核心产品，确立了同类最佳BTK抑制剂的标杆地位，获批适应症最广泛，并在美国市场继续保持 领先优势，这得益于其在五个适应症中展现出的优异疗效、良好的安全 ...

Core Viewpoint - BeiGene reported strong financial performance for the first half of 2025, achieving significant revenue growth and profitability, driven by product sales and effective cost management [1][2][3] Financial Performance - Total revenue for the first half of 2025 reached RMB 17.518 billion, a year-on-year increase of 46.0% [1] - Product revenue amounted to RMB 17.360 billion, reflecting a growth of 45.8% compared to the previous year [1] - Operating profit was RMB 799 million, and net profit attributable to shareholders was RMB 450 million, marking a turnaround from losses in the same period last year [1] - The company updated its revenue guidance for 2025, now expecting total revenue between RMB 35.8 billion and RMB 38.1 billion, with a gross margin forecast of 80% to 90% [1] Product Performance - The BTK inhibitor, Zanubrutinib (Brukinsa), achieved global sales of RMB 12.527 billion in the first half of 2025, a 56.2% increase year-on-year [3] - In the U.S. market, Zanubrutinib sales reached RMB 8.958 billion, up 51.7%, driven by strong demand across all indications [3] - The PD-1 inhibitor, Tislelizumab, generated sales of RMB 2.643 billion, a 20.6% increase, benefiting from new indications and increased hospital access in China [4] R&D Pipeline - The company is at a critical juncture in its R&D pipeline, expecting over 20 milestone events in the next 18 months across hematological and solid tumor indications [6] - BeiGene has advanced 15 new molecular entities into clinical trials from 2019 to 2023, with over 10 new entities entering trials in 2024 alone [6] - The company has established a robust global clinical development platform, conducting over 170 trials across 40 countries with more than 25,000 patients enrolled [6] Future Developments - In hematological oncology, BeiGene has three fully owned products, including Zanubrutinib and two candidates in Phase 3 trials, which are expected to meet unmet needs in chronic lymphocytic leukemia (CLL) [7] - In solid tumors, the company is advancing multiple products, including a CDK4 inhibitor for breast cancer and a PRMT5 inhibitor, with clinical trials expected to commence in the near future [8][9]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 海外監管公告 本公告乃百濟神州有限公司（BeOne Medicines Ltd., 「本公司」）根據香港聯合交易 所有限公司證券上市規則第13.10B條作出。 茲載列本公司於上海證券交易所網站刊發的《百濟神州有限公司自願披露關於 2025年度經營業績預測調整的公告》，僅供參閱。 承董事會命 百濟神州有限公司 主席 歐雷強先生 香港，2025年8月6日 於本公告日期，本公司董事會包括主席兼執行董事歐雷強先生、非執行董事王 曉東博士，以及獨立非執行董事Olivier Brandicourt博士、Margaret Han Dugan 博士、Michael Goller先生、Anthony C. Hooper先生、Ranjeev Krishana先生、 Alessandro Riva博士、Cora ...