股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年5月31日 狀態: 重新提交 致：香港交易及結算所有限公司 公司名稱: 百濟神州有限公司 (根據瑞士法律註冊成立的公司) 呈交日期: 2025年8月6日 FF301 FF301 （1）自遷址及存續於2025年5月27日（瑞士時間）生效起，百濟神州有限公司（"本公司"）於2025年4月28日通過的特別決議案採納之組織章程細則（"瑞士章程"）亦立即生效。根據瑞士章 程，本公司的股本區間範圍為138,687.8308美元（下限）至231,146.3847美元（上限），每股面值為0.0001美元。根據瑞士法律，本公司董事會有權在2029年4月28日之前，隨時或不時在股本區 間內增加或減少股本。 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06160 | 說明 | 請見 ...

Core Insights - BeiGene reported strong financial performance for Q2 2025, achieving total revenue of 17.518 billion RMB, a year-on-year increase of 46.0% [1] - The company turned profitable with an operating profit of 799 million RMB and a net profit attributable to shareholders of 450 million RMB, marking a significant turnaround from losses in the previous year [1] - BeiGene updated its revenue guidance for the full year 2025, now expecting revenue between 35.8 billion RMB and 38.1 billion RMB, with a gross margin forecast of 80% to 90% [1] Financial Performance - Total revenue for the first half of 2025 reached 17.518 billion RMB, with product revenue at 17.360 billion RMB, reflecting a growth of 45.8% compared to the previous year [1][2] - The sales of the BTK inhibitor, Zebrutinib, reached 12.527 billion RMB in the first half of 2025, a 56.2% increase year-on-year, with U.S. sales contributing 8.958 billion RMB, up 51.7% [3] - The PD-1 inhibitor, Tislelizumab, generated sales of 2.643 billion RMB, a 20.6% increase, driven by new indications approved for reimbursement in China [3] Product Development and Market Position - BeiGene's CEO emphasized the company's commitment to sustainable growth and its leading position in the global oncology market, particularly with its core product, Tislelizumab [2] - The company is advancing two additional blood cancer products in Phase 3 clinical trials, with key data expected soon, which will further strengthen its market position [2] - BeiGene plans to achieve over 20 research milestones in the next 18 months, indicating a robust pipeline in both hematologic and solid tumor treatments [2]

Performance Highlights - BeiGene (06160.HK) reported a revenue of 17.518 billion yuan for the first half of the year, a year-on-year increase of 46%; product revenue was 17.36 billion yuan, up 45.8%; net profit was 450 million yuan, turning from loss to profit [2] - Uni-President China (00220.HK) achieved approximately 17.087 billion yuan in revenue for the first half, a year-on-year increase of 10.6%; net profit was about 1.287 billion yuan, up 33.2% [2] - Zhiyu City Technology (09911.HK) announced a positive profit forecast, expecting mid-term revenue of approximately 3.135 to 3.215 billion yuan, a year-on-year increase of about 38.0% to 41.5%; net profit is expected to be around 470 to 510 million yuan, a year-on-year growth of approximately 108.9% to 126.7% [2] Earnings Forecasts - New World Development Company (00086.HK) expects mid-term net profit to increase to no less than 800 million HKD year-on-year [3] - Weizhi Jinkou (02003.HK) anticipates mid-term net profit exceeding 200 million HKD, a significant increase year-on-year [3] - Wing Chan Industrial (01596.HK) forecasts mid-term net profit of approximately 48.7 million HKD, turning from loss to profit [3] - Huaxian Optoelectronics (00334.HK) expects mid-term net profit to exceed 48.8 million HKD, a year-on-year increase of over 600% [3] - Maifushi (02556.HK) predicts mid-term net profit of approximately 31.8 to 41 million HKD, turning from loss to profit [4] - Xinwei Medical-B (06609.HK) expects mid-term net profit to exceed 40 million HKD, turning from loss to profit [5] - China Nuclear Technology (00611.HK) anticipates mid-term net profit growth of over 15% [6] Earnings Warnings - Hongxing Printing Group (00450.HK) expects mid-term net loss of approximately 49 million HKD, a significant increase year-on-year [7] - Zhongyu Land (01224.HK) forecasts mid-term net loss of approximately 40 million HKD, turning from profit to loss [7] - Beihai Group (00701.HK) anticipates mid-term net loss of 36 to 40 million HKD [8] Real Estate Sales Data - China Overseas Development (00688.HK) reported cumulative contract property sales of approximately 132 billion yuan for the first seven months, a year-on-year decrease of 18.3% [9] - Yuexiu Property (00123.HK) achieved cumulative contract sales of approximately 67.506 billion yuan for the first seven months, a year-on-year increase of about 11.7% [9] - Poly Property Group (00119.HK) reported contract sales of approximately 29.5 billion yuan for the first seven months, a year-on-year decrease of 13.49% [10] - China Overseas Hongyang Group (00081.HK) reported cumulative contract sales of 18.649 billion yuan for the first seven months, a year-on-year decrease of 12.2% [10] - Jindi Commercial Real Estate (00535.HK) reported cumulative contract sales of approximately 6.98 billion yuan for the first seven months, a year-on-year decrease of 37.37% [10] - Agile Group (03383.HK) reported pre-sale amount of approximately 5.69 billion yuan for the first seven months [11] - Hongyang Real Estate (01996.HK) reported cumulative contract sales of 3.208 billion yuan for the first seven months, a year-on-year decrease of 41.6% [12] - Zhengrong Real Estate (06158.HK) reported cumulative contract sales of approximately 2.701 billion yuan for the first seven months, a year-on-year decrease of 30.6% [12] - Jingrui Holdings (01862.HK) reported cumulative contract sales of approximately 571 million yuan for the first seven months, a year-on-year decrease of 52.54% [13] Company News - CITIC Securities (06030.HK) reported that its subsidiary, Huaxia Fund, achieved revenue of 4.258 billion yuan and net profit of 1.123 billion yuan in the first half, with assets under management totaling 285.1237 billion yuan [14] - Xinyi International (00732.HK) reported a cumulative operating revenue of approximately 9.566 billion HKD for the first seven months, a year-on-year decrease of about 5.3% [15] - Heng Rui Pharmaceutical (01276.HK) received orphan drug designation from the US FDA for its injection of Rikan Trastuzumab combined with Adebali for gastric cancer or gastroesophageal junction adenocarcinoma indications [15] - Fuhong Hanlin (02696.HK) completed the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanlikang® for active renal glomerulonephritis in China [15] - China Biopharmaceutical (01177.HK) announced that its self-developed TQ05105 (JAK/ROCK inhibitor) has been included in the breakthrough therapy designation program for the treatment of chronic graft-versus-host disease [15] Buyback Activities - HSBC Holdings (00005.HK) repurchased approximately 1.65 billion HKD worth of about 1.714 million shares at a price of 95.8 to 96.75 HKD [16] - Hang Seng Bank (00011.HK) spent approximately 22.6347 million HKD to repurchase 200,000 shares at a price of 112.8 to 113.6 HKD [17] - Yum China (09987.HK) repurchased approximately 6.264 million HKD worth of 16,800 shares at a price of 369.8 to 376 HKD [17]

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]

Core Viewpoint - Beigene, Ltd. reported significant financial results for the second quarter of 2025, showing a substantial increase in total revenue compared to the same period in 2024, driven by product sales and collaboration revenue. Financial Information - Total revenue for the three months ended June 30, 2025, was $1,315.3 million, up from $929.2 million in the same period of 2024, representing a 41.5% increase [3]. - Product revenue for the six months ended June 30, 2025, reached $2,410.6 million, compared to $1,668.1 million in 2024, marking a 44.4% increase [3]. - Gross profit for the three months ended June 30, 2025, was $1,150.7 million, compared to $791.0 million in 2024, reflecting a 45.4% increase [3]. - Operating expenses for the three months ended June 30, 2025, totaled $1,062.8 million, up from $898.2 million in 2024, indicating a 18.3% increase [3]. - The net loss for the three months ended June 30, 2025, was $94.3 million, compared to a net loss of $120.4 million in 2024, showing an improvement [3]. Balance Sheet Information - As of June 30, 2025, total assets amounted to $6,298.4 million, compared to $5,920.9 million as of December 31, 2024 [4]. - Total liabilities were $2,527.9 million as of June 30, 2025, down from $2,588.7 million at the end of 2024 [4]. - Shareholders' equity increased to $3,770.5 million as of June 30, 2025, compared to $3,332.2 million at the end of 2024 [4]. Cash Flow Information - The net cash used in operating activities for the six months ended June 30, 2025, was $307.7 million, compared to $404.2 million in 2024, indicating a reduction in cash outflow [5]. - Cash and cash equivalents as of June 30, 2025, were $2,756.1 million, compared to $2,592.7 million at the end of 2024 [5]. Business Description - Beigene is a global biotechnology company focused on developing innovative cancer therapies to improve accessibility and affordability for patients worldwide [7]. - The company relocated its registered office to Switzerland in the second quarter of 2025, which did not affect its financial reporting under U.S. GAAP [7].

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） ...