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 年半年度持续督导跟踪报告 根据《证券发行上市保荐业务管理办法》（以下简称"《保荐办法》"）、 《上海证券交易所科创板股票上市规则》（以下简称"《科创板上市规则》"）、 《科创板上市公司持续监管办法（试行）》等有关法律、法规的规定，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（以下与中国国际金融股份 有限公司合称"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"）持续督导工作的联席保荐机构，负责百济神州上市后的持续督导工 作，并出具 2023 年半年度持续督导跟踪报告，本持续督导期间为 2023 年 1 月 1 日至 2023 年 6 月 30 日。 | 序号 | 工作内容 | 持续督导情况 | | | | --- | --- | --- | --- | --- | | 建立健全并有效执行持续督导工作制 | 联席保荐机构已建立健全并有效执行 | 度，并针对具体的持续督导工作制定相 | 了持续督导制度，并制定了相应的工作 | 1 | | 应的工作计划。 | 计划。 | | | | | 根据中国 ...

FF304 翌日披露報表 (股份發行人 ── 已發行股本變動及/或股份購回) 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) 呈交日期： 2023年8月31日 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市(註11) | 是 | | | 證券代號 (如於香港聯交所上市) | | 06160 | 說明 | | | | | | | 發行股份 | (註6及7) | | 股份數目 | 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 (註4、6及7) | | 每股發行價 (註1及7) | 上一個營業日 的每股收市價 (註5) | 發行價較市值的折讓/ 溢價幅度(百分比) (註7) | | 於下列日期開始時的結存(註2) | | 2023年7月31日 | 1,257,246,655 | | | | | | | 1). 於股份獎勵計劃下發行股份 | | | 160 ...

Financial Performance - As of June 30, 2023, the company has accumulated losses of CNY 56.191 billion due to high investment in drug research and development, production, and commercialization[4]. - The company reported a total revenue of RMB 1.2 billion for the first half of 2023, representing a 25% increase year-over-year[15]. - The company's revenue for the first half of 2023 reached RMB 7,251,228 thousand, representing a 72.23% increase compared to RMB 4,210,254 thousand in the same period last year[20]. - The net profit attributable to shareholders for the same period was -RMB 5,218,922 thousand, an improvement from -RMB 6,663,816 thousand year-on-year[21]. - The company reported a net loss of RMB 200 million for the first half of 2023, narrowing from a loss of RMB 300 million in the same period last year[15]. - The net cash flow from operating activities was -RMB 5,103,818 thousand, which is a larger outflow compared to -RMB 3,337,338 thousand in the previous year[21]. - The company's total assets decreased by 5.77% to RMB 41,672,966 thousand from RMB 44,224,173 thousand at the end of the previous year[21]. - The company’s product revenue for the first half of 2023 reached 6.696 billion yuan, an increase of 82.2% year-on-year[127]. - Total revenue for the first half of 2023 was 7.251 billion yuan, up 72.2% compared to the previous year[127]. - The net loss attributable to shareholders for the first half of 2023 was 5.219 billion yuan[127]. Research and Development - Research and development expenses for the reporting period amounted to CNY 5.882 billion, representing a 17.28% increase compared to the same period last year[4]. - The company has allocated RMB 300 million for research and development in 2023, focusing on innovative therapies[15]. - The R&D expenditure accounted for 81.12% of the revenue, a decrease of 38.01 percentage points from 119.13% in the previous year[22]. - The company has initiated approximately 140 clinical trials, enrolling over 21,000 participants across about 45 regions[26]. - The company has a robust pipeline with multiple products in various stages of clinical trials, including BTK inhibitors and PD-1 inhibitors[49][50]. - The company has developed a pipeline of over 60 preclinical research projects, with about half having the potential to be first-in-class or best-in-class[118]. - The company has received approval for 11 indications for its product 百悦泽® (BRUKINSA®), with over 65 markets approved globally[112]. - The company has established a global clinical development team of over 3,000 employees, executing more than 140 ongoing or planned clinical trials[118]. - The company is focused on maximizing BTK occupancy and minimizing off-target effects with 百悦泽®[34]. - The company is committed to ongoing clinical trials to support the full approval of its products based on the results of confirmatory studies[54]. Regulatory Approvals and Compliance - The company is actively seeking regulatory approvals and expanding production and manufacturing facilities for its drug candidates[4]. - The company emphasizes the importance of maintaining and expanding regulatory approvals for its drugs and candidates[8]. - The company has received regulatory approval for its lead product in China, expected to drive significant revenue growth in the coming quarters[15]. - Baiyueze® received approval from Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL) on May 30, 2023[28]. - Baiyueze® was granted four registration approvals by NMPA, including two new indications for adult patients with newly diagnosed CLL or small lymphocytic lymphoma (SLL) on May 6, 2023[28]. - The company is supporting Novartis in the regulatory review process for百泽安® in various regions, including the US and EU[38]. - The FDA has completed a site inspection for百泽安®'s BLA application for ESCC, with the review process ongoing[38]. - The company is awaiting further formal approvals for 百悦泽® based on confirmatory trial results[34]. - The company is focused on new drug target development and drug resistance mechanism research through its functional genomics platform, which integrates gene editing and bioinformatics tools[104]. - The company is subject to compliance risks with Chinese laws and regulations, particularly regarding foreign investment, which may increase compliance costs and affect its investment activities[200]. Market Expansion and Strategic Partnerships - The company plans to expand its market presence in Europe, targeting a 15% market share by 2025[15]. - The company is exploring potential acquisition opportunities to enhance its product pipeline and market reach[15]. - The company has established strategic partnerships with over 20 biotech and pharmaceutical companies, enhancing its product pipeline[125]. - The company has partnered with leading biopharmaceutical companies like Amgen and Novartis for the development and commercialization of innovative drugs[26]. - The company is focused on expanding its market presence through strategic partnerships and collaborations for drug commercialization in Asia and beyond[54]. - The company has signed strategic cooperation agreements with Amgen, Novartis, and Bristol-Myers Squibb, but there are uncertainties regarding the realization of expected financial and operational synergies[153]. Risks and Challenges - The company faces risks of continued losses and potential expansion of these losses if drug candidates fail clinical trials or do not receive regulatory approval[4]. - The company acknowledges various risk factors that may impact its business and financial performance, as detailed in the management discussion section[9]. - The company faces risks related to the market acceptance of its drugs, which may not achieve sufficient recognition among medical professionals and patients[136]. - The company has limited experience in commercializing self-developed and licensed drugs, which may lead to underperformance in commercialization results[137]. - The competitive landscape is intense, with numerous global pharmaceutical and biotech companies developing drugs for similar cancer indications, posing a risk to the company's market opportunities[139]. - The company’s ability to generate substantial product sales revenue may be hindered if it cannot establish or maintain effective internal sales and marketing capabilities[138]. - The company may experience increased costs and slowed drug development due to delays in clinical trials, which can severely impact its business and financial condition[143]. - The company faces significant risks related to the quality and accuracy of clinical data, which may lead to delays or termination of clinical trials, adversely affecting business and financial outlook[152]. - The company is at risk of being delisted if it fails to meet the requirements set forth by the Shanghai Stock Exchange regarding continuous operation capability[133]. - The company may incur additional costs and face management distractions due to the complexities involved in strategic partnerships and collaborations[153]. Production and Supply Chain - The company is constructing a new commercialization production base and clinical R&D center in Hopewell, New Jersey, expected to be completed in 2024[119]. - The production capacity at the Guangzhou facility has reached 64,000 liters, with ongoing construction of antibody-drug conjugate (ADC) facilities and a new biopharmaceutical production building, also expected to be completed in 2024[119]. - The company relies on external suppliers for part of its drug production, which may lead to risks in commercial-scale production and management of manufacturing processes[147]. - The company has faced significant risks due to reliance on limited CMO suppliers, which may lead to production delays and increased costs[148]. - The company’s production activities rely on multiple suppliers, but some supply chains depend on single-source suppliers, which could lead to significant business damage if disruptions occur[150]. - The company is dependent on third-party manufacturers for drug production, and disruptions to these suppliers could delay or halt drug development and commercialization[160]. Innovation and Intellectual Property - The company has obtained 13 new invention patents during the reporting period, bringing the total to 86[109]. - The total number of patents held by the company now stands at 90, reflecting its commitment to innovation and intellectual property development[109]. - The company has developed a proprietary biological research platform that has produced over 10 clinical-stage drugs in the past decade[75]. - The company has established a comprehensive technology system for drug development, covering early discovery to commercialization across various platforms[99]. - The company is leveraging its clinical data to enhance its competitive positioning in the oncology market, aiming for best-in-class status for its therapies[57]. Global Market Trends - The global oncology drug market is projected to reach $296.2 billion by 2025 and $468.8 billion by 2030, with a compound annual growth rate (CAGR) of 9.6% from 2025 to 2030[82]. - The US oncology drug market is expected to grow to $139.1 billion by 2025 and $218.0 billion by 2030, with a CAGR of 9.4% during the same period[84]. - The Chinese oncology drug market is forecasted to reach RMB 374.7 billion by 2025 and RMB 609.4 billion by 2030, with a CAGR of 10.2% from 2025 to 2030[86]. - The global tumor immunotherapy market is anticipated to reach $97.1 billion by 2025 and $216.0 billion by 2030, with a CAGR of 17.3%[88]. - The US tumor immunotherapy market is projected to grow to $52.0 billion by 2025 and $104.3 billion by 2030, with a CAGR of 14.9%[90]. - The Chinese tumor immunotherapy market is expected to expand to RMB 49.5 billion by 2025 and RMB 198.0 billion by 2030, with a CAGR of 31.9%[92].

A 股代码：688235 A 股简称：百济神州 公告编号：2023-028 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 关于与关联方共同投资暨关联交易的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 若后续项目公司在标的物业的挂牌转让程序中竞价成功，则项目公司将与转 让方签署产权交易合同（以下简称"正式转让协议"），并通过股东增资及自筹 资金的方式取得标的物业的所有权（以下简称"本次资产收购"，与本次认购合 称为"本次交易"）。标的物业的转让价款及其后续总投入中，以股东增资形式 投入的金额不超过 6,000 万美元，其余资金以项目公司自筹资金形式投入，最终 投资金额以项目建设实际投入为准。 2、本次与关联方共同增资，构成关联交易，但不构成《上市公司重大资产 重组管理办法》规定的重大资产重组，实施不存在重大法律障碍。 3、本次交易相关议案已经公司董事会审议通过，关联董事易清清先生已回 避表决，本次交易无需提交公司股东大会审议。 4、截至本公告披露之日，标的物业的正式转让协议尚未签署， ...

A 股代码：688235 A 股简称：百济神州 公告编号：2023-027 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 关于公司为子公司提供担保及子公司为子公司提供 担保的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 1、被担保人：（1）BeiGene Switzerland GmbH（以下简称"百济神州瑞 士"），系百济神州有限公司（以下简称"公司"）的全资子公司；（2）北京 英仁伟业生物科技有限公司（以下简称"英仁伟业"），系公司的全资子公司。 2、本次担保金额及已实际为其提供的担保余额：（1）公司拟为百济神州 瑞士向 HSBC Bank Plc, London, Zurich Branch（以下简称"汇丰银行苏黎世分 行"）申请的 3,000,000 美元信贷额度（以下简称"瑞士信贷"）提供担保（以 下简称"瑞士担保"）；（2）英仁伟业拟向中国银行股份有限公司北京雅宝路 支行（以下简称"中行北京雅宝路支行"）申请 257,000,000 元人民币的固定资 产 ...

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 与关联方共同投资暨关联交易的核查意见 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（高盛高华证 券有限责任公司现已更名为"高盛（中国）证券有限责任公司"，以下与中国国 际金融股份有限公司合称"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》以及《上海证券交易所上市公 司自律监管指引第5号——交易与关联交易》等有关规定，对百济神州与关联方 共同投资暨关联交易进行了审慎核查，具体情况如下： 一、本次交易概述 根据《上市公司信息披露管理办法》《上海证券交易所科创板股票上市规则》 （以下简称"《上市规则》"）和《百济神州有限公司关联交易管理制度》（以下简 称"《A 股关联交易管理制度》"）的规定，高岳与持有公司已发行股份总数 5%以 上的股东 HHLR Fund, L.P.（以下简称"HHLR"）受共同控制，因此本次认购及 未来可能的增加 ...

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 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 日发布的《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。 A 股代码：6882 ...

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 为子公司提供担保及子公司为子公司提供担保事项的核查意见 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（高盛高华证 券有限责任公司现已更名为"高盛（中国）证券有限责任公司"，以下与中国国 际金融股份有限公司合称"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8号—— 上市公司资金往来、对外担保的监管要求》等有关规定，对百济神州为子公司提 供担保及子公司为子公司提供担保事项进行了审慎核查，具体情况如下： 一、担保情况概述 （一）担保基本情况 为满足百济神州之子公司 BeiGene Switzerland GmbH（以下简称"百济神州 瑞士"）生产经营和业务发展的需求，百济神州瑞士拟向 HSBC Bank Plc, London, Zurich Branch（以下简称"汇丰银行苏黎世分行"）申请 3,000,000 ...

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。 BeiGene, Ltd. 百濟神州有限公司 （於開曼群島註冊成立的有限公司） （股份代號：06160） 截至2023年6月30日止六個月 中期業績公告 百濟神州有限公司連同其子公司（「本公司」或「百濟神州」或「我們」）謹此公佈本 公司截至2023年6月30日止六個月（「報告期」）的未經審核簡明綜合業績連同2022 年相應期間的比較數字，其乃根據美國公認會計原則（「美國公認會計原則」）編製 並由本公司董事會（「董事會」）審計委員會（「審計委員會」）審閱。 財務摘要 1 • 截至2023年6月30日止六個月的收入總額較截至2022年6月30日止六個月增 加約394.9百萬美元或約60.9%至約1,043.1百萬美元。產品收入較截至2022 年6月30日止六個月增加約398.0百萬美元或約70.3%至約964.0百萬美元。 • 截至2023年6月30日止六個月的開支總額較截至2022年6月30日止六個月增 加 ...

Financial Performance - Total revenue for the six months ended June 30, 2023, increased by approximately $394.9 million or about 60.9% to approximately $1,043.1 million compared to the same period in 2022[2]. - Product revenue for the same period rose by approximately $398.0 million or about 70.3% to approximately $964.0 million[2]. - Total expenses for the six months ended June 30, 2023, increased by approximately $202.2 million or about 13.2% to approximately $1,733.0 million compared to the same period in 2022[2]. - Net loss for the six months ended June 30, 2023, decreased by approximately $271.4 million or about 27.1% to approximately $729.6 million compared to the same period in 2022[2]. - Basic and diluted loss per share for the six months ended June 30, 2023, was $0.54, a decrease of 28.0% from $0.75 for the same period in 2022[2]. Cash and Assets - Cash and cash equivalents as of June 30, 2023, were $3,410.4 million, down from $3,869.6 million as of December 31, 2022[6]. - Total assets as of June 30, 2023, amounted to $5,728.7 million, a decrease from $6,379.3 million as of December 31, 2022[6]. - Total liabilities as of June 30, 2023, were $1,930.2 million, down from $1,995.9 million as of December 31, 2022[6]. - The total equity as of June 30, 2023, was $3,798,559 thousand, a decrease from $5,196,919 thousand as of June 30, 2022, indicating a decline of about 27%[9]. Research and Development - The company has established over 120 clinical trials with more than 21,000 participants across approximately 45 regions, including over 35 pivotal or potentially registrable trials[10]. - The company has three self-developed and approved drugs, with a focus on increasing drug accessibility and affordability for cancer patients globally[10]. - Research and development expenses for the six months ended June 30, 2023, amounted to $831.348 million, up from $768.122 million in the same period of 2022, reflecting an increase of about 8%[74]. - The company has a strategic collaboration agreement with Amgen for the commercialization and development of Amgen's oncology products in China, effective January 2, 2020[39]. Collaboration and Licensing - The company received a $650,000,000 upfront payment from Novartis as part of the collaboration and licensing agreement for the development and commercialization of Tislelizumab[32]. - The company is eligible for up to $1,300,000,000 in milestone payments upon achieving regulatory milestones and up to $250,000,000 upon reaching sales milestones under the agreement with Novartis[32]. - The company expanded its collaboration with Novartis by signing an option, collaboration, and licensing agreement for the development, production, and commercialization of the investigational TIGIT inhibitor, Osemitamab, in Novartis' region[35]. Financial Obligations and Commitments - Total significant contractual obligations amount to $1.799 billion, with short-term obligations of $1.034 billion and long-term obligations of $765 million as of June 30, 2023[158]. - The company has a remaining co-development funding commitment of $549.8 million related to a collaboration agreement with Amgen for global development costs[162]. - Capital commitments as of June 30, 2023, stand at $381.2 million, primarily for the construction of production and clinical R&D facilities in New Jersey and expansions in Guangzhou and Suzhou, China[165]. Market Presence and Growth - Revenue from China was $540.828 million for the six months ended June 30, 2023, compared to $403.164 million in 2022, reflecting a growth of about 34%[98]. - Revenue from the United States increased to $362.307 million in the first half of 2023, up from $156.269 million in 2022, marking a growth of approximately 132%[98]. - The company expects continued growth driven by increased sales of Baiyueze® and Baizean® in both the U.S. and China markets[129]. Employee and Management Compensation - The company reported total compensation for key management personnel of $22.803 million for the six months ended June 30, 2023, slightly down from $23.086 million in 2022[96]. - Total employee compensation costs for the six months ended June 30, 2023, were $753 million, compared to $662.2 million for the same period in 2022[175]. Governance and Compliance - The Audit Committee consists of three independent non-executive directors, with Mr. Thomas Malley serving as the Chairman, ensuring compliance with financial reporting and internal controls[179]. - The company has implemented its own insider trading policy, which meets or exceeds the standards set forth in the Hong Kong Listing Rules[181]. Future Outlook - The company expects significant revenue growth in 2023 and beyond, with product revenue growth anticipated to exceed operating expense growth in the short term[117]. - The company continues to focus on market expansion and new product development as part of its strategic initiatives moving forward[103].