Investment Rating - The investment rating for the company is "Buy" [6] Core Insights - The company reported a revenue of 27.214 billion yuan for 2024, an increase of 56.19% year-on-year, and a net loss of 4.978 billion yuan, which is a reduction of 1.738 billion yuan compared to the previous year [1] - The growth in product revenue is primarily attributed to the sales of self-developed products Baiyueze® (Zebutinib capsules) and Baizean® (Tislelizumab injection), as well as sales growth from Amgen authorized products [2] - The company is actively expanding in overseas markets, with Baiyueze® having been approved in over 70 markets globally, treating more than 180,000 patients [3] - The company has a robust pipeline with several innovative products, including Sonrotoclax, which is undergoing multiple potential registration trials, and BGB-16673, a BTK degrader that has received FDA fast track designation [4][5] Financial Summary - The company forecasts revenues of 34.938 billion yuan, 42.048 billion yuan, and 48.165 billion yuan for 2025, 2026, and 2027 respectively, representing year-on-year growth rates of 28%, 20%, and 15% [9] - The projected net profit for 2025 is 410 million yuan, with significant growth expected in subsequent years, reaching 3.567 billion yuan in 2026 and 6.291 billion yuan in 2027 [11] - The earnings per share (EPS) are expected to be 0.29 yuan for 2025, 2.55 yuan for 2026, and 4.49 yuan for 2027, indicating a strong recovery and growth trajectory [11] Market Performance - The company's stock closed at 246.91 yuan, with a 52-week high of 258.0 yuan and a low of 111.22 yuan [6] - The total market capitalization is approximately 345.788 billion yuan [6]

Investment Rating - The report maintains a positive investment rating for the pharmaceutical industry, focusing on innovation and growth opportunities in various segments [4]. Core Insights - The pharmaceutical sector is experiencing a comprehensive recovery, with a focus on innovative drug development, particularly in oncology, autoimmune diseases, GLP-1, stem cell therapy, and gene therapy [1][2]. - The report highlights the importance of domestic innovation in pharmaceuticals, with significant attention on the upcoming AACR and ASCO conferences, where numerous Chinese companies are expected to present their research [2][13]. - The report emphasizes the potential for growth in the CXO sector due to recovering domestic demand and stable overseas demand, suggesting a valuation recovery for leading companies [8]. - The report identifies key companies to watch, including 恒瑞医药, 百济神州, and others across various segments such as innovative drugs, medical devices, and IVD [3]. Summary by Sections Innovative Drugs - The report notes the approval of 康方依沃西单抗 for first-line treatment of PD-L1 positive NSCLC, showing a 22.3% reduction in mortality risk [2]. - It highlights the upcoming AACR conference with over 120 Chinese pharmaceutical companies presenting nearly 300 new drug research results [13]. CXO Sector - The CXO sector is expected to benefit from supportive policies and a reduction in geopolitical risks, leading to a potential valuation uplift [8]. Traditional Chinese Medicine - The report suggests monitoring companies related to pediatric medications, such as 济川药业 and 葵花药业, due to their relevance to fertility subsidies [2]. Blood Products - The report emphasizes the growth potential in the immunoglobulin market over the next 3-5 years, driven by increased demand and pricing improvements [2][25]. Vaccines - The vaccine sector is under pressure, but there are opportunities in HPV vaccines and other high-value products [27]. Upstream Supply Chain - The report recommends focusing on companies with strong brand recognition and overseas growth potential in the chemical and biological reagent sectors [30]. IVD Sector - The report indicates that the IVD industry is poised for growth due to the implementation of centralized procurement policies and increasing domestic demand [33]. Medical Devices - The report highlights the potential for growth in the CGM market, particularly with the FDA approval of related products [38]. Medical Services - The report suggests focusing on eye and dental medical service companies, anticipating a boost from consumer stimulus policies [44]. Offline Pharmacies - The report notes that the pharmacy sector is stabilizing, with a recommendation to focus on companies with strong supply chain capabilities [46]. Raw Materials - The report discusses the importance of quality and cost management in the raw materials sector, suggesting a focus on companies with strong product capabilities [50]. Innovative Devices - The report emphasizes the potential for AI applications in medical devices, particularly in surgical navigation and pathology screening [53]. Instrumentation - The report anticipates a recovery in the scientific instrumentation sector, driven by increased domestic demand and new product launches [57].

Investment Rating - The report maintains a positive investment rating for the pharmaceutical industry, highlighting a recovery and focus on innovation [4]. Core Views - The pharmaceutical sector is experiencing a sustained recovery in fundamentals, supported by favorable policies, with a focus on innovative drug growth, particularly in areas such as oncology, autoimmune diseases, GLP-1, stem cell therapy, and gene therapy [1][2]. - The report emphasizes the importance of domestic pharmaceutical substitution and the growth of medical consumption, especially in aesthetic medicine [1]. Summary by Sections Innovative Drugs - The AACR conference is ongoing, with significant participation from over 120 Chinese pharmaceutical companies presenting nearly 300 new drug research results [11]. - Key approvals include the domestic approval of 康方依沃西单抗 for PD-L1 positive NSCLC and the FDA approval of 派安普利单抗 for nasopharyngeal carcinoma [2][72]. CXO Sector - The CXO sector is expected to see valuation recovery due to supportive policies for innovative drug development and a reduction in geopolitical risks [6]. Traditional Chinese Medicine - The SW secondary index for traditional Chinese medicine has underperformed compared to the broader market, indicating challenges in this segment [19]. Blood Products - The report highlights the increasing demand for immunoglobulin products and the potential for price improvements in the blood products sector, particularly for companies like 天坛生物 and 派林生物 [23]. Vaccines - The vaccine sector is facing challenges due to low birth rates, but there is potential for growth in HPV vaccines and other areas [25]. Upstream Supply Chain - The report suggests focusing on companies with strong brand and operational capabilities in the chemical and biological reagent sectors [28]. IVD (In Vitro Diagnostics) - The IVD industry is expected to benefit from the implementation of centralized procurement policies, which may accelerate domestic substitution [31]. Medical Devices - The report recommends attention to the CGM market, particularly products from 三诺生物, as they align with the growth of GLP-1 drugs [36]. Medical Services - The report suggests focusing on eye and dental medical service companies, anticipating a boost from consumer stimulus policies [43]. Offline Pharmacies - The offline pharmacy sector is stabilizing, with a recommendation to focus on companies with strong supply chain capabilities [45]. Raw Materials - The report emphasizes the importance of quality and cost management in the raw materials sector, suggesting a focus on companies like 华海药业 and 海正药业 [49]. Innovative Instruments - The report highlights the potential for AI applications in the medical device sector, particularly in surgical navigation and pathology screening [52]. Instrument Equipment - The scientific instrument sector is expected to recover as demand improves, with a focus on companies enhancing their market presence through new product launches [57]. Low-value Consumables - The report notes a potential recovery in the low-value consumables sector, particularly for companies like 采纳股份 and 美好医疗 [60].

百济神州有限公司 2024年度 营业收入扣除情况专项说明 | | | 页 次 | | --- | --- | --- | | 一、 | 2024年度营业收入扣除情况专项说明 | 1 - 2 | 目录 二、 2024年度营业收入扣除情况的说明 3 - 4 关于百济神州有限公司 2024年度营业收入扣除情况专项说明 安永华明（2025）专字第70033281_A03号 百济神州有限公司 百济神州有限公司董事会： 安永华明（2025）专字第70033281_A03号 百济神州有限公司 （本页无正文） 安永华明会计师事务所（特殊普通合伙） 中国注册会计师：阳开华 我们接受委托，审计了百济神州有限公司的财务报表，包括2024年12月31日的合 并资产负债表、2024年度的合并利润表、合并股东权益变动表和合并现金流量表以及 相关财务报表附注，并于2025年4月27日出具了编号为安永华明（2025）审字第 70033281_A01号的无保留意见审计报告。 根据《上海证券交易所上市公司自律监管指南第2号——业务办理》、《上海证券 交易所科创板上市公司自律监管指南第9号——财务类退市指标：营业收入扣除》的规 定，百济神州有限公 ...

百济神州有限公司 2024年度 内部控制审计报告 内部控制审计报告 安永华明（2025）专字第70033281_A01号 百济神州有限公司 百济神州有限公司全体股东： 按照《企业内部控制审计指引》及中国注册会计师执业准则的相关要求，我们审 计了百济神州有限公司2024年12月31日的财务报告内部控制的有效性。 一、公司对内部控制的责任 按照《企业内部控制基本规范》、《企业内部控制应用指引》、《企业内部控制评价 指引》的规定，建立健全和有效实施内部控制，并评价其有效性是百济神州有限公司 董事会的责任。 二、注册会计师的责任 我们的责任是在实施审计工作的基础上，对财务报告内部控制的有效性发表审计 意见，并对注意到的非财务报告内部控制的重大缺陷进行披露。 三、内部控制的固有局限性 内部控制具有固有局限性，存在不能防止和发现错报的可能性。此外，由于情况 的变化可能导致内部控制变得不恰当，或对控制政策和程序遵循的程度降低，根据内 部控制审计结果推测未来内部控制的有效性具有一定风险。 四、财务报告内部控制审计意见 我们认为，百济神州有限公司于2024年12月31日按照《企业内部控制基本规范》 和相关规定在所有重大方面保持 ...

一、主要会计数据和财务指标 | 报告期指标 | 2024年年报 | 2023年年报 | 本年比上年增减(%) | 2022年年报 | | --- | --- | --- | --- | --- | | 基本每股收益（元） | -3.6400 | -4.9500 | 26.46 | -10.1800 | | 每股净资产（元） | 17.46 | 18.53 | -5.77 | 22.44 | | 每股公积金(元) | 61.5 | 60.07 | 2.38 | 59.58 | | 每股未分配利润(元) | -45.25 | -42.58 | -6.27 | -37.72 | | 每股经营现金流(元) | - | - | - | - | | 营业收入(亿元) | 272.14 | 174.23 | 56.2 | 95.66 | | 净利润(亿元) | -49.78 | -67.16 | 25.88 | -136.42 | | 净资产收益率(%) | -20.20 | -23.86 | 15.34 | -38.83 | 数据四舍五入，查看更多财务数据>> | 名称 持有数量(万股) | | 占总股本比例 | 增减情 ...

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) 備註： (1)第一章節/1/A部在計算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時，參照了上市發行人已發行股份數目總額 （包括於香港聯交所及上海證券交易所 科創板上市的普通股份）。 (2)第一章節/1/A/1部所列於股份獎勵計劃下發行股份来自本公司第三版經修訂及重列之2016 期權及激勵計劃授权的股份池，且該等股份為就向本公司一位前董事授予的 受限制股份單位而發行。請參考後續證券變動月報表，以了解股權计划股份池中未来可发行的股份剩余数量。 (3)第一章節/1/A部所述開始及結束日期的結存数量不包括向公司的託管公司發行的普通股，該等股份用以換取相應數量的美國存託股份,旨在確保其託管公司可隨時動用 美國存託股份用於滿足受限制股份單位的歸屬及不時行使任何期權。详情請參考後續證券變動月報表。 FF305 第 2 頁 共 6 頁 v 1.3.0 FF305 呈交日期： 2025年4月28日 如上市發行人的已 ...

Financial Performance - The company reported a significant increase in revenue, achieving a total of $1.5 billion for the fiscal year, representing a 25% year-over-year growth[9]. - In 2024, the company's total global revenue is approximately $3.8 billion, an increase of about $1.4 billion compared to the previous year, with operating losses reduced by approximately $600 million[16]. - The company reported cash and cash equivalents of $2.6 billion as of December 31, 2024, reflecting a strong financial position[28]. - Since 2023, the current product portfolio and core product revenue have increased by 73%, with expectations for significant growth in 2025 and beyond[28]. - The company achieved a significant reduction in US GAAP operating losses and recorded its first non-GAAP operating profit in fiscal year 2024[28]. - Positive operating cash flow was generated in both Q3 and Q4 of 2024, marking a turnaround after years of cash outflows[28]. - Cumulative losses reached $8.6 billion as of December 31, 2024, primarily due to R&D expenses and operational costs[191]. - The company expects a positive GAAP operating income for the full year of 2025, despite potential future losses[192]. - Cash used in operating activities was $100 million, $1.2 billion, and $1.5 billion for the years ending December 31, 2024, 2023, and 2022, respectively[193]. - The company has generated insufficient revenue from drug sales to support its operations, despite having enough cash to meet operational needs for at least the next 12 months[194]. Market Expansion and Strategy - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[9]. - The company plans to enhance its digital marketing strategy, aiming for a 40% increase in online sales[9]. - The company is exploring strategic acquisitions to enhance its product portfolio, with a budget of $500 million allocated for potential deals[9]. - The company is committed to creating long-term value for shareholders through strategic partnerships and careful capital deployment[28]. - The company is focused on expanding its market presence through strategic collaborations and innovative product development[66]. Product Development and Pipeline - The company has advanced 13 differentiated new molecular entities (NMEs) into clinical trials in 2024, targeting common cancers such as breast, lung, and gastrointestinal cancers[20]. - The company has developed a pipeline of innovative solid tumor products, with key proof-of-concept catalysts expected in the next 6 to 18 months[20]. - The company is conducting extensive clinical projects globally to evaluate the efficacy of its BTK inhibitor, 百悅澤® (Zebutinib), for various B-cell malignancies[67]. - The pipeline includes 101 B-cell malignancies and 102 B-cell malignancies, indicating a strong focus on hematological cancers[63]. - The company has a diverse pipeline of products with multiple candidates in various stages, including 3 in Phase 3 and 5 in Phase 2 trials as of February 27, 2025[63]. Regulatory and Compliance - The company is committed to maintaining compliance with regulatory standards across all markets, ensuring no disruptions in operations[9]. - Regulatory compliance in the pharmaceutical industry is complex and costly, with potential significant adverse effects on business operations[155]. - Non-compliance with regulatory requirements can lead to severe sanctions, including product recalls and license revocations, as seen with the suspension of ABRAXANE® in 2020[156]. - The company faces risks related to healthcare fraud and abuse laws, which could result in civil penalties and reputational damage[157]. - Regulatory changes in China may complicate drug approval processes, impacting timely commercialization of products[155]. Clinical Trials and Research - The clinical project for Sonrotoclax has enrolled over 1,800 patients, and it is currently undergoing late-stage clinical trials, including a Phase 3 trial for CLL patients[18]. - The company plans to initiate a Phase 3 head-to-head trial against Pirtobrutinib in 2025, aligning with its strategy to improve current treatment options[18]. - The ongoing clinical trials for Baiyueze® include several combination therapies targeting MCL, MZL, and CLL/SLL[68]. - The CELESTIAL-TN CLL trial aims to compare the efficacy of sonrotoclax combined with Baiyueze® against venetoclax combined with obinutuzumab, with enrollment completed in Q1 2025[73]. - The company has initiated a pivotal phase 2 expansion study for R/R CLL, with plans for a confirmatory phase 3 study in early 2025[76]. Competitive Landscape - The company is facing intense competition from various global and regional biopharmaceutical companies, necessitating a strong and flexible R&D strategy[122]. - Key competitors for the drug Bai Yue Ze® include AbbVie and Johnson & Johnson, with competing products already on the market[124]. - The company is committed to continuous investment in innovation and brand drug development to effectively compete in the current and future markets[127]. Financial Risks and Challenges - The company may need additional financing to fund operations and complete the development of candidate drugs[193]. - The company faces significant adverse impacts on its liquidity and financial condition due to negative cash flow and current debt structure, with no assurance of obtaining sufficient cash from other sources for operational funding[195]. - Raising additional capital may lead to shareholder dilution and restrict operational capabilities, with potential adverse terms affecting rights to technology or drug candidates[196]. - The company is exposed to foreign exchange risks due to expenses and revenues in currencies other than USD or HKD, particularly RMB, EUR, and AUD, which may negatively impact financial performance[198]. Intellectual Property - As of February 14, 2025, BeiGene holds 63 US patents, 15 European patents, 28 Japanese patents, and 70 Chinese patents, along with multiple pending patent applications[115]. - The patent protection for key drugs includes various compositions and methods expiring between 2031 and 2043, ensuring a robust intellectual property portfolio[116]. - The drug "Zebutinib" has multiple patent protections in the US expiring as late as 2043, covering substance compositions and treatment methods[116]. Patient Access and Reimbursement - The company offers patient assistance programs to help patients afford innovative drugs, typically ceasing when drugs are included in the national medical insurance catalog[61]. - The commercial success of the company's drugs heavily relies on the reimbursement levels provided by government health departments and private insurers, which can significantly impact business operations[137]. - The process of obtaining insurance and reimbursement approval from third-party payers in the U.S. is time-consuming and costly, with no guarantee of achieving adequate reimbursement rates[138]. Manufacturing and Production - The company has established production facilities in Suzhou and Guangzhou, with the Suzhou facility covering 52,000 square meters and an annual capacity of approximately 600 million tablets and capsules, expected to begin commercial supply by mid-2025[103]. - The Guangzhou facility has a total area of approximately 158,000 square meters, with a first-phase and second-phase factory completed in September 2019 and December 2020, respectively, and a total capacity of 64,000 liters after the third-phase factory certification in 2024[104]. - The company relies on a limited number of third-party CMO and CROs for the production of several drugs and raw materials, ensuring compliance with regulatory requirements and internal quality standards[105].

本文约 2 5 0 0 字，推荐阅读时长 1 5 分钟，欢迎关注新财富公众号。 1 引言 4月14日，美国商务部宣布启动对进口药品的国家安全调查。这一调查覆盖了所有进口药品，包括成 品仿制药、原研药以及用于生产这些药品的关键药用成分。此举属于特朗普政府根据1962年《贸易扩 展法》第232条对多个行业进行的关税调查的一部分。虽然调查尚未结束，预计结果将在270天内公 布，但业内普遍认为，这将赋予特朗普政府对进口药品和原料药征收关税的权力。特别是对中国等主 要药品出口国的影响，可能会带来严重的供应链中断及成本上升。 事实上，美国每年从中国进口药品总额约60亿美元，其中大量为抗生素、抗病毒及心血管药物等基础 药物。一旦关税进一步扩大实施，这些进口药品的成本预计将明显上升，对美国本土药品生产商带来 直接冲击。为应对这种风险，特朗普政府提出多项措施推动产业本土化。 分析师预计，如果对来自中国的API征收10%的关税，仿制药企业的利润将下跌2%-3%，创新药利润 下跌可能更严重。 2 美国关税筑墙， 中概股 跌宕 自2025年特朗普重新执政以来，美国政府出台了一系列针对生物医药产业的重要政策，核心目标是强 化美国医药产 ...

Group 1 - The Hong Kong innovative drug sector has rebounded rapidly due to a favorable external environment, with the China Securities Hong Kong Innovative Drug Index (931787) experiencing a significant recovery since its low on April 9, 2023 [1][3] - As of April 25, 2023, the index reached a peak of 979.92 points, showing a maximum cumulative increase of 37.43% from its previous low [1] - The overall increase in the Hong Kong innovative drug sector has outperformed the Hang Seng Technology Index, which has only seen a year-to-date increase of 12.48% compared to the innovative drug index's 31.03% [3] Group 2 - Recent data indicates a collective performance improvement among Hong Kong innovative drug companies, significantly exceeding market expectations [4] - In 2024, 10 out of 12 Hong Kong innovative drug companies with a market capitalization over 10 billion HKD reported positive revenue growth, with 8 companies also showing positive profit growth [4] - The company with the highest revenue growth is CloudTop New Drug-B (01952), with a revenue growth rate of 341.8%, while Innovent Biologics (01801) reported a net profit growth of 91.8% [4] Group 3 - The trend of "going global" has become a key topic, with Chinese pharmaceutical companies achieving significant growth in overseas licensing transactions [6][8] - The total transaction amount for licensing-out by Chinese pharmaceutical companies reached a historical high of 51.9 billion USD in 2024, indicating a strong global competitiveness in innovative drug development [6] - The NewCo model has emerged as a favorable strategy for domestic biotech companies, allowing for cash flow support and risk sharing in international collaborations [8] Group 4 - New industry trends in pharmaceuticals, such as weight-loss drugs, dual-antibody drugs, ADC drugs, and innovative medical devices, are expected to create new investment opportunities [9] - The Chinese government is increasing support for innovative drug exports, as evidenced by recent policies aimed at facilitating the import of research materials for biopharmaceutical companies [9] - Despite market fluctuations due to trade tensions, the pharmaceutical sector remains relatively insulated, presenting a favorable opportunity for large-scale investments [9] Group 5 - The Hong Kong innovative drug sector is poised for a valuation recovery, with significant inflows of capital from southbound investors since the beginning of the year [11] - As of April 24, 2023, net capital inflows from A-share investors into Hong Kong stocks reached 611.1 billion HKD, with healthcare becoming the second most net inflow sector [11] - The current price-to-earnings ratio (TTM) for the pharmaceutical and biotechnology sector is 27.1, indicating that the sector is undervalued compared to other growth sectors [12][13]