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。 請參閱百濟神州有限公司（「百濟神州」或「本公司」）於2023年6月16日和2025年4 月30日就Pharmacyclics LLC（「Pharmacyclics」）發起的專利侵權指控發佈的公告。 本公司宣佈，Pharmacyclics決定不對美國專利商標局的最終書面決定提起上 訴，該最終書面決定宣布Pharmacyclics在專利授權後複審程序中受到百濟神 州質疑的第11,672,803號美國專利（「'803專利」）的全部權利無效。百濟神州和 Pharmacyclics於2025年9月30日（美國時間）向相關地方法院提交一份共同協議， 自願撤回訴訟案件，案件已做出終局處理。 承董事會命 百濟神州有限公司 主席 歐雷強先生 香港，2025年10月2日 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） 於本公告日期，本公司董事會包括主席兼執 ...

Market Sector - The Sci-Tech Innovation Board (STAR Market) index increased by 51.20% in the first three quarters of 2025, ranking second among various sector indices, outperforming the North Exchange 50, Shenzhen 50, and Shanghai 50 indices [2] - As of the end of Q3 2025, the total market capitalization of the STAR Market reached 10.95 trillion yuan, an increase of 3.33 trillion yuan from 7.62 trillion yuan at the end of Q2 2025, representing a growth rate of 43.66%, which is higher than other sectors [4] - The total trading volume of the STAR Market reached 25.93 trillion yuan in the first three quarters of 2025, with an average trading volume of 440.32 billion yuan per stock, which is lower than the average trading volumes of stocks in the Shanghai and Shenzhen main boards and the ChiNext [6] - The average daily turnover rate of the STAR Market was 2.99% in the first three quarters of 2025, higher than that of the Shanghai main board but lower than that of the Shenzhen main board, ChiNext, and North Exchange [8] - The price-to-book ratio of the STAR Market was 5.78 times at the end of Q3 2025, higher than that of the ChiNext and Shanghai and Shenzhen main boards [11] - The financing balance of the STAR Market reached 244.335 billion yuan at the end of Q3 2025, an increase of 99.034 billion yuan from 145.301 billion yuan at the beginning of the year [13] - The margin trading balance of the STAR Market was 0.829 billion yuan at the end of Q3 2025, an increase of 0.037 billion yuan from 0.459 billion yuan at the beginning of the year [15] Individual Stocks - As of the end of Q3 2025, SMIC led with a market capitalization exceeding 700 billion yuan, followed by Haiguang Information, Cambricon Technologies, and BeiGene, with 11 companies having market capitalizations exceeding 100 billion yuan [18] Industry Themes - In the first three quarters of 2025, companies listed on the STAR Market were primarily distributed across three Wind Sci-Tech theme industries, with the new generation information technology industry leading with four companies, followed by high-end equipment manufacturing and biotechnology industries, each with one company [29] - Among the seven companies issued on the STAR Market in the first three quarters of 2025, six were listed under Standard One, which requires positive net profits for the last two years and a cumulative net profit of no less than 50 million yuan, or a positive net profit for the last year with operating income of no less than 100 million yuan, and an expected market capitalization of no less than 1 billion yuan [31] - The companies issued on the STAR Market in the first three quarters of 2025 came from Beijing and Jiangsu (two each), and Hubei, Zhejiang, and Guangdong (one each) [34] - The total IPO financing on the STAR Market in the first three quarters of 2025 was 7.901 billion yuan, a year-on-year decrease of 9.99%, with three companies raising over 1 billion yuan, three raising between 500 million to 1 billion yuan, and one raising less than 500 million yuan [36] - Yitang Co., Ltd. led the IPO financing in the first three quarters of 2025 with 2.497 billion yuan, while Yingshi Innovation and Xingfu Electronics each raised over 1 billion yuan [40]

Core Insights - The report from Zhongyou Securities highlights that BeiGene achieved a net profit attributable to shareholders of 450 million yuan in the first half of the year, a significant improvement from a net loss of 2.88 billion yuan in the same period last year [1] - In Q2 2025, the company reported a net profit of 540 million yuan, compared to a net loss of 970 million yuan in the same quarter of the previous year [1] - BeiGene has raised its full-year revenue guidance from the previous range of 4.9-5.3 billion USD to a new range of 5.0-5.3 billion USD, while maintaining its guidance for positive GAAP operating profit for the year [1] Financial Performance - The company reported a substantial turnaround in net profit, moving from a loss of 2.88 billion yuan to a profit of 450 million yuan year-on-year [1] - The Q2 2025 results show a net profit of 540 million yuan, indicating a strong recovery compared to the previous year's loss of 970 million yuan [1] Product Performance - The sales of the drug Zebrutinib showed stable growth quarter-on-quarter, while the drug Dazalutamide experienced rapid market expansion [1] - BeiGene is positioned as a leading company in the innovative drug export sector, showcasing strong global commercialization capabilities [1] Future Outlook - The company is approaching a harvest period for its research pipeline, indicating potential for future growth and profitability [1] - The initial coverage of the company has been rated as "Buy," reflecting positive sentiment towards its future performance [1]

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [2][9]. Core Insights - The company reported a significant increase in revenue and net profit for the first half of 2025, with total revenue reaching 17.52 billion yuan, a 46% increase year-on-year, and a net profit of 450 million yuan compared to a loss of 2.88 billion yuan in the same period last year [5][6]. - The company has raised its full-year revenue guidance from 4.9-5.3 billion USD to 5-5.3 billion USD, while maintaining its guidance for positive GAAP operating profit for the year [5][6]. Financial Performance - In Q2 2025, the company achieved a revenue of 9.47 billion yuan, a 42.7% increase year-on-year, and a net profit of 540 million yuan, compared to a loss of 970 million yuan in the same quarter last year [5][6]. - The global revenue for the drug Zebutinib reached 1.74 billion USD in the first half of 2025, with a year-on-year growth of 54.7%, driven by strong performance in the US and Europe [6][7]. Product Development - The company is advancing its product pipeline, with several key trials underway, including a Phase III trial for a combination therapy involving Zebutinib [7][8]. - The company anticipates significant data releases in the second half of 2025 for various products, including a KRAS inhibitor and ADCs [8]. Earnings Forecast - The company is projected to achieve revenues of 37.1 billion yuan, 47.15 billion yuan, and 58.18 billion yuan for the years 2025, 2026, and 2027, respectively, with corresponding net profits of 820 million yuan, 4.07 billion yuan, and 8.07 billion yuan [9][11].

Core Viewpoint - BeiGene's stock price has shown significant volatility and growth in 2023, with a notable increase in revenue and net profit for the first half of the year [2][3]. Stock Performance - As of September 30, BeiGene's stock rose by 2.02% to 307.09 CNY per share, with a trading volume of 5.59 billion CNY and a market capitalization of 473.13 billion CNY [1]. - Year-to-date, BeiGene's stock price has increased by 90.72%, with a 1.17% rise in the last five trading days, a 5.47% decline over the past 20 days, and a 37.62% increase over the last 60 days [2]. Financial Performance - For the period from January to June 2025, BeiGene reported a revenue of 17.518 billion CNY, representing a year-on-year growth of 46.03%, and a net profit attributable to shareholders of 450 million CNY, up 115.63% year-on-year [2]. Shareholder Information - As of June 30, 2025, the number of shareholders for BeiGene was 23,300, a decrease of 3.90% from the previous period, with an average of 4,976 circulating shares per shareholder, an increase of 4.11% [2]. - Among the top ten circulating shareholders, notable changes include an increase in holdings by China Europe Medical Health Mixed A and a decrease in holdings by Wan Jia You Xuan [3].

Core Conclusion - The investment logic for innovative drugs indicates that 2025 will mark a new recovery starting point for China's innovative drug industry after a deep adjustment, driven by a "triple resonance" of policy, industry, and capital [3][5][7]. Policy Insights - The Chinese government has explicitly supported innovative drugs in the 2025 Government Work Report, with subsequent policies aimed at high-quality development and commercial insurance for innovative drugs, clearing development obstacles across the entire chain [3][5]. Industry Dynamics - The internationalization process is accelerating, with the License-out model becoming a key path for value realization. In the first three quarters of 2025, upfront payments for licensing transactions reached $5.7 billion, surpassing the total for 2024 and accounting for 23.4% of the global total, indicating a significant enhancement in the global value chain position of Chinese innovative drug assets [5][7]. Capital Market Trends - After a deep adjustment from 2022 to 2024, industry valuations are returning to rational levels, with continuous improvement in the fundamentals of companies. In the first half of 2025, sales revenue from 17 commercialized innovative drug companies grew by 30% year-on-year, with leading companies like Innovent Biologics achieving profitability, marking a phase of value reassessment in the industry [7]. Market Size and Growth - The global innovative drug market is expected to reach $782.6 billion in 2024, accounting for 51.3% of the global pharmaceutical market, and is projected to grow to $1,119 billion by 2029, with a compound annual growth rate (CAGR) of 7.4%, outpacing the overall pharmaceutical market growth of 6.4% [14]. Industry Structure - The innovative drug industry chain is divided into three main segments: upstream (raw materials and support), midstream (R&D and production), and downstream (distribution and payment), forming a complete value chain from scientific discovery to market application [19][21][24]. Business Model Transformation - Chinese innovative drug companies are transitioning from a single reliance on domestic market sales to a dual-driven international strategy of "domestic sales + License-out," marking a new phase where product strength and business model innovation are equally emphasized [28][29]. Revenue Sources - The revenue sources for innovative drug companies are diversifying, including domestic insurance sales, License-out income, and overseas market sales. In 2023, insurance spending on innovative drugs reached 90 billion yuan, maintaining rapid growth since 2019 [28][29][34]. BD Model Growth - The BD (Business Development) model has become a core engine for commercialization, with the total amount of BD transactions involving Chinese innovative drug companies skyrocketing from $5.06 billion in 2020 to $41.76 billion by August 2025, indicating a fundamental shift in the industry's business model [37][38]. Key Segments to Watch - The innovative drug industry includes six key segments: small molecule drugs, large molecule drugs, cell therapy, gene therapy, mRNA vaccines, and precision medicine, each deserving in-depth research [43].

2025 中期報告 BeOne Medicines Ltd. （根據瑞士法律註冊成立的公司） Cancer has no borders. Neither do we. 目錄 | 公司資料 | 2 | | --- | --- | | 前瞻性陳述 | 4 | | 管理層討論及分析 | 7 | | 其他資料 | 28 | | 未經審核中期簡明綜合經營表 | 82 | | 未經審核中期簡明綜合全面虧損表 | 83 | | 未經審核中期簡明綜合資產負債表 | 84 | | 未經審核中期簡明綜合股東權益報表 | 86 | | 未經審核中期簡明綜合現金流量表 | 87 | | 未經審核中期簡明綜合財務報表附註 | 89 | | 釋義 | 124 | | 技術詞彙 | 128 | 1 百濟神州有限公司 • 2025 中期報告 公司資料 董事會 執行董事 歐雷強先生 （主席兼首席執行官） 非執行董事 王曉東博士 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 A ...

BeOne Medicines Ltd. 百濟神州有限公司 (a corporation incorporated under the laws of Switzerland) （根據瑞士法律註冊成立的公司） (Stock Code 股份代號: 06160) Dear non-registered shareholder(s), September 26, 2025 Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter dated February 28, 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", BeOne Medicines Ltd. (the "Company") is writing to remind you that the Company has ad ...

BeOne Medicines Ltd. 百濟神州有限公司 (Stock Code 股份代號: 06160) September 26, 2025 Dear registered shareholder(s), Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter dated February 28, 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", BeOne Medicines Ltd. (the "Company") is writing to remind you that the Company has adopted electronic dissemination of corporate communications (the "Corporate Comm ...

Drug Development and Commercialization - BeOne Medicines Ltd. reported significant advancements in drug commercialization and regulatory approvals, indicating a strong pipeline for future growth[9]. - The company is focused on expanding its sales and marketing capabilities, aiming to launch and commercialize new drugs upon approval[10]. - BeOne Medicines Ltd. is actively developing both small molecule drugs and large molecule biologics to meet global demand, enhancing its production and clinical research facilities[10]. - The company emphasizes the importance of maintaining and expanding regulatory approvals for its drugs and candidates[9]. - BeOne Medicines Ltd. is assessing the potential market size for its drugs and candidates, indicating a strategic focus on market access and acceptance rates[10]. - The company is focused on the successful completion of clinical trials and obtaining regulatory approvals for its candidate drugs[10]. - The company maintains a leading position in the BTK inhibitor market with Baiyueze® across five approved indications in the U.S.[16]. - The European Medicines Agency granted priority medicine designation for BGB-16673, a BTK degrader, for patients previously treated with BTK inhibitors[17]. - The company received positive opinions from the CHMP recommending the approval of Baiyueze® for preoperative and postoperative treatment in high-risk resectable non-small cell lung cancer patients[19]. - The company has launched a new generation BCL2 inhibitor, Sotokura, showing positive results in clinical trials for adult patients with mantle cell lymphoma[17]. - The company anticipates over 20 research milestones within the next 18 months, including advancements in solid tumor pipelines targeting various high-incidence cancers[16]. Financial Performance - Total revenue increased by 44.7% from $1.680 billion for the six months ended June 30, 2024, to $2.433 billion for the six months ended June 30, 2025[28]. - Product revenue net increased by 44.5% to $2.411 billion for the six months ended June 30, 2025, compared to $1.668 billion for the same period last year[29]. - Sales of Baiyueze® reached $1.741 billion, a 54.7% increase from $1.126 billion year-over-year[29]. - Baiyueze® global sales totaled $1.741 billion, with U.S. sales at $1.247 billion, reflecting a 50.1% increase from $830 million[30]. - Baiyueze® sales in Europe reached $266 million, a 79.7% increase, driven by market share growth across major European markets[30]. - The company achieved GAAP profitability for the first time in both Q1 and Q2 of 2025, with positive free cash flow in Q2[25]. - Net profit for the six months ended June 30, 2025, was $95.6 million, compared to a net loss of $371.6 million in the same period last year[27]. - Adjusted net profit for the six months ended June 30, 2025, was $389.0 million, compared to a loss of $122.6 million in the same period of 2024[46]. Research and Development - The company has a dedicated oncology research team of over 1,200 scientists, ensuring continuous innovation and market leadership[22]. - The company has invested in various technology platforms, including CDAC protein degraders and bispecific antibodies, to enhance its research and innovation capabilities[22]. - R&D expenses rose by 10.0% to $1.007 billion, while total operating expenses increased by 12.2% to $2.004 billion[27]. - External R&D expenses increased by $70.132 million (21.2%) to $400.259 million, driven by higher costs associated with advancing clinical projects[36]. Cash Flow and Liquidity - Cash and cash equivalents were approximately $2.8 billion as of June 30, 2025[25]. - Operating cash flow provided $307,680 thousand, a significant increase of $711,800 thousand compared to the same period last year, driven by substantial revenue growth and a gross profit increase of $359,700 thousand[64]. - The company plans to utilize existing cash to meet significant cash needs, including operational, capital, and production expenditures[69]. - Cash used in investing activities was $188,546 thousand, a decrease from $320,863 thousand in the previous year, primarily due to reduced capital expenditures[65]. Debt and Equity - Total debt decreased by 6.2% from $1.018 billion as of December 31, 2024, to $954.5 million as of June 30, 2025[60]. - The company's debt-to-equity ratio decreased from 30.6% as of December 31, 2024, to 25.3% as of June 30, 2025, primarily due to a reduction in debt and an increase in shareholder equity[87]. - The company has $615.4 million in outstanding floating-rate debt as of June 30, 2025, with a potential increase of approximately $6.2 million in annual pre-tax interest expense for every 100 basis points rise in interest rates[80]. Corporate Governance - The company is committed to maintaining high standards of corporate governance and has adhered to the applicable corporate governance code principles[179]. - The audit committee consists of four independent non-executive directors, with Shalini Sharp serving as the chair, ensuring compliance with financial reporting and internal controls[181]. - The remuneration committee is composed of three independent non-executive directors, with Margaret Han Dugan as the chair, responsible for reviewing and recommending executive compensation[182]. - The nomination and corporate governance committee is currently led by Anthony C. Hooper, ensuring compliance with the Hong Kong listing rules regarding board composition[183]. Shareholder Information - The total number of issued shares as of June 30, 2025, is 1,539,858,562 shares[106]. - Amgen Inc. holds 246,269,426 shares, representing 15.99% of the total shares[101]. - The company has issued 21,880,885 shares under equity awards, which are currently considered circulating shares[97]. - The company has a stock option plan that allows for the issuance of shares to employees, with 133,000,000 shares held by a subsidiary for this purpose[106]. Employee Stock Options and Incentives - The company plans to continue expanding its stock option program to incentivize employee performance and retention[156]. - The exercise price for options granted under the revised 2016 plan must not be lower than the higher of the fair market value at the time of grant or the average closing price over the previous five trading days[133]. - The total number of unexercised stock options as of the report date is 64,383,926[155]. - The stock options granted are subject to a vesting schedule, with 25% vesting on the first anniversary and the remaining 75% vesting monthly over 36 months[152].