美国证券交易委员会 华盛顿特区 20549 _____________________ ______________________ 根据 1934 年证券交易法 第 13 或 15（d）条规定提交的 临时报告 报告日期（所报告最早事件之日期）：2025 年 5 月 27 日 百济神州有限公司 BEONE MEDICINES LTD. （注册人章程中列明的注册人准确名称） 瑞士 001-37686 98-1209416 （注册地所在州或其他司法管辖区） （委员会档案编号） （国税局雇主识别号） c/o BeOne Medicines I GmbH 4051 Aeschengraben 27, 21st Floor （邮政编码） Basel, Switzerland （主要办事处地址） +41-616851900 （注册人电话号码，包括区号） BeiGene, Ltd. c/o Mourant Governance Services (Cayman) Limited Grand Cayman Cayman Islands KY1-1108 电话： (345) 949-4123 （此前名称和此前住址，如自上次报告 ...

BeOne Medicines AG (BeOne Medicines Ltd.) (BeOne Medicines SA) 百济神州有限公司 之 组织章程细则 （根据于2025年4月28日通过的特别决议案予以采纳） Abschnitt 1 第一章 Firma, Sitz, Zweck und Dauer der 公司名称、注册地、经营宗旨和存续期限 Gesellschaft Artikel 1 第1条 Name, Sitz Unter der Firma BeOne Medicines AG 公司名称、 BeOne Medicines Ltd. (BeOne Medicines AG) (BeOne Medicines Ltd) (BeOne Medicines 注册地 (BeOne Medicines SA)（"本公司"）系一家公 SA) (die Gesellschaft) besteht eine 司，注册地为瑞士巴塞尔城市州巴塞尔。 Aktiengesellschaft mit Sitz in Basel, Kanton Basel-Stadt, Schweiz. Artikel 2 第2条 Zwe ...

BeOne Medicines Ltd. 百济神州有限公司 一家瑞士公司，注册地址位于瑞士巴塞尔城市州巴塞尔 (a) 本《组织条例》（"本条例"）由BeOne Medicines Ltd.（"公司"）董事会（"董 事会"）根据于1911 年3 月30 日颁布并经不时修订的《瑞士债法典》 （"《 瑞 士债法典》"）第716b条以及公司的《公司章程》 （"《公司章程》 "）第19条第2 款、第21条第1款至第3款和第22条第3款的规定制定。 (b) 公司执行机构的公司治理、内部组织、职责、权力和责任受以下条款规 范： (i) 《公司章程》； (ii) 本条例 ； (iii) 公司的《企业管治准则》 （" "）； 《企业管治准则》 (iv)《董事会组成政策》；以及 (v) 常设委员会章程。 (a) 公司的执行机构如下 ： (i) 董事会，由董事会成员组成（分别称为"董事"）； (ii) 董事会主席（"董事会主席"）； (iii) 首席独立董事（根据第3(c)条任命）； (iv) 董事会的常设委员会和其他委员会（"委员会"）； (v) 公司的首席执行官（"首席执行官"）；以及 (vi) 公司的执行管理层（包括首席执行 ...

Policy Developments - The National Medical Products Administration (NMPA) has announced the implementation of the "Quality Management Standards for Online Sales of Medical Devices," effective from October 1, 2025. Regulatory authorities are required to guide online sellers and e-commerce platforms in conducting internal training and assessments related to quality management systems, product information display, and risk monitoring [2]. Drug and Device Approvals - BeiGene announced positive results from the Phase 2 clinical trial (DeLLphi-307) of tarlatamab for treating extensive-stage small cell lung cancer (ES-SCLC) patients in China, with detailed data to be presented at an upcoming medical conference [4]. Capital Market Activities - Shanghai BoYin Biotechnology Co., Ltd. has completed a multi-million angel round financing, led by Zhangjiang Life and Health Industry Incubation Angel Fund, with funds aimed at advancing the company's product pipeline and early clinical validation of its first product [7]. Industry Developments - Yuheng Pharmaceutical has signed a co-promotion agreement with Xinghe Pharmaceutical for Pemafibrate, a novel selective PPARα modulator, which will take effect on June 1, 2025. This agreement is expected to enhance Yuheng's product pipeline and potential profit growth, although it will face competition from established products [9]. Shareholder Activities - Chengdu XianDao announced that shareholder Anji Dongfang Jiayu Enterprise Management Partnership reduced its stake by 1 million shares, decreasing its ownership from 6.2% to 5.95% [12]. - BioVeda China RMB Investment Limited plans to reduce its stake in AoJing Medical by up to 135,550 shares, having already reduced its holdings by 34,510 shares, representing 0.25% of the total shares [13].

金融界2025年5月26日消息，工银前沿医疗股票A(001717) 最新净值2.9540元，下跌1.86%。该基金近1个 月收益率4.79%，同类排名62|864；近3个月收益率9.08%，同类排名51|853；今年来收益率12.28%，同 类排名93|850。 工银前沿医疗股票A股票持仓前十占比合计59.05%，分别为：恒瑞医药（10.11%）、科伦药业 （8.01%）、药明康德（7.72%）、百济神州-U（6.85%）、信立泰（4.90%）、泽璟制药-U （4.77%）、鱼跃医疗（4.60%）、新诺威（4.36%）、华东医药（4.20%）、海思科（3.53%）。 来源：金融界 公开资料显示，工银前沿医疗股票A基金成立于2016年2月3日，截至2025年3月31日，工银前沿医疗股 票A规模90.81亿元，基金经理为赵蓓。 简历显示：赵蓓女士:硕士,曾在中再资产管理股份有限公司担任投资经理助理。2010年加入工银瑞信,现 任研究部副总监、医疗保健研究团队负责人,2014年11月18日至今,担任工银医疗保健行业股票型基金基 金经理;2015年4月28日至今,担任工银瑞信养老产业股票型基金基金经理;2016年2月 ...

Core Viewpoint - The article discusses the performance and holdings of the Industrial and Commercial Bank of China Medical Healthcare Stock Fund, highlighting its recent net value, returns, and top holdings [1]. Fund Performance - The latest net value of the ICBC Medical Healthcare Stock Fund is 2.5580 yuan, reflecting a decrease of 1.16% - The fund's return over the past month is 3.52%, ranking 172 out of 940 in its category - Over the last six months, the return is 9.79%, with a ranking of 202 out of 914 - Year-to-date, the return stands at 12.24%, ranking 98 out of 926 [1]. Fund Holdings - The top ten holdings of the ICBC Medical Healthcare Stock Fund account for a total of 39.79%, with the following key positions: - Heng Rui Medicine: 8.90% - WuXi AppTec: 5.12% - Aier Eye Hospital: 4.94% - BeiGene: 3.77% - Zai Lab: 3.52% - New Horizon Health: 3.27% - Mindray Medical: 2.80% - Yuwell Medical: 2.76% - United Imaging Healthcare: 2.47% - Innovent Biologics: 2.24% [1]. Fund Management - The ICBC Medical Healthcare Stock Fund was established on November 18, 2014, and as of March 31, 2025, it has a total scale of 2.724 billion yuan - The fund is managed by Zhao Bei and Ding Yang, both of whom have extensive experience in the healthcare sector [1][2].

Core Viewpoint - The recent developments in the innovative drug sector, particularly the record-breaking licensing deal and the upcoming ASCO conference, highlight the growing competitiveness and potential of Chinese pharmaceutical companies in the global market [4][5]. Group 1: Market Performance - The Hong Kong Innovative Drug ETF (159570) opened high but closed lower, experiencing a 1% pullback after four days of gains last week, with trading volume reaching 300 million, indicating strong liquidity [1]. - Major component stocks of the ETF mostly declined, with notable drops including a more than 4% decrease for 3SBio and over 3% for both WuXi AppTec and Rongchang Biopharmaceutical [2]. Group 2: Licensing Deal - A historic licensing agreement was reached where Pfizer will pay a $1.25 billion upfront fee to Chinese companies for the PD-1/VEGF dual antibody SSGJ-707, with potential total payments reaching $4.8 billion [4]. - This deal sets a new record for Chinese innovative drugs entering the international market and is expected to enhance market valuation expectations for the innovative drug sector [4]. Group 3: ASCO Conference Insights - The upcoming ASCO conference is anticipated to showcase the global competitiveness of Chinese pharmaceutical companies, with numerous clinical studies being presented [5]. - Key highlights include the performance of domestic drugs that have shown potential to outperform established treatments, such as the combination of Bemarituzumab and Anlotinib against Keytruda in NSCLC [5]. - CAR-T therapies are also making significant strides, with Kintor Pharmaceuticals presenting promising data for their CLDN18.2 CAR-T therapy [5]. Group 4: Innovative Drug ETF Characteristics - The Hong Kong Innovative Drug ETF (159570) has a high concentration in innovative drugs, with over 85% of its weight in this category, making it the highest among all pharmaceutical indices [6]. - The ETF features a low valuation, with a five-year price-to-sales ratio at the 48.5th percentile, indicating potential undervaluation in the innovative drug sector [6].

公开资料显示，工银前沿医疗股票C基金成立于2020年11月23日，截至2025年3月31日，工银前沿医疗 股票C规模13.80亿元，基金经理为赵蓓。 金融界2025年5月21日消息，工银前沿医疗股票C(010685) 最新净值2.9140元，增长1.53%。该基金近1个 月收益率4.11%，同类排名420|1001；近3个月收益率9.30%，同类排名81|988；今年来收益率13.47%， 同类排名116|978。 工银前沿医疗股票C股票持仓前十占比合计59.05%，分别为：恒瑞医药（10.11%）、科伦药业 （8.01%）、XD药明康（7.72%）、百济神州-U（6.85%）、信立泰（4.90%）、泽璟制药-U （4.77%）、鱼跃医疗（4.60%）、新诺威（4.36%）、华东医药（4.20%）、海思科（3.53%）。 来源：金融界 简历显示：赵蓓女士:硕士,曾在中再资产管理股份有限公司担任投资经理助理。2010年加入工银瑞信,现 任研究部副总监、医疗保健研究团队负责人,2014年11月18日至今,担任工银医疗保健行业股票型基金基 金经理;2015年4月28日至今,担任工银瑞信养老产业股票型基金基金经理;2 ...

Core Viewpoint - The article emphasizes the unstoppable rise of Chinese innovative pharmaceutical companies, highlighting their ability to provide life-saving products and the significant growth potential in the industry [2][3][22]. Group 1: Company Performance - BeiGene's revenue is projected to grow from 9.5 billion in 2022 to 38 billion in 2025, showcasing a substantial annual increase [3]. - Other companies like Kintor Pharmaceutical, YaoPharma, and Diligent Pharma are also mentioned as having significant product potential and market impact [5][7]. - The article notes that innovative drugs have undergone rigorous scientific validation, ensuring their efficacy and safety [9]. Group 2: Industry Growth - China's medical insurance expenditure has increased from approximately 2 trillion to 3 trillion, indicating a net increase of 1 trillion over five years, which supports the growth of the pharmaceutical sector [14]. - The article argues that innovative drugs are not subject to centralized procurement, allowing companies to negotiate prices while considering their profitability [14]. - The global market for Chinese innovative drugs is expanding, with the potential for these products to meet the needs of various countries [19][22]. Group 3: Investment Opportunities - The innovative drug sector is expected to produce numerous tenfold and hundredfold stocks due to the rapid growth of companies like BeiGene, Innovent Biologics, and others, which are maintaining growth rates of over 50% [30][32]. - The article suggests that the pharmaceutical industry has multiple distinct tracks, allowing companies to grow without directly competing against each other [32]. - The potential for high returns in the innovative drug sector is highlighted, with the expectation of significant sales growth in the coming years [30][31].

Summary of the Conference Call Company Overview - The company, transitioning to B1 Medicines, was founded in February 2010 and has grown to over 11,000 employees globally, focusing on innovative medicines for patients worldwide [5][4] - The company aims to solidify its leadership in hematology, advance its pipeline, and deliver strong financial performance as it moves into 2025 [5][6] Hematology Franchise - B1 Medicines is the only company with three wholly owned, potentially best-in-class medicines for Chronic Lymphocytic Leukemia (CLL) [6] - The lead product, Brukinza, is the only BTK inhibitor to demonstrate complete and sustained BTK inhibition and has shown superiority to IMBRUVICA in head-to-head trials [6][12] - In Q1, the company achieved a revenue share lead in the CLL market just two years post-launch [6][10] - The second asset, Sonro, is a second-generation BCL2 inhibitor, with ongoing Phase III trials and a recent filing for relapsed-refractory CLL in China [7][8] - The third asset is a first-in-class BTK degrader, with over 600 patients dosed and a Phase III trial initiated [8] Financial Performance - The company reported $1.1 billion in sales for Q1, a 50% year-over-year increase, marking its first quarter of GAAP income [9][10] - The financial profile has significantly improved compared to previous years, setting a strong foundation for 2025 [11][21] Market Dynamics and Competition - The company believes in the long-term benefits of fixed-duration therapy for patients, despite competition from Akala [16] - Concerns were raised about the efficacy and safety of competing therapies, particularly regarding patient populations and outcomes [17][18] - The company sees significant opportunities in first-line Mantle Cell Lymphoma (MCL) and other B-cell malignancies, estimating over 20,000 new cases annually across these indications [19][20] Pipeline and R&D Strategy - B1 Medicines had 13 New Molecular Entities (NMEs) enter the clinic last year, the highest in the industry, with 10 proof of concept data readouts expected in 2025 [8][9] - The company is focused on a portfolio approach to manage risks associated with pricing pressures and competition [24] - Upcoming R&D Day on June 26 will highlight the company's strategy to build franchises in key disease areas, including lung cancer and breast cancer [36][39] Regulatory and Approval Insights - The company is pursuing accelerated approval opportunities for Sonro in the U.S. and is engaging with regulatory authorities regarding undetectable MRD rates as a surrogate endpoint [30][31] - The development review committee has clear go/no-go criteria for new molecules, ensuring focus on impactful investigational medicines [40] Commercial Strategy - The company is optimistic about the market potential for Tivimbra, particularly in upper GI cancers, with a global PD-1 market opportunity estimated at $50 billion [46][47] - Tivimbra has received frontline esophageal and gastric labels, with a focus on differentiation and competitive pricing [48][49] Geographic Revenue Diversity - The company has evolved to resemble a global multinational pharma, with significant growth opportunities in Europe and other markets [51][52] Conclusion - B1 Medicines is well-positioned in the hematology market with a strong pipeline and financial performance, while also preparing for future growth in solid tumors and expanding its global presence [53][54]