Core Insights - The company is focusing on enhancing operational efficiency through specific cost management measures to achieve profitability breakthroughs [1] Group 1: Product Strategy and Development - The company's product portfolio strategy emphasizes rapid generation of early clinical proof-of-concept data, leveraging a global development operation model that offers speed and cost advantages [2] - The company possesses one of the largest oncology research teams in the industry, excelling in small molecule and antibody drug discovery, supported by three proprietary platform technologies: Antibody-Drug Conjugates (ADC), bispecific antibodies, and Chimeric Degraders [2] - Over the next 18 months, the company anticipates more than 20 milestone advancements in its hematological and solid tumor pipelines [2] Group 2: Financial Performance and Projections - In the second quarter, the company updated its 2025 revenue forecast, projecting revenues between 35.8 billion to 38.1 billion RMB, with a gross margin guidance of 80% to 90% [2] Group 3: Market Expansion and Product Promotion - The product Bai Ze An® has been approved in 47 global markets, with 20 new markets added to the reimbursement list this quarter, including Japan, Europe, and Australia [2] - Bai Ze An® revenue grew by 22% year-over-year in the second quarter, maintaining market leadership in China while also contributing revenue from newly launched markets [2] Group 4: Future Development Directions - The company’s Chimeric Degrader Activating Compound (CDAC) technology platform is designed to induce protein ubiquitination and degradation, targeting traditionally undruggable targets through structurally designed bifunctional small molecules [2]

Core Viewpoint - BeiGene reported strong financial performance for the first half of 2025, with significant revenue growth and a return to profitability, highlighting its position as a leading global biotech company focused on innovative cancer therapies [1][2]. Financial Performance - The company achieved revenue of 17.518 billion yuan, a year-on-year increase of 46.03%, and a net profit of 450 million yuan, compared to a loss of 2.877 billion yuan in the same period last year [1]. - Operating cash flow reached 1.631 billion yuan, improving from a negative 3.1 billion yuan in the previous year [1]. Product Performance - The sales of the BTK inhibitor, Brukinsa (Zebutinib), totaled 12.527 billion yuan, reflecting a 56.2% year-on-year growth, with U.S. sales at 8.958 billion yuan (up 51.7%), European sales at 1.918 billion yuan (up 81.4%), and Chinese sales at 1.192 billion yuan (up 36.5%) [1]. - The PD-1 monoclonal antibody, Tislelizumab (百泽安), generated sales of 2.643 billion yuan, a 20.6% increase, driven by new indications being included in insurance coverage in China [2]. R&D Investment - R&D expenses reached 7.278 billion yuan, a 9.8% increase, representing 41.54% of total revenue, indicating a strong commitment to innovation [2]. - The company has a global R&D team of over 3,700 people, enabling faster and cost-effective drug development compared to traditional CRO models [3]. Production Capacity - BeiGene established production bases in Suzhou and Guangzhou for small molecule and large molecule biologics, with annual production capacity of approximately 600 million tablets and capsules in Suzhou and 65,000 liters in Guangzhou [4]. - A new clinical R&D and biologics manufacturing facility in New Jersey, USA, has a capacity of 8,000 liters, set to enhance production capabilities [4]. Innovative Platforms - The company is advancing its CDAC platform, which targets traditionally undruggable proteins and aims to overcome resistance issues associated with conventional small molecule inhibitors [4].

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 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 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 [1] Revenue Breakdown - The growth in product revenue was primarily driven by 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, marking a 56.2% year-on-year increase, with U.S. sales contributing 8.96 billion yuan, up 51.7% [2] - European sales of Baiyueze® totaled 1.92 billion yuan, a significant increase of 81.4%, while sales in China reached 1.19 billion yuan, growing by 36.5% [2] Product Performance - 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 and is the only one with flexible dosing options [3] - The company has conducted over 35 clinical trials involving approximately 7,100 patients for Baiyueze®, which is now approved in 75 markets worldwide [3] R&D and Future Prospects - The company is advancing its next-generation self-developed pipeline products with a focus on rapid early clinical concept validation [4] - The global R&D team consists of over 3,700 personnel, collaborating with regulatory bodies and researchers across more than 45 countries [4] - The company anticipates over 20 milestone advancements in its hematological and solid tumor pipelines within the next 18 months [4]

Core Viewpoint - The announcement presents the preliminary financial data for BeiGene, Ltd. for the first quarter of 2025, highlighting significant revenue growth driven by the sales of its self-developed products, particularly Brukinsa and Tislelizumab, while also noting a net loss for the period [4][13]. Financial Data Summary - In Q1 2025, product revenue reached 7.985 billion RMB, a year-on-year increase of 49.9% [4] - Total operating revenue for Q1 2025 was 8.048 billion RMB, up 50.2% compared to the previous year [4] - The net profit attributable to the parent company was -0.095 billion RMB [4] - Total assets at the end of the reporting period were 42.126 billion RMB, a decrease of 1.7% from the beginning of the period [4] - Shareholder equity attributable to the parent company increased by 4.3% to 25.206 billion RMB [4] Product Performance - Global sales of Brukinsa totaled 5.692 billion RMB in Q1 2025, reflecting a 63.7% year-on-year growth [5] - In the U.S., sales of Brukinsa reached 4.041 billion RMB, a 61.9% increase, driven by demand growth, particularly in chronic lymphocytic leukemia (CLL) [5] - European sales of Brukinsa were 0.836 billion RMB, up 75.4%, attributed to market share gains in major European markets [5] - In China, Brukinsa sales amounted to 0.590 billion RMB, a 43.1% increase, maintaining a leading market position in the BTK inhibitor segment [5] Clinical Development and Regulatory Progress - Brukinsa is the most widely approved BTK inhibitor globally, with ongoing clinical trials in over 30 countries and regions [7] - The product has received approvals for multiple indications in the U.S., EU, and China, with plans for further regulatory submissions in 2025 [7] - Tislelizumab sales reached 1.245 billion RMB in Q1 2025, a 19.3% increase, driven by new indications and increased patient demand in China [6] - Tislelizumab has been approved for 14 indications in China, with a strong market presence in the PD-1 segment [6] Strategic Initiatives - The company is advancing its pipeline of next-generation products and emphasizes a rapid concept validation strategy in its global clinical development [9] - The internal R&D team consists of approximately 3,700 personnel, focusing on high-quality data generation and resource optimization [9] - The company plans to present data on various products, including antibody-drug conjugates and multi-specific antibodies, throughout 2025 [9] Corporate Developments - The company received shareholder approval to adopt a new English name, BeOne Medicines Ltd., and plans to relocate its registered office to Switzerland [12] - Recent patent decisions have favored the company, enhancing its intellectual property position [12] - An investor R&D day is scheduled for June 26, 2025, to showcase developments in breast cancer and broader solid tumor treatment portfolios [12]

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。 BeiGene, Ltd. 百濟神州有限公司 （於開曼群島註冊成立的有限公司） （股份代號：06160） 內幕消息 百濟神州有限公司 截至2024年12月31日止三個月未經審核業績 及截至2024年12月31日止全年經審核業績以及業務進展 本公告乃根據香港聯合交易所有限公司證券上市規則（「上市規則」）第13.09條及 根據證券及期貨條例（香港法例第571章）第XIVA部而刊發。 百濟神州有限公司（「本公司」或「百濟神州」）欣然公佈其截至2024年12月31日 止第四季度的未經審核綜合財務業績及截至2024年12月31日止全年的經審核綜 合財務業績以及業務進展。 本公司欣然公佈本公司及其附屬公司截至2024年12月31日第四季度未經審核綜合 財務業績（「季度業績」）及截至2024年12月31日止全年經審核綜合財務業績（「全 年業績」）以及關鍵業務進展、主要管線亮點、企業進展和2025年財務指引（「業務 進展 ...