Investment Rating - The report maintains a positive outlook on the overseas pharmaceutical sector, particularly focusing on innovative drugs and industry chain opportunities, with an investment rating of "Overweight" [1][6]. Core Insights - Multiple policies are supporting the development of the innovative drug industry, with domestic innovative drug transactions reaching historical highs in both value and quantity. The sector's valuation has rebounded from a low point, and leading companies are achieving profitability through increased commercial sales and licensing income [6][8]. - Companies like BeiGene are experiencing significant growth, with global sales exceeding $1 billion in Q3 2025, marking a 51% year-on-year increase. The company anticipates a positive GAAP operating profit for the full year 2025, raising its revenue guidance to $5.1-5.3 billion [1][6]. - Innovent Biologics is expanding its pipeline with a dual focus on oncology and non-oncology products, expecting to achieve positive non-IFRS net profit and EBITDA in 2024, with continued growth projected for 2025 [2][6]. - The report highlights the increasing R&D investments by leading pharmaceutical companies, which are enhancing their innovative pipelines and accelerating their transformation towards innovation [3][7]. Summary by Sections Section 1: Overseas Pharmaceuticals - The report emphasizes the focus on innovative drugs and the opportunities within the industry chain for 2026, noting the historical highs in transaction amounts and numbers for domestic innovative drugs going overseas [6][8]. - BeiGene's overseas sales are highlighted, with Q3 2025 global sales surpassing $1 billion and a significant year-on-year profit turnaround [1][6]. - Innovent Biologics is noted for its strategic partnerships and expected profitability in the coming years [2][6]. Section 2: Pharma Sector - Leading companies are rapidly increasing their R&D investments, which is expected to strengthen their innovative pipelines and global competitiveness [3][7]. - Companies like Hansoh Pharmaceutical and China Biologic Products are projected to see substantial growth in their innovative product revenues, with significant contributions expected in the coming years [3][7]. Section 3: CXO Sector - The report indicates a recovery in investment and financing for innovative drugs, which is likely to drive early-stage R&D investments and boost demand [8]. - Emerging fields such as peptides and ADCs are expected to open new growth opportunities, with a recommendation to focus on companies like WuXi AppTec and WuXi Biologics [8].

Core Insights - BeOne Medicines showcases its leadership in B-cell malignancies at the ASH 2025 conference, presenting extensive new data from its hematology portfolio, including BRUKINSA, sonrotoclax, and BGB-16673 [1][3][4] Group 1: BRUKINSA (Zanubrutinib) - BRUKINSA demonstrates sustained overall survival of 84% and 88% after COVID adjustment, with a landmark progression-free survival (PFS) superiority of 74% at 6 years in treatment-naïve chronic lymphocytic leukemia (CLL) [5] - Long-term data from the SEQUOIA and ALPINE studies confirm BRUKINSA's role as the backbone of CLL therapy, with continuous treatment showing clinically meaningful benefits [6][11] - BRUKINSA is positioned as the preferred BTK inhibitor due to its manageable side effect profile, including lower incidences of fatigue and pain compared to other treatments [8] Group 2: Sonrotoclax - Sonrotoclax, a next-generation BCL2 inhibitor, shows promising clinical activity in B-cell malignancies, with early trials indicating rapid undetectable minimal residual disease (uMRD) rates in treatment-naïve CLL patients [22][23] - The FDA has granted Breakthrough Therapy Designation for sonrotoclax in relapsed or refractory mantle cell lymphoma (MCL) and Fast Track Designation for MCL and Waldenström macroglobulinemia [24] Group 3: BGB-16673 - BGB-16673 is a potential first-in-class BTK protein degrader, with nearly 800 patients dosed in clinical trials, including three Phase 3 trials in relapsed/refractory CLL [25][26] - The drug is designed to degrade both wildtype and mutant forms of BTK, addressing resistance issues seen in patients with progressive disease [25] Group 4: Clinical Presentations and Data - Nearly 50 abstracts accepted for presentation at ASH 2025, including six oral presentations highlighting the efficacy and safety of BeOne's hematology assets [1][4] - Presentations will include real-world evidence and modeling approaches to refine understanding of treatment outcomes with BTK inhibitors [7][20] Group 5: Company Overview - BeOne Medicines is a global oncology company focused on developing innovative treatments for cancer, with a commitment to improving access to medicines for patients worldwide [32][33]

Market Overview - The Hang Seng Index (HSI) closed at 25,824.00, down by 6.65 points or 0.03% as of November 19, 16:00 Eastern Time [1] - The index's highest price during the day was 25,935.21, while the lowest was 25,751.31, with a trading volume of 43.34 million shares [1] Major Blue-Chip Stocks Performance - HSBC Holdings closed at HKD 107.800, down by HKD 1.800 or 1.64% compared to the previous close [2][3] - Tencent Holdings closed at HKD 622.500, down by HKD 1.000 or 0.16% [3] - Alibaba Group (ADR) saw an increase, closing at HKD 156.400, up by HKD 1.800 or 1.16% [3] - Xiaomi Group closed at HKD 38.820, down by HKD 1.960 or 4.81% [3] - AIA Group closed at HKD 77.950, down by HKD 0.600 or 0.76% [3] Stock Price Changes - The stock prices of major companies showed mixed results, with some experiencing declines while others saw slight increases [2][3] - Notable declines included Kuaishou Technology, which closed at HKD 63.500, down by HKD 1.150 or 1.78% [3] - Ctrip Group saw an increase, closing at HKD 574.500, up by HKD 10.000 or 1.77% [3]

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].

高开涨近5%。 消息面上，11月17日，百济神州宣布III期HERIZON-GEA-01研究取得积极结果。该研究旨在评估在联合化疗的基础上，HER2靶向双特异性抗体泽尼达妥单 抗单药或联合PD-1抑制剂替雷利珠单抗作为HER2阳性局部晚期或转移性胃食管腺癌（GEA，包括胃癌、胃食管结合部腺癌和食道癌）一线治疗的有效性和 安全性。 中信建投此前指出，百济神州泽布替尼持续放量，上调全年业绩指引。考虑到公司BTK海外放量超预期，以及PD-1在欧盟、日本等其他国家上市放量，以 及BCL-2、BTK CDAC、CDK4等重磅管线持续兑现带来商业化进一步兑现，维持"买入"评级。 编辑/doris ...

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） ...

方正证券表示，当下时点更应积极看多，新一轮行情有别于今年第一轮估值修复的轰轰烈烈行情，未来 创新药将呈现核心龙头震荡上行，新机会继续涌现的慢牛行情。 恒生医药ETF（159892）聚焦创新+药品主线，涵盖创新药、CXO、互联网药店等细分领域，具备较强 的创新特征，契合创新、出海等主线方向。 百济神州的三季报相当于给创新药行情注入了稳定剂，提示中国原研新药可以在国际市场获得丰厚的回 报和利润，打开创新药行情空间。 方正证券表示，本轮创新药从8月中下旬进行调整状态，部分个股尤其是港股调整剧烈，市场对创新药 的核心逻辑出现怀疑，部分市场资金在国际博弈扰动下有减仓，但实质上创新药BD的逻辑从未改变。 从后续一二级层出不穷的BD可以印证，部分个股调整剧烈是预期过高、过于超前导致，不是行情逻辑 的证伪或终结，这点从龙头稳健的走势上可见一斑。 ...

截至发稿，百济神州(06160.HK)涨4.36%、药捷安康-B(02617.HK)涨3.77%、科济药业-B(02171.HK)涨 1.89%。 ...