Group 1 - The company has adjusted its 2025 annual operating performance forecast to provide investors with a clearer understanding of its business performance and future prospects [1][2] - The adjustment in expected operating income is primarily attributed to the leading position of Baiyueze in the US market and its continued expansion in Europe and other key global markets [3] Group 2 - For the first half of 2025, the company's product revenue reached 17.36 billion RMB, a year-on-year increase of 45.8%, while total operating revenue was 17.52 billion RMB, up 46.0% from the previous year [9] - The net profit attributable to the parent company for the first half of 2025 was 450 million RMB, with total assets at 44.87 billion RMB, an increase of 4.8% from the beginning of the period [9][19] - Baiyueze's global sales totaled 12.53 billion RMB in the first half of 2025, representing a year-on-year growth of 56.2%, with US sales at 8.96 billion RMB, up 51.7% [10][11] Group 3 - Baiyueze is the only BTK inhibitor with flexible dosing options, and it has been approved in 75 markets globally, with ongoing clinical trials in over 30 countries [12] - The company is also advancing its next-generation pipeline products and emphasizes a rapid concept verification strategy in its global clinical development [14] - The company has a significant presence in the oncology research field, with a large team dedicated to small molecule and antibody drug discovery [14] Group 4 - The company has initiated several key clinical trials for its products, including the global phase III trial for Sonrotoclax in combination with Baiyueze for CLL patients [15][16] - The company plans to launch multiple clinical trials for various cancer treatments in the coming years, including trials for breast cancer and lung cancer [17]

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。 A 股代码：688235 A 股简称：百济神州 公告编号：2025-028 港股代码：06160 港股简称：百济神州 美股代码：ONC 百济神州有限公司 2025年半年度主要财务数据公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 特别提示： 本公告所载的百济神州有限公司（以下简称"百济神州"或"公司"）2025 年半年度主要财务数据为初步核算数据，未经会计师事务所审计，具体数据以公司 2025 年半年度报告中披露的数据为准，提请投资者注意投 ...

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]