A股代码：688235 A股简称：百济神州 公告编号：2023-029 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 关于董事会审计委员会主席变更的公告 2023 年 9 月 15 日 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。 经百济神州有限公司（以下简称"公司"）董事会审议通过，自 2023 年 9 月 13 日起，Anthony C. Hooper 先生获委任为董事会审计委员 会（以下简称"审计委员会"）主席。Thomas Malley 先生不再担任审 计委员会主席，但将继续担任审计委员会成员。 审计委员会由三名成员构成，包括 Anthony C. Hooper 先生、 Thomas Malley 先生以及 Corazon (Corsee) D. Sanders 博士。Anthony C. Hooper 先生为审计委员会主席。 特此公告。 百济神州有限公司董事会 ...

| | | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2023年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 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9月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 | 06160 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 9,500,000,000 | USD | | 0.0001 USD | | 950,000 | | 2. 股份分類 | ...

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） 授出購股權及受限制股份單位 本公告乃根據上市規則第17.06A、17.06B以及17.06C條作出。於2023年8月31 日，董事會薪酬委員會根據2016期權及激勵計劃的條款向三名承授人授出可認購 合共4,178股美國存託股份的購股權並向二百四十五名承授人授出涉及合共65,001 股美國存託股份的受限制股份單位。 2016期權及激勵計劃項下的購股權 於2023年8月31日，董事會薪酬委員會根據2016期權及激勵計劃的條款授予三名 承授人可認購合共4,178股美國存託股份的購股權。 授出購股權詳情 購股權詳情如下： 1 授出日期： 2023年8月31日 承授人數目： 三名 已授出購股權涉及的 相關股份數目： 54,314 購股權總數（美國存託股份）: 4,178 因已授出購股權獲行使而可予 認購的新美國 ...

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） 員工購股計劃 本公告乃根據上市規則第17.06A、17.06B以及17.06C條作出。本公司宣佈，2018 員工購股計劃的新一輪認購期自2023年9月1日起至2024年2月29日止。合資格僱 員將於認購期結束後購買股份（包括以美國存託股份的形式），購股資金從其認購 期所得薪金中扣除。 2018員工購股計劃概要 2018員工購股計劃使合資格僱員可按市價15%折讓申購股份（包括以美國存託股 份的形式）。僱員可於認購期結束後購買股份，購股資金可從其認購期內所得薪金 中扣除。2018員工購股計劃由薪酬委員會管理。 認購期詳情 上述參與者系本公司及指定子公司的全職僱員且不屬於如下任何一類人士：(a)本 公司董事、最高行政人員或主要股東或其各自聯繫人；(b)獲授或將獲授超逾上市 規則第17.03D條項下1%個人限 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2023年7月31日 狀態: 重新提交 致：香港交易及結算所有限公司 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9月6日 I. 法定/註冊股本變動 | 2. 股份分類 | 其他分類 (請註明) | 股份類別 | 其他類別 (請註明) | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 | N/A | 說明 | 非指定股份 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,000,000 USD | | 0.0001 | USD | | 50,000 | 第 1 頁 ...

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9月1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) | ...

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， ...