Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its investigational BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapies [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Group 1: Clinical Trial Details - The BGB-11417-201 study is a global, multicenter, single-arm, open-label Phase 1/2 trial that enrolled 125 adult MCL patients previously treated with BTK inhibitors and anti-CD20 therapies [1] - In the first part of the study, 22 patients received daily doses of either 160 mg or 320 mg of Sotorasib to assess safety and tolerability, leading to the determination of the recommended dose for the second part [1] - The second part involved 103 patients receiving the recommended daily dose of 320 mg to evaluate the efficacy and safety of Sotorasib [1] Group 2: Efficacy and Safety Results - The study achieved the primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), indicating clinically meaningful responses in the patient population [2] - Secondary efficacy endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS), also showed positive results [2] - The safety profile of Sotorasib was generally well-tolerated, with manageable toxicity, marking an important milestone in BeiGene's product portfolio for hematologic malignancies [2] Group 3: Regulatory and Market Implications - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in the MCL indication [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study, CELESTIAL-RRMCL (BGB-11417-302), is ongoing, with the first patient enrolled earlier this year [2]

百济神州有限公司 自愿披露关于索托克拉临床试验进展的公告 A 股代码：688235 A 股简称：百济神州 公告编号：2025-034 港股代码：06160 港股简称：百济神州 美股代码：ONC 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。 重要内容提示： 1、百济神州有限公司（以下简称"公司"）公告在研 BCL2 抑制剂索托克拉 用于治疗既往接受过布鲁顿氏酪氨酸激酶（BTK）抑制剂和抗 CD20 治疗的套细 胞淋巴瘤（MCL）成人患者的 1/2 期临床研究（BGB-11417-201）取得积极结果， 并计划在即将召开的学术大会上公布全部数据。 1 注册分类：化学药品 1 类 索托克拉（Sonrotoclax）是一款新一代且具有同类最优潜力的在研 B 细胞淋 巴瘤 2（BCL2）抑制剂，BCL2 是帮助肿瘤细胞存活的几种蛋白质之一。索托克 拉类属 BH3 类似物，可模拟自然细胞死亡信号。实验室和早期药物开发研究结 果表明，索托克拉是一种具有强效性和特异性的 BCL2 抑制剂，半衰期短且无蓄 积。索托克拉在多种 B 细胞恶性 ...

百济神州8月29日披露半年报，公司上半年实现营业收入175.18亿元，同比增长46.03%；归属于上市公 司股东的净利润4.5亿元，上年同期净亏损28.77亿元；基本每股收益0.32元。 ...

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。 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。 茲載列本公司於上海證券交易所網站刊發的《百濟神州有限公司關於公司2025年 度「提質增效重回報」行動方案的半年度評估報告》，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29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 Ri ...

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2025年半年度募 集資金存放與實際使用情況的專項報告》，僅供參閱。 承董事會命 百濟神州有限公司 主席 歐雷強先生 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、Corazon (Corse ...

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2025年半年度報 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29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、Corazon (Corsee) ...

[Financial Performance](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported strong Q2 2025 revenue growth, achieved GAAP profitability, and generated positive free cash flow [Q2 2025 Key Financial Metrics](index=1&type=section&id=Q2%202025%20Key%20Financial%20Metrics) The company's Q2 2025 featured 42% revenue growth, a return to GAAP net income, and positive free cash flow Q2 & H1 2025 Financial Highlights (vs. 2024) | | Three Months Ended June 30, | | Six Months Ended June 30, | | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **% Change** | **2025** | **% Change** | | **Total revenue** | $1,315.3M | 42% | $2,432.6M | 45% | | **GAAP income (loss) from operations** | $87.9M | 182% | $99.0M | 127% | | **Adjusted income (loss) from operations*** | $274.9M | 467% | $414.3M | 519% | | **GAAP net income (loss)** | $94.3M | 178% | $95.6M | 126% | | **Adjusted net income (loss)*** | $252.8M | 985% | $389.0M | 417% | | **GAAP diluted EPS per ADS** | $0.84 | 173% | $0.85 | 124% | | **Adjusted diluted EPS per ADS*** | $2.25 | 923% | $3.48 | 397% | | **Free Cash Flow*** | $219.8M | 207% | $207.4M | 131% | - Global BRUKINSA revenues **increased 49% to $950 million** versus the second quarter of 2024[3](index=3&type=chunk) [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Product revenue growth was driven by strong BRUKINSA sales, with gross margin improving due to product mix and efficiencies - The increase in product revenue to **$1.3 billion** was primarily attributable to increased sales of BRUKINSA, with the U.S. being the largest market at **$685 million**[5](index=5&type=chunk) Q2 2025 Product Revenue Breakdown (vs. Q2 2024) | Product | Q2 2025 Revenue | YoY Growth | | :--- | :--- | :--- | | **BRUKINSA (Global)** | $950M | 49% | | - U.S. Sales | $684M | 43% | | - Europe Sales | $150M | 85% | | **TEVIMBRA (Global)** | $194M | 22% | - GAAP gross margin as a percentage of global product sales **increased to 87.4%** in Q2 2025 from 85.0% in Q2 2024, due to a higher sales mix of global BRUKINSA and cost productivity improvements[6](index=6&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses rose due to increased R&D and SG&A investments, though operating leverage improved Q2 2025 Operating Expenses (GAAP, in thousands) | Expense Category | Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $524,896 | $454,466 | 15% | | Selling, general and administrative | $537,913 | $443,729 | 21% | | **Total operating expenses** | **$1,062,809** | **$898,195** | **18%** | - R&D expenses increased primarily due to advancing preclinical and early clinical programs into late-stage development[9](index=9&type=chunk) - SG&A expenses increased due to continued investment in global commercial expansion, while SG&A as a percentage of product sales **improved to 41%** for Q2 2025[10](index=10&type=chunk) [Profitability and Cash Flow](index=3&type=section&id=Net%20Income%20and%20Cash%20Flow) The company achieved significant GAAP net income and positive free cash flow, marking a substantial year-over-year turnaround - GAAP net income for Q2 2025 was **$94 million**, an increase of $215 million over the prior-year period's loss, primarily due to revenue growth and improved operating leverage[11](index=11&type=chunk) - Free Cash Flow for Q2 2025 was **$220 million**, an increase of $425 million over the prior-year period[12](index=12&type=chunk) [Full Year 2025 Guidance](index=4&type=section&id=Full%20Year%202025%20Guidance) The company raised its full-year revenue guidance and upgraded its cash flow outlook to positive free cash flow Updated Full Year 2025 Guidance | Metric | Prior FY 2025 Guidance | Current FY 2025 Guidance | | :--- | :--- | :--- | | **Total Revenue** | $4.9 - $5.3B | **$5.0 - $5.3B** | | **GAAP Operating Expenses** | $4.1 - $4.4B | $4.1 - $4.4B (Unchanged) | | **GAAP Gross Margin %** | Mid-80% range | **Mid to high-80% range** | | **GAAP Operating Income** | Positive FY 2025 | Positive FY 2025 (Unchanged) | | **Cash Flow** | Positive FY 2025 cash flow from operations | **Positive FY 2025 free cash flow** | - The updated guidance is driven by expectations of strong revenue growth from BRUKINSA, improved gross margin, and continued operating leverage[13](index=13&type=chunk) [Business and Pipeline Highlights](index=4&type=section&id=Business%20and%20Pipeline%20Highlights) The company advanced its commercial products and clinical pipeline, anticipating over 20 R&D milestones in 18 months [Core Marketed Products](index=4&type=section&id=Core%20Marketed%20Products) BRUKINSA and TEVIMBRA gained new approvals and expanded market access, strengthening their global commercial presence - **BRUKINSA is now approved in 75 markets** and received U.S. FDA approval and a positive CHMP opinion for a new film-coated tablet formulation[16](index=16&type=chunk) - **TEVIMBRA is now approved in 47 markets**, receiving European Commission approval for new indications and a positive CHMP opinion for resectable NSCLC[16](index=16&type=chunk) [Clinical-Stage Programs](index=5&type=section&id=Select%20Clinical-Stage%20Programs) The pipeline advanced with key trial initiations and positive regulatory designations in hematology, oncology, and immunology - Hematology program advancements: - **Sonrotoclax (BCL2 inhibitor):** Submissions accepted in China for R/R CLL and R/R MCL; first patient enrolled in a global Phase 3 trial for R/R CLL[20](index=20&type=chunk) - **BGB-16673 (BTK CDAC):** Received EMA PRIME designation for Waldenstrom's macroglobulinemia (WM); initiated global and China Phase 3 trials for R/R CLL[20](index=20&type=chunk) - **Zanidatamab (HER2-targeting bispecific antibody):** Received regulatory approval and launched commercially in China for second-line HER2-high-expression biliary tract cancer[18](index=18&type=chunk) - **Tarlatamab (AMG 757):** Achieved acceptance of BLA and priority review in China for 3L+ small cell lung cancer (SCLC)[20](index=20&type=chunk) [Anticipated R&D Milestones](index=6&type=section&id=Anticipated%20R&D%20Milestones) Over 20 R&D milestones are expected in the next 18 months, including key approvals and data readouts in 2H 2025 - The company anticipates **more than 20 R&D milestones** in the next 18 months across its hematology and solid tumor pipeline[2](index=2&type=chunk)[3](index=3&type=chunk) Selected Upcoming Milestones | Program | Milestone | Timing | | :--- | :--- | :--- | | **BRUKINSA** | EC approval of tablet formulation | 2H 2025 | | **TEVIMBRA** | EU approval for neoadjuvant/adjuvant early stage NSCLC | 2H 2025 | | **Sonrotoclax** | Data readout of Phase 2 trial and potential global accelerated approval submissions for R/R MCL | 2H 2025 | | **BGB-16673** | Initiate Phase 3 head-to-head trial vs. pirtobrutinib for R/R CLL | 2H 2025 | | **Zanidatamab** | Readout of primary PFS data from Phase 3 trial for 1L HER2+ gastroesophageal adenocarcinoma | 2H 2025 | [Appendix: Financial Statements](index=9&type=section&id=Appendix%3A%20Financial%20Statements) This section provides detailed unaudited financial statements and a reconciliation of GAAP to non-GAAP measures [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28U.S.%20GAAP%29) The statement shows a significant turnaround to a net income of $94.3 million for Q2 2025 from a loss in Q2 2024 Q2 2025 Statement of Operations Highlights (in thousands) | Line Item | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total revenues | $1,315,300 | $929,166 | | Gross profit | $1,150,694 | $791,034 | | Income (loss) from operations | $87,885 | $(107,161) | | **Net income (loss)** | **$94,320** | **$(120,405)** | [Condensed Consolidated Balance Sheet](index=10&type=section&id=Select%20Condensed%20Consolidated%20Balance%20Sheet%20Data%20%28U.S.%20GAAP%29) Total assets grew to $6.3 billion and total equity increased to $3.8 billion as of June 30, 2025 Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $2,786,086 | $2,638,747 | | **Total assets** | **$6,298,394** | **$5,920,910** | | Total liabilities | $2,527,919 | $2,588,688 | | **Total equity** | **$3,770,475** | **$3,332,222** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Select%20Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28U.S.%20GAAP%29) The company generated $263.6 million in net cash from operating activities in Q2 2025, a strong year-over-year improvement Cash Flow Highlights (in thousands) | Cash Flow Activity | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $263,598 | $307,680 | | Net cash used in investing activities | $(66,605) | $(188,546) | | Net cash provided by financing activities | $35,025 | $1,248 | | **Net increase in cash** | **$255,495** | **$147,339** | [Reconciliation of GAAP to Non-GAAP Measures](index=12&type=section&id=RECONCILIATION%20OF%20SELECTED%20GAAP%20MEASURES%20TO%20NON-GAAP%20MEASURES) This section details adjustments for non-cash items, reconciling GAAP net income to an adjusted net income of $252.8 million - The company provides non-GAAP measures to offer additional insight into operating performance, excluding non-cash items like share-based compensation, depreciation, and amortization[36](index=36&type=chunk) Q2 2025 GAAP to Non-GAAP Net Income Reconciliation (in thousands) | | Amount | | :--- | :--- | | **GAAP net income** | **$94,320** | | Plus: Share-based compensation expenses | $150,553 | | Plus: Depreciation | $29,854 | | Plus: Amortization of intangibles | $5,760 | | Other adjustments | $(17,072) | | **Adjusted net income** | **$252,822** | Q2 2025 Free Cash Flow Reconciliation (in thousands) | | Amount | | :--- | :--- | | Net cash provided by operating activities (GAAP) | $263,598 | | Less: Purchases of property, plant and equipment | $(43,826) | | **Free Cash Flow (Non-GAAP)** | **$219,772** |

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 3.62% on August 29, with a trading volume of 2.004 billion yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of August 28, 2024, the fund's latest share count was 6.619 billion, with a total size of 6.126 billion yuan, reflecting an increase of 1574.08% in shares and 1521.35% in size year-to-date [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 85.10% during the tenure [2] - The top holdings of the fund include Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant weightings such as 9.52% for Innovent Biologics and 9.47% for WuXi Biologics [2] - The fund's recent trading activity shows a cumulative trading amount of 34.226 billion yuan over the last 20 trading days, averaging 1.711 billion yuan per day [1]

百济神州有限公司2025 年半年度报告 公司代码：688235 公司简称：百济神州 百济神州有限公司 2025 年半年度报告 1 / 221 百济神州有限公司2025 年半年度报告 重要提示 一、 本公司董事会及董事、高级管理人员保证半年度报告内容的真实性、准确性、完整性，不 存在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 二、 重大风险提示 公司是一家全球肿瘤创新治疗公司，专注于为全世界的癌症患者研发创新抗肿瘤药物，提升 药物可及性和可负担性。截至 2025 年 6 月 30 日，公司累计未弥补亏损为人民币 622.17 亿元。这 主要由于新药研发、生产、商业化是一个投资大、周期长、风险高的过程，公司在药物早期发现、 临床前研究、临床开发、监管审查、生产、商业化推广等多个环节持续投入。报告期内，公司研 发费用为人民币 72.78 亿元，与上年同期相比增长 9.80%。研发投入用于产品管线的临床前研究、 临床试验、合作研发等。 尽管由于产品销售增长超过费用增长，公司预计 2025 年全年营业收入将大于营业成本、销售 费用、管理费用及研发费用之总和，2025 年经营活动产生的现金流量扣除购建固 ...

A 股代码：688235 A 股简称：百济神州 公告编号：2025-033 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年半年度募集资金存放与实际使用情况的专项报告 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。 一、募集资金基本情况 （一）实际募集资金金额及资金到账情况 经中国证券监督管理委员会于 2021 年 11 月 16 日出具的《关于同意百济神 州有限公司首次公开发行股票注册的批复》（证监许可[2021]3568 号）批准，百 济神州有限公司（以下简称"公司"）首次公开发行人民币普通股（A 股）股票（以 下简称"本次发行"）115,055,260 股，每股发行价格为人民币 192.60 元，募集资 金总额为人民币 2,215,964.31 万元；扣除发行费用后的募集资金净额为人民币 2,163,015.49 万元。上述募集资金已于 2021 年 12 月 8 日全部到位，安永华明会 计师事务所（特殊普通合伙）对公司本次发行的募集资金到位情况进行了审验， 并于 2021 年 ...