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百济神州:百济神州有限公司关于与关联方共同投资暨关联交易的进展公告


2024-03-05 13:20
A 股代码:688235 A 股简称:百济神州 公告编号:2024-006 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进展公告 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。 甲方(转让方):张江集团 乙方(受让方):项目公司 (二)产权交易标的 交易合同标的为甲方所持有的上海张江(集团)有限公司部分资产(张江总 部园头部企业及上市公司总部区(B4-02)在建工程项目)。 一、本次交易概述 百济神州有限公司(以下简称"百济神州"或"公司")于 2023 年 8 月 28 日召开董事会审议通过了公司的全资子公司 BeiGene(Hong Kong)Co., Limited (百济神州(香港)生物科技有限公司)与公司的关联方 GaoYue Centurion II Holdings Limited 分别认购公司的全资子公司 BeiGene Shanghai(以下简称"开曼 百济神州上海")新发行的 94 股普通股、5 股普通股,并由开曼百济神州上海 的境内全 ...
百济神州:港股公告:翌日披露报表


2024-03-01 09:58
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 第 1 頁 共 5 頁 v 1.2.5 FF304 | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | 於香港聯交所上市(註11) | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如於香港聯交所上市) | | 說明 | | 人民幣股份 (於上海證券交易所科創板上市,股份代號:688235) | | | | | 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) | 2024年2月28日 | 115,055,260 | | | | | | | 1). 其他 (請註明) | | | 0 | % | | | % | | 不适用 | | | | | | | ...
百济神州(688235) - 百济神州有限公司投资者关系活动记录表(2024年2月)


2024-02-29 23:46
A股代码:688235 A股简称:百济神州 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 投资者关系活动记录表 (2024年2月) 投资者关系 √特定对象调研 √分析师会议 □媒体采访 □业绩说明会 活动类别 □新闻发布会 √路演活动 □现场参观 □一对一沟通 √其他(电话会议) 参与单位 3W Fund 、 Capital Group 、 Fullerton Fund 、 Janchor 及人员 Partners、OrbiMed、Point72、Principal Asset Management、Prudence Investment、Zeal Asset Management、安信基金、宝盈基金、碧云资 ...
BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia


Businesswire· 2024-02-29 15:00
Core Insights - BeiGene announced a new matching adjusted indirect comparison (MAIC) showing BRUKINSA (zanubrutinib) has advantages in progression-free survival and complete response over acalabrutinib in relapsed or refractory chronic lymphocytic leukemia (CLL) [1][2] - The analysis will be presented at the 28th Annual International Congress on Hematologic Malignancies in Miami from February 29 to March 3 [1] Efficacy Comparison - The MAIC indicates that BRUKINSA shows improved investigator-assessed progression-free survival with a hazard ratio (HR) of 0.77 (95% CI: 0.55-1.07) in the unadjusted population and HR of 0.68 (95% CI: 0.46-0.99) in the adjusted population [3] - The odds ratio (OR) for complete response favored BRUKINSA with OR of 2.88 (95% CI: 1.18-7.02) in the unadjusted population and OR of 2.90 (95% CI: 1.13-7.43) in the adjusted population [3] Study Methodology - The MAIC matched individual patient-level data from the ALPINE trial against aggregate data from the ASCEND trial, using an unanchored MAIC due to the absence of a common comparator arm [2] - Adjustments were made for key patient characteristics and the impact of COVID-19 on study outcomes [2] Previous Limitations Addressed - The new MAIC addresses significant limitations found in a previously published MAIC, including the exclusion of final analysis data from ALPINE and lack of adjustment for COVID-19 impacts [3] BRUKINSA's Market Position - BRUKINSA is the only BTK inhibitor demonstrating progression-free survival superiority compared to ibrutinib in R/R CLL, as shown in the ALPINE trial [3] - The drug is approved in 70 markets globally, including the U.S., China, and EU, and is under development for additional indications [4] Development Program - The global development program for BRUKINSA includes over 5,000 subjects enrolled across 29 countries and regions [5]
百济神州:港股公告:翌日披露报表


2024-02-29 10:20
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: 2024年2月29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) | | 2024年2月26日 | 1,240,686,604 | | | | | | | 1). 於股份獎勵計劃下發行股份 | | | 355 ...
国际化再加速,美国超越中国成为产品收入最大贡献地区


浦银国际证券· 2024-02-28 16:00
Investment Rating - Maintains a "Buy" rating with target prices of $275 (US), HK$165 (HK), and RMB 175 (CH) [1] Core Views - The US has surpassed China as the largest contributor to product revenue, driven by strong growth of Zanubrutinib in 4Q23 [1] - Cost control measures are showing initial results, with operational efficiency expected to improve further in 2024 [1] - The company is on track to achieve profitability, supported by faster-than-expected internationalization [1] Revenue and Growth - 4Q23 US revenue reached $310 million, a 101.5% YoY increase, with product sales growing 150% YoY [1] - US product sales surpassed China for the first time, with China's 4Q23 product sales at $267 million [1] - US revenue accounted for 49.4% of total revenue in 4Q23 and 45.9% for the full year 2023, up 8.5 and 10.4 percentage points YoY, respectively [1] - Full-year 2023 product sales increased by 74.5% YoY, while operating expenses grew only 12.5% [1] Operational Efficiency - Operating expenses grew at 1/6th the rate of product sales in 2023, compared to 1/5th in 2022, indicating improved efficiency [1] - R&D expenses are expected to rise slightly in 2024, while sales and administrative expenses will increase moderately [1] - The company plans to maintain a lean commercial team for PD-1 overseas, keeping operating expenses under control [1] 2024 Catalysts - Zanubrutinib's market expansion in the US, including the anticipated approval of the FL indication in March 2024 [1] - Potential approvals for Tislelizumab in esophageal squamous cell carcinoma (US) and non-small cell lung cancer (Europe) [1] - Data readouts for Sonrotoclax (BCL-2) in MM, MDS, and AML, as well as BTK CDAC in refractory MCL and CLL [1] - Phase II data for Tislelizumab combinations with OX40, HPK1, LAG3, and TIM3 in various cancers [1] Valuation and Financials - 2024 and 2025 net loss forecasts narrowed by 0.5% and 16.5%, respectively, reflecting improved operational efficiency [1] - DCF valuation assumes a WACC of 8.1% and a perpetual growth rate of 3.0%, resulting in a market cap of $28.7 billion [1] - Revenue is projected to grow from $3.09 billion in 2024 to $4.43 billion in 2026, with a net profit of $103 million expected in 2026 [5] Market Performance - Current stock prices: $160.3 (US), HK$99.1 (HK), and RMB 125.0 (CH) [2][3][4] - Potential upside: +72% (US), +66% (HK), and +40% (CH) [2][3][4] - 52-week price ranges: $133.0-$272.5 (US), HK$82.7-HK$167.3 (HK), and RMB 98.5-RMB 170.5 (CH) [2][3][4]
Expect a productive 2024 for early pipeline assets


Zhao Yin Guo Ji· 2024-02-28 16:00
Investment Rating - Maintain BUY rating for BeiGene, indicating strong potential for over 15% return in the next 12 months [2][4]. Core Insights - BeiGene is expected to have a productive 2024, driven by strong sales momentum of zanubrutinib, which recorded total product sales of US$631 million in 4Q23, reflecting a 6% quarter-over-quarter (QoQ) and 86% year-over-year (YoY) increase [2]. - Zanubrutinib's sales reached US$1.29 billion in full-year 2023, with a forecast of US$1.9 billion for 2024, representing a 46% YoY growth [2]. - The company is advancing its pipeline with potential blockbusters like sonrotoclax and BGB-16673, with multiple Phase 3 studies expected to start in 2024 [2]. - BeiGene's financial health is improving, with a gross profit margin of 82.7% in FY23, up from 77.2% in FY22, and a significant reduction in the SG&A ratio [2]. Financial Summary - Total revenue for FY23 was US$2.459 billion, with a projected increase to US$2.902 billion in FY24 [3][17]. - Net loss for FY23 was US$882 million, expected to decrease to US$1.1 billion in FY24 and further to US$225 million in FY25, with profitability anticipated from FY26 [2][3]. - The company had US$2.3 billion in net cash at the end of 2023, indicating no immediate need for further equity financing [2]. Target Price - The target price for BeiGene has been revised from US$295.67 to US$268.20, indicating a 67% upside potential from the current price of US$160.26 [4].
2023年亏损进一步收窄,泽布替尼突破10亿美金


申万宏源· 2024-02-27 16:00
Investment Rating - The investment rating for the company is "Buy" (maintained) [6] Core Views - The company reported a narrowing loss for 2023, with a revenue of 17.423 billion, a year-on-year increase of 82%, and a net profit attributable to shareholders of -6.716 billion, compared to -13.642 billion in the previous year [6][7] - The significant revenue growth is primarily driven by the overseas sales of the drug Zebutinib, which reached 9.138 billion, surpassing 1 billion USD, with a year-on-year growth of 138.7% [6][7] - The company expects to achieve profitability starting in 2025, with an adjusted net profit forecast of 1.178 billion for that year [7] Summary by Sections Financial Performance - In 2023, the company achieved total revenue of 17.423 billion, with a year-on-year growth rate of 82.1% [8] - The net profit attributable to shareholders for 2023 is projected at -6.716 billion, an improvement from -13.642 billion in 2022 [9] - The company’s gross margin is expected to remain strong, with projections of 84.1% for 2023 and 85.3% for 2025 [8] Product Development and Market Expansion - Zebutinib's overseas market growth is a key driver for revenue, with plans for further international expansion of the PD-1 monoclonal antibody, which has received approvals in the EU and the UK [7] - The company is actively pursuing additional indications for its PD-1 product in various regions, including the US and Europe, with expected regulatory decisions in 2024 [7] Future Outlook - The company has adjusted its profit forecasts, expecting a net profit of -4.078 billion for 2024, with a significant turnaround anticipated in 2025 [7][9] - The operational efficiency improvements alongside revenue growth are expected to contribute to the narrowing of losses and eventual profitability [6][7]
百济神州2023年业绩点评:泽布替尼放量持续提速,管线步入收获期


Guotai Junan Securities· 2024-02-27 16:00
Investment Rating - The report maintains a "Buy" rating for the company [3][4]. Core Insights - The company achieved a revenue of $2.46 billion in 2023, representing a year-on-year increase of 73.7%. The product revenue for Q4 2023 and the entire year reached $630 million and $2.19 billion, respectively, with growth rates of 86.0% and 74.5% [3]. - The annual sales of Zepzelca exceeded $1 billion, with a year-on-year growth of 129%. In Q4 2023, sales reached $413 million, reflecting a 135% increase year-on-year and a 15% increase quarter-on-quarter [3]. - The company’s R&D expenses were $1.779 billion in 2023, up 8.4% year-on-year, with cash and equivalents at $3.2 billion, indicating a strong financial position [3]. Summary by Sections Financial Performance - The company reported a revenue of $2.46 billion in 2023, with a significant increase in product revenue, particularly in Q4 [3][7]. - The operating loss under GAAP decreased by 18% in Q4 and 33% for the full year [3]. Product Pipeline - Zepzelca is expected to receive FDA and NMPA approvals for R/R FL in March and June 2024, respectively. The company anticipates approvals for multiple indications of its products in 2024 [3]. - The report highlights the potential for the company’s pipeline to enter a revenue-generating phase, with several products expected to gain regulatory approval in the near term [3]. Market Position - The company is experiencing robust growth in overseas markets, contributing to the strong sales performance of Zepzelca and other products [3]. - The report notes the positive opinion from the European Medicines Agency regarding the approval of Tislelizumab for NSCLC indications, indicating progress in international expansion [3].
BeiGene's Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA


Businesswire· 2024-02-27 11:00
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. T ...