Financial Performance - The company's global revenue for 2023 reached approximately RMB 17.423 billion, an increase of about RMB 7.857 billion compared to 2022[3]. - The net loss for the year decreased by approximately RMB 6.926 billion, with cumulative unremitted losses amounting to RMB 57.688 billion as of December 31, 2023[3]. - The company's operating revenue for 2023 reached CNY 17,423,344 thousand, an increase of 82.13% compared to CNY 9,566,409 thousand in 2022[22]. - The net profit attributable to shareholders for 2023 was CNY -6,715,859 thousand, showing an improvement from CNY -13,642,041 thousand in 2022[22]. - The basic earnings per share for 2023 was CNY -4.95, an improvement from CNY -10.18 in 2022[23]. - The company's total assets decreased by 7.02% to CNY 41,121,675 thousand at the end of 2023, down from CNY 44,224,173 thousand in 2022[22]. - The net cash flow from operating activities for 2023 was CNY -7,793,254 thousand, slightly improved from CNY -7,799,707 thousand in 2022[22]. - The company reported a quarterly operating revenue of CNY 5,624,008 thousand in Q3 2023, with a net profit attributable to shareholders of CNY 1,340,817 thousand for the same quarter[26]. - The company's net assets attributable to shareholders decreased by 17.24% to CNY 25,103,342 thousand at the end of 2023, down from CNY 30,331,059 thousand in 2022[22]. - The weighted average return on equity for 2023 was -23.86%, an improvement from -38.83% in 2022[23]. Research and Development - Research and development expenses for the year were RMB 12.813 billion, representing a growth of 14.90% year-over-year[3]. - Research and development expenses accounted for 73.54% of operating revenue in 2023, a decrease of 43.04 percentage points from 116.58% in 2022[23]. - The total R&D investment for the year reached CNY 12,813,453 thousand, representing a 14.90% increase from CNY 11,152,086 thousand in the previous year[121]. - The company has a total R&D personnel count of 3,744, representing 35.7% of the total workforce, with an average salary of CNY 827,200[129]. - The company has established six core technology platforms to enhance R&D efficiency and facilitate seamless transitions between R&D, production, and clinical applications[115]. - The company has over 50 preclinical projects, with expectations to advance several candidates into clinical trials within the next 12 months[87]. Drug Development and Approvals - The company achieved a total of 12 new drug applications (NDAs) submitted to regulatory authorities during the year, reflecting its strong pipeline development[16]. - The company is actively seeking regulatory approvals for candidate drugs and expanding production and manufacturing facilities[3]. - The company has three self-developed and approved drugs, with 百悦泽® (Zebutinib) approved in 70 countries and regions, 百泽安® (Tislelizumab) approved in China, the EU, and the US, and 百汇泽® (Pamiparib) approved in China[31]. - 百泽安® received EU approval for three indications in non-small cell lung cancer (NSCLC) on April 23, 2024[34]. - 百悦泽® was granted accelerated approval by the FDA for use in combination with the anti-CD20 monoclonal antibody Obinutuzumab for adult patients with relapsed or refractory follicular lymphoma[34]. - The company has received approvals for various products targeting multiple cancers, including NSCLC and melanoma, with a focus on expanding market presence in China and globally[38]. - The company is actively pursuing new product development and regulatory approvals to strengthen its portfolio in oncology[39]. Market Strategy and Expansion - The company plans to expand its market presence in Europe and Asia, targeting a 30% increase in market share by 2025[16]. - The company has entered into strategic partnerships with three major pharmaceutical firms to enhance its distribution network and accelerate product launches[16]. - The company is focused on innovative drug development, aligning with national strategies to accelerate key technology advancements in new drug creation, with no signs of industry overcapacity or decline[143]. - The company has established partnerships for commercialization rights in various regions, enhancing its market reach[38]. - The company is committed to advancing its pipeline of innovative therapies to address unmet medical needs in oncology[39]. Risks and Challenges - The company continues to face risks related to drug development, regulatory approvals, and market acceptance, which may impact future profitability[3]. - The primary reason for the losses is that most of the product pipeline is still in the new drug development stage, resulting in significant R&D expenditures that have been increasing during the reporting period[143]. - The company faces risks related to the market acceptance of its drugs, which may not be recognized by medical professionals, patients, or third-party payers, impacting sales and profitability[144]. - The company must demonstrate the safety and efficacy of its candidate drugs in clinical trials to obtain regulatory approvals, and there is no guarantee that applications will be accepted or reviewed[149]. - The complexity and high costs associated with obtaining drug approvals from regulatory agencies such as NMPA, FDA, and EMA pose significant risks for the company[150]. - The company faces risks related to the clinical trials of candidate drugs, including potential delays or failures to demonstrate safety and efficacy, which could hinder regulatory approval[192]. Financial Position and Funding - The company has incurred significant financial risks due to negative cash flow, which may affect its ability to fund drug development and commercialization[177]. - The company may need to seek additional financing through equity issuance or debt financing, which could dilute shareholder equity[178]. - The company is exposed to credit risk from distributors and customers, which may increase as the business expands[179]. - The company has approximately $1.1 billion invested in government money market funds and $4.29 million in time deposits as of December 31, 2023[180]. - The company acknowledges the potential adverse effects of external financial market conditions on its ability to secure financing[180]. Regulatory Compliance - The pharmaceutical industry is highly regulated in China, and changes in regulations may increase compliance costs and affect the company's ability to develop and commercialize drugs[185]. - The company’s drug development and commercialization are subject to strict regulatory oversight, which can lead to significant compliance costs and potential sanctions[186]. - Non-compliance with regulatory requirements could lead to significant adverse impacts on the company's business, including potential product recalls and market withdrawal[188]. - The company must comply with comprehensive regulatory requirements from agencies such as the NMPA, FDA, and EMA, which includes ongoing assessments of compliance with drug manufacturing and quality control standards[188]. Clinical Trials and Patient Recruitment - The company has conducted over 130 clinical trials, enrolling more than 22,000 participants across approximately 45 countries and regions[31]. - Clinical trial patient recruitment difficulties may lead to delays in clinical development activities[194]. - Adverse events related to drugs and candidates could result in interruptions or delays in clinical trials, potentially harming the company's reputation and financial status[195]. Corporate Governance and Audit - The company has engaged Ernst & Young as its auditor for both domestic and international accounting standards[21]. - The company’s auditor, Ernst & Young, has not been subject to inspections by the US Public Company Accounting Oversight Board for prior fiscal years, raising concerns about audit quality[198]. - The company believes it meets the auditing requirements set by the U.S. Public Company Accounting Oversight Board, which may prevent further classification as a Commission-Identified Issuer[199].

2023年年度募集资金存放与实际使用情况的专项报告 A 股代码：688235 A 股简称：百济神州 公告编号：2024-013 港股代码：06160 港股简称：百济神州 美股代码：BGNE 百济神州有限公司 经中国证券监督管理委员会于 2021 年 11 月 16 日出具的《关于同意百济神 州有限公司首次公开发行股票注册的批复》（证监许可[2021]3568 号）批准，百 济神州有限公司（以下简称"公司"）首次公开发行人民币普通股（A 股）股票（以 下简称"本次发行"）115,055,260 股，每股发行价格为人民币 192.60 元，募集资 金总额为人民币 2,215,964.31 万元；扣除发行费用后的募集资金净额为人民币 2,163,015.49 万元。上述募集资金已于 2021 年 12 月 8 日全部到位，安永华明会 计师事务所（特殊普通合伙）对公司本次发行的募集资金到位情况进行了审验， 并于 2021 年 12 月 8 日出具了安永华明（2021）验字第 61119809_A03 号《验资 报告》。募集资金到账后，已全部存放于经公司董事会或董事会审计委员会批准 开设的募集资金专项账户内。 本公司董 ...

百济神州有限公司 已审财务报表 2023年度 百济神州有限公司 目 录 | | | 页 | | 次 | | --- | --- | --- | --- | --- | | 一、 | 审计报告 | 1 | - | 6 | | 二、 | 已审财务报表 | | | | | | 合并资产负债表 | 7 | - | 8 | | | 合并利润表 | 9 | - | 10 | | | 合并股东权益变动表 | 11 | - | 12 | | | 合并现金流量表 | 13 | - | 14 | | | 财务报表附注 | 15 | - | 117 | | | 补充资料 | | | | | | 1.非经常性损益明细表 | | 1 | | | | 2.净资产收益率和每股收益 | | 2 | | | | 3.中国企业会计准则与美国公认会计原则编报差异调节表 | 2 | - | 3 | 审计报告 安永华明（2024）审字第70033281_A01号 百济神州有限公司 百济神州有限公司全体股东： 一、审计意见 我们审计了百济神州有限公司的财务报表，包括2023年12月31日的合并资产负债 表，2023年度的合并利润表、合并股东权益变动表和 ...

中国国际金融股份有限公司、高盛（中国）证券有限责任公司 关于百济神州有限公司 2023年度募集资金存放与使用情况的核查意见 中国国际金融股份有限公司与高盛（中国）证券有限责任公司（以下合称"联 席保荐机构"）作为百济神州有限公司（以下简称"百济神州"或"公司"）首次公开 发行人民币普通股（A股）股票并在科创板上市的联席保荐机构，根据《上海证 券交易所科创板股票上市规则》《上海证券交易所科创板上市公司自律监管指引 第1号——规范运作》《上市公司监管指引第2号——上市公司募集资金管理和使 用的监管要求（2022年修订）》等有关规定，就百济神州2023年度募集资金存放 与使用情况进行了审慎核查，具体情况如下： 一、募集资金基本情况 （一）实际募集资金金额及资金到账情况 经中国证券监督管理委员会于 2021 年 11 月 16 日出具的《关于同意百济神 州有限公司首次公开发行股票注册的批复》（证监许可[2021]3568 号）批准，百 济神州首次公开发行人民币普通股（A 股）股票（以下简称"本次发行"） 115,055,260 股，每股发行价格为人民币 192.60 元，募集资金总额为人民币 2,215,964.31 ...

百济神州有限公司 2024 年度"提质增效重回报"行动方案 百济神州有限公司（以下简称"公司"）积极贯彻落实科创板上市公司"提质 增效重回报"专项行动，践行"致力于做生物科技产业的变革者，为全世界的癌 症患者提供有效、可及且可负担的药物"的使命，在研发创新、财务管理、公司 治理及投资者关系等方面采取积极措施，以进一步提高公司质量，保障投资者权 益，促进公司健康可持续发展。主要举措如下： 一、 聚焦创新性肿瘤药物领域，稳固核心竞争力 公司是一家全球肿瘤创新公司，专注于发现和开发创新性疗法，旨在为全球 癌症患者提高药物可及性和可负担性。 公司目前共有 3 款自主研发并获批上市药物，包括百悦泽®（泽布替尼，一 款用于治疗多种血液肿瘤的布鲁顿氏酪氨酸激酶（BTK）小分子抑制剂）、百泽 安®（替雷利珠单抗，一款用于治疗多种实体瘤及血液肿瘤的抗 PD-1 抗体免疫疗 法）和百汇泽®（帕米帕利，一款具有选择性的 PARP1 和 PARP2 小分子抑制剂）。 百悦泽®已在美国、中国、欧盟、英国、加拿大、澳大利亚等 70 个国家和地区获 批上市，百泽安®已在中国、欧盟和美国获批上市，百汇泽®也已在中国上市。通 过利用公司强大的 ...

百济神州有限公司 审计委员会本着审慎勤勉的原则，认真履行审计监督职责。2023 年度，审计委 员会共计召开十二次会议并作出二次书面决议。Thomas Malley 先生应出席审计委 员会会议十二次，实际出席十一次，未出席 2023 年 3 月 28 日召开的审计委员会会 议。Corazon (Corsee) D. Sanders 博士应出席审计委员会会议十二次，实际出席十一 次，未出席 2023 年 4 月 27 日召开的审计委员会会议。Anthony C. Hooper 先生出席 了历次会议。审计委员会全体委员均签署了历次书面决议，2023 年度审计委员会会 议及书面决议审议的主要内容如下： 1、公司及子公司根据美国公认会计原则及美国证券交易委员会适用规则编制的 截至 2022 年 12 月 31 日年度经审计财务业绩、截至 2023 年 3 月 31 日三个月的财务 1 业绩、截至 2023 年 6 月 30 日三个月及六个月的财务业绩，以及截至 2023 年 9 月 30 日三个月及九个月的财务业绩。 2、公司及子公司截至 2022 年 12 月 31 日全年业绩及根据香港联合交易所有限 公司证券上市规 ...

百济神州有限公司 1、资质条件 安永华明于 1992 年 9 月成立，2012 年 8 月完成本土化转制，从一家中外合作 的有限责任制事务所转制为特殊普通合伙制事务所。安永华明总部设在北京，注册 地址为北京市东城区东长安街 1 号东方广场安永大楼 17 层 01-12 室。截至 2023 年 末拥有合伙人 245 人，首席合伙人为毛鞍宁先生。安永华明拥有财政部颁发的会计 师事务所执业资格，于美国公共公司会计监督委员会（US PCAOB）注册，是中国 首批获得证券期货相关业务资格和 H 股企业审计资格事务所之一，在证券业务服务 方面具有丰富的执业经验和良好的专业服务能力。截至 2023 年末，安永华明拥有 执业注册会计师近 1,800 人，其中拥有证券相关业务服务经验的执业注册会计师超 过 1,500 人。 2、风险承担能力水平 安永华明具有良好的投资者保护能力，已按照相关法律法规要求计提职业风险 基金和购买职业保险，保险涵盖北京总所和全部分所。已计提的职业风险基金和已 购买的职业保险累计赔偿限额之和超过人民币 2 亿元。安永华明近三年不存在任何 因与执业行为相关的民事诉讼而需承担民事责任的情况。 3、执业记录 ...

2023 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 | 51 | | 財務概要 | 141 | | 管理層討論及分析 | 142 | | 董事及高級管理層 | 169 | | 董事會報告 | 178 | | 企業管治報告 | 237 | | 獨立核數師報告 | 268 | | 綜合財務報表 | 273 | | 釋義 | 368 | | 技術詞彙 | 373 | 1 百濟神州有限公司 • 2023 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 Donald W. Glazer先生 Michael Goller先生 Anthony C. Hooper先生 （附註2） Ranjeev Krishana先生 Alessandro Riva博士 Corazon (Corsee) D. Sand ...

2023年 百济神州 负责任商业和 可持续发展 报告 报告目录 来自管理层的一封信 3 | 负责任商业和可持续发展举措 | 5 | | --- | --- | | 指导原则 | 6 | | 战略和流程 | 7 | | 2023年目标和进展 | 9 | | 推进全球健康 13 | | | 创新和临床开发举措 | 15 | | 追求药物的广泛可及性 | 20 | | 推进全球健康公平 22 | | | 百济神州基金会 23 | | | 支持患者 | 25 | | 赋能员工 | 27 | | 团队建设 28 | | | 员工敬业度和支持 | 29 | | 薪酬和福利 | 31 | | 职业发展 | 33 | | 归属感文化 | 35 | | 员工志愿服务 | 37 | | 健康与安全 | 38 | | 可持续创新 39 | | | --- | --- | | 2023年目标与进展 | 40 | | 我们的气候治理 41 | | | 我们的气候战略 42 | | | 我们的气候风险管理 | 45 | | 我们的气候指标 46 | | 负责任运营 . . . . . . . . . . . . . . . . . . ...

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[8]. - Global revenue reached approximately $2.5 billion in 2023, an increase of about $1 billion compared to 2022, while net loss decreased by approximately $1.1 billion[12]. - The company has over $3.2 billion in cash and cash equivalents as of December 31, 2023, with product revenue of $2.2 billion expected to continue growing significantly in 2024 and beyond[20]. - Cumulative losses reached $8 billion as of December 31, 2023, primarily due to R&D expenses and operational costs[119]. - The net loss for the company was $900 million, $2 billion, and $1.5 billion for the years 2023, 2022, and 2021, respectively[120]. User Growth and Market Expansion - User data showed a 30% increase in active users, reaching 2 million by the end of the fiscal year[9]. - The company is expanding its market presence in Europe, targeting a 15% market share by 2025[9]. - Baiyueze® global sales increased by 128.5% in 2023 compared to 2022, establishing a strong position in hematology[19]. - Baiyueze® has been approved in over 65 markets, with ongoing applications for additional approvals, enhancing its market presence[20]. Product Development and Pipeline - New product launches included two innovative therapies, expected to contribute approximately $300 million in revenue in the upcoming year[9]. - The company is exploring potential acquisitions to bolster its product pipeline, with a budget of $500 million allocated for this purpose[9]. - The company has conducted over 130 clinical trials with more than 22,000 participants across approximately 45 regions, demonstrating significant clinical development capabilities[12]. - The company has a pipeline of candidate drugs with multiple phases, including Sonrotoclax in Phase 1 for BCL2 and Zebrutinib in Phase 2 for BTK[41]. Research and Development - Research and development expenses increased to $400 million, reflecting a 10% rise as the company focuses on new drug candidates[9]. - The internal clinical team consists of over 3,000 members, allowing the company to conduct trials without relying on contract research organizations (CROs)[17]. - The company is committed to advancing its research and development efforts to bring new therapies to market[41]. Regulatory Approvals and Compliance - The company has received accelerated approval for multiple indications, with full approval contingent on the results of confirmatory clinical trials[24]. - The FDA is reviewing a supplemental NDA for Baiyueze® to treat R/R follicular lymphoma, with a decision expected by March 2024[26]. - The company is actively pursuing new product approvals in the EU and the US, indicating a robust pipeline for future growth[25]. - The company must demonstrate the safety and efficacy of candidate drugs in clinical trials before obtaining regulatory approval for commercial sale, which involves comprehensive data submission[108]. Strategic Partnerships and Collaborations - Strategic partnerships were established with two major pharmaceutical companies, expected to enhance distribution capabilities and market access[9]. - The company has partnered with Novartis for market development in the vast Chinese market, enhancing its promotional capabilities[24]. - The collaboration agreement allows BeiGene to retain commercialization rights for one out of every three approved products, with a potential additional five-year royalty period post-commercialization[73]. Competition and Market Risks - The company operates in a highly competitive environment with significant competition from global biopharmaceutical companies and smaller regional firms[84]. - The company faces competition from multiple PD-1 and PD-L1 antibody drugs, with several approved in China as of December 25, 2023[85]. - The company recognizes the need for substantial investment in R&D to maintain competitiveness against well-capitalized rivals[86]. Financial Risks and Funding - The company may need to seek additional funding through public or private offerings, debt financing, collaborations, and licensing arrangements to meet its operational needs[120]. - The company faces significant risks in obtaining additional capital under acceptable terms due to market uncertainties, which could delay or reduce R&D plans[121]. - 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[123]. Intellectual Property and Patent Management - The company holds key patents for its drugs and late-stage clinical candidates, with several expiring between 2031 and 2043, including major compounds like BeiGene's Bruton tyrosine kinase inhibitor and anti-cancer antibodies[81]. - The company acknowledges the limited duration of patent protections and the potential for challenges to the validity and enforceability of its patents[82]. - The company may incur high costs and time delays due to litigation if generic drug companies file Abbreviated New Drug Applications (ANDAs) challenging its patents, which could impact product revenue significantly[128]. Operational Challenges and Compliance - The company faces significant challenges in managing growth, including the need to hire and integrate additional personnel across various functions such as clinical operations and marketing[146]. - The company is subject to complex and evolving regulations regarding personal data collection and transfer, which could lead to increased operational costs and penalties[148]. - The company may face significant costs and operational disruptions due to unexpected demand or shortages of raw materials, labor disputes, or natural disasters[134]. Data Security and Cyber Risks - The company collects and stores sensitive data, including legally protected patient health information and identifiable personal data of employees, which increases operational risks[157]. - The complexity and frequency of cyber threats are expected to increase over time, potentially leading to significant financial losses[157]. - The company has implemented systems and controls to mitigate risks, but the costs of maintaining these measures are high and require continuous updates[158]. Environmental and Regulatory Compliance - The company faces risks related to environmental, health, and safety regulations, which could result in fines or significant costs if not adhered to[156]. - The evolving regulatory landscape in China regarding human genetic resources is expected to become stricter, impacting the company's operations[149]. - Compliance with the Cybersecurity Law, Data Security Law, and PIPL may substantially increase service provision costs and require significant operational changes[166].