瑞士 001-37686 98-1209416 美国证券交易委员会 华盛顿特区 20549 _____________________ 8-K 表格 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 11 月 13 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） c/o BeOne Medicines I GmbH 94 Aeschengraben 27 Basel 4051 Switzerland （主要办事处地址）（邮政编码） +41 61 685 19 00 （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） 根据证券交易法第 12(b)条注册的证券： 各类别名称 交易代码 注册所在之各交易所名称 每股代表 13 股面值 0.0001 美元普通股之美国存托股 ONC 纳斯达克全球精选市场 每股面值 0.0001 美元之普通股* 06160 香港联合交易所有限公司 （注册人电话号码，包括区号） 不适用 （如自上一份报告起有改动，则为公司曾用名或原地址） ...

Core Insights - The Sci-Tech Innovation Board (STAR Market) has become a key indicator of the performance and development trends of "hard technology" enterprises in China, with significant growth in R&D investment and net profit [1][2]. Group 1: Performance Metrics - As of November 13, 592 companies on the STAR Market reported a total R&D investment of nearly 120 billion yuan and total revenue exceeding 1.1 trillion yuan for the first three quarters, with a net profit growth of 75% year-on-year in Q3 [1]. - For the first three quarters of 2025, STAR Market companies achieved a revenue of 1,105 billion yuan, a year-on-year increase of 7.9%, and a net profit of 49.27 billion yuan, up 8.9% year-on-year [2]. - Over 70% of STAR Market companies reported revenue growth, and nearly 60% reported net profit growth, with 158 companies seeing net profit increases exceeding 50% [2]. Group 2: R&D Investment - The total R&D investment for STAR Market companies reached 119.75 billion yuan, which is 2.4 times the net profit, with a median R&D intensity of 12.4%, leading all A-share sectors [4]. - The "1+6" reform initiated in June aims to support unprofitable tech companies, with 35 such companies showing promising development by prioritizing R&D [4]. Group 3: Sector Performance - The integrated circuit sector saw 121 related companies on the STAR Market achieve a revenue growth of 25% and a net profit growth of 67% in the first three quarters [6]. - The artificial intelligence sector has emerged as a new growth pillar, with companies like Cambrian and Haiguang Information reporting revenue increases of nearly 24 times and 55%, respectively [6]. - The biopharmaceutical sector experienced a revenue growth of 11% and a net profit growth of 48%, with nine new drugs approved for market and significant international business development [7].

Core Viewpoint - The innovation drug sector in China is experiencing significant growth, with companies transitioning from followers to leaders in the global market, driven by strong clinical results and increasing international competitiveness [4][5][6]. Group 1: Market Performance - As of November 18, the Sci-Tech Innovation Drug ETF (589120) showed volatility with a near 2% fluctuation, currently up by 0.11%, and attracted 7.86 million yuan in investments the previous day [1][3]. - The component stocks of the ETF displayed mixed performance, with notable gains from Baiyi Tianheng (up over 2%) and Baiyi Shenzhou (up over 1%), while others like Junshi Biosciences and Borui Pharmaceuticals experienced declines [3]. Group 2: Clinical Developments - Baiyi Shenzhou announced positive results from its Phase III HERIZON-GEA-01 study, evaluating the efficacy and safety of its HER2-targeted bispecific antibody in treating advanced gastric cancer [4]. - Baiyi Tianheng reported that its innovative EGFR×HER3 dual antibody ADC achieved significant results in a Phase III trial for esophageal squamous cell carcinoma, marking a milestone as the first ADC to meet dual endpoints in this indication [4]. Group 3: Industry Trends - The Chinese innovative drug sector is evolving, with companies like Heng Rui Pharmaceutical and Han Sen Pharmaceutical successfully transitioning to innovation-driven models, while new entrants like Baiyi Tianheng are emerging as global leaders [5]. - The trend of Chinese pharmaceutical companies expanding internationally is accelerating, with increasing recognition from multinational corporations as a source of innovative solutions [6]. Group 4: Financial Performance - The A-share pharmaceutical and biotechnology sector reported a total revenue of 600.4 billion yuan and a net profit of 40.6 billion yuan in Q3 2025, with the Sci-Tech Innovation Drug Index showing a remarkable net profit growth of 68.44% year-on-year [6][7]. - The diversification of revenue models is enhancing the potential for profitability among innovative drug companies, with expectations for companies like Baiyi Shenzhou and Xinda Biopharmaceuticals to achieve profitability by 2025-2027 [6][7]. Group 5: Investment Potential - The innovative drug sector is seen as having "double-click" potential, driven by supportive policies, technological advancements, and the increasing trend of international business development [7]. - The combination of profit growth and valuation improvement is expected to drive stock price increases in the innovative drug sector, with the Sci-Tech Innovation Drug ETF positioned to capitalize on these trends [7].

Group 1 - The core viewpoint of the article highlights that BeiGene announced positive results from the Phase III HERIZON-GEA-01 study, which evaluates the efficacy and safety of the HER2-targeted bispecific antibody, Zanidatamab, either as a monotherapy or in combination with the PD-1 inhibitor, Tislelizumab, for first-line treatment of HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma [3] Group 2 - CITIC Securities previously noted that BeiGene's Bruton tyrosine kinase (BTK) inhibitor is experiencing sustained growth, leading to an upward revision of the company's full-year performance guidance [3] - The company anticipates that the overseas sales of BTK will exceed expectations, along with the commercialization of PD-1 in the EU, Japan, and other countries, as well as the continued realization of significant pipelines such as BCL-2, BTK CDAC, and CDK4 [3] - The firm maintains a "Buy" rating on BeiGene's stock [3]

每经AI快讯，百济神州(06160.HK)高开逾3%，截至发稿，涨3.53%，报223.2港元，成交额1196.27万港 元。 （文章来源：每日经济新闻） ...

Core Viewpoint - The current adjustment in the innovative drug sector, particularly in Hong Kong stocks, has led to skepticism about the core logic of innovative drugs, but the underlying business development (BD) logic remains unchanged [1] Group 1: Market Dynamics - The adjustment in certain stocks is attributed to overly high expectations rather than a fundamental change in market logic, as evidenced by the stable performance of leading companies [1] - The third-quarter report from BeiGene serves as a stabilizing factor for the innovative drug market, indicating that Chinese original research drugs can yield substantial returns and profits in international markets [1] Group 2: Future Outlook - The current market phase should be viewed positively, with a new round of market activity expected to differ from the previous valuation recovery, leading to a slow bull market characterized by core leaders moving upward [1] - The Hang Seng Medical ETF (159892) focuses on innovation and pharmaceuticals, covering various segments such as innovative drugs, CXO, and online pharmacies, aligning with the themes of innovation and international expansion [1]

Core Viewpoint - The stocks of BeiGene (06160.HK), Zai Lab (02617.HK), and Kintor Pharmaceutical (02171.HK) have shown positive performance, with increases of 4.36%, 3.77%, and 1.89% respectively, indicating a favorable market sentiment towards these companies [1] Company Performance - BeiGene's stock has risen by 4.36% [1] - Zai Lab's stock has increased by 3.77% [1] - Kintor Pharmaceutical's stock has grown by 1.89% [1] Industry Sentiment - The overall market sentiment appears to be positive towards the biotech sector, as evidenced by the stock performance of the mentioned companies [1]

Core Viewpoint - BeiGene (06160) experienced a significant increase in stock price, rising by 3.53% to HKD 223.2, with a trading volume of HKD 11.96 million, following the announcement of positive results from the Phase III HERIZON-GEA-01 study [1] Group 1: Study Results - The HERIZON-GEA-01 study evaluates the efficacy and safety of the HER2-targeted bispecific antibody, Zhenidamab, either as a monotherapy or in combination with the PD-1 inhibitor, Tislelizumab, for first-line treatment of HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) [1] Group 2: Market Outlook - CITIC Securities (601066) noted that BeiGene's Zebutini is experiencing continuous growth, leading to an upward revision of the annual performance guidance [1] - The company anticipates that the overseas growth of BTK will exceed expectations, along with the launch of PD-1 in the EU, Japan, and other countries, contributing to further commercialization of key pipelines such as BCL-2, BTK CDAC, and CDK4 [1] - The firm maintains a "Buy" rating on BeiGene [1]

Core Viewpoint - BeiGene (06160) experienced a significant stock increase of 3.53%, reaching HKD 223.2, following the announcement of positive results from the Phase III HERIZON-GEA-01 study [1] Group 1: Study Results - The HERIZON-GEA-01 study evaluated the efficacy and safety of the HER2-targeted bispecific antibody, Zhenidamab, either as a monotherapy or in combination with the PD-1 inhibitor, Tislelizumab, for first-line treatment of HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) [1] Group 2: Market Performance and Analyst Ratings - CITIC Securities previously noted that BeiGene's Bruton’s tyrosine kinase (BTK) product is experiencing significant growth, leading to an upward revision of the annual performance guidance [1] - The company is expected to see continued commercialization success from its key pipelines, including BTK, PD-1 in the EU and Japan, and other significant products like BCL-2, CDAC, and CDK4, maintaining a "Buy" rating [1]

Summary of BeOne Medicines Conference Call Company Overview - **Company**: BeOne Medicines (NasdaqGS:BGNE) - **Key Personnel**: John Euler (CEO), Aaron Rosenberg (CFO), Mark Lanesa (Chief Medical Officer of Solid Tumor) [2][4] Industry Insights - **Sector**: Biotechnology, specifically oncology - **Market Position**: BeOne is recognized as one of the fastest-growing biotech companies, achieving profitability and leading global revenue with its BTK inhibitor, Brukenza [2][4] Core Strategies and Unique Infrastructure - **R&D Approach**: BeOne has built its own infrastructure, termed the "B1 global superhighway," consisting of 6,000 personnel globally, with 2,000 in manufacturing and 4,000 in clinical trials across 40-50 countries [4][5] - **Cost Efficiency**: The company aims to reduce the high costs associated with clinical trials, which typically account for 75-90% of oncology medicine expenses [4][5] - **Research Output**: In the last two years, BeOne has introduced 16 new molecular entities into clinical trials, with a focus on hematology and solid tumors [5][6] Financial Performance - **Revenue Breakdown**: As of Q3 2025, 52% of revenue is from the U.S., with European sales growing 71% year-over-year, now accounting for 12% of total sales. The rest of the world saw a 133% year-over-year growth [11][12] - **Manufacturing Investment**: Over $800 million has been invested in a biologics facility in New Jersey, which will support production for Tovembara, a PD-1 therapy [14] CLL Franchise - **Key Products**: Brukenza is the leading BTK inhibitor globally, with a six-year milestone PFS of 74%, outperforming other monotherapy BTKs [15][16] - **Clinical Strategy**: BeOne is conducting head-to-head trials against competitors to validate the efficacy of its therapies [23][24] - **Future Prospects**: Anticipated approvals for Synrodoclaix in 2026 and the BTK degrader in 2027, aiming to expand treatment options for CLL patients [29] Solid Tumor Pipeline - **CDK4 Inhibitors**: BeOne plans to initiate a phase three trial for a CDK4 inhibitor in frontline HR-positive HER2-negative breast cancer, expecting superior PFS compared to existing treatments [30][32] - **PRMT5 Inhibitor**: The PRMT5 inhibitor is noted for its potency and CNS penetration, showing promise in various tumor types [33][34] Degrader Platforms - **BTK Degrader**: The BTK degrader is in phase three studies, with additional programs for KRAS and EGFR degraders progressing well [36][37] R&D Investment Strategy - **Financial Discipline**: BeOne aims for sustainable growth while maintaining a high bar for R&D investments, with $125 million in net income and $354 million in free cash flow reported [39][40] AI in Drug Development - **AI Utilization**: BeOne is exploring AI for drug discovery and clinical trials, recognizing the potential for improved efficiency but acknowledging challenges due to fragmented data [42][45] Conclusion - BeOne Medicines is positioned as a leader in the biotech sector with a robust pipeline, innovative R&D strategies, and a commitment to expanding its global footprint while maintaining financial discipline and exploring new technologies like AI for drug development.