Financial Performance - Total revenue for the year ended December 31, 2023, increased by approximately $1 billion or 73.7% to about $2.5 billion compared to the previous year[2]. - Product revenue rose by approximately $935.2 million or 74.5% to about $2.2 billion for the same period[2]. - The company reported a net loss of $881,708,000 for the year ended December 31, 2023, compared to a net loss of $2,003,815,000 in 2022, showing an improvement in loss by approximately 56%[81]. - The company reported a comprehensive loss of $903.7 million for the year ended December 31, 2023, compared to $2,099.2 million in the previous year[6]. - The net loss for the year ended December 31, 2023, was $881.7 million, a significant improvement from a net loss of $2.0 billion in 2022, representing a reduction of approximately 56%[7]. - Basic and diluted loss per share was $0.65, a decrease of 56.4% from $1.49 for the previous year[2]. - The company reported a net cash inflow from investing activities of $60.0 million in 2023, a decline from $1.08 billion in 2022[8]. Expenses and Liabilities - Operating expenses for the year ended December 31, 2023, increased by approximately $367.5 million or 12.6% to about $3.3 billion[2]. - Research and development expenses for the year were $1,778.6 million, compared to $1,640.5 million in the previous year[5]. - Total liabilities increased to $2,267.9 million as of December 31, 2023, compared to $1,995.9 million in the previous year[4]. - The company incurred $367.6 million in stock-based compensation expenses in 2023, an increase from $303.2 million in 2022, reflecting a rise of about 21%[9]. - The total equity as of December 31, 2023, was $3.54 billion, down from $4.38 billion in 2022, representing a decrease of approximately 19%[9]. Cash and Investments - Cash and cash equivalents as of December 31, 2023, were $3,171.8 million, down from $3,869.6 million as of December 31, 2022[3]. - The company raised $661.5 million from short-term borrowings in 2023, compared to $313.8 million in 2022, marking an increase of about 111%[8]. - Cash used in operating activities for 2023 was $1.16 billion, compared to $1.50 billion in 2022, indicating a decrease of about 23%[7]. - The company has a cash and cash equivalents balance of $3.2 billion as of December 31, 2023, providing a strong financial position[120]. Research and Development - The company has established an internal clinical team of over 3,000 members, conducting more than 130 clinical trials with over 22,000 participants across approximately 45 regions[10]. - The company has conducted over 40 key or potentially registrable clinical trials for its product portfolio[10]. - The company reported research and development expenses amounted to $1.779 billion for the year ended December 31, 2023, compared to $1.641 billion in 2022, reflecting an increase of 8.4%[108]. Collaborations and Licensing - The company received a non-refundable upfront payment of $650,000,000 from Novartis for the collaboration and licensing agreement for the development and commercialization of Tislelizumab[19]. - The company has licensed 14 additional approved drugs for commercialization in the Chinese market, leveraging its strong commercialization capabilities[10]. - The company has formed collaborations with leading biopharmaceutical companies, such as Amgen and Novartis, to develop and commercialize innovative drugs[10]. - The company and Novartis mutually agreed to terminate the collaboration agreement for Osemitamab in July 2023, regaining all global rights for the drug[25]. Market Performance - Global sales of Baiyueze® (Zebutinib) reached $1.3 billion in 2023, marking a 128.5% increase year-over-year[115]. - Baiyueze® sales grew by 128.5% in 2023 compared to 2022, establishing a strong position in the hematology market[119]. - The company’s product sales included $1,290,396,000 from Baiyueze® and $536,620,000 from Baizean® for the year ended December 31, 2023[79]. Governance and Compliance - The company has maintained compliance with all provisions of the Corporate Governance Code during the reporting period[173]. - The Audit Committee consists of three independent non-executive directors, with Anthony C. Hooper appointed as the chairman since September 13, 2023[172]. - The company has adopted its own insider trading policy, which is not less stringent than the standards set out in the Hong Kong Listing Rules Appendix C3 regarding the trading of securities by directors[174]. Future Outlook - The company plans to continue its focus on market expansion and new product development in the upcoming fiscal year[110]. - The company expects its existing cash and cash equivalents to meet operational and capital expenditure needs for at least the next 12 months as of December 31, 2023[147].

“一般情况下，药品专利包括物质成分专利、晶体专利、剂型专利等，泽布替尼物质成分的专利保护期 到2034年。但是针对泽布替尼这个药物，百济神州（688235.SH/06160.HK/BGNE.US）还有其他专利布 局，可以保护泽布替尼在2034年之后的一段时间也免受仿制药竞争。”3月下旬，接近百济神州专利诉讼 事件的人士告诉经济观察网。 公布2023年财报后，百济神州宣布在美国新泽西州联邦法院分别对山德士以及MSN Pharmaceuticals（以 下简称“MSN”）提起专利侵权诉讼，以应对两家公司要递交泽布替尼仿制药上市申请的情况。 泽布替尼是百济神州的核心产品之一，2023年收入近13亿美元，占总营收50%以上。 “这在药品行业是很常见的事情。”前述人士表示，特殊之处在于，以往这种针对仿制药的专利诉讼，起 诉方往往是国外的药企，而这次，起诉方是中国药企，并且针对的还是美国及其他国外市场。 泽布替尼此前也被指控侵犯专利。去年6月，美国药企艾伯维旗下公司Pharmacyclics指控泽布替尼侵犯 其伊布替尼专利，并已在美国地方法院提起诉讼。 作为拥有国内第一个“十亿美元分子”的药企，百济神州无论是发起专利诉讼 ...

Olivier Brandicourt博士 Margaret Han Dugan博士 Donald W. Glazer先生 Michael Goller先生 Anthony C. Hooper先生 Ranjeev Krishana先生 Alessandro Riva博士 Corazon (Corsee) D. Sanders博士 易清清先生 1 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） 董事名單及其角色與職能 百濟神州有限公司（「本公司」）董事會（「董事會」）成員載於下文。 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 董事會有五個董事會委員會。下表提供本公司每位董事所任職於這些委員會的成 員資料。 | | | | | | 商業及 | | --- | --- | --- | --- | --- | --- | | | 審計 | 薪酬 | 提名及企業 | 科學諮詢 | 醫學事務 | | | 委員會 | 委員會 | 管治委員會 | 委員會 | 諮詢委員會 | | 歐雷強先生 | | | | | | | 王曉東博士 ...

美国证券交易委员会 华盛顿特区 20549 _____________________ 8-K 表格 _____________________ 根据 1934 年证券交易法 第 13 或 15（d）条规定提交的 临时报告 报告日期（所报告最早事件之日期）：2024 年 3 月 19 日 百济神州有限公司 BEIGENE, LTD. （注册人章程中列明的注册人准确名称） 开曼群岛 001-37686 98-1209416 （注册地所在州或其他司法管辖区） （委员会档案编号） （国税局雇主识别号） c/o Mourant Governance Services (Cayman) Limited Cayman Islands （主要办事处地址）（邮政编码） +1 (345) 949 4123 （注册人电话号码，包括区号） 不适用 (如自上一份报告起有改动，则为公司曾用名或原地址) 若 8-K 表格的呈递旨在同时满足下列任何条例项下的注册人报告义务，请勾选相应方格： [ ] 根据证券法第 425 条发出书面通讯 (17 CFR 230.425) [ ] 根据交易法第 14a-12 条的征集资料 (17 CFR 24 ...

A 股代码：688235 A 股简称：百济神州 公告编号：2024-008 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 关于委任董事会商业及医学事务咨询委员会 成员的公告 经百济神州有限公司（以下简称"公司"）董事会审议通过，自 2024 年 3 月 19 日（美国东部时间）起，公司独立非执行董事 Olivier Brandicourt 博士获委 任为董事会商业及医学事务咨询委员会成员。 公司董事会商业及医学事务咨询委员会由五名成员组成，包括 Anthony C. Hooper 先生、Olivier Brandicourt 博士、Margaret Han Dugan 博士、Ranjeev Krishana 先生以及 Corazon (Corsee) D. Sanders 博士。Anthony C. Hooper 先生为 商业及医学事务咨询委员会主席。 特此公告。 百济神州有限公司董事会 2024 年 3 月 22 日 1 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。 ...

股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[百I Tnaf 济bol]e 神_Ti州tle]（ 6160） [评Tab级le_：Inv est] 增持 当前价格（港元）： 104.00 替雷利珠单抗在美获批，在研管线加速兑现 2024.03.17 海 ——公司跟踪点评 [ 交Ta易bl数e_M据a rket] 外 52周内股价区间（港元） 84.35- 丁丹(分析师) 甘坛焕(分析师) 姜铸轩(研究助理) 163.90 公 0755-23976735 021-38675855 021-38674878 当前股本（百万股） 1,358 司 dingdan@gtjas.com gantanhuan028803@gtjas.com jiangzhuxuan029022@gtjas.com 当前市值（百万港元） 141,186 证书编号 S0880514030001 S0880523080007 S0880123100004 （ 中 本报告导读： [ Table_PicQuote] 52周内股价走势图 国 替雷利珠单抗二线ESCC适应症在美国获批上市，多项研发管线陆续步入 ...

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） 審計委員會會議日期 百濟神州有限公司（「本公司」）謹此公佈，本公司董事會（「董事會」）審計委員會 會議將於2024年3月28日（香港時間）舉行，以（其中包括）審議及批准本公司及其 附屬公司截至2023年12月31日止全年業績及根據香港聯合交易所有限公司證券上 市規則（「香港上市規則」）刊發全年業績。本公司先前於2024年2月26日公佈其截 至2023年12月31日止全年業績，並以提交表格10-K的方式將其全年業績送交美國 證券交易委員會（「美國證券交易委員會」）存案。本公司根據香港上市規則刊發的 全年業績與本公司先前已公佈並送交美國證券交易委員會存案者相同，惟根據香 港上市規則所要求的指定附加資料及將本公司的全年業績從美國公認會計原則與 國際財務報表準則進行核對的結果除外。 承董事會命 百濟神州有限公 ...

A股代码：688235 A股简称：百济神州 公告编号：2024-007 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 自愿披露关于美国食品药品监督管理局批准替雷利珠 单抗用于治疗既往接受化疗后晚期或转移性食管鳞状 细胞癌患者的公告 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： 注册分类：治疗用生物制品 1 类 替雷利珠单抗是一款人源化 IgG4 抗 PD-1 单克隆抗体，对 PD-1 具 有高亲和力和结合特异性，设计目的旨在最大限度地减少与巨噬细胞中 的 Fcγ 受体结合，帮助人体免疫细胞识别并杀伤肿瘤细胞。 二、获得 FDA 批准情况 美国食品药品监督管理局（FDA）已批准替雷利珠单抗作为单药治 疗既往接受过系统化疗（不含 PD-1/L1 抑制剂）后不可切除或转移性食 管鳞状细胞癌（ESCC）的成人患者。替雷利珠单抗预计将于 2024 年下 半年在美国上市。 1、百济神州有限公司（以下简称"公司"）近日获悉，美国食品药 品监督管理局（FDA）已批准公司核心产品替雷利珠 ...

Company Overview - BeiGene, Ltd. is a global oncology company focused on developing innovative cancer treatments, with a commitment to improving access to medicines for patients worldwide [29]. FDA Approval - The U.S. FDA has approved TEVIMBRA® (tislelizumab-jsgr) as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor, with availability expected in the U.S. in the second half of 2024 [1][8]. Clinical Trial Results - The approval of TEVIMBRA is based on the RATIONALE 302 trial, which demonstrated a statistically significant survival benefit, with a median overall survival of 8.6 months for TEVIMBRA compared to 6.3 months for chemotherapy (p=0.0001; HR=0.70) [2][4]. - The trial involved 512 patients across 132 research sites in 11 countries, highlighting the global reach of the study [4]. Market Potential - Esophageal cancer is projected to see nearly 957,000 new cases by 2040, indicating a 60% increase from 2020, emphasizing the need for effective treatments [5]. - TEVIMBRA has been prescribed to over 900,000 patients globally, showcasing its potential impact on cancer treatment [3]. Future Developments - The FDA is currently reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for unresectable, recurrent, locally advanced, or metastatic ESCC, with target action dates set for July and December 2024 [3].

Company Overview - Pi Health is an oncology-focused health technology and clinical research company that aims to transform global access to innovative medicines and clinical trials [1] - The company was incubated as a subsidiary of BeiGene, Ltd. and has recently completed over $30 million in Series A funding to launch as an independent entity [1][5] - The funding round was led by AlleyCorp and Obvious Ventures, with additional investments from Invus Capital and global oncology leaders [1] Industry Challenges - The clinical trial system is characterized by low participation rates, with less than 8% of eligible cancer patients participating in studies, limiting understanding of the disease across diverse populations [2] - Current clinical trials infrastructure is inefficient, relying on outdated methods such as Excel spreadsheets and manual data entry, which complicates the process [4] Technological Innovation - Pi Health has developed FICS (Front-End Interoperable Capture Software), a comprehensive software solution that connects life science sponsors and trial sites, automating manual processes for faster and higher-quality data collection [4] - The software integrates generative AI to streamline clinical documentation, patient matching, data transformations, and adverse event monitoring, significantly reducing administrative burdens [5] Market Potential - The implementation of Pi Health's platform is expected to revolutionize the clinical trial system, enabling faster and more efficient delivery of life-saving drugs and treatments to patients [5] - The Series A funding will support the expansion of partnerships with global trial sites and life sciences companies, as well as further development of the FICS technology [5][6] Global Reach - Pi Health has established partnerships with oncology centers across the US, Brazil, Australia, and India, including a new cancer hospital in Hyderabad, India, to promote equitable access to clinical trials [7]