26H1 催化丰富、CDK4 抑制剂重点转向一线 Bcl2 抑制剂索托克拉：预计26H1 启动ZS 固定剂量方案对比AV方案的III 期试验，ASH 数据来看有望成 为BIC；BTK CDAC/BGB-16673：预计26H1 读出用于后线CLL 的II 期潜在关键试验数据； CDK4 抑制剂/BGB-43395：预计26H1 启动用于1L BC 的III 期试验（不再开发2L）； 事件 公司公布2025 年三季报，25Q1-Q3 收入为276.0 亿元（+44.2%），归母净利润为11.4 亿元（去年同期 为-36.9 亿元），扣非归母净利润为9.7 亿元（去年同期为-39.9 亿元）。25Q3 收入为100.8 亿元 （+41.1%），归母净利润为6.9 亿元（去年同期为-8.1 亿元），扣非归母净利润为7.1 亿元（去年同期 为-8.7 亿元）。公司同时将全年收入指引从此前的50-53 亿美元调整至51-53 亿美元、全年GAAP 经营利 润为正的指引不变。 核心观点 25Q3 泽布替尼突破10 亿美元， 费用环比稳中略降前三季度拆分来看，泽布替尼全球收入达27.8 亿美元 （+53.2%），其中美国1 ...

买入|维持 证券研究报告：医药生物 | 公司点评报告 发布时间：2025-11-21 股票投资评级 个股表现 -10% 2% 14% 26% 38% 50% 62% 74% 86% 98% 2024-11 2025-01 2025-04 2025-06 2025-09 2025-11 百济神州 医药生物 资料来源：聚源，中邮证券研究所 公司基本情况 | 最新收盘价（元） | 298.80 | | --- | --- | | 总股本/流通股本（亿股）15.41 / 1.15 | | | 总市值/流通市值（亿元）4,604 / 344 | | | 52 周内最高/最低价 | 326.08 / 155.01 | | 资产负债率(%) | 43.6% | | 市盈率 | -82.09 | | 第一大股东 | Amgen Inc.,安进公司 | 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 分析师:陈灿 SAC 登记编号:S1340525070001 Email:chencan@cnpsec.com 百济神州(688235) 盈利稳步提升 ...

有机构分析指出，目前，创新药指数已经自高点回调20%左右，部分创新药公司回调幅度达到 30%-50%，市场预期从八、九月份的过分乐观，切换至目前的偏悲观状态，而很多创新药公司的估值也 已经回归合理甚至低估的水平。站在当前时点，我们有理由对创新药板块重新乐观起来——中国创新药 企业正在重塑全球创新药研发生态体系，背靠强大的产业趋势，创新药行情虽有波折，但总会螺旋上 升。 把握创新药深度回调机遇，配置工具首选同类最大港股通创新药ETF（520880）及其场外联接基金 （025221），标的指数恒生港股通创新药精选指数具备三大独特优势： 1、纯粹，全面。不含CXO，纯正创新药！全面覆盖创新药研发类公司。 2、龙头占比大。前十大创新药龙头权重超71%，表征创新药硬核力量。 3、风险更可控。对流动性较差的成份股强制降权，有力管控尾部风险。 | | | 港股通创新药ETF (520880) 标的指数 | | | --- | --- | --- | --- | | | | 前十成份股权重高达71.51%,龙头优势显著 | | | 代码 | 简称 | 权重(%) | 总市值(亿港元) | | 6160.HK | 百济神州 | ...

11月18日，科创创新药板块冲高回落，截至10:16，科创创新药ETF汇添富（589120）早盘大幅震荡，振幅近2%，当前微涨0.11%，资金小跑进 场，科创创新药ETF汇添富（589120）昨日强势吸金786万元！ 科创创新药ETF汇添富（589120）标的指数成分股涨跌不一，百利天恒涨超2%，百济神州涨超1%，一度涨超3%，泽璟制药涨超1%，荣昌生物、 艾力斯微涨，君实生物、博瑞医药等回调。 特别是出海方面，国信证券表示，随着国产创新药的临床数据和临床进度在全球范围内的竞争力越来越强，创新药出海的趋势不断加强。关注创 新药在海外的临床进展以及数据读出。中国创新药产业已经体现出长期向好的发展趋势，并在近年集中体现在BD交易的爆发式增长。值得注意的 是，对于大部分国产创新药，对外授权通常只是全球开发的起点，合作伙伴在海外的开发进度，以及后续全球临床数据的读出可以进一步加强产 品在全球市场商业化的确定性。（来源于国信证券20251023《看好创新药长期逻辑，关注底部反转标的》） 【创新药进入收获期，戴维斯双击可期】 2025 年三季度，A 股医药生物板块472 家上市公司，共实现营业总收入6,004亿元，实现归 ...

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 ...

中信建投（601066）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。 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。 百济神州(06160)高开逾3%，截至发稿，涨3.53%，报223.2港元，成交额1196.27万港元。 ...

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。 智通财经APP获悉，百济神州(06160)高开逾3%，截至发稿，涨3.53%，报223.2港元，成交额1196.27万 港元。 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。 ...

Group 1 - The report highlights the focus on innovative drugs and the opportunities within the pharmaceutical industry chain, indicating a positive outlook for the Hong Kong pharmaceutical sector by 2026 [1][3] - Multiple policies are supporting the development of the innovative drug industry, with record highs in both transaction amounts and numbers for domestic innovative drugs going overseas [3][6] - The report notes a rebound in valuations for the sector, with leading companies achieving profitability through increased commercialization and licensing revenues [3][6] Group 2 - Key companies such as BeiGene and Innovent Biologics are experiencing significant sales growth, with BeiGene's global sales exceeding $1 billion in Q3 2025, marking a 51% year-on-year increase [3][4] - Innovent Biologics is expanding its pipeline and is expected to achieve positive non-IFRS net profit and EBITDA in 2024, with continued growth projected for 2025 [3][4] - The report emphasizes the strong performance of the CXO sector, driven by a recovery in investment and demand for early-stage research, particularly in emerging fields like peptides and ADCs [3][6] Group 3 - The report provides a detailed earnings forecast and valuation for key companies, indicating significant revenue growth for companies like BeiGene and Innovent Biologics, with projected revenues of $5.1 billion and $2.7 billion respectively for 2025 [4][6] - The pharmaceutical sector is noted for its robust performance, with companies like Sihuan Pharmaceutical and Hengrui Medicine showing strong revenue contributions from innovative products [4][6] - The report also highlights the increasing competitiveness of domestic innovative drugs on a global scale, with successful international collaborations and licensing agreements [3][6] Group 4 - The report indicates that the Hong Kong pharmaceutical market has shown impressive performance year-to-date, with the Hang Seng Healthcare Index significantly outperforming other markets, achieving an approximate 82% increase [15][16] - Valuations for Hong Kong pharmaceuticals are noted to be lower than those in A-shares and overseas markets, with a median PE of 17x for 2025 [15][16] - The report mentions a notable increase in the number of IPOs in the Hong Kong pharmaceutical sector, with over 20 new companies listed in 2025, raising substantial capital [40][41]

Core Insights - The company reported a significant increase in revenue and profitability for the first three quarters of 2025, with total revenue reaching RMB 27.595 billion, a year-on-year growth of 44.2%, and a net profit attributable to shareholders of RMB 1.139 billion, marking a turnaround from a loss to profit [3][4] Revenue Breakdown - The global revenue for the drug Zebutini (BTK) reached USD 1.04 billion in Q3 2025, reflecting a year-on-year increase of 50.8% and a quarter-on-quarter increase of 9.6% [4] - In the U.S., Zebutini generated USD 740 million, up 46.7% year-on-year and 8.0% quarter-on-quarter [4] - European sales of Zebutini amounted to USD 160 million, showing a year-on-year growth of 67.7% and a quarter-on-quarter increase of 8.4% [4] - In China, Zebutini's revenue was USD 90 million, with a year-on-year increase of 36.3% and a quarter-on-quarter rise of 11.1% [4] - The company anticipates a 5-10% growth in Zebutini's revenue in Q4 2025, projecting total global revenue for the drug to exceed USD 3.9 billion for the year [4] Profitability Forecast - The company has revised its revenue forecasts for FY25-27 to USD 5.3 billion, USD 6.4 billion, and USD 7.1 billion respectively, indicating a compound annual growth rate (CAGR) of 23% over three years [3] - The net profit forecasts for FY25-27 have also been adjusted to USD 360 million, USD 660 million, and USD 1.05 billion respectively, reflecting better-than-expected growth in sales and R&D expenses [3]

Core Insights - BeiGene's stock rose over 6% following the release of its Q3 2025 earnings report, with a current price of HKD 224.2 and a trading volume of HKD 239 million [1] Financial Performance - The company reported a revenue of RMB 27.595 billion for the first three quarters of 2025, representing a year-on-year growth of 44.2% [1] - Net profit attributable to shareholders was RMB 1.139 billion, marking a turnaround from a loss to profit [1] - Basic earnings per share stood at RMB 0.81 [1] Product Revenue Breakdown - Global revenue for Zebrutinib (BTK) reached USD 1.04 billion in Q3 2025, showing a year-on-year increase of 50.8% and a quarter-on-quarter increase of 9.6% [2] - Revenue from Zebrutinib in the U.S. was USD 740 million (up 46.7% year-on-year, up 8.0% quarter-on-quarter) [2] - European revenue for Zebrutinib was USD 160 million (up 67.7% year-on-year, up 8.4% quarter-on-quarter) [2] - Revenue from Zebrutinib in China was USD 90 million (up 36.3% year-on-year, up 11.1% quarter-on-quarter) [2] - The company anticipates a 5-10% quarter-on-quarter growth for Zebrutinib in Q4 2025, with global revenue expected to exceed USD 3.9 billion for the year [2] - Global revenue for Tislelizumab (PD-1) was USD 190 million, reflecting a year-on-year growth of 16.7% [2] Future Projections - Haitong International has revised its revenue forecasts for BeiGene for FY25-27 to USD 5.3 billion, USD 6.4 billion, and USD 7.1 billion respectively, indicating a three-year revenue CAGR of 23% [1] - The net profit forecasts for FY25-27 have also been adjusted to USD 360 million, USD 660 million, and USD 1.05 billion respectively, reflecting better-than-expected growth in sales and R&D expenses [1]