A 股代码：688235 A 股简称：百济神州 公告编号：2023-025 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 关于召开 2023 年半年度业绩说明会的公告 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、会议召开时间：2023 年 8 月 30 日(星期三)上午 09:00-10:00 2、会议召开地点：上海证券交易所上证路演中心（网址： http://roadshow.sseinfo.com/） 3、会议召开方式：上证路演中心网络互动 4、投资者可于 2023 年 8 月 23 日(星期三)至 8 月 29 日(星期 二)16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通 过公司邮箱 ir@beigene.com 进行提问。公司将在说明会上对投资者普 遍关注的问题进行回答。 百济神州有限公司（以下简称"公司"）将于 2023 年 8 月 30 日发 布公司 2023 年半年度报告，为便于广大投资者更全面深入地了解公 司 2023 年半年度经营 ...

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） 承董事會命 百濟神州有限公司 主席 歐雷強先生 香港，2023年8月14日 於本公告日期，本公司董事會包括主席兼執行董事歐雷強先生、非執行董事王曉 東博士，以及獨立非執行董事Margaret Han Dugan博士、Donald W. Glazer先生、 Michael Goller先生、Anthony C. Hooper先生、Ranjeev Krishana先生、Thomas Malley先生、Alessandro Riva博士、Corazon (Corsee) D. Sanders博士及易清清先 生。 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 的會議將於2023年8月25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20 ...

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3日， 董事會薪酬委員會根據2016期權及激勵計劃的條款向五名承授人授出可認購合共 5,133股美國存託股份的購股權並向四百二十四名承授人授出涉及合共87,092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3日，董事會薪酬委員會根據2016期權及激勵計劃的條款授予五名承 授人可認購合共5,133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 授出的代價： 零 已授出購股權的行使價： 每股美國存託股份209.03 美元（約每股普通股 125.42港元） 購股權的有效期： 購股權的有效期由授出日期起計為期十年，並將 於有效期屆滿時失 ...

Financial Performance - Product revenue for the second quarter reached $554 million, representing an 82% year-over-year increase[3] - BeiGene's net loss is expected to continue narrowing in 2023, indicating improved financial performance[2] - Net loss for Q2 2023 was $38.11 million, or $0.28 per share, a decrease from a net loss of $56.57 million, or $0.42 per share, in Q2 2022[9] - Total revenue for the three months ended June 30, 2023, was $595,261 thousand, representing a significant increase from $341,572 thousand in the same period of 2022, marking a growth of approximately 74.3%[16] - Product revenue for the six months ended June 30, 2023, reached $964,036 thousand, compared to $566,084 thousand in the prior year, indicating a year-over-year increase of about 70.2%[16] - The net loss for the three months ended June 30, 2023, was $(381,137) thousand, an improvement compared to a net loss of $(565,726) thousand in the same period of 2022, showing a reduction of about 32.6%[16] Product Sales and Growth - Global sales of BeiGene's BTK inhibitor, Brukinsa, amounted to $308 million in the second quarter, a 139% year-over-year increase and a 46% quarter-over-quarter increase[3] - Sales of Baiduzhe® in the U.S. amounted to $223.5 million, representing a 152.9% increase year-over-year, driven by increased usage among CLL/SLL adult patients[6] - Baiduzhe® sales in China for Q2 2023 were $48.5 million, up 32.2% year-over-year, reflecting growth across all approved indications[6] - Baizean® sales in China reached $149.5 million, a 42.5% year-over-year increase, attributed to improved market penetration and new patient demand from insurance coverage[7] Research and Development - The company is focused on expanding its innovative oncology drug pipeline and enhancing treatment options for patients globally[2] - The company held an investor R&D day to showcase its growing and diversified innovative pipeline and differentiated R&D strategies[3] - The company aims to reduce net losses in 2023 and improve the clinical development and registration of its drug candidates[18] - The company has established a strong R&D capability and strategic partnerships to accelerate the development of its diverse drug pipeline[17] Regulatory Approvals and Collaborations - The company received a positive opinion from the European Medicines Agency (EMA) supporting the use of Tazverik for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma who have previously received platinum-based chemotherapy[4] - The FDA has accepted a supplemental New Drug Application (sNDA) for Brukinsa in combination with Obinutuzumab for the treatment of relapsed/refractory follicular lymphoma, with a decision expected in Q1 2024[4] - The company announced multiple new registrations for Baiduzhe® in China, including sNDA applications for TN CLL/SLL and WM adult patients[5] - A collaboration with InnoCare Pharma was established for the global clinical development and commercialization rights of a preclinical ADC, complementing the company's existing ADC pipeline[5] Production and Capacity Expansion - The company is building production facilities to enhance clinical and production capabilities, with anticipated completion dates and capacity improvements[2] - The company is constructing a flagship production base in New Jersey with an investment exceeding $700 million, expected to be completed in 2024, covering over 1 million square feet[13] - The company is expanding its production capacity in Suzhou, which is expected to increase small molecule drug production capacity by over 5 times upon completion[13] Financial Position - Cash, cash equivalents, restricted cash, and short-term investments totaled $3.5 billion as of June 30, 2023, down from $4.5 billion at the end of 2022[9] - The company reported total assets of $5,728,736 thousand as of June 30, 2023, a decrease from $6,379,290 thousand on December 31, 2022, representing a decline of approximately 10.2%[15] - Cash, cash equivalents, restricted cash, and short-term investments decreased to $3,527,267 thousand from $4,540,288 thousand, a reduction of about 22.3%[15] - The company’s total liabilities decreased to $1,930,177 thousand from $1,995,935 thousand, a decline of about 3.3%[15] Operating Expenses - Operating expenses for Q2 2023 were $818 million, a 15.2% increase from $709.8 million in Q2 2022, while product revenue grew significantly[9] - The total expenses for the three months ended June 30, 2023, amounted to $913,976 thousand, compared to $780,971 thousand in the same period of 2022, representing an increase of about 17.0%[16] - Research and development expenses for the three months ended June 30, 2023, were $422,764 thousand, up from $378,207 thousand in the same period of 2022, reflecting a rise of approximately 11.8%[16]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 10-Q ___________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37686 BG ...

Financial Performance - The company's revenue for Q1 2023 reached CNY 3,066,389 thousand, representing a 57.4% increase year-over-year[4] - Product revenue accounted for CNY 2,807,965 thousand, marking a 69.0% growth compared to the same period last year[4] - The net loss attributable to shareholders was CNY -2,446,580 thousand, with a basic and diluted earnings per share of CNY -1.81[6] - Total revenue for Q1 2023 reached RMB 3,066,389 thousand, a 57.4% increase from RMB 1,947,858 thousand in Q1 2022[21] - Net loss for Q1 2023 was RMB 2,446,580 thousand, an improvement from a net loss of RMB 2,866,345 thousand in Q1 2022[22] - The total comprehensive loss for Q1 2023 was RMB -2,537,142 thousand, compared to RMB -3,063,036 thousand in Q1 2022[23] Expenses and Costs - Research and development expenses totaled CNY 2,818,146 thousand, constituting 91.9% of total revenue, a decrease of 37.3 percentage points from the previous year[6][10] - Total operating costs increased to RMB 5,640,428 thousand, up 19.5% from RMB 4,720,140 thousand in the same period last year[21] - R&D expenses rose to RMB 2,818,146 thousand, reflecting a 12% increase compared to RMB 2,516,771 thousand in Q1 2022[21] Cash Flow and Assets - The company reported a net cash flow from operating activities of CNY -3,577,897 thousand, indicating a significant cash outflow[4] - Cash flow from operating activities showed a net outflow of RMB 3,577,897 thousand, worsening from a net outflow of RMB 1,961,086 thousand in the previous year[24] - Cash and cash equivalents at the end of Q1 2023 totaled RMB 17,812,155 thousand, down from RMB 25,544,570 thousand at the end of Q1 2022[25] - The company's cash and cash equivalents were CNY 17,820,387 thousand, down from CNY 20,132,630 thousand in December 2022, representing a decline of approximately 6.5%[19] Assets and Liabilities - The total assets at the end of the reporting period were CNY 40,975,910 thousand, down 7.3% from the end of the previous year[6] - As of March 31, 2023, the company's total assets amounted to CNY 40,975,910 thousand, a decrease from CNY 44,224,173 thousand at the end of 2022[19] - The total liabilities decreased to CNY 12,377,256 thousand from CNY 13,893,114 thousand, indicating a reduction of approximately 10.9%[20] - The company's equity attributable to shareholders was CNY 28,598,654 thousand, down from CNY 30,331,059 thousand, a decline of about 5.7%[20] Shareholder Information - The company has a total of 1,362,652,101 shares issued, with 91.56% of shares held overseas[12] - The number of registered shareholders was 45,322, including 45,162 domestic shareholders and 8 American depositary share holders[15] Other Financial Activities - The company received government grants amounting to CNY 129,210 thousand during the period[7] - The total non-recurring gains and losses amounted to CNY 167,156 thousand after tax adjustments[7] - Investment activities generated a net cash inflow of RMB 1,538,416 thousand, compared to RMB 1,790,489 thousand in the same quarter last year[24] - The company received RMB 195,692 thousand from investment activities in Q1 2023, up from RMB 75,446 thousand in Q1 2022[25] Risks and Challenges - The company highlighted potential risks in drug development due to long R&D cycles and regulatory uncertainties, which may impact future performance[17]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 10-Q ___________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37686 B ...

Financial Performance - The company reported a cumulative loss of 50.972 billion yuan as of December 31, 2022, primarily due to high investment in drug research and development [4]. - BeiGene reported a total revenue of RMB 3.2 billion for the fiscal year 2022, representing a 25% increase year-over-year [15]. - The company achieved a net loss of RMB 1.5 billion in 2022, which is a 10% improvement compared to the previous year [15]. - The company's operating revenue for 2022 was RMB 9,566,409 thousand, representing a 26.06% increase compared to RMB 7,588,957 thousand in 2021 [22]. - The net profit attributable to shareholders for 2022 was a loss of RMB 13,642,041 thousand, worsening from a loss of RMB 9,747,673 thousand in 2021 [22]. - The net cash flow from operating activities for 2022 was a negative RMB 7,799,707 thousand, compared to a negative RMB 8,284,748 thousand in 2021 [22]. - The company's total assets decreased by 19.86% to RMB 44,224,173 thousand at the end of 2022, down from RMB 55,184,711 thousand at the end of 2021 [22]. - The basic earnings per share for 2022 was -10.18 yuan, compared to -8.08 yuan in 2021 [23]. - The company reported a cash position of RMB 2 billion at the end of 2022, providing a solid foundation for future investments [15]. - The company has not distributed profits or converted capital reserves into share capital for the 2022 fiscal year [6]. Research and Development - Research and development expenses for the year were 11.152 billion yuan, representing a year-over-year increase of 16.92% [4]. - The company has invested RMB 500 million in research and development for new technologies, particularly in bispecific antibodies and CAR-T therapies [15]. - Research and development expenses accounted for 116.58% of operating revenue in 2022, a decrease of 9.11 percentage points from 125.69% in 2021 [24]. - The total R&D investment for the current year is 11,152,086 thousand yuan, an increase of 16.92% compared to the previous year (9,538,418 thousand yuan) [109]. - The company has established a comprehensive organizational structure covering drug discovery, preclinical research, clinical trials, and commercialization [78]. - The company has advanced 15 self-developed clinical candidates into clinical trials and commercialization stages, supported by a strong clinical research team of over 2,700 employees globally [97]. - The company has a robust pipeline of candidate drugs, with several in various clinical trial phases, including 3 in Phase III for non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma (ESCC) [51]. - The company is committed to advancing its research in immune-oncology, as evidenced by its diverse pipeline targeting various cancers [53]. Drug Development and Pipeline - The company is focused on developing innovative and affordable oncology drugs to improve treatment outcomes for patients globally [4]. - BeiGene is advancing its pipeline with 10 new drug applications expected to be submitted in 2023, focusing on oncology and immunology [15]. - The company has established competitive advantages in research, clinical development, commercialization, and production [4]. - The company has a global clinical development and medical affairs team of over 2,700 employees, conducting more than 80 ongoing or planned clinical trials for over 50 drugs and candidates [31]. - The company has received regulatory approvals for its products in over 65 markets globally [35]. - The company has commercialized 13 licensed drugs in the Chinese market [31]. - The company has received conditional approval for 百悦泽® (Zanubrutinib) in China for adult patients with Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL) who have received at least one prior treatment [38]. - The company has initiated or completed 21 potential registrational clinical trials for 百雷利珠单抗 (Tislelizumab), including 13 Phase 3 trials and 4 pivotal Phase 2 trials [60]. Market Expansion and Strategy - The company expects revenue growth of 20% to 25% for the fiscal year 2023, driven by new product launches and market expansion [15]. - The company plans to expand its market presence in Europe and Asia, targeting a 15% increase in market share by the end of 2023 [15]. - The company is exploring strategic partnerships and potential acquisitions to enhance its product portfolio and accelerate growth [15]. - The company aims to establish a reputation as a leading biotech firm globally by continuously providing effective and differentiated drugs in the US, China, Europe, and other international markets [120]. - The company is expanding its commercial capabilities in the Asia-Pacific region and through distributor partnerships in Latin America and other emerging markets [119]. Risks and Challenges - The company continues to face risks of future losses as it expands its drug development pipeline and seeks regulatory approvals [4]. - The company acknowledges various risk factors that may impact its business and financial performance, as detailed in the management discussion section [5]. - The company faces risks related to the inability to achieve and maintain market recognition for its drugs, which could limit sales and profitability [132]. - The company has limited experience in commercializing self-developed and licensed drugs, which may lead to suboptimal commercialization results [133]. - The company faces risks if competitors develop and commercialize safer, more effective drugs, potentially diminishing its market opportunities [135]. - The company’s ability to maintain its core competitiveness is challenged by significant cumulative losses and ongoing R&D investments [130]. - The company may face significant additional costs and delays if its contract manufacturing organizations (CMOs) fail to meet regulatory standards [148]. - The company faces risks related to the loss of key management personnel, which could hinder research, development, and commercialization goals [162]. Regulatory and Compliance - The company must comply with stringent regulatory requirements for clinical trials, and failure to do so could result in unreliable clinical data and additional trials being mandated by regulatory authorities [149]. - The company is subject to strict regulatory oversight in the pharmaceutical industry in China, which may lead to increased compliance costs and potential delays in drug development [173]. - The company faces complex and costly regulatory compliance costs due to differences in regulations across regions [175]. - The company must continuously evaluate compliance with Good Manufacturing Practices (GMP) to avoid sanctions [176]. - The company is currently assessing the potential impacts of the new regulations on its operations and fundraising activities [199]. Collaborations and Partnerships - The company has partnered with leading biopharmaceutical companies like Amgen and Novartis for the development and commercialization of innovative drugs [31]. - The company has signed collaboration agreements with partners like Amgen, Novartis, and Bristol-Myers Squibb, but faces risks in achieving expected financial and operational synergies from these partnerships [151]. - The company has established strong collaborations with major cancer centers in China to develop drug combinations targeting specific cancers [117]. Production and Supply Chain - The company is constructing a new facility in Suzhou for small molecule drug production and a new base in New Jersey for commercial biopharmaceutical production [144]. - The company has established a commercial team of over 3,500 people to drive the application of its drugs in oncology, with leading positions in the BTK inhibitor and PD-1/PDL-1 categories in China [119]. - The company relies on external suppliers for part of its drug production, which poses risks related to production capacity and regulatory compliance [144]. - The company has faced significant risks from third-party manufacturers, including potential production delays and quality control issues, which could impact clinical trials and commercialization [146].

Financial Performance - BeiGene reported a significant increase in revenue, reaching $1.2 billion for the fiscal year 2022, representing a 30% year-over-year growth[7]. - The company reported a 40% increase in clinical trial enrollment, indicating strong interest in its investigational therapies[8]. - The company anticipates significant revenue growth in 2023 and beyond, expecting product revenue growth to exceed operating expense growth[18]. - Cumulative losses reached $7.1 billion as of December 31, 2022, primarily due to R&D expenses and operational costs[122]. - The company incurred net cash outflows of $1.5 billion, $1.3 billion, and $1.3 billion for the years ending December 31, 2022, 2021, and 2020, respectively, driven by net losses of $2 billion, $1.5 billion, and $1.6 billion[123]. - The company anticipates continued net losses in the foreseeable future as it expands drug development and seeks regulatory approvals[122]. Product Development and Pipeline - The company is investing $200 million in R&D for new drug candidates, focusing on oncology and immunology[8]. - The company has developed a robust pipeline of innovative therapies, including BCL-2 inhibitors and targeted therapies, with ongoing research on multiple early-stage products[16]. - The company has multiple clinical candidates in various stages, including 5 in Phase 3 trials and 5 designed as registrational Phase 2 trials for its drug 百悅澤® (Zebutinib) targeting B-cell malignancies[43]. - The company is conducting extensive global pivotal clinical projects for 百悅澤®, which has shown superior progression-free survival compared to ibrutinib[42]. - The company has established partnerships for the commercialization of its products in various markets, enhancing its market presence[20]. Market Expansion and Strategy - BeiGene aims to expand its market presence in Europe and Asia, with a target of increasing market share by 15% in these regions by 2024[7]. - The company plans to launch three new products in the next 18 months, targeting a market potential of $2 billion[8]. - The company has established advanced biopharmaceutical and small molecule drug production bases in China and is building a commercial-stage biopharmaceutical production and clinical R&D center in New Jersey, USA[11]. - The company has a global commercialization strategy for its oncology products, focusing on expanding market access in key regions[21]. Collaborations and Partnerships - The company has partnerships with leading biopharmaceutical companies like Amgen and Novartis for the development and commercialization of innovative drugs[11]. - The collaboration agreement with Amgen allows BeiGene to share up to $1.25 billion in development costs for global development of oncology pipeline products[68]. - The company has established a collaboration agreement with Novartis that includes an upfront payment of $650 million and potential milestone payments up to $1.3 billion based on regulatory achievements[71]. - The company has entered into strategic partnerships that may require non-recurring expenses and could dilute existing shareholders' equity[143]. Regulatory and Compliance Challenges - The company acknowledges the impact of COVID-19 on its clinical development, regulatory, commercial, production, and other operations[10]. - The company is subject to various healthcare fraud and abuse laws, which could lead to criminal sanctions and civil penalties[103]. - The company faces significant risks related to regulatory approvals and compliance, which may adversely impact its business operations[101]. - The company must comply with various regulatory requirements in different countries, which may lead to delays or inability to launch products in those markets[106]. Intellectual Property and Competition - The company relies on intellectual property protection for its drugs and candidates, and failure to maintain patents could lead to increased competition[128]. - The company faces significant competition from well-capitalized pharmaceutical companies that invest heavily in R&D and business development to enhance their product pipelines[85]. - The company’s products, including Baiyueze®, Baizean®, and Baihuize®, are expected to face competition from generics and other therapies[89]. - The company acknowledges the presence of numerous third-party patents, which increases the risk of infringement claims as the biotechnology and pharmaceutical sectors expand[133]. Manufacturing and Supply Chain - The company is constructing a biopharmaceutical production and clinical R&D center in New Jersey and a new small molecule production facility in Suzhou, China, while still depending on external suppliers[140]. - The company relies on third-party manufacturers for several commercial and clinical supply drugs, which poses risks if these suppliers fail to deliver adequate quantities or quality[140]. - The company has a commercial supply agreement with Catalent Pharma Solutions for the production of its drug in Kansas City, Missouri, for clinical and commercial supply in the US and other countries[65]. - Supply chain disruptions, including material shortages or natural disasters, could impact the company's contract manufacturers and suppliers[141]. Employee and Management Considerations - The company has over 9,000 employees, reflecting a 15% increase from approximately 8,000 at the beginning of the year[151]. - Retaining key management personnel is critical for the company's success, as their departure could hinder research, development, and commercialization goals[152]. - The competition for qualified personnel in the pharmaceutical and biotechnology sectors is intense, making it challenging to recruit and retain essential staff[153]. - The company plans to expand its management and operational staff significantly across the U.S., China, Europe, and other regions to support its growth strategy[151]. Financial Risks and Funding - The company may need to secure additional financing to fund operations and drug development, with potential reliance on public or private offerings, debt financing, or partnerships[123]. - The company faces risks related to potential dilution of shareholder equity if additional capital is raised through equity issuance or convertible bonds[125]. - The company is exposed to foreign exchange risks due to operations in currencies other than USD, particularly RMB, EUR, and AUD, which may negatively impact financial performance[126]. - The company anticipates continued growth in research, development, production, and commercialization capabilities, which may lead to management challenges[151].

A 股代码：688235 A 股简称：百济神州 公告编号：2023-008 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 关于召开 2022 年度业绩说明会的公告 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： 本次投资者说明会以网络互动形式召开，公司将针对 2022 年度 的经营成果及财务指标的具体情况与投资者进行互动交流和沟通，在 信息披露允许的范围内就投资者普遍关注的问题进行回答。 二、 说明会召开的时间、地点 （一） 会议召开时间：2023 年 4 月 26 日上午 09:00-10:00 （二） 会议召开地点：上海证券交易所上证路演中心（网址： http://roadshow.sseinfo.com/） （三） 会议召开方式：上证路演中心网络互动 1、会议召开时间：2023 年 4 月 26 日（星期三）上午 09:00-10:00 2、会议召开地点：上海证券交易所上证路演中心（网址： http://roadshow.sseinfo.com/） 3、会议召开方式： ...