Core Viewpoint - BeiGene (688235.SH) expects its revenue for 2025 to be between RMB 35.8 billion and RMB 38.1 billion, indicating a positive growth outlook for the company [1] Financial Projections - The total expected R&D expenses, along with sales and management expenses, are projected to be between RMB 29.5 billion and RMB 31.9 billion, consistent with previous adjustments [1] - The gross margin is anticipated to be in the mid-to-high range of 80% to 90%, which is an upward adjustment from prior estimates [1] Cash Flow Expectations - The company forecasts that its annual revenue will exceed the total of its operating costs, sales expenses, management expenses, and R&D expenses [1] - The net cash flow from operating activities, after deducting capital expenditures for fixed asset purchases, is expected to be positive [1]

百济神州公告，公司预计2025年营业收入将介于人民币358亿元至381亿元之间，较调整前的预测上调6 亿元。研发费用、销售及管理费用合计预计为人民币295亿元至319亿元之间，与调整前保持一致。毛利 率预计处于80%至90%的中高位区间，较调整前上调。公司预计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，且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 预计为正。 ...

[Company Announcement and Forward-Looking Statements](index=1&type=section&id=Company%20Announcement%20and%20Forward-Looking%20Statements) BeiGene announced Q2 and H1 2025 unaudited financial results and updated full-year guidance, including forward-looking statements and risk disclosures [Announcement Overview](index=1&type=section&id=Announcement%20Overview) BeiGene, Ltd. announced unaudited condensed consolidated financial results and business updates for Q2 and H1 2025, updating its full-year 2025 financial guidance, prepared under U.S. GAAP - BeiGene announced unaudited Q2 and H1 2025 financial results and business updates, along with updated full-year financial guidance[1](index=1&type=chunk)[2](index=2&type=chunk) - Financial statements are prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), differing from International Financial Reporting Standards (IFRS)[2](index=2&type=chunk) [Forward-Looking Statements and Risk Disclosures](index=2&type=section&id=Forward-Looking%20Statements%20and%20Risk%20Disclosures) This announcement contains forward-looking statements regarding R&D milestones, clinical development, global expansion, and future financial performance, with actual results potentially differing due to various risk factors - The report includes forward-looking statements concerning R&D milestones, clinical development, global expansion, future revenue, operating profit, cash flow, and gross margin[3](index=3&type=chunk) - Actual results may differ materially due to risks such as drug efficacy and safety, clinical outcomes, regulatory actions, commercialization capabilities, intellectual property protection, third-party reliance, and working capital[3](index=3&type=chunk) - The company advises shareholders and potential investors not to over-rely on Q2 results and 2025 financial guidance, and to exercise caution when trading company securities[4](index=4&type=chunk) [Q2 2025 Financial Results and Business Progress](index=3&type=section&id=Q2%202025%20Financial%20Results%20and%20Business%20Progress) BeiGene reported strong Q2 2025 financial results with significant revenue growth, improved profitability, and positive free cash flow, driven by core product performance and operational efficiency [CEO's Remarks and Performance Highlights](index=3&type=section&id=CEO's%20Remarks%20and%20Performance%20Highlights) CEO John Oyler highlighted the company's leadership in oncology and sustainable growth, particularly the strong performance of Brukinsa® and over 20 R&D milestones expected within 18 months - Co-founder, Chairman, and CEO John Oyler stated that the strong Q2 performance solidified the company's global leadership in oncology and demonstrated its capacity for sustainable, long-term growth[7](index=7&type=chunk) - Brukinsa® as a core product, set the benchmark for best-in-class BTK inhibitors, maintaining a leading position in the U.S. market[7](index=7&type=chunk) - Over **20 milestone advancements** are anticipated in the hematology and solid tumor pipelines within the next 18 months[7](index=7&type=chunk) 2025 Q2 Key Financial Data | Indicator | 2025 Q2 (Million USD) | YoY Growth Rate | | :--- | :--- | :--- | | Total Revenue | 1,300 | 42% | | Brukinsa® Global Revenue | 950 | 49% | | GAAP Diluted EPS | 0.84 | - | | Non-GAAP Diluted EPS | 2.25 | - | [Condensed Consolidated Financial Results](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Results) BeiGene achieved total revenue of $1.315 billion in Q2 2025, a 42% year-over-year increase, with H1 total revenue of $2.433 billion, and GAAP operating and net income turning profitable 2025 Q2 and H1 Condensed Consolidated Financial Results (GAAP) | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | Change (%) | 2025 H1 (Thousand USD) | 2024 H1 (Thousand USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Net Product Revenue | 1,302,076 | 921,146 | 41% | 2,410,606 | 1,668,064 | 45% | | Collaboration Revenue | 13,224 | 8,020 | 65% | 21,973 | 12,754 | 72% | | Total Revenue | 1,315,300 | 929,166 | 42% | 2,432,579 | 1,680,818 | 45% | | GAAP Operating Income (Loss) | 87,885 | (107,161) | 182% | 98,987 | (368,509) | 127% | | GAAP Net Income (Loss) | 94,320 | (120,405) | 178% | 95,590 | (371,555) | 126% | | GAAP Diluted EPS | 0.84 | (1.15) | 173% | 0.85 | (3.56) | 124% | | Free Cash Flow | 219,772 | (205,538) | 207% | 207,447 | (670,688) | 131% | [Revenue Analysis](index=4&type=section&id=Revenue%20Analysis) Q2 2025 total revenue reached $1.3 billion, primarily driven by increased Brukinsa® sales in the U.S. and Europe, with product revenue also at $1.3 billion, and the U.S. contributing $685 million - Total revenue for Q2 2025 was **$1.3 billion**, a **42% year-over-year increase**, primarily driven by increased sales of Brukinsa® in the U.S. and Europe[9](index=9&type=chunk) - Product revenue was **$1.3 billion**, with the U.S. market contributing **$685 million**, a **43% year-over-year increase**[9](index=9&type=chunk) - Sales of Amgen-licensed products and Tislelizumab also contributed to product revenue growth[9](index=9&type=chunk) [Gross Margin](index=5&type=section&id=Gross%20Margin) Q2 2025 GAAP gross margin increased to 87.4%, mainly due to a higher proportion of Brukinsa® global sales and improved production efficiency for Brukinsa® and Tislelizumab - GAAP gross margin on global product revenue for Q2 2025 increased to **87.4%** from 85.0% in the prior year period[10](index=10&type=chunk) - The increase in gross margin is primarily attributed to a higher proportion of Brukinsa® in global sales and improved production efficiency for Brukinsa® and Tislelizumab[10](index=10&type=chunk) - Adjusted gross margin (excluding depreciation and amortization) increased to **88.1%** from 85.4% in the prior year period[10](index=10&type=chunk) [Operating Expenses](index=5&type=section&id=Operating%20Expenses) Total operating expenses for Q2 2025 increased by 18% year-over-year to $1.063 billion, with R&D expenses up 15% and SG&A expenses up 21%, driven by clinical program advancement and global commercialization 2025 Q2 Operating Expenses (GAAP) | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | Change (%) | | :--- | :--- | :--- | | R&D Expenses | 524,896 | 454,466 | 15% | | SG&A Expenses | 537,913 | 443,729 | 21% | | Total Operating Expenses | 1,062,809 | 898,195 | 18% | - The increase in R&D expenses was primarily due to higher costs associated with advancing preclinical programs into clinical stages and early-stage clinical programs into later-stage development[13](index=13&type=chunk) - The increase in SG&A expenses was primarily due to the company's continued investment in global commercialization expansion, particularly in the U.S. and Europe[14](index=14&type=chunk) - In Q2 2025, SG&A expenses as a percentage of product revenue were **41%**, down from 48% in the prior year period, indicating improved operating leverage[14](index=14&type=chunk) [Core Product Sales Performance](index=5&type=section&id=Core%20Product%20Sales%20Performance) Brukinsa® demonstrated strong performance in the U.S. and European markets, with sales increasing by 43% and 85% year-over-year respectively, maintaining its lead in new patient market share among BTK inhibitors - Brukinsa® U.S. sales reached **$684 million**, a **43% year-over-year increase**, driven by strong demand growth across all approved indications[12](index=12&type=chunk) - Brukinsa® European sales reached **$150 million**, an **85% year-over-year increase**, primarily due to market share gains in all major European markets[12](index=12&type=chunk) - Brukinsa® continues to maintain a leading position in new patient market share among BTK inhibitor drugs[12](index=12&type=chunk) - Tislelizumab sales for Q2 2025 were **$194 million**, a **22% year-over-year increase**[12](index=12&type=chunk) [Net Income and Free Cash Flow](index=6&type=section&id=Net%20Income%20and%20Free%20Cash%20Flow) Q2 2025 GAAP net income was $94 million, a significant improvement from a loss in the prior year, driven by revenue growth and improved operating leverage, with free cash flow reaching $220 million - GAAP net income for Q2 2025 was **$94 million**, an increase of **$215 million** compared to a loss in the prior year period, primarily due to revenue growth and improved operating leverage[15](index=15&type=chunk) - Free cash flow was **$220 million**, an increase of **$425 million** compared to the prior year period[15](index=15&type=chunk) [Updated Full-Year 2025 Financial Guidance](index=7&type=section&id=Updated%20Full-Year%202025%20Financial%20Guidance) BeiGene updated its full-year 2025 revenue guidance to $5.0 billion to $5.3 billion, maintained operating expense guidance, and expects gross margin in the mid-to-high 80-90% range, with positive GAAP operating income and free cash flow 2025 Full-Year Financial Guidance Update | Indicator | Previous 2025 FY Guidance | Current 2025 FY Guidance | | :--- | :--- | :--- | | Total Revenue | $4.9 billion to $5.3 billion | $5.0 billion to $5.3 billion | | GAAP Operating Expenses | $4.1 billion to $4.4 billion | $4.1 billion to $4.4 billion | | GAAP Gross Margin % | Mid-80-90% range | Mid-to-High 80-90% range | | GAAP Operating Income | Positive for full year | Positive for full year | | Cash Flow | Positive cash flow from operations for full year | Positive free cash flow for full year | - Total revenue guidance was raised, benefiting from Brukinsa®'s leading position in the U.S. and continued expansion in Europe and other key global markets[17](index=17&type=chunk) - Gross margin is expected to be in the **mid-to-high 80-90% range**, attributed to improved product mix and enhanced production efficiency[17](index=17&type=chunk) - The company's GAAP operating expense guidance includes anticipated investments to support commercialization and research growth, aiming for sustained meaningful operating leverage[17](index=17&type=chunk) [Q2 Business Highlights](index=7&type=section&id=Q2%20Business%20Highlights) Key business highlights for Q2 include significant global regulatory and reimbursement progress for core products Brukinsa® and Tislelizumab, alongside advancements in multiple clinical-stage oncology and immunology programs [Core Commercial Product Progress](index=7&type=section&id=Core%20Commercial%20Product%20Progress) Brukinsa® received approvals in 75 markets, expanded reimbursement in 5, and gained FDA approval for a new film-coated tablet. Tislelizumab was approved in 47 markets, expanded reimbursement in 20, and received EU Commission and FDA approvals for new indications and dosing - Brukinsa® has been approved in **75 markets globally**, with new or expanded reimbursement in **5 markets** this quarter[18](index=18&type=chunk) - Brukinsa® received U.S. FDA approval for a new film-coated tablet formulation and a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use[18](index=18&type=chunk) - Tislelizumab has been approved in **47 markets globally**, with new or expanded reimbursement in **20 markets** this quarter, including Japan, Europe, and Australia[19](index=19&type=chunk) - Tislelizumab received European Commission approval for first-line treatment of metastatic or recurrent nasopharyngeal carcinoma and extensive-stage small cell lung cancer[19](index=19&type=chunk) - Tislelizumab received FDA approval for alternative dosing regimens of 150mg every two weeks and 300mg every four weeks for gastric cancer and esophageal squamous cell carcinoma[19](index=19&type=chunk) [Selected Clinical Stage Programs](index=8&type=section&id=Selected%20Clinical%20Stage%20Programs) The company made significant progress across multiple clinical programs, including hematology (Sonrotoclax, BGB-16673), lung cancer (Tarlatamab), GI cancer (Zanidatamab), and inflammation/immunology (BGB-45035, BGB-16673) [Hematology](index=8&type=section&id=Hematology) Sonrotoclax (BCL2 inhibitor) received priority review for its marketing application in China, with global Phase 3 trial enrollment initiated. BGB-16673 (BTK CDAC) received EU PRIME designation and initiated multiple Phase 3 and 2 trials - Sonrotoclax (BCL2 inhibitor) marketing applications for relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R mantle cell lymphoma (MCL) have been accepted in China and granted priority review[19](index=19&type=chunk) - The global Phase 3 trial of Sonrotoclax combined with an anti-CD20 antibody for R/R CLL has enrolled its first patient[19](index=19&type=chunk) - BGB-16673 (BTK CDAC) received Priority Medicines (PRIME) designation from the European Medicines Agency for the treatment of Waldenström's macroglobulinemia (WM) patients previously treated with a BTK inhibitor[19](index=19&type=chunk) - The global Phase 3 BGB-16673-302 trial and China Phase 3 BGB-16673-303 trial for BGB-16673 in R/R CLL have both enrolled their first patients[19](index=19&type=chunk)[20](index=20&type=chunk) - Patient enrollment has commenced for a potential registrational Phase 2 study of BGB-16673 for R/R WM[20](index=20&type=chunk) [Lung Cancer](index=9&type=section&id=Lung%20Cancer) Tarlatamab (AMG 757) marketing applications for third-line+ and second-line small cell lung cancer treatment in China have been accepted and granted priority review - The Biologics License Application (BLA) for Tarlatamab (AMG 757) for third-line and above treatment of small cell lung cancer has been accepted in China and granted priority review[20](index=20&type=chunk) - The BLA for Tarlatamab for second-line treatment of small cell lung cancer has been accepted in China[20](index=20&type=chunk) [Gastrointestinal Cancers](index=9&type=section&id=Gastrointestinal%20Cancers) Zanidatamab (HER2-targeted bispecific antibody) received regulatory approval in China for second-line treatment of HER2-high expressing biliary tract cancer and has been commercialized - Zanidatamab (Chinese trade name: Baihe'an®; HER2-targeted bispecific antibody) has received regulatory approval in China for second-line treatment of HER2-high expressing biliary tract cancer and has been commercialized[20](index=20&type=chunk) [Inflammation and Immunology](index=9&type=section&id=Inflammation%20and%20Immunology) Phase 1b trials for BGB-45035 (IRAK4 CDAC) in atopic dermatitis and prurigo nodularis, and BGB-16673 (BTK CDAC) in chronic spontaneous urticaria, have both enrolled their first patients - The Phase 1b trial for BGB-45035 (IRAK4 CDAC) in atopic dermatitis and prurigo nodularis has enrolled its first patient[21](index=21&type=chunk) - The Phase 1 trial for BGB-16673 (BTK CDAC) in chronic spontaneous urticaria has also enrolled its first patient[21](index=21&type=chunk) [Future Milestones](index=10&type=section&id=Future%20Milestones) BeiGene anticipates achieving key milestones across multiple products and therapeutic areas from H2 2025 to 2026, including Brukinsa® tablet approval, Tislelizumab subcutaneous formulation trial, Sonrotoclax data readout, and BGB-16673 head-to-head trial Expected Milestones (H2 2025 - 2026) | Product/Therapeutic Area | Expected Milestone | Expected Timeline | | :--- | :--- | :--- | | Brukinsa® | Marketing application for tablet formulation expected to receive European Commission approval | H2 2025 | | | Interim analysis of Phase 3 MANGROVE trial for first-line MCL expected to be completed | H2 2025 | | Tislelizumab | Marketing application for neoadjuvant and adjuvant treatment of early-stage NSCLC expected to receive European Commission approval | H2 2025 | | | Initiation of Phase 3 subcutaneous formulation trial expected | H2 2025 | | Hematology (Sonrotoclax) | Phase 2 data readout for R/R MCL expected, with potential for global accelerated approval submission | H2 2025 | | Hematology (BGB-16673) | Initiation of Phase 3 head-to-head trial against non-covalent BTK inhibitor pirtobrutinib for R/R CLL expected | H2 2025 | | Breast Cancer (BGB-43395) | Initiation of Phase 3 trial for second-line HR+/HER2- metastatic breast cancer expected | 2026 | | | Initiation of Phase 3 trial for first-line HR+/HER2- metastatic breast cancer expected | 2026 | | Lung Cancer (BGB-58067 & BG89894) | Completion of first patient enrollment for combination therapy trial expected | H2 2025 | | Gastrointestinal Cancers (Zanidatamab) | Primary progression-free survival data readout for Phase 3 trial in first-line HER2+ gastroesophageal adenocarcinoma, in collaboration with Zymeworks/Jazz, expected | H2 2025 | | Inflammation and Immunology (BGB-45035) | Completion of first patient enrollment for Phase 2 trial expected | H2 2025 | | | Potential proof-of-concept data for tissue IRAK4 degradation expected | H2 2025 | [Other Company Information](index=11&type=section&id=Other%20Company%20Information) The company announced its new English name BeOne Medicines Ltd. and domicile change to Switzerland, along with details for its Q2 2025 earnings conference call and general company overview [Company Name and Domicile Change](index=11&type=section&id=Company%20Name%20and%20Domicile%20Change) The company officially adopted its new English name, BeOne Medicines Ltd., and completed its domicile transfer from Cayman to Switzerland - The company officially adopted its new English name, **BeOne Medicines Ltd**[25](index=25&type=chunk) - Completed the transfer of its domicile from Cayman to Switzerland[25](index=25&type=chunk) [Conference Call and Webcast](index=11&type=section&id=Conference%20Call%20and%20Webcast) The company will host its Q2 2025 earnings conference call via webcast on Wednesday, August 6, 2025, at 8:00 AM ET (8:00 PM Beijing Time), accessible through its official website - The company will host its Q2 2025 earnings conference call via webcast on **Wednesday, August 6, 2025, at 8:00 AM ET** (8:00 PM Beijing Time)[26](index=26&type=chunk) - The webcast link is accessible through the investor page of BeiGene's official website (www.beonemedicines.com)[26](index=26&type=chunk) [About BeiGene](index=11&type=section&id=About%20BeiGene) BeiGene is a Switzerland-domiciled global oncology innovator focused on developing novel anti-cancer drugs for patients worldwide, boasting a rich portfolio, strong R&D, and a global team dedicated to enhancing drug accessibility and affordability - BeiGene is a Switzerland-domiciled global oncology innovation company dedicated to developing novel anti-cancer drugs for cancer patients worldwide[27](index=27&type=chunk) - The company possesses a rich product portfolio in hematology and solid tumors, coupled with strong in-house R&D capabilities and external strategic collaborations[27](index=27&type=chunk) - With a team of over **11,000 people** across six continents, the company is committed to comprehensively improving drug accessibility and affordability for more patients globally[27](index=27&type=chunk) [Investor and Media Contacts](index=12&type=section&id=Investor%20and%20Media%20Contacts) Provides contact information for investor relations and media inquiries Investor and Media Contacts | Investor Contact | Media Contact | | :--- | :--- | | Mi Zhou | Yiwei Yu | | +86 10 5895 8058 | +86 21 3159 1070 | | ir@beonemed.com | media@beonemed.com | [Notes to Financial Statements](index=13&type=section&id=Notes%20to%20Financial%20Statements) This section provides detailed U.S. GAAP condensed consolidated financial statements, including statements of operations, balance sheets, cash flows, and reconciliations of GAAP to non-GAAP financial measures [Condensed Consolidated Statements of Operations (U.S. GAAP)](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(U.S.%20GAAP)) Presents condensed consolidated statements of operations for the three and six months ended June 30, 2025, detailing key financial metrics including revenue, cost of sales, gross profit, operating expenses, operating income, net income, and EPS Condensed Consolidated Statements of Operations (GAAP) - Three Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Product Revenue | 1,302,076 | 921,146 | | Collaboration Revenue | 13,224 | 8,020 | | Total Revenue | 1,315,300 | 929,166 | | Cost of Sales - Product | 164,606 | 138,132 | | Gross Profit | 1,150,694 | 791,034 | | R&D Expenses | 524,896 | 454,466 | | SG&A Expenses | 537,913 | 443,729 | | Operating Income (Loss) | 87,885 | (107,161) | | Net Income (Loss) | 94,320 | (120,405) | | Diluted EPS (Loss) | 0.84 | (1.15) | Condensed Consolidated Statements of Operations (GAAP) - Six Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Product Revenue | 2,410,606 | 1,668,064 | | Collaboration Revenue | 21,973 | 12,754 | | Total Revenue | 2,432,579 | 1,680,818 | | Cost of Sales - Product | 329,608 | 263,067 | | Gross Profit | 2,102,971 | 1,417,751 | | R&D Expenses | 1,006,783 | 915,104 | | SG&A Expenses | 997,201 | 871,156 | | Operating Income (Loss) | 98,987 | (368,509) | | Net Income (Loss) | 95,590 | (371,555) | | Diluted EPS (Loss) | 0.85 | (3.56) | [Condensed Consolidated Balance Sheet Summary Data (U.S. GAAP)](index=14&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Summary%20Data%20(U.S.%20GAAP)) Provides a summary of condensed consolidated balance sheet data as of June 30, 2025, and December 31, 2024, showing key items such as cash, accounts receivable, inventory, property, plant, and equipment, total assets, liabilities, and shareholders' equity Condensed Consolidated Balance Sheet Summary Data (GAAP) | Indicator | 2025-06-30 (Thousand USD) | 2024-12-31 (Thousand USD) | | :--- | :--- | :--- | | Cash, Cash Equivalents & Restricted Cash | 2,786,086 | 2,638,747 | | Accounts Receivable, Net | 770,776 | 676,278 | | Inventory | 502,867 | 494,986 | | Property, Plant & Equipment, Net | 1,615,792 | 1,578,423 | | Total Assets | 6,298,394 | 5,920,910 | | Total Liabilities | 2,527,919 | 2,588,688 | | Total Shareholders' Equity | 3,770,475 | 3,332,222 | [Unaudited Condensed Consolidated Statements of Cash Flows Summary Data (U.S. GAAP)](index=15&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20Summary%20Data%20(U.S.%20GAAP)) Presents unaudited condensed consolidated statements of cash flows for the three and six months ended June 30, 2025, including net cash from operating, investing, and financing activities, and cash and cash equivalents at period-end Condensed Consolidated Statements of Cash Flows Summary Data (GAAP) - Three Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Cash from Operating Activities | 263,598 | (95,588) | | Net Cash Used in Investing Activities | (66,605) | (111,032) | | Net Cash Provided by Financing Activities | 35,025 | 23,017 | | Cash, Cash Equivalents & Restricted Cash at Period End | 2,786,086 | 2,617,931 | Condensed Consolidated Statements of Cash Flows Summary Data (GAAP) - Six Months Ended June 30 | Indicator | 2025 (Thousand USD) | 2024 (Thousand USD) | | :--- | :--- | :--- | | Net Cash from Operating Activities | 307,680 | (404,160) | | Net Cash Used in Investing Activities | (188,546) | (320,863) | | Net Cash Provided by Financing Activities | 1,248 | 185,310 | | Cash, Cash Equivalents & Restricted Cash at Period End | 2,786,086 | 2,617,931 | [Explanation Regarding the Use of Non-GAAP Financial Measures](index=16&type=section&id=Explanation%20Regarding%20the%20Use%20of%20Non-GAAP%20Financial%20Measures) The company provides non-GAAP financial measures to offer a more comprehensive view of operating performance by excluding non-cash and special items, supplementing but not replacing GAAP metrics for investor understanding and comparison - The company provides non-GAAP financial measures, including adjusted operating expenses, operating loss, net income, and EPS, to offer additional information on its operating performance[37](index=37&type=chunk) - Non-GAAP measures adjust GAAP data by excluding non-cash items such as share-based compensation expense, depreciation, and amortization, as well as certain unusual or significant items[37](index=37&type=chunk) - These non-GAAP financial measures should be considered supplementary to, and not as a substitute for or superior to, financial measures prepared in accordance with U.S. GAAP[37](index=37&type=chunk) [Reconciliation of Selected GAAP to Non-GAAP Financial Measures](index=17&type=section&id=Reconciliation%20of%20Selected%20GAAP%20to%20Non-GAAP%20Financial%20Measures) This section provides detailed reconciliation tables between GAAP and non-GAAP financial measures, covering cost of sales, R&D, SG&A, operating expenses, operating income, net income, EPS, and free cash flow, to clearly illustrate specific adjustments and their impact GAAP to Adjusted Cost of Sales - Product Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | GAAP Cost of Sales - Product | 164,606 | 138,132 | | Less: Depreciation | 3,321 | 2,684 | | Less: Amortization of Intangible Assets | 5,749 | 1,177 | | Adjusted Cost of Sales - Product | 154,643 | 134,271 | GAAP to Adjusted R&D Expenses Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | GAAP R&D Expenses | 524,896 | 454,466 | | Less: Share-based Compensation Expense | 64,392 | 55,406 | | Less: Depreciation | 16,447 | 16,551 | | Adjusted R&D Expenses | 444,057 | 382,509 | GAAP to Adjusted Operating Income (Loss) Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | GAAP Operating Income (Loss) | 87,885 | (107,161) | | Add: Share-based Compensation Expense | 150,553 | 130,694 | | Add: Depreciation | 29,854 | 23,754 | | Add: Amortization of Intangible Assets | 5,760 | 1,177 | | Adjusted Operating Income (Loss) | 274,945 | 48,464 | GAAP to Adjusted Diluted EPS (Loss) Reconciliation | Indicator | 2025 Q2 (USD) | 2024 Q2 (USD) | | :--- | :--- | :--- | | GAAP Diluted EPS (Loss) | 0.84 | (1.13) | | Add: Share-based Compensation Expense | 1.34 | 1.23 | | Add: Depreciation | 0.27 | 0.22 | | Add: Amortization of Intangible Assets | 0.05 | 0.01 | | Adjusted Diluted EPS (Loss) | 2.25 | 0.22 | Free Cash Flow (Non-GAAP) Reconciliation | Indicator | 2025 Q2 (Thousand USD) | 2024 Q2 (Thousand USD) | | :--- | :--- | :--- | | Net Cash from Operating Activities (GAAP) | 263,598 | (95,588) | | Less: Purchases of Property, Plant & Equipment | (43,826) | (109,950) | | Free Cash Flow (Non-GAAP) | 219,772 | (205,538) |

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2025, and 2024, detailing financial performance, position, and cash flows, alongside the company's redomiciliation Condensed Consolidated Statements of Operations Highlights (Q2 & H1 2025 vs 2024) | Financial Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | H1 2025 (in thousands) | H1 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $1,315,300 | $929,166 | $2,432,579 | $1,680,818 | | **Gross Profit** | $1,150,694 | $791,034 | $2,102,971 | $1,417,751 | | **Income (Loss) from Operations** | $87,885 | $(107,161) | $98,987 | $(368,509) | | **Net Income (Loss)** | $94,320 | $(120,405) | $95,590 | $(371,555) | | **Diluted EPS ($)** | $0.06 | $(0.09) | $0.07 | $(0.27) | | **Diluted EPS per ADS ($)** | $0.84 | $(1.15) | $0.85 | $(3.56) | Condensed Consolidated Balance Sheet Highlights | Balance Sheet Item | As of June 30, 2025 (in thousands) | As of Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Total Current Assets** | $4,310,221 | $3,991,593 | | **Total Assets** | $6,298,394 | $5,920,910 | | **Total Current Liabilities** | $2,209,837 | $2,214,899 | | **Total Liabilities** | $2,527,919 | $2,588,688 | | **Total Shareholders' Equity** | $3,770,475 | $3,332,222 | Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30) | Cash Flow Item | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | **Net Cash Provided by (Used in) Operating Activities** | $307,680 | $(404,160) | | **Net Cash Used in Investing Activities** | $(188,546) | $(320,863) | | **Net Cash Provided by Financing Activities** | $1,248 | $185,310 | | **Net Increase (Decrease) in Cash** | $147,339 | $(568,053) | - The company redomiciled from the Cayman Islands to Switzerland during the second quarter of 2025, which did not change the accounting basis under U.S. GAAP[22](index=22&type=chunk)[23](index=23&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes strong Q2 2025 performance to significant revenue growth, particularly from BRUKINSA, achieving GAAP profitability and improved operating leverage while maintaining strong liquidity - Key highlights for Q2 2025 include a **42%** increase in total revenues to **$1.3 billion**, a **49%** increase in global BRUKINSA revenues to **$950 million**, and a shift to profitability with GAAP diluted EPS per ADS of **$0.84**[97](index=97&type=chunk) Q2 2025 vs Q2 2024 Net Product Revenue Breakdown (in thousands) | Product | Q2 2025 Revenue | Q2 2024 Revenue | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | BRUKINSA® | $949,840 | $637,399 | $312,441 | 49.0% | | TEVIMBRA® | $193,524 | $158,410 | $35,114 | 22.2% | | XGEVA® | $81,318 | $55,054 | $26,264 | 47.7% | | BLINCYTO® | $25,587 | $19,131 | $6,456 | 33.7% | | KYPROLIS® | $19,416 | $15,936 | $3,480 | 21.8% | | **Total Product Revenue** | **$1,302,076** | **$921,146** | **$380,930** | **41.4%** | - R&D expenses increased **15.5%** to **$524.9 million** in Q2 2025, driven by advancing preclinical programs like Sonrotoclax (BCL2i) into later stages[110](index=110&type=chunk)[112](index=112&type=chunk) - SG&A expenses rose **21.2%** to **$537.9 million** due to global commercial expansion, but decreased as a percentage of product sales from **48.2%** to **41.3%**[115](index=115&type=chunk) Contractual Obligations as of June 30, 2025 (in thousands) | Obligation | Total | Short Term (<1 Year) | Long Term (>1 Year) | | :--- | :--- | :--- | :--- | | Operating lease commitments | $79,054 | $10,608 | $68,446 | | Purchase commitments | $130,087 | $105,910 | $24,177 | | Debt obligations | $954,485 | $808,394 | $146,091 | | Interest on debt | $39,869 | $28,533 | $11,336 | | Co-development funding commitment | $242,916 | $220,869 | $22,047 | | **Total** | **$1,515,180** | **$1,238,641** | **$276,539** | [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on its floating-rate debt and significant foreign currency exchange risk, particularly from its RMB-denominated operations - The company is exposed to interest rate risk on **$615.4 million** of outstanding floating-rate debt, where a **100-basis point** increase in interest rates would increase annual pre-tax interest expense by approximately **$6.2 million**[159](index=159&type=chunk) - The company faces significant foreign currency exchange risk, particularly from its RMB-denominated operations and deposits, with a hypothetical **10%** appreciation in the U.S. dollar against the RMB resulting in an increased foreign exchange loss of approximately **$11.7 million** as of June 30, 2025[161](index=161&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[165](index=165&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025[166](index=166&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in two significant legal matters: a patent infringement lawsuit from Pharmacyclics regarding BRUKINSA and a trade secret misappropriation lawsuit from AbbVie - In the Pharmacyclics litigation concerning BRUKINSA, the U.S. Patent and Trademark Office (USPTO) issued a Final Written Decision on April 29, 2025, invalidating all challenged claims of the patent in question, with Pharmacyclics' request for review subsequently denied[170](index=170&type=chunk)[171](index=171&type=chunk) - The company is vigorously defending against a lawsuit filed by AbbVie Inc. in September 2024, which alleges misappropriation of trade secrets related to the company's BTK degrader program, including BGB-16673[172](index=172&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section details comprehensive risks including commercialization, clinical development, regulatory hurdles, financial stability, intellectual property, third-party reliance, operational challenges, and specific risks related to China operations and Swiss redomiciliation - Commercial risks include potential failure of medicines to gain market acceptance, substantial competition from major pharmaceutical companies, and unfavorable pricing or reimbursement regulations from payors like Medicare or China's NRDL[177](index=177&type=chunk)[181](index=181&type=chunk)[186](index=186&type=chunk) - The company faces significant regulatory risks, including the lengthy and unpredictable approval processes of the FDA, NMPA, and EMA, and the potential for clinical trials to fail to demonstrate safety and efficacy[197](index=197&type=chunk)[212](index=212&type=chunk) - Financial risks include a history of significant net losses (**$8.5 billion** accumulated deficit as of June 30, 2025) and the potential need for additional financing to fund operations and development programs[234](index=234&type=chunk)[236](index=236&type=chunk) - Risks related to doing business in China are substantial, including potential intervention by the PRC government, uncertainties in the interpretation and enforcement of Chinese laws (e.g., data security, overseas listings), and limitations on repatriating funds[345](index=345&type=chunk)[346](index=346&type=chunk)[355](index=355&type=chunk) - The recent redomiciliation to Switzerland introduces new risks, including changes in shareholder rights, less flexibility in capital management due to stricter shareholder voting requirements, and potential Swiss withholding taxes on dividends[426](index=426&type=chunk)[427](index=427&type=chunk)[431](index=431&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=98&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales of equity securities, no specific use of proceeds, and no issuer purchases of its equity securities for the period - None reported for the period[433](index=433&type=chunk) [Defaults Upon Senior Securities](index=98&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon its senior securities during the period - None reported for the period[434](index=434&type=chunk) [Mine Safety Disclosures](index=98&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[435](index=435&type=chunk) [Other Information](index=98&type=section&id=Item%205.%20Other%20Information) This section discloses the adoption and modification of Rule 10b5-1 trading arrangements by two executive officers during the quarter Director and Officer Trading Arrangements (Rule 10b5-1) | Name (Title) | Action (Date) | Nature of Arrangement | Duration | Aggregate Securities | | :--- | :--- | :--- | :--- | :--- | | Chan Lee (SVP, General Counsel) | Adoption (May 14, 2025) | Sale | August 13, 2026 | Up to 36,671 ADSs plus net ADSs from RSU vestings | | Dr. Xiaobin Wu (President, COO) | Modification (May 14, 2025) | Sale | August 13, 2026 | Up to 89,794 ADSs | [Exhibits](index=99&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the 10-Q, including corporate governance documents, executive agreements, and required certifications - Key exhibits filed include: - 3.1: Articles of Association of BeOne Medicines Ltd - 10.1-10.5: Executive Employment Agreements for key officers - 10.18: Fifth Amended and Restated 2018 Employee Share Purchase Plan - 31.1 & 31.2: Certifications of Principal Executive Officer and Principal Financial Officer[441](index=441&type=chunk)[442](index=442&type=chunk)[443](index=443&type=chunk)

Core Insights - The article highlights the significant progress of Chinese innovative pharmaceuticals, particularly focusing on the outbound licensing strategy and business development (BD) as key drivers for growth in the global market [1][2][3] Group 1: Company Developments - Heng Rui Pharmaceutical has completed 13 outbound licensing deals from 2018 to 2024, involving 16 molecular entities with a potential total transaction value of approximately $14 billion and upfront payments totaling around $600 million [1] - In 2025, Heng Rui's momentum continues with a $19.7 billion deal with Merck for its Lp(a) oral small molecule project and a partnership with GSK that brings in $5 billion upfront and a potential future revenue of $12 billion [1] - The company reported a revenue of 27.985 billion yuan in 2024, a year-on-year increase of 22.63%, and a net profit of 6.337 billion yuan, up 47.28% [9] Group 2: Industry Trends - The Chinese innovative pharmaceutical sector is experiencing a surge in outbound licensing deals, with the total value of BD transactions reaching $64.08 billion in 2024, marking a historical high [4][5] - The global pharmaceutical industry is facing a "patent cliff" with a total risk exposure of $354 billion due to patent expirations, creating a heightened demand for quality innovative assets from China [3][4] - The number of active innovative drug R&D pipelines in China reached 3,575 in 2024, surpassing the U.S. for the first time, with a significant increase in the number of first-in-class (FIC) drugs [8] Group 3: Strategic Shifts - The BD model has evolved from a tactical choice to a core pillar of globalization strategy for Chinese pharmaceutical companies, enabling them to secure immediate funding and share risks [5][6] - Companies like Bai Li Tian Heng and Kang Ning Jie Rui have achieved remarkable revenue growth through strategic partnerships, with Bai Li Tian Heng reporting a staggering 1,685.19% year-on-year increase in revenue following a major licensing deal [5][6] - The article emphasizes the importance of building strong commercialization capabilities as a foundation for long-term competitiveness, moving beyond reliance on BD for survival [9][10] Group 4: Policy and Capital Support - The growth of BD transactions is supported by a decade of favorable policies and capital influx, including reforms in drug approval processes and financing mechanisms for biotech companies [7][8] - The Chinese pharmaceutical industry has seen a significant increase in the number of companies going public, with over 56 firms raising more than 110 billion HKD since the introduction of new listing rules [7] - The article notes that the combination of policy support and capital investment has led to a qualitative leap in innovative drug development in China [8][9] Group 5: Future Outlook - The future of Chinese innovative pharmaceuticals is characterized by a focus on global clinical trials, tighter international collaborations, and the emergence of differentiated products [15] - The industry is moving towards a more collaborative ecosystem, aiming for a balance between individual company growth and collective industry advancement [15] - The article concludes that the ongoing transformation in the Chinese pharmaceutical sector is paving the way for a historic leap from "global follower" to "global leader" in innovation [10][15]

Group 1 - The core viewpoint of the article emphasizes that under the pressure of medical insurance policies, going overseas has become an inevitable choice for China's innovative pharmaceutical industry due to increasing aging population and limited domestic market space for innovative drugs [3][8] - The pressure on medical insurance balance is growing, with the elderly population reaching 217 million in 2023, accounting for 15.4% of the total population, leading to increased medical demand and expenditure [9][11] - The proportion of commercial insurance in medical expenses is only 6.5%, significantly lower than in countries like the US and Japan, making it difficult to support innovative drug payments in the short term [12][15] Group 2 - Despite financing pressures in the primary and secondary markets, the enthusiasm for domestic innovative drug research and development remains high, with a 11.2% year-on-year increase in clinical approvals for innovative drugs in 2024 [31][32] - In 2024, a record 39 domestic innovative drugs were approved for market launch, indicating a significant growth in the innovative drug pipeline [33][34] - The number of clinical trials for innovative drugs in China has surpassed that of the US, ranking first globally, with 1,903 trials registered in 2024 [45][49] Group 3 - The overseas market offers higher pricing and larger market space for innovative drugs, with the price of innovative drug Zebutini in China being only about 3% of its price in the US and Europe [23][25] - Japan's experience shows that innovation and going overseas are essential paths to break domestic pressures, as seen in the historical context of Japan's pharmaceutical industry [27][28] - The case of Takeda Pharmaceutical illustrates that innovation and international expansion are crucial for growth, with its revenue from the US market reaching 51.5% by 2024 [28][29] Group 4 - License out transactions are rapidly increasing, with 2024 seeing a total transaction amount exceeding $10 billion, accounting for 31.9% of heavy transactions globally [5][77] - The types of license out transactions are becoming more diverse, with emerging technologies like ADC and dual antibodies gaining traction [81][82] - The research and development stage of license out projects is shifting earlier, with 64% of products in the preclinical stage in 2024 [83][84] Group 5 - Foreign investments are gradually expanding from purchasing innovative drug products to acquiring domestic innovative pharmaceutical companies, as seen in recent acquisitions by AstraZeneca and Genmab [89][90] - The NewCo model is emerging as a new financing method, allowing domestic innovative pharmaceutical companies to split off parts of their product pipelines to attract investment [92][93]

Group 1 - The core viewpoint highlights the strong performance and growth of the Kexin Pharmaceutical ETF managed by Jiashi, with significant trading activity and inflows [2] - As of August 4, the Kexin Pharmaceutical ETF Jiashi has seen a weekly average trading volume of 58.54 million yuan, ranking first among comparable funds [2] - The fund's scale increased by 12.30 million yuan over the past two weeks, also leading among comparable funds [2] - The fund's net asset value has risen by 50.01% over the past year, placing it in the top 15.64% of index equity funds [2] Group 2 - The top ten weighted stocks in the Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index account for 49.14% of the index, with leading companies including United Imaging Healthcare and BeiGene [2][4] - The biopharmaceutical industry is expected to stabilize and grow throughout 2025, supported by favorable policies for innovative drug development and medical equipment updates [5] - The transition to the 2.0 era of innovative drugs in China is marked by a qualitative improvement, with domestic new drugs expected to participate deeply in the global market over the next decade [4]

Summary of BeiGene Conference Call Company Overview - **Company**: BeiGene - **Date**: August 4, 2025 Key Industry Insights - BeiGene is positioned to achieve profitability due to the market expansion of products like Zanubrutinib, supported by significant R&D investments totaling hundreds of billions [2][8] - The company is advancing in the CDK inhibitor space, particularly focusing on selective CDK4 inhibitors to enhance safety, with preliminary efficacy data disclosed [2][5] - BeiGene is actively pursuing global multi-center clinical development to reduce costs and accelerate timelines, which enhances asset value and lowers risk [2][6] Core Points and Arguments - **R&D Investment**: BeiGene has invested hundreds of billions in R&D, utilizing both expensing and capitalization methods to support self-sustaining capabilities and global clinical development [2][8] - **CDK Inhibitors**: The company plans to initiate a Phase III study for second-line HR-positive breast cancer in Q4 2025, with ongoing exploration of CDK12 and CDK2 products [2][11] - **Clinical Development Strategy**: By independently conducting clinical trials, BeiGene has reduced costs and improved speed, allowing for quicker proof of concept (POC) results [2][6] - **Protag Platform**: The BDK protect product has entered Phase III trials, showing a progression-free survival (PFS) of 22.8 months, significantly outperforming similar drugs [2][12] - **ADC Developments**: BeiGene's B7H4 ADC has shown an overall response rate (ORR) of 48%, with plans to start Phase III trials in 2026 [2][17] - **Collaboration Opportunities**: As early pipelines yield POC results, BeiGene is expected to gain leverage in partnerships, particularly in the HR-positive breast cancer market [2][7] Additional Important Insights - **Safety Concerns**: BeiGene is addressing safety issues associated with CDK4/6 inhibitors, with initial results indicating a favorable safety profile compared to competitors [2][10] - **Future Plans**: The company anticipates 2025 to be a pivotal year for transitioning to profitability, with multiple early pipeline data readouts expected [2][23] - **Innovative Approaches**: BeiGene is exploring new drug mechanisms in the KRAS inhibitor space and has developed multi-specific antibody technologies [2][19][22] - **Market Potential**: The PRMT5 target for MTAP mutant tumors presents significant market potential, with plans for combination therapies to enhance efficacy [2][21] This summary encapsulates the critical insights and strategic directions of BeiGene as discussed in the conference call, highlighting its commitment to innovation and market expansion in the biopharmaceutical industry.

Core Points - The China Securities Hong Kong 100 Pharmaceutical and Health Index (H100 Pharmaceutical, L11185) reported a significant increase, with a 20.90% rise over the past month, 36.74% over the past three months, and an impressive 88.77% year-to-date [1] Group 1 - The index is classified according to the China Securities industry classification standards, with all securities in each industry forming the corresponding industry index sample [1] - The base date for the index is December 31, 2004, with a base point of 1000.0 [1] - The index is fully composed of stocks listed on the Hong Kong Stock Exchange, with a 100.00% allocation [1] Group 2 - The composition of the H100 Pharmaceutical Index includes 54.55% in chemical drugs, 19.02% in biological drugs, 15.26% in pharmaceutical and biotechnology services, and 11.18% in medical commerce and services [1] - The index sample is adjusted biannually, with adjustments occurring on the next trading day after the second Friday of June and December [2] - Weight factors are generally fixed until the next scheduled adjustment, with special circumstances allowing for temporary adjustments [2]

Core Viewpoint - The article discusses the significant price disparity of prescription drugs in the U.S. compared to other developed countries, leading to new policies aimed at price control and the potential impact on multinational pharmaceutical companies and emerging markets [1][2]. Group 1: U.S. Drug Pricing Policies - U.S. prescription drug prices are 2-3 times higher than those in other developed countries, with some innovative drugs priced at 10 times higher than in China [1] - New policies require pharmaceutical companies to provide "most favored nation pricing" to U.S. Medicare, sign contracts for price locking, renegotiate overseas prices to "repatriate profits," and promote direct sales for price transparency [1][2] - The Pharmaceutical Research and Manufacturers of America (PhRMA) criticized these policies, claiming they would undermine U.S. innovation [1][2] Group 2: Multinational Pharmaceutical Companies' Strategies - Companies like Johnson & Johnson, Pfizer, and Merck are adopting multi-faceted strategies to balance profits and compliance, including adjusting global pricing strategies [3] - Some companies are lowering prices in the U.S. while increasing prices in other markets to maintain profit margins, with AstraZeneca already announcing price reductions for certain drugs in the U.S. [3][4] - To offset profit losses, companies may raise prices in emerging markets like China, where the annual treatment cost for PD-1 drugs is approximately 1.16 million yuan, ten times higher than in China [4] Group 3: Cost Optimization Strategies - Cost reduction is a core objective, leveraging China's low-cost advantages, where biopharmaceutical R&D costs are 1/5 to 1/10 of those in the U.S. [5] - Pfizer has signed over $1 billion in CDMO orders with Chinese companies to transfer some biopharmaceutical production to China, reducing production costs by 30% [5][6] - Companies are also transferring non-core technologies to China to avoid tariffs and lower costs, such as Pfizer's collaboration with Chinese firms to establish PD-1 production bases [6][7] Group 4: Legal and Policy Maneuvering - Industry associations and pharmaceutical companies are using legal and political avenues to resist new policies, with PhRMA planning to appeal to the WTO regarding the "most favored nation pricing" requirement [10] - They are lobbying Congress, arguing that foreign price controls could reduce U.S. R&D investment by $10 billion annually [10] Group 5: Opportunities and Challenges for Chinese Companies - Chinese companies are positioned to benefit from accelerated domestic substitution, with local biosimilars gaining price advantages [11] - CDMO businesses are expanding, with WuXi Biologics reporting a 144% year-on-year increase in CDMO revenue in the first half of 2025 [12] - Chinese pharmaceutical companies are also achieving breakthroughs in international markets through licensing agreements, with total upfront payments reaching $2.329 billion in the first half of 2025 [13] Group 6: Beneficiary Companies - Companies in the biosimilar sector, such as Innovent Biologics and Antengene, are expected to gain market share as multinational firms raise prices in China [16] - WuXi Biologics is recognized as a leading global CDMO, while other companies like Eastone and Hengrui are also expanding their CDMO projects [17] - Chinese firms that have established production facilities in India and Southeast Asia, like Huahai Pharmaceutical, are likely to benefit from reduced reliance on the U.S. market [19]