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]

Group 1 - The core point of the news is the performance of the Zhongyin Innovation Medical Mixed A fund, which has shown significant growth in its net value and returns over various time frames [1] - As of April 21, 2025, the latest net value of Zhongyin Innovation Medical Mixed A is 1.6127 yuan, reflecting a growth of 2.27% [1] - The fund's one-month return is 14.21%, ranking 9th out of 4672 similar funds; the three-month return is 36.72%, ranking 18th out of 4599; and the year-to-date return is 34.02%, ranking 36th out of 4590 [1] Group 2 - The top ten stock holdings of Zhongyin Innovation Medical Mixed A account for a total of 70.60%, with significant positions in companies such as Heng Rui Pharmaceutical (9.81%), Innovent Biologics (8.55%), and others [1] - The fund was established on November 13, 2019, and as of December 31, 2024, it has a total scale of 2.02 billion yuan [1] - The fund manager, Zheng Ning, has a background in asset management and has held various positions in the industry since 2022 [2]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology sector [7]. Core Insights - The report highlights the emergence of the "Protein Degradation 2.0" era, focusing on domestic companies involved in this field [12][18]. - The pharmaceutical sector is expected to experience a structural bull market in 2025, driven by supportive policies for commercial health insurance and innovation in drug development [14]. Summary by Sections Recent Review - During the week of April 14-18, the Shenwan Pharmaceutical Index decreased by 0.36%, outperforming the ChiNext Index but underperforming the CSI 300 Index [12]. - The market showed a recovery with small-cap innovative drugs performing well, while the overall pharmaceutical sector remained volatile [13]. Future Outlook - Short to medium-term strategies focus on self-sufficiency in research instruments and upstream components, deepening the exploration of innovative drugs, and identifying high-growth companies based on Q1 reports [14]. - By 2025, a positive trading atmosphere is anticipated, with structural growth likely in the pharmaceutical sector [14]. Investment Strategy - **Pharmaceutical Style Rhythm**: Key companies include innovative drug firms such as Sanofi, BeiGene, and others focusing on self-sufficiency like BGI Genomics and others [15]. - **Pharmaceutical Industry Logic**: Emphasis on innovative drugs with commercial potential, self-sufficiency in medical devices, and new technologies like AI in medicine [16]. Protein Degradation Sector - The report discusses the rapid advancement in the targeted protein degradation (TPD) field, with over 95 projects in clinical development globally, including 35 in China [24]. - Notable domestic companies in the TPD space include Innovent Biologics, BeiGene, and others, with several new drugs recently approved for clinical trials [26][25]. Subsector Performance - The innovative drug index decreased by 0.60% during the week, while the generic drug sector saw a 1.80% increase, indicating a shift in market focus [36]. - The traditional Chinese medicine index outperformed the overall pharmaceutical index, highlighting a potential area for investment [43]. Key Events - The report notes significant events such as the approval of innovative drugs by companies like CanSino Biologics and the performance of various pharmaceutical firms in their quarterly reports [41][34].

Core Viewpoint - The recent performance of the Zhongyin Innovation Medical Mixed A fund shows a decline in net value but strong returns over various time frames, indicating potential resilience in the healthcare investment sector [1]. Fund Performance Summary - The latest net value of Zhongyin Innovation Medical Mixed A is 1.5786 yuan, down by 2.81% - The fund's one-month return is 13.30%, ranking 7 out of 4623 in its category - The three-month return stands at 38.74%, ranking 14 out of 4566 - Year-to-date return is 31.19%, ranking 24 out of 4559 [1]. Holdings Summary - The top ten stock holdings of Zhongyin Innovation Medical Mixed A account for a total of 70.60%, with the following key positions: - Heng Rui Pharmaceutical: 9.81% - Xinda Bio: 8.55% - Huaneng Pharmaceutical: 8.41% - Kangfang Biotech: 8.35% - Kangnuo Ya-B: 8.32% - Kelun Botai: 7.87% - BeiGene-U: 6.24% - Rongchang Bio: 5.96% - Hansoh Pharmaceutical: 3.98% - Xin Nuo Wei: 3.11% [1]. Fund Manager Background - Zheng Ning, the fund manager, has a master's degree and extensive experience in the investment sector, having previously worked at Taikang Asset Management and Zhonggeng Fund Management - Zheng joined Zhongyin Fund Management in 2022 and has managed multiple funds since then, including the Zhongyin Innovation Medical Mixed Fund [2].

长按即可参与 药监局加入ICH后审评审批提速 ， 2023年国产创新药平均获批周期缩短至6.2年 ， 较2018年减 少3年 。 医保谈判动态调整机制 ， 2024年新增7款抗癌药纳入医保 ， 价格降幅收窄至40% ， 保护创新回报 。 中国在高端医药 ， 如抗癌药 、 疫苗 、 基因编辑技术 ， 存在对进口的依赖 ， 供应链自主可控 迫在眉睫 ， 目前 mRNA 疫苗 、 中和抗体等领域的突破已验证中国 生物医药 的创新能力 。 医 药自主可控成刚需 ， 2023年中国医药进口依存度仍达35% ， 高端设备 、 原料药 、 生物制剂 依赖欧美 ， 关税战后加速国产替代 。 2024年 《 医药工业高质量发展行动计划 》 提出2025 年创新药占比提升至40% ， 2023年仅25% ， 高端医疗器械国产化率突破70% ， 2023年约 50% 。 医药行业增长确定性极强 ， 中国60岁以上人口占比2024年突破21% ， 2035年将达30% ， 慢 性病用药 、 肿瘤药 、 康复器械需求激增 。 人均医疗支出增速超GDP ， 2023年人均医疗支出 6200元 ， 仅为美国的1/6 ， 2025年预计突破 ...

Core Viewpoint - The article discusses the implications of the U.S. government's decision to impose tariffs on imported pharmaceuticals, highlighting potential impacts on global pharmaceutical supply chains and the strategies that Chinese innovative drug companies may adopt in response [2][6][10]. Group 1: Impact of Tariffs on Pharmaceutical Industry - The U.S. tariffs on pharmaceuticals aim to encourage multinational companies to establish production facilities in the U.S., thereby reducing reliance on imports [2][5]. - Analysts suggest that the tariff policy may lead to increased instability in the global pharmaceutical supply chain, particularly affecting Chinese innovative drug companies' international strategies [2][6]. - The tariffs could result in higher export costs and reduced profit margins for Chinese companies that depend on the U.S. market [6][10]. Group 2: Responses from Chinese Innovative Drug Companies - Several Chinese innovative drug companies are assessing the potential impacts of the tariffs, with some indicating that they may face valuation pressures in the short term [2][6]. - Companies like Hengrui Medicine and Zai Lab have stated that the tariffs will have limited impact on their operations due to their low reliance on U.S. sales [7][8]. - Analysts recommend that Chinese companies accelerate local production in the U.S. to mitigate tariff risks and explore supply chain diversification in lower-cost regions [10][11]. Group 3: Long-term Strategies and Market Dynamics - The article emphasizes the importance of maintaining strong research and development capabilities and diversifying risk through licensing agreements [3][12]. - The global pharmaceutical landscape may shift, with Indian pharmaceutical companies potentially benefiting from the changes in the supply chain dynamics [6][10]. - The article notes that while geopolitical risks are significant, the ultimate competitive advantage for innovative drug companies lies in their ability to deliver clinical value and innovation [12].

Core Viewpoint - The article emphasizes that innovative pharmaceuticals are gaining significant momentum, potentially becoming a new investment focus due to various favorable factors in both domestic and international markets [3][8][30]. Group 1: Demand Expansion - Chinese innovative pharmaceutical companies are accelerating their global expansion, with 18 original innovative drugs approved overseas by the end of 2024, leading to a total transaction amount of $51.9 billion in licensing deals [9][15]. - The demand from domestic markets is also increasing, as the National Medical Insurance Fund's expenditure growth is at its highest in four years, indicating a potential for accelerated commercialization and improved profitability for innovative drug companies [18][20]. - The optimization of medical procurement policies is expected to enhance profit expectations for pharmaceutical companies, leading to a potential revaluation of their earnings [19][20]. Group 2: Supply Side Improvements - The integration of AI in innovative drug development is projected to reduce research and development cycles from 8-11 years to 5-7 years, while also decreasing costs by 25%-30% [23][26]. - The easing of global monetary policy, particularly with the Federal Reserve's interest rate cuts, is expected to facilitate easier financing for innovative drug companies, enhancing their research capabilities [25][26]. Group 3: Financial Performance - Recent financial reports indicate a strong performance among innovative drug companies, with notable revenue growth and a trend towards profitability. For instance, Innovent Biologics reported a revenue of approximately 9.422 billion yuan, a year-on-year increase of 51.8% [27]. - Several companies, including Baiyi Tianheng and Kexing Biotech, have shown significant revenue growth, with Baiyi Tianheng achieving a staggering 936.3% increase [29]. - The year 2025 is anticipated to be a turning point for many innovative drug companies, marking a transition from losses to profitability [29][30]. Group 4: Market Characteristics - Compared to A-share innovative pharmaceuticals, Hong Kong-listed innovative drug companies exhibit higher R&D expenditure rates and a greater proportion of overseas revenue, indicating stronger competitive advantages [32][33]. - The largest innovative drug ETF in A-shares, with a scale of nearly 11.6 billion yuan, reflects the growing interest and liquidity in this sector [36][37].