百济神州有限公司 2024年度 非经营性资金占用及其他关联资金往来情况的专项说明 | 目录 | | --- | | | | | 一、 | 非经营性资金占用及其他关联资金往来情况的专项说明 | 1 - 2 | | --- | --- | --- | | 二、 | 非经营性资金占用及其他关联资金往来情况的说明 | 3 - 6 | 非经营性资金占用及其他关联资金往来情况的专项说明 安永华明（2025）专字第70033281_A04号 百济神州有限公司 非经营性资金占用及其他关联资金往来情况的专项说明（续） 安永华明（2025）专字第70033281_A04号 百济神州有限公司 （本页无正文） 百济神州有限公司董事会： 我们审计了百济神州有限公司的2024年度财务报表，包括2024年12月31日的合并 资产负债表，2024年度的合并利润表、合并股东权益变动表和合并现金流量表以及相 关财务报表附注，并于2025年4月27日出具了编号为安永华明（2025）审字第 70033281_A01号的无保留意见审计报告。 按照《上市公司监管指引第8号——上市公司资金往来、对外担保的监管要求》的 要求，百济神州有限公司编制了后附的2 ...

Financial Performance - The company reported a cumulative loss of RMB 62.667 billion as of December 31, 2024, primarily due to high investments in drug research and development [3]. - The company does not plan to distribute profits or increase capital reserves through stock conversion for the 2024 fiscal year [7]. - The company's operating revenue for 2024 reached ¥27,213,955, representing a 56.19% increase compared to ¥17,423,344 in 2023 [29]. - The net profit attributable to shareholders for 2024 was -¥4,978,287, an improvement from -¥6,715,859 in 2023 [29]. - The net cash flow from operating activities improved to -¥1,259,052 in 2024, significantly better than -¥7,793,254 in 2023 [29]. - The basic earnings per share for 2024 was -¥3.64, compared to -¥4.95 in 2023 [30]. - The company reported a quarterly operating revenue of ¥8,078,098 in Q4 2024, with a net profit of -¥1,291,593 for the same quarter [36]. - The company experienced a significant reduction in losses, with the net profit attributable to shareholders improving in each quarter of 2024 compared to the previous year [31]. - The company plans to continue investing in its research pipeline and commercial operations to support global expansion [31]. Research and Development - Research and development expenses for the reporting period amounted to RMB 14.14 billion, representing a year-on-year increase of 10.35% [3]. - The company is focused on the research, development, and commercialization of innovative drugs, establishing competitive advantages in these areas [4]. - The company has a differentiated product portfolio, including the BTK inhibitor Baiyueze®, which has been approved in over 70 markets globally and is leading in the treatment of R/R CLL patients [46]. - The company has a robust pipeline with multiple candidates in various clinical stages, including Sonrotoclax and BGB-16673, targeting different types of cancers [78]. - The company has established a comprehensive organizational structure covering drug discovery, preclinical research, global clinical trials, and commercialization [120]. - The total R&D investment for the current year reached ¥14,139,839, an increase of 10.35% compared to ¥12,813,453 from the previous year [158]. - The company holds a total of 294 invention patents, including 62 in the United States, 63 in China, 26 in Japan, and 14 in Europe [154][156]. - The company has initiated 70 clinical trials for its PD-1 monoclonal antibody, with over 130,000 patients treated globally [161]. - The company has developed a tumor organ platform that closely mimics in vivo conditions, improving the evaluation of drug efficacy [7]. Market Strategy and Expansion - The company anticipates a revenue guidance of RMB 5 billion for the upcoming fiscal year, reflecting a growth of approximately 20% [20]. - BeiGene plans to expand its market presence in Europe, targeting a 15% market share by 2025 [20]. - The company has initiated a strategic partnership with a leading biotech firm to co-develop a novel cancer therapy, aiming for a market launch in 2026 [20]. - The company is focused on expanding its commercialization efforts in Asia, Australia, and New Zealand for various products [79]. - The company has established strategic partnerships with renowned pharmaceutical companies, enhancing its product pipeline and commercialization capabilities [178]. Regulatory Approvals and Product Launches - The company has received FDA approval for two new indications, expected to significantly boost sales in the next quarter [20]. - Bai Ze An® received FDA approval for use in first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma on December 27, 2024 [52]. - The European Medicines Agency (EMA) recommended the approval of Bai Ze An® (Tislelizumab) for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) on March 31, 2025 [52]. - The company has received approval for three self-developed anti-tumor products in multiple countries, indicating significant commercial potential [172]. Risks and Challenges - The company faces various risks in its operations, which are detailed in the management discussion and analysis section of the report [5]. - The company faces risks related to the market acceptance of its drugs, which may not achieve sufficient recognition among medical professionals and patients [186]. - The complexity and unpredictability of the regulatory approval process for drugs can lead to delays or failures in obtaining necessary approvals, impacting the company's ability to market its products [192]. - Clinical development is time-consuming and costly, with high uncertainty regarding the outcomes of later-stage trials, which may not align with earlier positive results [197]. - The company may experience increased costs and delays in drug development and approval processes due to various factors, including public health crises and regulatory inspections [196]. Workforce and Organizational Structure - The company has over 11,000 employees, reflecting its growth since its establishment in 2010 [51]. - The number of R&D personnel increased to 3,905, up from 3,744 in the previous period, with R&D personnel accounting for 35.3% of the total workforce [165]. - Average salary for R&D personnel rose to RMB 956 thousand, compared to RMB 886 thousand in the previous period [165]. - The management team possesses extensive experience across the entire drug development lifecycle, contributing to the company's competitive advantage in bringing innovative drugs to market [180].

一、主要会计数据和财务指标 | 报告期指标 | 2024年年报 | 2023年年报 | 本年比上年增减(%) | 2022年年报 | | --- | --- | --- | --- | --- | | 基本每股收益（元） | -3.6400 | -4.9500 | 26.46 | -10.1800 | | 每股净资产（元） | 17.46 | 18.53 | -5.77 | 22.44 | | 每股公积金(元) | 61.5 | 60.07 | 2.38 | 59.58 | | 每股未分配利润(元) | -45.25 | -42.58 | -6.27 | -37.72 | | 每股经营现金流(元) | - | - | - | - | | 营业收入(亿元) | 272.14 | 174.23 | 56.2 | 95.66 | | 净利润(亿元) | -49.78 | -67.16 | 25.88 | -136.42 | | 净资产收益率(%) | -20.20 | -23.86 | 15.34 | -38.83 | 数据四舍五入，查看更多财务数据>> | 名称 持有数量(万股) | | 占总股本比例 | 增减情 ...

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]

金融界4月28日消息，上证指数低开震荡，中证海外中国五年规划指数 (中国五年规划，H11160)报 1602.09点。 从中证海外中国五年规划指数持仓样本的行业来看，可选消费占比53.46%、通信服务占比18.78%、医 药卫生占比9.63%、工业占比7.89%、主要消费占比3.89%、原材料占比3.60%、信息技术占比2.49%、公 用事业占比0.28%。 据了解，中证海外中国五年规划指数从海外交易所上市的中国内地公司中选取受惠于中国五年规划的上 市公司证券组成指数样本，以反映在海外交易所上市中国内地企业中受惠于中国五年规划的上市公司证 券的整体表现。该指数以2007年06月29日为基日，以679.999点为基点。 资料显示，指数样本每半年调整一次，样本调整实施时间分别为每年6月和12月的第二个星期五的下一 交易日。权重因子随样本定期调整而调整，调整时间与指数样本定期调整实施时间相同。在下一个定期 调整日前，权重因子一般固定不变。特殊情况下将对指数进行临时调整。当样本退市时，将其从指数样 本中剔除。样本公司发生收购、合并、分拆等情形的处理，参照计算与维护细则处理。 从指数持仓来看，中证海外中国五年规划指数十 ...

2025 年 4 月 28 日 行业研究 国产减肥药将步入商业化，重视企业销售能力 ——医药生物行业跨市场周报（20250420） 要点 行情回顾：上周，医药生物指数上涨 1.16%，跑赢沪深 300 指数 0.77pp，跑输 创业板综指 1.08pp，在 31 个子行业中排名第 15，表现一般。港股恒生医疗健 康指数上周收涨 8.44%，跑赢恒生国企指 6.12pp。 上市公司研发进度跟踪：上周，百济神州的注射用 BGB-B2033、诺诚健华的注 射用 ICP-B794 的临床申请新进承办；百济神州的 BG-68501 片和 BGB-43395 片的 IND 申请新进承办。博瑞医药的 BGM0504、华东医药的 HDM1002 正在进 行三期临床；舒泰神的 STSP-0902 正在进行二期临床、正大天晴的 TQB3019 正在进行一期临床。 本周观点：国产减肥药将步入商业化，重视企业销售能力 全球减肥药的竞争日趋白热化，尤其以诺和诺德与礼来的竞争备受关注。从二者 的市场竞争经验来看，未来减肥药市场的销售业绩并不完全取决于临床数据，诺 和诺德在销售方面更加优秀的表现更多来自于其出色的营销策略，一方面是持续 以 ...

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 ...