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百济神州:港股公告:员工购股计划
2024-09-08 07:34
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2024年9月3日起至2025年2月28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員工購股計劃由董事會薪酬委員會管理。 認購期詳情 2018員工購股計劃項下的認購期通常從每年3月1日及9月1 日開始,持續六個月,除非董事會薪酬委員會提前另行決 定。就上市規則第17章而言,認購期被視為歸屬期。 資格: 於適用認購 ...
百济神州:港股公告:证券变动月报表
2024-09-05 10:34
FF301 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: 2024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: 2024年9月5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 (如上市) | 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 ...
百济神州:港股公告:授出购股权及受限制股份单位
2024-09-05 10:34
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2024年8月30 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3,754股美國存託股份的購股權並向一百七十九名承授人授出涉及合共66,829 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2024年8月30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3,754股美國存託股份的購股權。 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。 授出的代價: 零 已授出購股權的行使價: 每股美國存託股份198.37 美元(約每股普通股 119.02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 於有效期屆滿時失效,或倘服務關係於有效期屆 滿前終 ...
百济神州:港股公告:翌日披露报表
2024-09-02 10:18
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 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: 2024年9月2日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 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 | 是 | | | 證券代號 (如上市) | 06160 | 說明 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | 事件 | | 已發行股份 ...
百济神州(688235) - 2024 Q2 - 季度财报
2024-08-29 10:34
Financial Performance - As of June 30, 2024, the company has accumulated an unremitted loss of RMB 60.566 billion, primarily due to high investment in drug research and development, production, and commercialization[3]. - BeiGene reported a total revenue of RMB 1.2 billion for the first half of 2024, representing a 15% increase year-over-year[14]. - The company achieved a net loss of RMB 600 million, which is a 10% improvement compared to the same period last year[14]. - The company's revenue for the first half of 2024 reached CNY 11,996,406 thousand, a 65.44% increase compared to CNY 7,251,228 thousand in the same period last year[18]. - The net profit attributable to shareholders was a loss of CNY 2,877,389 thousand, an improvement from a loss of CNY 5,218,922 thousand year-over-year[18]. - The net cash flow from operating activities showed a reduced outflow of CNY 3,102,466 thousand, compared to CNY 5,103,818 thousand in the previous year[18]. - The company reported a net cash flow from operating activities of RMB -3.102 billion during the reporting period[159]. - The company reported a cumulative loss of RMB 60.566 billion as of June 30, 2024, indicating ongoing financial challenges and risks of continued losses[125]. Research and Development - Research and development expenses for the reporting period amounted to RMB 6.628 billion, representing a year-on-year increase of 12.68%[3]. - The company invested 55.25% of its revenue in R&D, a decrease of 25.87 percentage points from 81.12% in the previous year[19]. - The company has received a total of 34 new invention patents in the reporting period, bringing the cumulative total to 262[103]. - The company has established a comprehensive technology system for the entire process from early discovery to commercialization of anti-tumor drugs, leveraging various drug technology platforms applicable to oncology and other fields[91]. - The company is focused on advancing its research and development efforts, particularly in the areas of oncology and precision medicine[96][97]. - The company has over 50 preclinical projects, with expectations to advance several candidates to clinical trial stages within the next 12 months[72]. - The company is conducting 11 pivotal clinical trials for BRUKINSA®, with a focus on new indications and commercialization[105]. - The company has initiated two potential registration studies for BGB-16673, with over 300 subjects enrolled[106]. Product Development and Pipeline - BeiGene is advancing its pipeline with 5 new drug applications submitted to the FDA, aiming for approvals by the end of 2024[13]. - The company plans to expand its market presence in Europe, targeting a 30% increase in market share by 2025[14]. - The company is actively pursuing market expansion and new product development strategies to enhance its growth trajectory[28]. - The company has established a global clinical team of over 3,000 members, conducting more than 140 clinical trials across over 45 countries[27]. - The company has developed three self-researched anti-tumor products that have been approved for sale in over 70 markets globally, indicating significant commercial potential[115]. - The company is expanding its clinical pipeline with promising candidates in various cancer types, including ongoing studies for CDK4 inhibitors and other targeted therapies[124]. - The company is exploring potential acquisitions to bolster its product portfolio and market reach[14]. Market and Sales Performance - The company expects revenue growth to accelerate, projecting a 25% increase for the full year 2024[14]. - Global sales of the self-developed BTK inhibitor Baiyueze® totaled 8.018 billion CNY, a year-on-year increase of 122.0%, solidifying its leadership position in the hematologic oncology field[121]. - Sales of Baiyueze® in the U.S. amounted to 5.903 billion CNY, reflecting a 134.4% year-on-year growth, with over 60% of the quarterly demand increase coming from expanded use in chronic lymphocytic leukemia (CLL)[121]. - Sales of Baiyueze® in Europe reached 1.057 billion CNY, a significant increase of 231.6%, driven by market share gains across major markets including Germany, Italy, Spain, France, and the UK[121]. - Sales of Baiyueze® in China totaled 873 million CNY, up 30.5%, with the product maintaining a leading market share in the BTK inhibitor segment[121]. - Sales of Baizean® reached 2.191 billion CNY, a year-on-year increase of 19.4%, attributed to new patient demand from recently included indications in the medical insurance catalog[121]. Regulatory and Compliance Challenges - The company faces significant risks related to its ability to achieve profitability and maintain operations, with potential delisting risks if financial conditions do not improve[125]. - The company may face delays or challenges in obtaining regulatory approvals for its candidate drugs, impacting its ability to bring products to market[134]. - The company must navigate varying regulatory requirements across different countries, which can complicate the approval process for its drug candidates[136]. - The company is subject to significant risks related to compliance with Chinese laws and regulations, particularly concerning foreign investment, which may impact its operations and financial performance[187]. - The company faces potential regulatory scrutiny regarding foreign investments in China, which may significantly impact its business structure and financial performance[192]. Strategic Partnerships and Collaborations - The company has established collaborations with clinical hospitals to obtain primary tumor samples for its tumor organoid platform, facilitating more relevant drug efficacy studies[96]. - The company has signed collaboration agreements with Amgen to commercialize several oncology products in China, but there are risks associated with the inability to successfully develop and commercialize these products[147]. - The company has established strategic partnerships with renowned pharmaceutical companies, introducing 14 authorized commercial products and over 20 clinical development products[119]. Operational and Management Risks - The company faces risks related to the loss of key management personnel, which could hinder its ability to achieve research, development, and commercialization goals[155]. - The company has not insured key personnel, making it vulnerable to the loss of critical talent[155]. - The company is exposed to cybersecurity risks that could disrupt operations and lead to significant financial losses[156]. - The company’s operations may be affected by natural or man-made disasters, public health crises, and other business interruptions, which could lead to significant costs and resource reallocations[151]. Future Outlook and Growth Strategies - The company is committed to advancing its research and development efforts, particularly in the areas of oncology and precision medicine[96][97]. - The company aims to maximize the commercial potential of its products through strong clinical development and global sales capabilities[117]. - The company is focusing on expanding its market presence through strategic approvals in key international markets[12][15][18][19][21].
百济神州:百济神州有限公司关于公司2024年度“提质增效重回报”行动方案的半年度评估报告
2024-08-29 10:34
百济神州有限公司 关于公司 2024 年度"提质增效重回报"行动方案的 半年度评估报告 公司是一家全球肿瘤治疗创新公司,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、澳大利亚等超过 70 个国家和地 区获批上市,百泽安®已在中国、欧盟、美国和澳大利亚获批上市,百汇泽®也已 在中国上市。通过利用公司强大的商业化能力,公司获授权许可在中国市场商业 化另外 14 款已获批药物。在全球临床开发及商业化能力的支持下,公司已与世 界领先生物制药公司(如安进公司(安进)及北京诺华制药有限公司)建立合作, 以开发及商业化创新药物。 公司致力于通过内部研发或与志同道合的合作伙伴携手,推动同类最佳或同 类首创的临床候选药物研发,从而为全球患者提供 ...
百济神州:百济神州有限公司2024年半年度募集资金存放与实际使用情况的专项报告
2024-08-29 10:34
A 股代码:688235 A 股简称:百济神州 公告编号:2024-021 截至 2024 年 6 月 30 日,公司累计使用募集资金人民币 1,596,113 万元,公 司募集资金使用及结存情况如下: | 金额单位:人民币千元 | | --- | 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 2024年半年度募集资金存放与实际使用情况的专项报告 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。 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 2,163,01 ...
百济神州:港股公告:百济神州有限公司截至2024年6月30日止六个月中期业绩公告
2024-08-27 10:14
財務摘要 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2024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2024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2023 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」或 「GAAP」)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。 截至2024年6月30日止六個月的收入合計較截至2023年6月30日止六個月增加約 637.8百萬美元或約61.1%至約1,680.8百萬美元。產品收入較截至2023年6月30 日止六個月增加約704.0百萬美元或約73.0%至約1,668.1百萬美元。 截至2024年6月30日止六個月的經營費用合計較截至2023年6月30日止六 ...
百济神州:百济神州有限公司关于召开2024年半年度业绩说明会的公告
2024-08-21 09:52
A 股代码:688235 A 股简称:百济神州 公告编号:2024-020 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 2024 年半年度业绩说明会的公告 百济神州有限公司(以下简称"公司")将于 2024 年 8 月 30 日 发布公司 2024 年半年度报告,为便于广大投资者更全面深入地了解 公司 2024 年半年度经营成果、财务状况,公司计划于 2024 年 8 月 30 日(星期五)上午 09:00-10:00 举行 2024 年半年度业绩说明会,就投资 者关心的问题进行交流。 一、 说明会类型 本次投资者说明会以网络互动形式召开,公司将针对 2024 年半 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 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:2024 年 8 月 30 日(星期五)上午 09:00-10:00 2、会议召开地 ...
百济神州:2024Q2公司业绩表现超预期,实现非GAAP经营利润盈利
天风证券· 2024-08-16 00:30
Investment Rating - The report maintains a "Buy" rating for the company, with an expected relative return of over 20% in the next 6 months [7][24] Core Views - The company's 2024Q2 performance exceeded expectations, achieving non-GAAP operating profit for the first time [1] - Revenue growth in 2024H1 was strong, with total revenue reaching $1.68 billion, a 61% YoY increase [1] - The company's core product, Zanubrutinib, showed rapid growth in the US market, with Q2 sales reaching $479 million, a 114% YoY increase [3][12] - Tislelizumab continued to expand its market in China, with Q2 sales of $158 million, a 6% YoY increase [4][15] - R&D and sales expense ratios significantly decreased, contributing to improved operational efficiency [2] Financial Performance - 2024Q2 revenue was $929 million, a 56% YoY increase, with a net loss of $120 million, a 68% YoY reduction in losses [1] - Adjusted operating profit for 2024Q2 reached $48.46 million, marking the first quarterly profit [1] - R&D expenses for 2024Q2 were $454 million, with an expense ratio of 49%, a 22 percentage point YoY decrease [2] - Sales and administrative expenses for 2024Q2 were $444 million, with an expense ratio of 48%, a 19 percentage point YoY decrease [2] Product Performance - Zanubrutinib global sales reached $1.126 billion in 2024H1, a 61% YoY increase, with Q2 sales of $637 million, a 107% YoY increase [3] - In the US, Zanubrutinib sales accounted for 29.44% of the BTK inhibitor market in 2024Q2, up from 1.16% in 2021Q2 [14] - Tislelizumab's total revenue in 2024H1 was $303 million, a 15% YoY increase, with Q2 revenue of $158 million, a 6% YoY increase [4] Pipeline Progress - Sonrotoclax, a BCL2 inhibitor, completed the first patient enrollment for its Phase III trial in combination with Zanubrutinib for TN CLL patients [4] - BGB-16673, a BTK CDAC drug, entered Phase I/II clinical trials for B-cell malignancies, showing promising safety and anti-tumor activity in early data [4] Market Expansion - Zanubrutinib gained approval for its sixth indication in China for FL treatment in May 2024 [3] - Tislelizumab received new approvals in China for gastric cancer and small cell lung cancer in 2024Q2, bringing its total approved indications in China to 11 [4][15] - Tislelizumab's esophageal squamous cell carcinoma treatment was approved in the US in March 2024, with its first-line treatment for the same indication under review [4]