2024 年度報告 Cancer has no borders. Neither do we. 目錄 | 公司資料 | 2 | | --- | --- | | 前瞻性陳述 | 4 | | 業務 | 8 | | 風險因素 | 43 | | 財務概要 | 129 | | 管理層討論及分析 | 130 | | 董事及高級管理層 | 153 | | 董事會報告 | 162 | | 企業管治報告 | 229 | | 獨立核數師報告 | 259 | | 綜合財務報表 | 264 | | 釋義 | 349 | | 技術詞彙 | 355 | 1 百濟神州有限公司 • 2024 年度報告 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 （附註1） Margaret Han Dugan博士 Michael Goller先生 Anthony C. Hooper先生 Ranjeev Krishana先生 Alessandro Riva博士 Corazon (Corsee) D. Sanders博士 Shalini Sharp女士 （附註 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 百濟神州有限公司 (於開曼群島註冊成立的有限公司) 備註： (1)第一章節/1/A部在計算已發行股份佔有關股份發行前的現有已發行股份數目百分比時，參照了上市發行人已發行股份數目總額 （包括於香港聯交所及上海證券交易所 科創板上市的普通股份）。 (2)第一章節/1/A/1部所列於股份獎勵計劃下發行股份来自本公司第三版經修訂及重列之2016 期權及激勵計劃授权的股份池，且該等股份為就向本公司一位前董事授予的 受限制股份單位而發行。請參考後續證券變動月報表，以了解股權计划股份池中未来可发行的股份剩余数量。 (3)第一章節/1/A部所述開始及結束日期的結存数量不包括向公司的託管公司發行的普通股，該等股份用以換取相應數量的美國存託股份,旨在確保其託管公司可隨時動用 美國存託股份用於滿足受限制股份單位的歸屬及不時行使任何期權。详情請參考後續證券變動月報表。 FF305 第 2 頁 共 6 頁 v 1.3.0 FF305 呈交日期： 2025年4月28日 如上市發行人的已 ...

Financial Performance - The company reported a significant increase in revenue, achieving a total of $1.5 billion for the fiscal year, representing a 25% year-over-year growth[9]. - In 2024, the company's total global revenue is approximately $3.8 billion, an increase of about $1.4 billion compared to the previous year, with operating losses reduced by approximately $600 million[16]. - The company reported cash and cash equivalents of $2.6 billion as of December 31, 2024, reflecting a strong financial position[28]. - Since 2023, the current product portfolio and core product revenue have increased by 73%, with expectations for significant growth in 2025 and beyond[28]. - The company achieved a significant reduction in US GAAP operating losses and recorded its first non-GAAP operating profit in fiscal year 2024[28]. - Positive operating cash flow was generated in both Q3 and Q4 of 2024, marking a turnaround after years of cash outflows[28]. - Cumulative losses reached $8.6 billion as of December 31, 2024, primarily due to R&D expenses and operational costs[191]. - The company expects a positive GAAP operating income for the full year of 2025, despite potential future losses[192]. - Cash used in operating activities was $100 million, $1.2 billion, and $1.5 billion for the years ending December 31, 2024, 2023, and 2022, respectively[193]. - The company has generated insufficient revenue from drug sales to support its operations, despite having enough cash to meet operational needs for at least the next 12 months[194]. Market Expansion and Strategy - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[9]. - The company plans to enhance its digital marketing strategy, aiming for a 40% increase in online sales[9]. - The company is exploring strategic acquisitions to enhance its product portfolio, with a budget of $500 million allocated for potential deals[9]. - The company is committed to creating long-term value for shareholders through strategic partnerships and careful capital deployment[28]. - The company is focused on expanding its market presence through strategic collaborations and innovative product development[66]. Product Development and Pipeline - The company has advanced 13 differentiated new molecular entities (NMEs) into clinical trials in 2024, targeting common cancers such as breast, lung, and gastrointestinal cancers[20]. - The company has developed a pipeline of innovative solid tumor products, with key proof-of-concept catalysts expected in the next 6 to 18 months[20]. - The company is conducting extensive clinical projects globally to evaluate the efficacy of its BTK inhibitor, 百悅澤® (Zebutinib), for various B-cell malignancies[67]. - The pipeline includes 101 B-cell malignancies and 102 B-cell malignancies, indicating a strong focus on hematological cancers[63]. - The company has a diverse pipeline of products with multiple candidates in various stages, including 3 in Phase 3 and 5 in Phase 2 trials as of February 27, 2025[63]. Regulatory and Compliance - The company is committed to maintaining compliance with regulatory standards across all markets, ensuring no disruptions in operations[9]. - Regulatory compliance in the pharmaceutical industry is complex and costly, with potential significant adverse effects on business operations[155]. - Non-compliance with regulatory requirements can lead to severe sanctions, including product recalls and license revocations, as seen with the suspension of ABRAXANE® in 2020[156]. - The company faces risks related to healthcare fraud and abuse laws, which could result in civil penalties and reputational damage[157]. - Regulatory changes in China may complicate drug approval processes, impacting timely commercialization of products[155]. Clinical Trials and Research - The clinical project for Sonrotoclax has enrolled over 1,800 patients, and it is currently undergoing late-stage clinical trials, including a Phase 3 trial for CLL patients[18]. - The company plans to initiate a Phase 3 head-to-head trial against Pirtobrutinib in 2025, aligning with its strategy to improve current treatment options[18]. - The ongoing clinical trials for Baiyueze® include several combination therapies targeting MCL, MZL, and CLL/SLL[68]. - The CELESTIAL-TN CLL trial aims to compare the efficacy of sonrotoclax combined with Baiyueze® against venetoclax combined with obinutuzumab, with enrollment completed in Q1 2025[73]. - The company has initiated a pivotal phase 2 expansion study for R/R CLL, with plans for a confirmatory phase 3 study in early 2025[76]. Competitive Landscape - The company is facing intense competition from various global and regional biopharmaceutical companies, necessitating a strong and flexible R&D strategy[122]. - Key competitors for the drug Bai Yue Ze® include AbbVie and Johnson & Johnson, with competing products already on the market[124]. - The company is committed to continuous investment in innovation and brand drug development to effectively compete in the current and future markets[127]. Financial Risks and Challenges - The company may need additional financing to fund operations and complete the development of candidate drugs[193]. - The company faces significant adverse impacts on its liquidity and financial condition due to negative cash flow and current debt structure, with no assurance of obtaining sufficient cash from other sources for operational funding[195]. - Raising additional capital may lead to shareholder dilution and restrict operational capabilities, with potential adverse terms affecting rights to technology or drug candidates[196]. - The company is exposed to foreign exchange risks due to expenses and revenues in currencies other than USD or HKD, particularly RMB, EUR, and AUD, which may negatively impact financial performance[198]. Intellectual Property - As of February 14, 2025, BeiGene holds 63 US patents, 15 European patents, 28 Japanese patents, and 70 Chinese patents, along with multiple pending patent applications[115]. - The patent protection for key drugs includes various compositions and methods expiring between 2031 and 2043, ensuring a robust intellectual property portfolio[116]. - The drug "Zebutinib" has multiple patent protections in the US expiring as late as 2043, covering substance compositions and treatment methods[116]. Patient Access and Reimbursement - The company offers patient assistance programs to help patients afford innovative drugs, typically ceasing when drugs are included in the national medical insurance catalog[61]. - The commercial success of the company's drugs heavily relies on the reimbursement levels provided by government health departments and private insurers, which can significantly impact business operations[137]. - The process of obtaining insurance and reimbursement approval from third-party payers in the U.S. is time-consuming and costly, with no guarantee of achieving adequate reimbursement rates[138]. Manufacturing and Production - The company has established production facilities in Suzhou and Guangzhou, with the Suzhou facility covering 52,000 square meters and an annual capacity of approximately 600 million tablets and capsules, expected to begin commercial supply by mid-2025[103]. - The Guangzhou facility has a total area of approximately 158,000 square meters, with a first-phase and second-phase factory completed in September 2019 and December 2020, respectively, and a total capacity of 64,000 liters after the third-phase factory certification in 2024[104]. - The company relies on a limited number of third-party CMO and CROs for the production of several drugs and raw materials, ensuring compliance with regulatory requirements and internal quality standards[105].

Group 1 - The core viewpoint of the article highlights the performance of the CSI Hong Kong-Shanghai Biotech Theme Index, which reflects the overall performance of listed companies in the biotech sector from mainland China and Hong Kong [1][3] - The CSI Hong Kong-Shanghai Biotech Theme Index has shown an increase of 0.82% over the past month, 12.93% over the past three months, and 12.21% year-to-date [1] - The index consists of 50 sample companies involved in biopharmaceuticals, pharmaceuticals, and biotech services, with a base date of December 28, 2018, set at 1000.0 points [1] Group 2 - The top ten weighted companies in the index include: Heng Rui Medicine (13.16%), BeiGene (10.43%), WuXi AppTec (8.41%), Mindray Medical (7.71%), WuXi Biologics (5.15%), Innovent Biologics (4.82%), CanSino Biologics (3.91%), Shanghai Pharmaceuticals (2.74%), China National Pharmaceutical Group (2.45%), and Shanghai RAAS Blood Products (1.83%) [1] - The market share of the index holdings is distributed as follows: Hong Kong Stock Exchange 41.72%, Shanghai Stock Exchange 35.62%, and Shenzhen Stock Exchange 22.66% [1] Group 3 - In terms of industry composition, biopharmaceuticals account for 43.26%, chemical drugs for 25.78%, pharmaceutical and biotech services for 21.39%, and medical devices for 9.57% [2] - The index samples are adjusted semi-annually, with adjustments occurring on the next trading day after the second Friday of June and December each year [2] - Special circumstances may lead to temporary adjustments to the index, including the removal of samples that are delisted or changes due to mergers, acquisitions, or other corporate actions [2]

Core Viewpoint - The China Overseas Five-Year Plan Index has shown a recent decline of 6.82% over the past month, but has increased by 12.88% over the last three months and 13.97% year-to-date, reflecting the performance of listed companies benefiting from China's Five-Year Plan [1] Group 1: Index Performance - The China Overseas Five-Year Plan Index opened at 1602.09 points and has a base date of June 29, 2007, with a base point of 679.999 [1] - The index has experienced a monthly decline of 6.82%, a three-month increase of 12.88%, and a year-to-date increase of 13.97% [1] Group 2: Index Holdings - The top ten holdings of the index include Alibaba (18.02%), Tencent Holdings (15.72%), Meituan-W (7.17%), Pinduoduo (6.2%), BYD Company (4.45%), JD.com (2.71%), SMIC (2.06%), BeiGene Ltd (1.8%), Xpeng Motors (1.42%), and Kuaishou-W (1.41%) [1] - The index's market distribution shows that 60.71% of holdings are listed on the Hong Kong Stock Exchange, 24.79% on the New York Stock Exchange, and 13.79% on the Nasdaq Global Select Market [2] Group 3: Industry Breakdown - The industry composition of the index indicates that consumer discretionary accounts for 53.46%, communication services for 18.78%, healthcare for 9.63%, and industrials for 7.89% [2] - Other sectors include consumer staples (3.89%), materials (3.60%), information technology (2.49%), and utilities (0.28%) [2] Group 4: Index Adjustment Mechanism - The index samples are adjusted biannually, with adjustments implemented on the next trading day following the second Friday of June and December [3] - Weight factors are generally fixed until the next scheduled adjustment, with special circumstances allowing for temporary adjustments [3]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology sector [4]. Core Viewpoints - The domestic weight loss drug market is entering commercialization, emphasizing the importance of sales capabilities for companies [1][19]. - The competition in the global weight loss drug market is intensifying, particularly between Novo Nordisk and Eli Lilly, where marketing strategies play a crucial role in sales performance [19][23]. - Companies with advanced R&D progress and strong sales execution will hold competitive advantages in the commercialization phase of weight loss drugs [1][19]. Summary by Sections Market Review - The pharmaceutical and biotechnology index rose by 1.16%, outperforming the CSI 300 index by 0.77 percentage points but underperforming the ChiNext index by 1.08 percentage points, ranking 15th among 31 sub-industries [1][15]. - The Hong Kong Hang Seng Healthcare Index increased by 8.44%, outperforming the Hang Seng Index by 6.12 percentage points [1][15]. Company Updates - Recent clinical application updates include Baiyi Shenzhou's injection BGB-B2033 and Nuo Cheng Jian Hua's injection ICP-B794, both newly undertaken [27]. - Ongoing clinical trials include Bo Rui Pharmaceutical's BGM0504 and Hua Dong Pharmaceutical's HDM1002, currently in Phase III [27]. Investment Strategy - The report suggests a structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: in-hospital payments, out-of-pocket payments, and overseas payments [2]. - Key recommended companies include Heng Rui Pharmaceutical, Mai Rui Medical, and United Imaging Healthcare [2]. Company Profit Forecasts and Valuation - Heng Rui Pharmaceutical is rated "Accumulate" with a projected EPS of 0.99 yuan for 2024 and a PE ratio of 51 [3]. - Mai Rui Medical is rated "Buy" with a projected EPS of 11.47 yuan for 2024 and a PE ratio of 19 [3]. - United Imaging Healthcare is also rated "Buy" with a projected EPS of 2.88 yuan for 2024 and a PE ratio of 44 [3].

本文约 2 5 0 0 字，推荐阅读时长 1 5 分钟，欢迎关注新财富公众号。 1 引言 4月14日，美国商务部宣布启动对进口药品的国家安全调查。这一调查覆盖了所有进口药品，包括成 品仿制药、原研药以及用于生产这些药品的关键药用成分。此举属于特朗普政府根据1962年《贸易扩 展法》第232条对多个行业进行的关税调查的一部分。虽然调查尚未结束，预计结果将在270天内公 布，但业内普遍认为，这将赋予特朗普政府对进口药品和原料药征收关税的权力。特别是对中国等主 要药品出口国的影响，可能会带来严重的供应链中断及成本上升。 事实上，美国每年从中国进口药品总额约60亿美元，其中大量为抗生素、抗病毒及心血管药物等基础 药物。一旦关税进一步扩大实施，这些进口药品的成本预计将明显上升，对美国本土药品生产商带来 直接冲击。为应对这种风险，特朗普政府提出多项措施推动产业本土化。 分析师预计，如果对来自中国的API征收10%的关税，仿制药企业的利润将下跌2%-3%，创新药利润 下跌可能更严重。 2 美国关税筑墙， 中概股 跌宕 自2025年特朗普重新执政以来，美国政府出台了一系列针对生物医药产业的重要政策，核心目标是强 化美国医药产 ...

Core Viewpoint - The recent incident involving the articles published by "Meisi Oncology New Frontier" highlights the intensifying competition in the PD-1 monoclonal antibody market, indicating a shift towards a saturated market where established players dominate future growth opportunities [4][5][8]. Market Dynamics - The PD-1 monoclonal antibody market has transitioned from a "golden track" to a "red ocean" due to increased product launches leading to homogenization of competition [5][8]. - Major players like Merck's "K drug" (pembrolizumab) and Bristol-Myers Squibb's "O drug" (nivolumab) continue to show strong sales, with projected global revenues of approximately $29.5 billion and $10.1 billion respectively for 2024 [5][6]. - In China, BeiGene's tislelizumab leads with sales of 4.467 billion yuan, a 17.4% increase year-on-year, while Innovent's sintilimab and Junshi Biosciences' toripalimab also report significant growth [6][7]. Competitive Landscape - The market is characterized by a clear division between leading companies with established products and newer entrants struggling to gain market share [8][9]. - Companies that fail to differentiate their products or adapt to the competitive landscape are increasingly exiting the PD-1 market, with at least six companies having withdrawn in the past four years [9][12]. Future Trends - The emergence of PD-1 bispecific antibodies is seen as a potential game-changer, with products like Ivosidenib showing superior efficacy in clinical trials compared to traditional PD-1 monoclonal antibodies [14][15]. - The potential for PD-1 bispecifics to address "hard-to-treat" patient populations and improve outcomes in various cancer types is being recognized as a significant opportunity for innovation [16]. Broader Applications - Beyond oncology, PD-1 inhibitors are being explored for autoimmune diseases, with ongoing clinical trials for conditions like rheumatoid arthritis [19][20]. - The distinction between PD-1 inhibitors and PD-1 agonists is crucial, as the latter has not yet seen any products approved for market, indicating a potential area for future development [20].

Investment Rating - The industry investment rating is maintained at "Outperform the Market" [3][41]. Core Insights - The pharmaceutical fund allocation structure remains balanced, with the overall allocation ratio at a historically low level. As of Q1 2025, the active pharmaceutical fund size reached 188.5 billion yuan, an increase of 12.6 billion yuan from Q4 2024. The passive pharmaceutical fund size reached a historical high of 140.4 billion yuan [4][10]. - The top three sectors for active pharmaceutical theme funds in Q1 2025 are innovative drugs (34%), traditional pharmaceuticals (26%), and CDMO (17%). Notable holdings include BeiGene, Zai Lab, Innovent Biologics, and others, which have seen significant increases in their positions [4][19]. - The pharmaceutical sector's heavy holdings in all funds account for 9.5% (+0.5 percentage points), while the heavy holdings excluding pharmaceutical funds stand at 4.6% (+0.5 percentage points), indicating an increase but still at a relatively low level [5]. Summary by Sections Fund Size and Share - As of Q1 2025, the active pharmaceutical fund size is 188.5 billion yuan, up 12.6 billion yuan from Q4 2024. The passive pharmaceutical fund size is 140.4 billion yuan, marking a historical peak [4][7]. - The active pharmaceutical fund share is 124.6 billion shares, down 15.2 billion shares from Q4 2024, primarily due to stock price increases. The passive pharmaceutical fund share is 266.2 billion shares, up 41.2 billion shares, also reaching a historical high [10][10]. Sector Allocation - As of Q1 2025, there is an over-allocation in innovative drugs, CDMO, traditional pharmaceuticals, and CRO, while sectors like commercial circulation and traditional Chinese medicine are under-allocated [16][18]. - The top holdings in the innovative drug sector include Zai Lab, BeiGene, and others, with significant increases in their market values from Q4 2024 to Q1 2025 [19]. Heavy Holdings - The pharmaceutical sector's heavy holdings in all funds account for 9.5%, with a slight increase, while the ratio excluding pharmaceutical funds is 4.6% [5][5]. - The report highlights the top ten pharmaceutical heavy holdings in both active and passive funds, indicating a trend towards innovative drug companies [21][24].

于 2025 年 4 月 24 日向美国证券交易委员会提交 编号：333 - 美国证券交易委员会 华盛顿特区 20549 F-6 表格 根据 1933 年证券法提交的 由美国存托凭证证明的美国存托股份 注册声明 百济神州有限公司 BEIGENE, LTD. （发行人章程中列明的存托证券发行人准确名称） 不适用 （发行人名称的英文） 开曼群岛 （发行人注册地或组织机构所在的司法管辖区） 花旗银行 CITIBANK, N.A. （存托银行章程中列明的存托银行准确名称） 388 Greenwich Street New York, New York 10013 (877) 248-4237 （存托银行主要办事处地址，包括邮政编码和电话号码，包括区号） Cogency Global Inc. 122 East 42nd Street, 18th Floor New York, New York 10168 (800) 221-0102 （送达代理人的地址，包括邮政编码和电话号码，包括区号） Mitchell S. Bloom 先生 Edwin M. O'Connor 先生 Marishka DeToy 先生 Good ...