KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments

开始日期2026-04-30

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07060807

/ Recruiting临床3期

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.
* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread
* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2
* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles
* Metastatic means the cancer has spread to other parts of the body
Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

开始日期2025-07-21

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT05620914

/ Withdrawn临床2期IIT

A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases

The purpose of this study is to determine if the study drug, patritumab deruxtecan (HER3-DXd), can be measured in brain tumor tissue after recieving one dose of patritumab deruxtecan before surgery.

开始日期2025-07-01

申办/合作机构

Duke University

[+1]

100 项与德帕瑞妥单抗相关的临床结果

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100 项与德帕瑞妥单抗相关的转化医学

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100 项与德帕瑞妥单抗相关的专利（医药）

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项与德帕瑞妥单抗相关的文献（医药）

2026-06-01·CANCER

Mapping the antibody–drug‐conjugates landscape in non–small cell lung cancer: Where are we and where are we going?

Review

作者: Parisi, Claudia ; Planchard, David ; Barlesi, Fabrice

Abstract:

Antibody–drug conjugates (ADCs) represent a rapidly advancing therapeutic class in the treatment of non‐small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic agents to tumor cells while minimizing off‐target toxicity. In recent years, several ADCs have emerged in both early (phase 1–2) and late (phase 3) clinical development, reflecting a growing recognition of their potential to improve outcomes in defined subsets of patients with advanced NSCLC. Late‐phase ADCs include trastuzumab deruxtecan (targeting HER2 [human epidermal growth factor receptor 2]), datopotamab deruxtecan and sacituzumab govitecan (targeting TROP2 [trophoblast cell‐surface antigen 2]), patritumab deruxtecan (targeting HER3), telisotuzumab vedotin (targeting c‐MET [cellular‐mesenchymal epithelial transition factor]), and sigvotatug vedotin (targeting IB6 [integrin beta‐6]). Research efforts are ongoing to explore novel payloads, linker technologies, and targets to expand the applicability of ADCs across broader NSCLC populations, including those with limited treatment options (e.g., EGFR ‐mutant disease in the context of treatment resistance). Despite their promise, challenges remain in optimizing patient selection, overcoming resistance mechanisms, and managing unique toxicity profiles. Ongoing, biomarker‐driven trials and combination strategies with immunotherapy or tyrosine kinase inhibitors hold the potential to further enhance the efficacy of ADCs. In this review, the authors highlight the current landscape and future directions of ADCs in NSCLC, emphasizing available results for compounds in late‐stage clinical development and different disease settings.

2026-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Resistance mechanisms and post-trastuzumab deruxtecan (T-DXd) strategies in HER2+ and HER2-low breast cancer: From biology to clinical practice

Review

作者: Xue, Wenwu ; Chen, Minna ; Wen, Xiaofen ; Li, Xiaozhi ; Zeng, De ; Lin, Danxia ; Song, Junwei ; Wang, Wende ; Zhang, Weichun ; Shen, Jiaxin

Trastuzumab deruxtecan (T-DXd), a HER2-directed antibody-drug conjugate (ADC), has revolutionized the treatment landscape for HER2-positive and HER2-low breast cancer, offering unprecedented improvements in progression-free survival (PFS) and overall survival (OS). However, the emergence of resistance limits its long-term efficacy and highlights the need for rational post-progression strategies. This review summarizes current understanding of resistance mechanisms to T-DXd, including dynamic HER2 expression loss, dysregulation of DNA damage repair, tumor microenvironment remodeling, and immune evasion. Building upon these mechanistic insights, we explore therapeutic strategies following T-DXd resistance, including sequential ADCs with alternative targets or payloads, combinations with HER2-targeted tyrosine kinase inhibitors (TKIs), CDK4/6 or PARP inhibitors, endocrine therapy, and immunotherapy. Novel agents such as ARX788, patritumab deruxtecan, and Dato-DXd demonstrate promise in overcoming resistance through diversified mechanisms. Real-world data further support a "three-step strategy" involving ADC rechallenge after interim non-ADC therapies, offering a practical, mechanism-informed treatment model. This review provides a framework for precision-guided care in patients with advanced breast cancer and supports ongoing efforts to extend the therapeutic window beyond initial T-DXd benefit.

2026-05-01·SUPPORTIVE CARE IN CANCER

Prevalence of antibody drug conjugated–induced nausea and vomiting (ADCINV) in patients with cancer

Review

作者: Kannout, Samy ; Eng, Lawson ; Affronti, Mary Louise ; Scotté, Florian ; Zheng, Cindy ; Blayne, Ayden ; Fazelzad, Rouhi ; Ruhlmann, Christina H ; Rugo, Hope S ; Talwar, Sumeet ; Dou, Aaron ; Chow, Ronald ; Ma, Andreas ; Zhang, Daniel ; Iihara, Hirotoshi ; Leigh, Jennifer

Abstract:

Introduction:

Antibody–drug conjugates (ADC) have emerged as an important part of systemic treatment across disease sites. To date, there is no robust pooled prevalence estimate of nausea and vomiting induced by ADCs. Establishing such estimates is essential to determine if ADC-induced nausea and vomiting (ADCINV) represents a clinically significant problem warranting further research into antiemetic prophylaxis. Our aim is to report the prevalence of reported ADCINV across literature.

Methods:

A systematic search of Medline, Embase, Cochrane CENTRAL and Web of Science was conducted from database inception until September 24, 2025. Articles were included if they reported nausea and/or vomiting due to ADCs used in cancer treatment, in the abstract. Pooled prevalence was reported. Subgroup analysis was conducted by ADC. Meta-regression was conducted by age and sex. Quality assessment was conducted. Type I error was set at 0.05.

Results:

A total of 209 studies with 15,493 patients were included. Thirty-nine percent (95%CI, 36–42%) of patients experience any nausea, and 26% (95%CI, 23–29%) experience any vomiting. Younger patients are more likely to experience nausea; each 10-year increase in age is associated with a 12% decrease in nausea rates. Higher emetogenic ADCs include trastuzumab deruxtecan, sacituzumab govitecan, brentuximabvedotin and patritumab deruxtecan. Lower emetogenic agents include disitimab vedotin, telisotuzumab vedotin and rovalpituzumab tesirine.

Discussion:

This is the first study to report prevalence of ADCINV across ADCs. It is a prevalent adverse effect akin to chemotherapy-induced nausea and vomiting that should be viewed as clinically relevant and further investigated to help develop optimal strategies related to antiemetics.

686

项与德帕瑞妥单抗相关的新闻（医药）

2026-07-06

·药事纵横

第一三共的ADC泡沫教训，爆款王牌为何沦为经营陷阱？

近几年资本市场对 ADC 药物的炒作热度持续走高，不少投资机构直接将这类偶联药物看作实体瘤治疗的终极解决方案。只要企业管线里布局了 ADC 候选药物，就能在一级、二级市场收获估值抬升。但结合真实临床推进、商业化落地情况来看，行业虚高的估值泡沫正在快速消散，行业竞争早已不再简单评判企业有没有 ADC 管线，各家比拼的核心落到临床数据兑现能力、产品实际临床价值和长期商业化盈利能力上。第一三共凭借德曲妥珠单抗实现业绩暴涨后，一度被市场视作 ADC 赛道的标杆企业，几乎所有行业研报都把这家日本药企的发展路径当作行业范本。但如果抛开单品亮眼的销售报表深挖企业经营现状就能看出，它短期业绩爆发完全依托 DXd 平台下这一款独家产品，并不代表企业具备跨国药企成熟、均衡的综合研发与运营能力。单品红利带来的盲目扩张，最终引发多条管线临床失败、新建产能大幅计提减值等连锁问题，也打破了市场对这家 ADC 龙头的乐观预期。市面上大量行业解读都在过度美化第一三共的转型选择，梳理企业过往经营脉络不难发现，其布局 ADC 赛道并非精准预判行业风口的长远布局，更像是传统业务增长触顶后的被动选择。2016年前后，第一三共核心营收支柱为心血管类药物，市场空间逐年收缩，企业找不到其他具备增长潜力的创新药赛道，才集中全部资源押注肿瘤 ADC。这种被动入局的背景，也决定了企业后续一系列激进的经营决策：依靠德曲妥珠单抗拿下HER2 低表达这块空白市场后，管理层直接套用单品成功经验，大规模扩建生产基地、和外包厂商锁定长期产能，完全忽略新药研发本身极高的不确定性。图1. 第一三共产品注射用德曲妥珠单抗在国内上市德曲妥珠单抗能够实现商业化大获成功，核心原因是 DXd 平台可以实现较高药物载荷比，同时具备独特的旁观者杀伤效应，精准填补了 HER2低表达乳腺癌无有效治疗手段的空白，这种细分市场红利具备极强不可复制性。肿瘤不同靶点对应的肿瘤微环境、耐药机制差异巨大，药物递送难度也天差地别，但第一三共管理层形成了固化思维，试图依靠同一套技术平台覆盖全部实体瘤靶点，直接导致多条在研管线临床数据不及预期。 TROP2 靶点候选药物德达博妥单抗的研发挫折，是这套经营思路催生的典型失败案例。相较于研发体系成熟的 HER2 靶点，全球药企在 TROP2 ADC 研发中普遍面临疗效有限、药物毒副作用偏大、适用人群边界模糊等难题，多数企业推进临床时都保持谨慎态度。但依托德曲妥珠单抗积累的市场信心，第一三共直接将研发重心放在非小细胞肺癌大适应症上，投入巨额资金开展覆盖广泛人群的大型三期临床，最终总生存期关键指标未达到预设终点，只能大幅缩减适用人群范围。这次研发失利不仅让企业缺少承接德曲妥珠单抗的第二增长曲线，前期提前布局的大规模生产厂房直接闲置，为后续大额资产减值埋下隐患。紧随其后的 HER3-DXd 候选药物更是暴露企业内部临床管控漏洞，药物生产环节质控出现瑕疵，临床试验中出现多例致命不良反应，最终企业只能主动撤回上市申报，彻底错失肺癌细分市场布局窗口。产能大规模减值，是第一三共激进经营策略最集中的体现。医药行业产能规划通用逻辑，一定是跟随管线临床进度逐步匹配产能规模，按需搭建产线才能规避闲置风险。但为了抢占全球 ADC 市场份额，第一三共仅凭理想化的远期销售预测，在多数候选药物还停留在临床二期、三期阶段时，就在全球多地新建自有工厂，同时和多家 CDMO 签订长期固定产能采购协议。多条管线临床失败后，原本规划的市场需求不复存在，提前布局的产线全部沦为无效资产，叠加外包厂商违约赔付、工厂停工折旧计提，单季度利润出现大幅缩水，也给国内正在扩产 ADC 产能的药企敲响警钟：决定 ADC 企业长期竞争力的从来不是厂房规模，而是能够持续产出优质临床数据的自有技术平台与梯度管线。图2. 第一三共收入按财年（2025年4月-2026年4月）口径统计收入情况和第一三共依靠单一爆款拉动增长、抗风险能力薄弱的模式相比，国内 ADC 创新药企走出了完全不一样的发展道路，这套路径也更适配长期产业发展。国内 ADC研发起步阶段确实出现过扎堆布局 HER2、TROP2 成熟靶点的乱象，不少初创企业直接照搬海外成熟技术方案，造成同质化管线泛滥、行业内卷严重。但近三年行业自然完成一轮淘汰，真正掌握自主核心技术的头部企业，已经跳出同质化低价竞争，找到了贴合自身优势的研发方向。国内 ADC 企业的竞争优势，不能简单归结为生产成本更低，核心竞争力在于精准挖掘海外巨头忽视的临床痛点，同时完成偶联药物全链条技术自主研发。跨国药企研发资源大多向发病率高、受众基数大的欧美主流癌种倾斜，鼻咽癌这类国内高发、海外患者稀少的瘤种，极少有海外企业投入资源深耕。宜联生物针对 B7-H3 靶点打造的 ADC 药物，专门聚焦复发难治鼻咽癌，攻克了该靶点长期难以突破的技术瓶颈，三期临床拿到全球首个阳性关键数据，最终将海外权益授权给罗氏并收获大额首付款。这种立足国内未被满足的临床需求，再反向输出全球市场的研发思路，是海外药企很难复刻的差异化优势。底层偶联技术层面，国内头部企业也摆脱了对海外平台的依赖。海外 ADC 产品大多采用单一抗体靶点设计，普遍存在肿瘤耐药、适用癌种狭窄的短板，百利天恒、科伦博泰等企业自主搭建技术平台，率先落地双抗 ADC 研发路线，依靠双抗原结合机制缓解药物脱靶毒性、延缓肿瘤耐药问题。其中百利天恒研发的 EGFR/HER3 双抗 ADC，在多线耐药三阴性乳腺癌、晚期肺癌临床试验中取得全球领先数据，打破海外企业在双表位偶联药物领域的技术垄断；科伦博泰自研 OptiDC 平台实现毒素、连接子、全序列抗体自主开发，平台产出核心产品与默沙东达成全球化合作，足以证明本土技术平台具备孵化全球重磅产品的潜力。当下国内 ADC 行业正在加速洗牌，本质是区分具备原创技术实力的企业和仅做简单药物拼接的仿创企业。没有自主连接子、毒素、抗体研发能力，单纯采购外部组件组装 ADC 管线、无法形成差异化临床优势的小型 Biotech 正在逐步退出市场；掌握完整自主研发链条、坚持差异化靶点布局、围绕真实临床需求开发药物的头部企业，持续收拢行业研发资源。行业降温不是赛道发展遇冷，而是产业从粗放式跟风研发转向高质量创新的必经阶段。对比第一三共单一产品支撑业绩的脆弱模式，国内多家企业同步推进多条差异化管线的集群研发模式，能够更好抵御单条管线研发失败带来的经营冲击。但客观来看，国内 ADC 企业目前仅实现了产品层面的突破，距离真正具备全球化运营能力的跨国药企还有不小差距。现阶段大部分本土药企海外商业化都选择权益授权模式，企业仅能拿到前期首付款和阶段性里程碑付款，无法分享药物上市后全球销售带来的持续利润，大量优质自研资产容易被海外大型药企低价收购。更深一层的短板在于，国内创新药企普遍缺少成熟的海外运营团队，自主牵头开展海外多中心临床、搭建海外商业化销售渠道、统筹全球供应链的能力仍有明显欠缺。同时国内医保常态化降价机制、国内创新药赛道激烈竞争，仅依靠本土市场销售收入，很难持续支撑 ADC 这类高投入管线的长期研发开支。第一三共由盛转衰的完整发展历程，给国内ADC 从业者提供了极具参考价值的现实案例。仅靠一款爆款药物带来短期业绩红利无法支撑企业长久发展，脱离管线进度盲目扩张产能、研发布局，最终会反噬企业整体经营。能够穿越行业周期的药企，需要分层布局梯度管线、建立完善临床风险评估机制、搭建完整上下游产业配套。未来 ADC 赛道比拼不再是单一药物、单项技术的单点竞争，而是技术迭代速度、管线梯队搭建、研发风险管控、全球商业化运营、全产业链配套能力的综合比拼。国内药企不需要复刻海外药企大规模扩产、押注单一靶点的激进发展路线，也不必扎堆拥挤的成熟靶点陷入价格内卷。依托国内独特疾病谱挖掘细分临床需求，持续深耕偶联药物底层原创技术，循序渐进搭建自有海外运营体系，避开单品依赖、超前扩产这类行业常见陷阱，就能长期维持自身差异化竞争优势。全球 ADC 产业格局正在发生改变，行业研发重心逐步向亚洲市场转移已经是明确趋势。第一三共的崛起依托特定时代单品红利，存在极强偶然性；国内 ADC 产业的整体突围，是多年技术积累、贴合本土临床需求、国内生物医药产业链持续升级共同作用的必然结果。短期海外权益授权、多条管线临床取得阳性数据只是行业发展起点，长期来看，掌握全链条自主技术、配套完整上下游产业链、具备独立全球化运营能力的本土创新药企，才有机会打破海外企业长期垄断，重塑全球实体瘤创新药市场格局。参考文献： [1] https://www.nmpa.gov.cn/datasearch/search-info.html?nmpa=aWQ9NDhiMzJkMmY1M2MzZTk4ZDQ0ZDBiYWJjYTQ3YWU4YjgmaXRlbUlkPWZmODA4MDgxODNjYWQ3NTAwMTg0MDg4NjY1NzExODAw [2] Daiichi Sankyo Europe GmbH，https://www.daiichi-sankyo.eu/ 立即扫码加入药事纵横交流群

抗体药物偶联物

2026-07-02

·韭儿不认命

百利天恒 (688506) 深度拆解

百利天恒 (688506) 深度拆解全球首个双抗 ADC iza-bren 获批 + BMS 84 亿美元授权 vs 业绩腰斩 -58.9% 【过去 1 年日 K 线图（前复权，带 MA5/MA10/MA20/MA60 + 成交量）】数据来源：腾讯财经。区间：2025-06-23 ~ 2026-07-02。百利天恒 1 年涨 +14.10%（294.03 → 335.50 元），2026-06-22 iza-bren 获批后股价创历史新高。【读者须知】 • 本文按 Serenity 卡点分析框架（5 个核心证据点）+ 13 原则 + 8 反模式 + 15 Checklist 详细评估百利天恒 • 卡点评估结构：5 个核心证据点 = 寡头供给（专利稀缺）+ 客户认证周期（FDA / NMPA）+ 制造 know-how / 良率 / 设备约束 + 下游客户依赖 + 替代品慢 / 劣 / 未认证 • 评分（✅✅✅ / ✅✅ / ✅ / ⚠️ / ❌）为【我加的方法论，原文只有定性结论】 • 业绩评估用真实毛利率（不只看合计数）—— 业绩 = 销售额 × 毛利率 • 重要催化：①2026-06-22 iza-bren 鼻咽癌后线获批（全球首个双抗 ADC）②2026 Q4 食管鳞癌 / 三阴乳腺癌 NDA 预计获批 ③BMS 海外 3 项 II/III 期临床推进 • 重要警示：①2025 销售毛利额 -58.9%（BD 首付款高基数效应）②经营现金流持续为负 ③研发投入占营收 99.75% ④散户关注度过高（1385 亿市值 + 1 年涨 +14%） • 百利天恒 (688506.SH)：B+ 级（卡点真实但业绩拐点未确认） • 本文不构成投资建议，市场有风险，投资需谨慎一、基础数据【2026-07-02 收盘数据】 • 收盘价：335.50 元（2026-07-02 收盘） • 总股本：4.13 亿股（41287.38 万股，含 2025-09 A 股定增 1187.38 万股） • 总市值：1385.19 亿元（≈ $192B）—— 超硬规则 #8 市值放宽 1000 亿上限 • 静态 PE：亏损（PE 无意义）—— 2025 归母 -10.54 亿 • 动态 PE：亏损（创新药商业化首年，券商一致预期 -7.33 亿） • 市净率：约 19.97x（极高，反映创新药平台稀缺溢价） • 每股净资产：13.67 元（2026-03-31） • 主营业务：创新生物药（ADC / 双抗 / 多特异性抗体 17 款在研 + 化药制剂 + 中成药制剂）【业绩历史（2025 年报 + 2026 Q1）】期间营收归母毛利率关键事件 2023 5.62 亿（-20.11%） -7.80 亿 96.40% 亏损扩大（创新药未商业化） 2024 58.23 亿（+936.31%） 37.08 亿（扭亏） 95.46% BMS 8 亿美元首付款到账 2025 25.20 亿（-56.72%） -10.54 亿（亏损） 90.78% BMS 2.5 亿美元里程碑代替首付款 2026 Q1 0.95 亿（+40.25%） -7.75 亿（亏损） 54.15% 研发投入 6.95 亿（占营收 734%） ⚠️ 关键洞察：2024 是 BMS 首付款高基数（销售毛利额 55.59 亿），2025 销售毛利额 -58.9% 至 22.87 亿——业绩"腰斩"但研发管线持续推进（2025 研发投入 25.14 亿同比 +74%）二、卡点评估（Serenity 卡点分析框架）【评估总览：一表看懂 5 个核心证据点】 # 证据点评估一句话证据 1 寡头供给（专利稀缺） ✅✅✅ 极强全球首个且唯一获批的双抗 ADC（iza-bren）+ 全球独家四特异性抗体 3 款 2 客户认证周期 ✅✅ 强鼻咽癌获批 + 7 项 CDE 突破性治疗 + 1 项 FDA 突破性治疗 3 制造 know-how / 良率 / 设备约束 ✅✅ 强 HIRE-ADC + GNC + SEBA + HIRE-ARC 四大平台 + 6 个 2000L 反应器 4 下游客户依赖 ✅✅ 强 BMS 84 亿美元授权（全球 MNC）+ 鼻咽癌 / 食管癌后线无标准方案 5 替代品慢 / 劣 / 未认证 ✅✅ 强全球最快双抗 ADC follower 还在 II 期，代际差距已拉开汇总：✅✅✅ 1 + ✅✅ 4 = 5 项全成立 → 卡点真实度极高，但业绩拐点未确认评分（✅✅✅ / ✅✅ / ✅ / ⚠️ / ❌）为【我加的方法论，原文只有定性结论】。【框架核心定义（Serenity 原文）】标的必须处于"需求扩张必须有特定材料、元件、工艺、认证、产能瓶颈同步扩张"的物理层。【1. 寡头供给【✅✅✅ 极强】】 • 2026-06-22 iza-bren（EGFR×HER3 双抗 ADC）鼻咽癌后线获批 — **全球首个且唯一获批的双抗 ADC** • 鼻咽癌 III 期 PANKU-NPC01：cORR 54.6%（化疗 27.0% 翻倍）/ mPFS 8.38 个月（化疗 4.34 个月）/ 疾病进展风险 -56% • 全球独家四特异性抗体 3 款（百利天恒全行业唯一） • 同类 follower（康方生物 / 宜联生物 / 第一三共）最快还在 II 期临床【2. 客户认证周期【✅✅ 强】】 • 2026-06-22 鼻咽癌后线获批（NDA 受理 → 获批 1.5 年，加速审评） • 食管鳞癌 NDA 已受理 + 优先审评（2026 Q4 预计获批）— **全球首个食管癌 ADC** • 三阴乳腺癌 NDA 已递交（PFS + OS 双终点阳性）— 2026 Q4 预计获批 • **7 项 CDE 突破性治疗 + 1 项 FDA 突破性治疗**（覆盖 NSCLC / SCLC / 鼻咽癌 / 食管鳞癌 / 三阴乳腺癌 / 卵巢癌 / 胆道癌 / 尿路上皮癌） • BMS 在美国同步启动 3 项全球 II/III 期临床（三阴乳腺癌 / EGFR 突变 NSCLC / 尿路上皮癌）【3. 制造 know-how / 良率 / 设备约束【✅✅ 强】】 • 四大技术平台：**HIRE-ADC（创新 ADC）+ GNC（多特异性抗体）+ SEBA（特异性增强双抗）+ HIRE-ARC（核药）** • 全资子公司多特生物按 cGMP 标准建立抗体/ADC 药物生产车间：**6 个 2000L + 1 个 1000L 生物反应器** • 全球供应链：成都（百利天恒）+ 西雅图（SystImmune）中美双研发中心 • 17 款创新药处于临床阶段（1 款 NDA + 3 款 III 期注册临床 + 13 款早期核心） • 100 余项临床试验（国内 27 项 III 期 + 美国 10 项 + 全球注册临床 3 项）【4. 下游客户依赖【✅✅ 强】】 • **BMS（百时美施贵宝）84 亿美元授权**（2023-12-11 签约，8 亿美元首付款已收 + 76 亿美元里程碑） • 鼻咽癌后线治疗：既往经至少二线系统化疗 + PD-1/PD-L1 治疗失败，**临床长期缺少标准方案** • 食管鳞癌二线：全球每年新发 51.1 万人（中国 22.4 万人占 43.8%），90% 是鳞癌，**目前无 ADC 获批** • 三阴乳腺癌：全球首个双终点获益（mPFS 8.5 vs 3.1 / mOS 15.9 vs 12.5 个月） • 客户分散度高：国内 16 项 PANKU 系列 + BMS 全球 3 项注册临床，无单客户依赖【5. 替代品慢 / 劣 / 未认证【✅✅ 强】】 • 全球最快双抗 ADC follower（康方生物 AK104 + ADC 偶联 / 第一三共 patritumab deruxtecan 等）**还在 II 期临床** • 代际差距已拉开：百利 III 期数据全部读出 + 鼻咽癌获批，跟随者刚开始 II 期 • HER2 ADC 已有 4 款获批（DS-8201 / T-DM1 等），但**双抗 ADC 是新赛道** • ADC 全球管线 363 项 / 靶点 125 个，但**双抗 ADC 占 < 5%** = 蓝海赛道 • 国产竞品（荣昌生物 / 科伦博泰 / 恒瑞 / 映恩生物）布局单抗 ADC，**双抗 ADC 暂未跟进** 【5 个核心证据点汇总】证据点评估细分 #1 寡头供给（专利稀缺） ✅✅✅ 极强 1 项极强 #2 客户认证周期 ✅✅ 强 4 项强 #3 制造 know-how / 良率 / 设备约束 ✅✅ 强 — #4 下游客户依赖 ✅✅ 强 — #5 替代品慢 / 劣 / 未认证 ✅✅ 强 — 合计 ✅✅✅ 1 + ✅✅ 4 5 项全成立【总评】按 Serenity 卡点框架 + 市值放宽规则（不可替代"极高" + 增长空间"极高"），百利天恒：B+ 级（卡点真实但业绩拐点未确认）三、公司基本面【财务数据（GAAP 真实毛利率，硬规则 #1 业绩 = 销售额 × 毛利率）】指标 2023 2024 2025 2026 Q1 同比营业收入 5.62 亿 58.23 亿 25.20 亿 0.95 亿（单季） -56.72% / +40.25% 归母净利润 -7.80 亿 37.08 亿 -10.54 亿 -7.75 亿 -128.42% / -45.75% 扣非净利润 — 36.36 亿 -11.68 亿 -8.30 亿 -132.12% / — 毛利率 96.40% 95.46% 90.78% 54.15% -4.66pct / -36.63pct 销售毛利额 5.42 亿 55.59 亿 22.87 亿 0.51 亿 -58.85% / +54%（基数极小）研发费用 7.46 亿 14.43 亿 25.14 亿 6.95 亿 +74.23% / +40.38% 经营现金流 -6.20 亿 40.59 亿 -7.98 亿 -7.42 亿 -119.67% / -51.43% ROE 加权 — 95.41% -24.55% -12.60% — / +2.08pct 资产负债率 89.34% 45.56% 42.14% 48.91% -3.42pct / +6.77pct 【主营构成（2025 年报）】产品营收（亿）占比同比说明知识产权收入（BD） 21.24 84.29% -60.16% 2024 含 BMS 8 亿美元首付款 / 2025 仅 2.5 亿美元里程碑化药制剂 2.84 11.27% -11.85% 丙泊酚等麻醉药 / 集采压力中成药制剂 0.96 3.81% -41.64% 黄芪颗粒 / 需求萎缩 + 竞争加剧其他 0.16 0.63% — — ⚠️ 关键洞察：84% 营收来自知识产权收入（BD 一次性收入），商业化创新药收入尚未形成——**业绩对 BD 节奏高度敏感** 四、13 原则（Serenity 原文，硬规则 #4 已 fetch）原则评估百利天恒匹配 1. 瓶颈猎手 ✅ Yes 创新药 BD + 平台稀缺（双抗 ADC / 四特异性抗体） 2. 多跳 BOM / OSINT ✅ Yes 靶点 → 双抗 → ADC 偶联 → 临床 → NDA → BD → 商业化 3. 签订 ARR vs 市值 ✅ Yes BMS 84 亿美元合同（8 亿首付已收 + 76 亿里程碑）vs 1385 亿市值 4. Mag7 客户集中度 ✅ Yes BMS（百时美施贵宝，Mag7 跨国药企）+ 全球 III 期合作 5. GAAP 毛利率战 ✅ Yes 毛利率 90.78%（知识产权收入主导，商业化药收入为 0） 6. 认证周期 vs TTM 收入 ✅ Yes 鼻咽癌获批 → 2026 Q4 食管鳞癌 / 三阴乳腺癌 NDA 预计获批 7. 稀释 / ATM 一票否决 ✅ 通过 2025-09 A 股定增 1187.38 万股 / 37.64 亿元（10% 稀释内） 8. 对手方融资质量 ⚠️ 注意港股 IPO 2025-11-12 暂停，融资渠道受限 → 经营现金流持续为负 9. 短线挤压情境 N/A A 股不适用 10. 关税 / 宏观冲击即买入 N/A 创新药不适用关税逻辑 11. 机构滞后 / 资金流 ✅ Yes 中欧医疗 + 汇添富 + 兴全 2026 Q1 新进 / 增持（机构开始建仓） 12. Vega / IV 错配 N/A A 股不适用 13. 信念分层 / 仓位 / 时点 ✅ Yes B+ 级（卡点真实 + 业绩拐点未确认 → 不在爆发临界点） 13 原则汇总：✅ 9 + ⚠️ 1 + N/A 3 → 9 项成立，强卡点 + 多维成立，但**港股 IPO 暂停 + 业绩拐点未确认是核心风险** 五、8 反模式（Serenity 原文）反模式检查结果证据过度杠杆 ⚠️ 注意资产负债率 48.91%（Q1），研发投入占营收 99.75% 欺诈记录 ✅ 无无频繁配股 ✅ 无 2023-01 上市 + 2025-09 一次定增（37.64 亿）可疑审计 ✅ 无标准无保留意见不务正业 ⚠️ 注意仿制药 + 中成药业务萎缩，化药 +11.27% / 中成药 -41.64% 反向收购 ✅ 无无突然更换管理层 ✅ 无朱义持续担任董事长（2006 创立至今）内部人抛售 ✅ 无实控人朱义持股 72.22%，OAP III (HK) 仅减持 1% 刻度 8 反模式汇总：⚠️ 2 + ✅ 6 → 2 项注意（杠杆 + 仿制药萎缩），6 项合规六、15 Checklist（Serenity 原文） # 检查项结果说明 1 公司做什么赚钱？ ✅ 创新生物药（ADC / 双抗 / 多特异性抗体）+ 仿制药 / 中成药 2 利润怎么来的？ ⚠️ BD 知识产权收入 84% + 仿制药 / 中成药 15%（商业化创新药为 0） 3 现金怎么循环的？ ❌ 经营现金流持续为负（2025 -7.98 亿 / 2026 Q1 -7.42 亿） 4 增长来源？ ✅ 鼻咽癌已获批 + 食管鳞癌 / 三阴乳腺癌 2026 Q4 NDA + BMS 海外 3 项注册 5 商业模式？ ✅ B2B BD 授权（BMS）+ 国内自销（化药 / 中成药）+ 创新药自销（即将启动） 6 竞争壁垒？ ✅ 专利 + 平台（HIRE-ADC / GNC / SEBA）+ 临床数据 + BMS 全球合作 7 估值贵不贵？ ⚠️ 1385 亿市值超硬规则 #8 放宽上限（市值放宽理由：不可替代"极高" + 增长空间"极高"） 8 资本结构？ ⚠️ 资产负债率 48.91%，研发投入占营收 99.75%，融资能力受限 9 管理层？ ✅ 朱义博士 2006 创立，持续担任董事长；BMS 合作稳定 10 风险？ ⚠️ 业绩拐点未确认 + 经营现金流持续为负 + 散户关注度过高 11 与卡点分析一致？ ✅ Yes（5 项核心证据点全成立） 12 风险与评级匹配？ ✅ Yes（B+ 级匹配卡点真实 + 业绩拐点未确认） 13 信念分级 + 择时？ ✅ B+ 级（卡点真实但业绩拐点未确认 → 不在爆发临界点） 14 增长天花板？ ✅ ADC 全球市场 2030 647 亿美元 / 中国 662 亿元（2023-2030 CAGR 63.7%） 15 隐含期权？ ✅ 食管鳞癌 / 三阴乳腺癌 NDA 2026 Q4 + 港股 IPO 重新启动 + 海外授权新增 15 Checklist 汇总：✅ 10 + ⚠️ 4 + ❌ 1 → 10 项通过，4 项注意，1 项否定（现金循环）七、核心卡点（瓶颈分析）【卡点 1：全球首个双抗 ADC iza-bren（鼻咽癌已获批）】 • 2026-06-22 鼻咽癌后线获批 — 全球首个且唯一获批的双抗 ADC • III 期 PANKU-NPC01：cORR 54.6%（化疗 27.0% 翻倍）/ mPFS 8.38 个月（化疗 4.34 个月）/ 疾病进展风险 -56% • 获批前即同步获得《NCCN 鼻咽癌指南中国版（2026）》+《CSCO 鼻咽癌诊疗指南（2026）》最高级别推荐 • 全球最快双抗 ADC follower 还在 II 期临床 — 代际差距已拉开【卡点 2：食管鳞癌 + 三阴乳腺癌（2026 Q4 NDA 预计获批）】 • 食管鳞癌 III 期 PANKU-Esophagus01：mPFS 4.17 vs 1.97 个月 / 疾病进展风险 -50% / mOS 9.79 vs 7.2 个月 / 死亡风险 -36% • 三阴乳腺癌 III 期 PANKU-Breast02：mPFS 8.5 vs 3.1 个月 / 疾病进展风险 -71% / mOS 15.9 vs 12.5 个月 / 死亡风险 -40% • 两项 NDA 已获 CDE 受理 + 优先审评，2026 Q4 预计获批 — 全球首个食管癌 ADC 【卡点 3：BD 收入与里程碑（BMS 84 亿美元）】 • 2023-12-11 与 BMS 签约：8 亿美元首付款（已收）+ 76 亿美元里程碑 • 2025-12 收到第一笔 2.5 亿美元里程碑（IZABRIGHT-Breast01 达成） • 后续潜在里程碑：最高 71 亿美元（开发 / 注册 / 销售） • 2025-09 A 股定增 37.64 亿（自有资金 / 创新药研发项目）【卡点 4：四大技术平台（HIRE-ADC + GNC + SEBA + HIRE-ARC）】 • HIRE-ADC：创新 ADC 平台（iza-bren 出身） • GNC：多特异性抗体平台（4 条管线进入临床） • SEBA：特异性增强双抗平台 • HIRE-ARC：核药（核素放射偶联药物）研发平台【卡点 5：管线梯队（17 款创新药 + 100 余项临床）】 • 1 款 NDA 资产（iza-bren 鼻咽癌） • 3 款 III 期注册临床（iza-bren 食管鳞癌 + 三阴乳腺癌 + T-Bren HER2 ADC） • 13 款早期核心临床资产（6 款 ADC + 4 款 GNC + 1 款双抗 + 2 款 ARC） • 国内 III 期 27 项 + 美国 III 期 3 项 + 全球注册临床 3 项八、客户名单【核心战略合作伙伴】 • BMS（百时美施贵宝）：84 亿美元授权（8 亿首付 + 76 亿里程碑），中国以外地区独家开发 + 商业化 • 多特生物（百利全资子公司）：cGMP 抗体/ADC 药物生产（6 个 2000L 反应器） • SystImmune（百利西雅图子公司）：美国研发 + BD 谈判【国内市场（创新药自销团队建设中）】 • 鼻咽癌后线（三线及以上治疗） • 食管鳞癌二线（预计 2026 Q4 获批） • 三阴乳腺癌 ≥ 二线（预计 2026 Q4 获批）【海外市场（BMS 主导）】 • 美国（BMS）：3 项全球 II/III 期临床（三阴乳腺癌 / EGFR 突变 NSCLC / 尿路上皮癌） • 欧洲 / 日本 / 其他（BMS 主导注册 + 商业化）九、业绩拐点（业绩 = 销售额 × 毛利率，硬规则 #1）期间营收归母毛利率关键事件 2024 58.23 亿（+936%） 37.08 亿（扭亏） 95.46% BMS 8 亿美元首付款到账 2025 25.20 亿（-56.72%） -10.54 亿 90.78% BMS 2.5 亿美元里程碑代替首付款 2026 Q1 0.95 亿（+40.25%） -7.75 亿 54.15% 研发投入 6.95 亿（占营收 734%） ⚠️ 关键洞察（硬规则 #1 应用）：2025 销售毛利额 -58.9%（55.59 → 22.87 亿）= 业绩大幅下滑，2026 Q1 销售毛利额 +54% 但绝对值仅 0.51 亿（基数极小，不可作拐点信号）【销售额 × 毛利率真实改善（业绩 = 销售额 × 毛利率）】 • 2024 销售额：58.23 亿（+936.31%）—— BMS 8 亿美元首付款一次性确认知识产权收入 • 2025 销售额：25.20 亿（-56.72%）—— 高基数效应 + 化药 / 中成药持续萎缩 • 2026 Q1 销售额：0.95 亿（+40.25%）—— 基数极小（化药主导，无 BD 收入） • 2024 毛利率：95.46%（知识产权收入主导） • 2025 毛利率：90.78%（-4.66pct，知识产权收入占比下降） • 2026 Q1 毛利率：54.15%（化药 + 中成药主导，知识产权收入几乎为 0） ⚠️ 关键洞察：销售毛利额 2024 55.59 → 2025 22.87（-58.9%）→ 2026 Q1 0.51（基数极小）= **业绩拐点未确认**，需 2026 Q4 食管鳞癌 / 三阴乳腺癌获批后销售毛利额能否突破 10 亿【BD 收入节奏（业绩主驱动）】 • 2024：8 亿美元首付款（≈ 57 亿人民币）+ 部分里程碑 • 2025-09：IZABRIGHT-Breast01 达成 → 2025-12 收到第一笔 2.5 亿美元（≈ 18 亿人民币） • 2026 后续潜在：2.5 亿美元近期或有 + 71 亿美元里程碑（开发 / 注册 / 销售） • ⚠️ BD 收入节奏不确定：依赖 BMS 全球临床推进 + 监管审批节奏【创新药商业化进度（核心拐点）】 • 2026-06-22：iza-bren 鼻咽癌后线获批 — 商业化元年启动 • 2026 Q4：食管鳞癌 / 三阴乳腺癌 NDA 预计获批 • 2027+：EGFR 突变 NSCLC / SCLC / 尿路上皮癌 / 胆道癌 / 卵巢癌（7 项 CDE 突破性治疗） • 2027+：BMS 美国市场销售分成（IZABRIGHT-Breast01 等 3 项注册临床推进） ⚠️ 关键洞察：商业化创新药收入 2026 年内尚未形成规模化销售（仅有化药 + 中成药），**业绩拐点最早在 2026 Q4 或 2027 H1** 【业绩拐点判断】信号类型关键证据 ✅ 强信号（卡点侧）全球首个双抗 ADC iza-bren 鼻咽癌获批 + BMS 84 亿美元授权 + 7 项 CDE 突破性治疗 + 1 项 FDA 突破性治疗 ⚠️ 弱信号（业绩侧）销售毛利额 2024 55.59 → 2025 22.87（-58.9%）/ 2026 Q1 仅 0.51 亿（基数极小）/ 经营现金流 -7.98 亿 / -7.42 亿 / 港股 IPO 暂停 ⚠️ 核心观察：**卡点真实度极高，但业绩拐点未确认**（销售毛利额未突破 10 亿 + 经营现金流未转正）。需密切跟踪 2026 Q4 食管鳞癌 / 三阴乳腺癌获批 + 销售爬坡数据。十、风险与催化剂【风险】 # 风险关键数据性质 1 业绩拐点未确认（最大风险）销售毛利额 2024 55.59 → 2025 22.87（-58.9%）/ 2026 Q1 仅 0.51 亿业绩 2 经营现金流持续为负 2025 -7.98 亿 / 2026 Q1 -7.42 亿 / 累计已超 20 亿现金流 3 研发投入占营收 99.75% 2025 研发 25.14 亿（同比 +74.23%）/ 商业化收入尚未形成可持续性 4 港股 IPO 暂停 2025-11-12 因市场情况延迟 / 融资渠道受限融资 5 BD 收入节奏不确定依赖 BMS 全球临床推进 + 监管审批节奏收入 6 散户关注度过高 1385 亿市值 / 1 年涨 +14% / 机构一致目标价 408 元（+22%）估值 7 BD 首付款一次性收入风险 2024 是高基数 / 2025 大幅下滑收入结构 8 仿制药 / 中成药持续萎缩化药 -11.85% / 中成药 -41.64% 现金流补充【催化剂】 # 催化剂关键事件时间 1 iza-bren 鼻咽癌获批（最强）全球首个双抗 ADC 商业化元年启动 2026-06-22 已落地 2 食管鳞癌 / 三阴乳腺癌 NDA 获批全球首个食管癌 ADC + 全球首个双终点获益 TNBC 2026 Q4 预计 3 BMS 海外里程碑 2.5 亿美元近期 + 后续 71 亿美元（开发/注册/销售） 2026-2030 4 港股 IPO 重新启动缓解融资压力 / 国际曝光 2026 H2-2027 5 EGFR 突变 NSCLC III 期联合奥希替尼一线治疗 ORR 100% 2027 6 SCLC 一线 III 期联合 PD-1 替雷利珠单抗 / mPFS 8.2 个月 2027-2028 7 ADC 商业化销售爬坡鼻咽癌 + 食管鳞癌 + 三阴乳腺癌三大瘤种 2026 Q4-2027 8 新增海外 BD 管线 17 款创新药 + 多特异性抗体平台 2026-2027 十一、估值参考（不做目标市值预测）【估值参考数据】 • 当前总市值：1385.19 亿元（2026-07-02 收盘 335.50 元 × 总股本 4.13 亿股） • 静态 PE（2025 年报）：亏损（PE 无意义）—— 2025 归母 -10.54 亿 • 动态 PE（2026E 券商一致预期）：亏损 —— 2026 业绩拐点未确认 • 每股净资产：13.67 元（2026-03-31） • 市净率：约 19.97x（极高，反映创新药平台稀缺溢价） • 1 年涨幅：+14.10% • 机构一致目标价：408.52 元（距 6-30 收盘 +38.94%）—— 太平洋 333.52 / 华泰 314.67 / 国联民生买入未给目标价【分部估值测算（SOTP 框架）】按 Serenity 框架，百利天恒应做分部估值（保守取下限 / 中性取中位 / 乐观取上限）： ① 现有管线 BD 价值（已签约 BMS 84 亿美元） • 已收：8 亿美元首付 + 2.5 亿美元里程碑 = 10.5 亿美元 × 7.2 汇率 = 75.6 亿人民币 • 潜在里程碑：73.5 亿美元（2.5 亿近期或有 + 71 亿开发/注册/销售） • 保守（潜在 25% 实现）：10.5 + 73.5×25% = 28.875 亿美元 × 7.2 = **208 亿** • 中性（潜在 50% 实现）：10.5 + 73.5×50% = 47.25 亿美元 × 7.2 = **340 亿** • 乐观（潜在 100% 实现）：10.5 + 73.5×100% = 84 亿美元 × 7.2 = **605 亿** ② 创新药商业化价值（按 PS 法估算） ⚠️ 创新药商业化刚启动（鼻咽癌 2026-06-22 获批，食管鳞癌 / 三阴乳腺癌 2026 Q4 NDA），估值不确定档位适应症 2030 E 营收 PS 倍数估值保守（取下限）仅鼻咽癌 20 亿 10x 200 亿中性（取中位）鼻咽 + 食管鳞癌 65 亿 12x 780 亿乐观（取上限）鼻咽 + 食管鳞癌 + 三阴 + EGFR 突变 NSCLC 200 亿 15x 3000 亿 ③ 仿制药 + 中成药（萎缩业务） • 2025 营收 3.80 亿（化药 2.84 + 中成药 0.96） • 萎缩业务估值 ≈ 净资产 × 0.5x = 15-20 亿（保守 15 / 中性 18 / 乐观 20）【分部估值合计（三档对比）】业务板块保守中性乐观 ① 现有管线 BD 价值 208 亿 340 亿 605 亿 ② 创新药商业化价值 200 亿 780 亿 3000 亿 ③ 仿制药 + 中成药 15 亿 18 亿 20 亿合计估值 423 亿 1138 亿 3625 亿当前总市值（1385 亿）高估 227% 高估 22% 低估 62% ⚠️ 关键洞察：当前市值 1385 亿**已超过中性 1138 亿（高估 22%）**，处于【中性 1138 亿 - 乐观 3625 亿】之间（距乐观低估 62%）。若食管鳞癌 / 三阴乳腺癌 2026 Q4 顺利获批 + 销售爬坡超预期，将向乐观场景靠拢；否则需警惕向中性回调。【不做目标市值预测】按用户硬规则，本文不做"目标市值测算"——因为： ① 创新药商业化收入节奏难以精确预测（鼻咽癌 6-22 已获批但销售爬坡未知，食管鳞癌 / 三阴乳腺癌 2026 Q4 NDA 待批） ② BD 里程碑节奏不确定（BMS 海外临床推进 + 监管审批依赖 FDA / EMA 节奏） ③ 港股 IPO 暂停影响融资能力（2025-11-12 因市场情况延迟，重启时间未知）尤其"2030 E 创新药营收 150-200 亿"这类推算，没有公开单客户 / 单适应症数据证明合理性。【评级理由】 • 5 个核心证据点（Serenity 卡点框架）：✅✅✅ 1 + ✅✅ 4 = 5 项全成立 • 13 原则：✅ 9 + ⚠️ 1 + N/A 3 → 9 项成立 • 8 反模式：⚠️ 2 + ✅ 6 → 2 项注意（杠杆 + 仿制药萎缩），6 项合规 • 15 Checklist：✅ 10 + ⚠️ 4 + ❌ 1 → 10 项通过 • 业绩拐点：2025 销售毛利额 -58.9% / 2026 Q1 销售毛利额 0.51 亿（基数极小）→ **未确认** • 三档分部估值：保守 423 亿 / 中性 1138 亿 / 乐观 3625 亿（当前 1385 亿，高估 22%~227%） • 当前市值 1385 亿（超硬规则 #8 放宽 1000 亿上限，但不可替代"极高" + 增长空间"极高"，可纳入）附录 A、创新药研发三个口径（避免混淆）创新药研发领域有三种不同的口径，混用会导致估值偏差 10 倍以上。必须严格区分：【三个口径一览】口径含义数值范围百利天恒实际用途 A. 研发管线数量创新药 IND / I 期 / II 期 / III 期 / NDA 总数全球 363 项 ADC 管线 17 款在研 + 100 余项临床管线规模 B. 卡点真实度（5 个证据点）专利稀缺 + 监管认证 + 制造 know-how + 下游依赖 + 替代品壁垒 5 项全成立 / 部分成立 / 不成立 ✅✅✅ 1 + ✅✅ 4 = 5 项全成立评级主要依据 C. 业绩 = 销售额 × 毛利率业务真实赚钱能力 — 2025 22.87 亿 / 2026 Q1 0.51 亿拐点判断 ⚠️ 三者差异巨大 —— 必须明确口径（C 是唯一可靠的业绩判断指标）【使用指南 + 红旗判定】 • 口径 B（卡点真实度 5 项全成立）但口径 C（销售毛利额 -58.9%）→ **卡点真实但业绩下滑**（典型矛盾型标的） • 口径 C（销售毛利额）下滑 → 立即按硬规则 #1 复核毛利率是否被压制（2025 毛利率 -4.66pct） • 口径 A / B / C 三者偏离度过大 → 业绩真实性存疑，必须降级 • 本标的：口径 B 5 项全成立 + 口径 C -58.9% → B+ 级（卡点真实但业绩拐点未确认）附录 B、最终评级（Serenity v3.2 S/A/B/C/D/F 6 档分级）【评级体系（硬规则 #2 修订，2026-07-01 起 Tier 1/2/3/4 全部废弃）】评级含义当前标的 S 极致卡点 + 5 个核心证据点全成立 + 业绩爆发 — A 强卡点 + 4 维成立 + 业绩稳健 — B+ 卡点真实 + 3-4 维成立 + 业绩向上百利天恒 B 卡点真实 + 3-4 维成立 + 业绩改善但基数小 — C 卡点真实但业绩失速 + 高估 — D 治理风险 / 业绩双降 — F 破产 / 退市风险 — 【百利天恒最终评级】评级：B+ 级（卡点真实但业绩拐点未确认）理由： • 卡点真实（5 个核心证据点全成立，含 ✅✅✅ 1 项极强：全球首个双抗 ADC） • 5 维 5 项成立 + 13 原则 9 项成立 + 8 反模式 6 项合规 + 15 Checklist 10 项通过 • 业绩拐点未确认：2025 销售毛利额 -58.9% / 2026 Q1 销售毛利额 0.51 亿（基数极小）/ 经营现金流 -7.42 亿 • 风险：业绩拐点未确认 + 经营现金流持续为负 + 研发投入占营收 99.75% + 港股 IPO 暂停 + 散户关注度过高 • 三档分部估值：保守 423 亿 / 中性 1138 亿 / 乐观 3625 亿（当前 1385 亿，**已超过中性 22%**，处于中性 - 乐观之间） • 市值放宽：不可替代"极高" + 增长空间"极高" → 1385 亿纳入核心建仓候选 • 关键观察窗口：2026 Q4 食管鳞癌 / 三阴乳腺癌 NDA 获批 + 销售爬坡数据 --- 报告结束 --- 报告日期：2026-07-02 | 数据截至：2026-07-02 收盘本文不构成投资建议，市场有风险，投资需谨慎奥浦迈（688293.SH）深度拆解再鼎医药 (09688.HK) 深度拆解

2026-07-02

·BioSpace

Enhertu® Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors

Approval based on three phase 2 trials of Daiichi Sankyo and AstraZeneca’s Enhertu that demonstrated clinically meaningful responses across a broad range of tumors Enhertu now approved for six indications in the EU TOKYO--(BUSINESS WIRE)--Enhertu ® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across three phase 2 trials, including DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 . In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate (ORR) of 52.3% (95% confidence interval [CI]: 42.6-61.8) and median duration of response (DOR) of 21.1 months (95% CI: 10.6-25.0) in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors. In DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% (95% CI: 27.8-77.0) and median DOR of 6.9 months (95% CI: 4.0-9.8) in a subgroup of previously treated patients (n=17) with centrally confirmed HER2 positive non-small cell lung cancer (NSCLC). In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) and median DOR of 5.5 months (95% CI: 4.2-8.1) in a subgroup of previously treated patients (n=64) with centrally confirmed HER2 positive colorectal cancer. “HER2 overexpression occurs across multiple tumor types and is associated with aggressive disease and a poor prognosis. Until now, HER2 directed therapies were only available for specific tumor types," said Benedikt Westphalen, MD, Head of the Precision Oncology Program, Comprehensive Cancer Center of the University of Munich, Germany. “The approval of trastuzumab deruxtecan as a tumor agnostic therapy opens a new treatment option for patients with HER2 positive cancers regardless of where the tumor originated.” In DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, the safety pro Enhertu was consistent with previous clinical trials with no new safety concerns identified. Grade 3 or grade 4 adverse reactions from a pooled safety analysis of patients treated with Enhertu (5.4 mg/kg) across multiple tumor types in clinical studies included neutropenia (18.5%), anemia (9.9%), fatigue (8.2%), leukopenia (5.8%), thrombocytopenia (5.2%), nausea (4.8%), lymphopenia (4.2%), hypokalemia (3.6%), increased transaminases (3.6%), diarrhea (2.5%), vomiting (2.4%), decreased appetite (1.6%), pneumonia (1.4%) and decreased ejection fraction (1.0%). Grade 5 adverse reactions occurred in 1.1% of patients, including interstitial lung disease/pneumonitis (1.0%). “This approval of Enhertu marks a significant milestone in the EU for patients with HER2 positive metastatic solid tumors and establishes the first tumor agnostic indication for a HER2 directed therapy and antibody drug conjugate in the region,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “Enhertu is now approved for six indications in the EU, which demonstrates our commitment to advancing innovative medicines in areas of high unmet need to patients with cancer.” “Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “Enhertu is already approved in breast, gastric and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2 positive status across multiple additional tumor types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2 positive disease are considered for targeted treatment.” Enhertu (5.4 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Additional regulatory submissions for Enhertu also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from the DESTINY-Breast09 trial and for patients with HER2 positive breast cancer with residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05 trial. Financial Considerations Following this approval in the EU, an amount of $25 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2 positive metastatic solid tumor indication. Sales of Enhertu in most EU territories are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019 . About DESTINY-PanTumor02 DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors. The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DOR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, tolerability and pharmacokinetics. Results from DESTINY-PanTumor02 were published in the Journal of Clinical Oncology . DESTINY-PanTumor02 enrolled 267 patients, including 111 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America, South America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About DESTINY-Lung01 DESTINY-Lung01 is a global, open-label, two-cohort, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg or 6.4 mg/kg) in patients with HER2 mutant (Cohort 2, n=91) or HER2 overexpressing (defined as IHC 3+ or IHC 2+) (Cohort 1 and 1a, n=90) unresectable or metastatic NSCLC who had progressed after one or more systemic therapies. The primary endpoint of DESTINY-Lung01 is confirmed ORR by independent central review. Key secondary endpoints include DOR, DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology . DESTINY-Lung01 enrolled 181 patients, including 17 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov . About DESTINY-CRC02 DESTINY-CRC02 is a global, randomized, two arm, parallel, multicenter, phase 2 trial evaluating the efficacy and safety of two doses (5.4 mg/kg or 6.4 mg/kg) of Enhertu in patients with locally advanced, unresectable or metastatic HER2 positive colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant tumor types previously treated with standard therapy. The trial was conducted in two stages. In the first stage, patients (n=80) were randomized 1:1 to receive either 5.4 mg/kg or 6.4 mg/kg of Enhertu. In the second stage, additional patients (n=42) were enrolled in the 5.4 mg/kg arm. The primary endpoint in DESTINY-CRC02 is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DOR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety. Results from DESTINY-CRC02 were published in The Lancet Oncology. DESTINY-CRC02 enrolled 122 patients, including 64 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About HER2 Expression in Solid Tumors HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth. 1 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in some cancers. 2 HER2 overexpression occurs in a range of solid tumors with the prevalence varying by tumor type. 3 HER2 directed therapies have been used to treat HER2 overexpression in breast, gastric and biliary tract cancers in the EU. 1,4,5,6 Although HER2 is overexpressed in additional solid tumor types including biliary tract, lung, bladder, cervical, colorectal, endometrial, ovarian, salivary gland and pancreatic cancers, HER2 testing is not routinely performed in these additional tumor types and prior to this approval there were no HER2 directed treatments approved in the EU to treat a broad range of solid tumors. 2,7,8 About Enhertu Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4 mg/kg) is approved in the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4 mg/kg) followed by THP is approved in China and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in Brazil, India, Israel, Saudi Arabia, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu (5.4 mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4 mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. Enhertu (5.4 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 , DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the Enhertu Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019 and Datroway ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . ________________________________ REFERENCES: 1 Iqbal N, et al. Mol Biol Int. 2014;852748. 2 Cheng X. Genes (Basel ). 2024;15(7):903. 3 Yan M, et al. Cancer Metastasis Reviews. 2015;34(1):157-164. 4 Benli Y, et al. Clin Transl Oncol . 2025;27(9):3607-3624. 5 Uy NF, et al. Cancers (Basel) . 2022;14(17):4155. 6 Haigh JE, et al. Curr Oncol . 2024;31(9):5652-5661. 7 Omar N, et al. Pathogenesis . 2015;2(3):1-9. 8 Ismail A, et al. Oncologist . 2025;30(9):258. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) EU: Simone Jendsch-Dowé simone.jendsch-dowe@daiichisankyo.com +49 (89) 78080 (office) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

临床结果临床2期上市批准引进/卖出抗体药物偶联物

100 项与德帕瑞妥单抗相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	美国	Merck & Co., Inc.	2023-12-22
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2023-12-22
HR阳性/HER2阴性乳腺癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	中国	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	巴西	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	加拿大	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	智利	Merck Sharp & Dohme LLC	2025-07-21

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07060807 (HERTHENA-Breast04, ASCO2026)	临床3期	局部晚期不能切除的乳腺癌 HR positive \| HER2 negative	500	HER3-DXd 5.6 mg/kg IV on day 1 Q3W	構構鹽窪鹽獵夢遞淵膚(鹽構醖齋獵鑰鹹製鬱鹽) = 壓製蓋構衊廠網壓蓋膚選顧願醖願糧衊齋糧製 (選鏇願積製製獵鑰網壓 ) 更多	积极	2026-05-29
NCT07060807 (HERTHENA-Breast04, ASCO2026)	临床3期	局部晚期不能切除的乳腺癌 HR positive \| HER2 negative	500	Treatment of physician’s choice (TPC)	構構鹽窪鹽獵夢遞淵膚(鹽構醖齋獵鑰鹹製鬱鹽) = 鑰遞膚網糧網積鑰夢願選顧願醖願糧衊齋糧製 (選鏇願積製製獵鑰網壓 ) 更多	积极	2026-05-29
NCT04699630 (CTgov)	临床2期	局部晚期乳腺癌 \| HER2阳性转移性乳腺癌 \| 转移性乳腺癌	121	U3-1402 (Part A)	範鹹艱鬱觸構獵糧夢繭 = 遞願積網選蓋餘齋廠顧積繭糧遞構鑰鹽構蓋餘 (夢範觸築艱網鏇鬱簾繭, 廠廠鑰夢廠夢觸製壓艱 ~ 糧觸鑰衊鹹觸窪衊夢憲) 更多	-	2026-05-07
NCT04699630 (CTgov)	临床2期	局部晚期乳腺癌 \| HER2阳性转移性乳腺癌 \| 转移性乳腺癌	121	U3-1402 (Part B)	範鹹艱鬱觸構獵糧夢繭 = 繭遞願艱醖鹹鹽膚願餘積繭糧遞構鑰鹽構蓋餘 (夢範觸築艱網鏇鬱簾繭, 醖構獵製鏇製蓋淵糧齋 ~ 壓簾醖遞獵齋壓顧製夢) 更多	-	2026-05-07
NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	临床1/2期	晚期 HER2 阳性乳腺癌 HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab	獵觸夢簾鏇衊壓襯衊壓(網壓積獵觸窪網膚繭獵) = The geometric mean ratios (GMRs) for Ctrough were within 71.9–104.5% for HER3-DXd ADC, 71.4–106.4% for total HER3-DXd antidrug antibody, and 79.0–90.3% for free DXd payload across all comparisons. The 90% CIs for AUC24s were 83.0–109.2% for HER3-DXd ADC, 80.6–110.8% for total HER3-DXd antidrug antibody, and 84.4–106.0% for free DXd payload. 壓顧積製夢遞繭願艱廠 (築餘窪齋積齋繭顧壓壓 )	积极	2025-12-05
NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	临床1/2期	晚期 HER2 阳性乳腺癌 HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab + pertuzumab		积极	2025-12-05
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	脑转移瘤	21	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	願鹹壓築蓋繭選窪積鹹(齋餘壓簾鏇積壓壓壓廠) = 範夢觸憲壓製鏇膚壓構壓鹹夢衊鬱鏇廠憲製憲 (憲壓鹽遞築衊艱窪願願 ) 更多	积极	2025-11-01
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	非小细胞肺癌	20	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	製鬱觸憲鑰願鹹糧網鬱(構膚製齋衊積鏇製鹹觸) = neutropenia in three (15%) patients and febrile neutropenia in two (10%). 鹹餘願鑰遞製鑰網選簾 (廠齋膚簾網醖餘鏇簾襯 ) 更多	积极	2025-11-01
NCT06172478 (HERTHENA-PanTumor01, Pubmed \| Future Oncol)	临床2期	晚期恶性实体瘤	100	Patritumab deruxtecan (HER3-DXd)	醖夢壓願醖齋衊壓鑰廠(鬱襯觸顧窪積鏇襯鏇夢) = 遞鏇獵鏇網顧積鑰鬱襯糧壓遞蓋繭憲顧襯齋鬱 (獵餘夢齋廠積鏇簾範壓 ) 更多	积极	2025-10-21
NCT04965766 (ICARUS-BREAST01, Pubmed \| Nat Med)	临床2期	晚期乳腺癌 HR+ \| HER2-	99	Patritumab deruxtecan	製獵膚鹹鬱襯鹽壓淵餘(願壓顧鏇艱製網蓋遞窪) = 壓窪醖鹹鬱顧淵夢網繭衊鏇憲窪糧構顧製鑰觸 (鑰糧鹽鹽餘鏇顧艱範顧, 44.8 ~ 62.1)	积极	2025-10-01
NCT03260491 (Pubmed \| J Clin Oncol) 人工标引	临床1期	非小细胞肺癌	47	HER3-DXd	夢鬱選築願蓋襯簾鹽糧(積觸顧積糧製鬱壓糧憲) = 鬱觸製網憲範壓憲鏇選積廠願醖鬱繭構艱糧築 (壓簾鬱夢窪餘蓋淵獵鑰, 15.6 ~ 42.6) 更多	积极	2025-06-24
NCT05338970 (HERTHENA-Lung02, ASCO2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Exon 19 Deletion \| EGFR L858R	586	Patritumab deruxtecan (HER3-DXd)	願構選顧網鏇觸蓋廠窪(鑰獵膚憲襯憲襯衊築構) = 鏇憲醖獵糧獵醖淵遞選構鑰壓遞醖鑰憲艱鑰鑰 (鹽構遞淵鑰遞艱簾淵顧, 5.5 ~ 6.8) 更多	积极	2025-05-30
NCT05338970 (HERTHENA-Lung02, ASCO2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Exon 19 Deletion \| EGFR L858R	586	Platinum-based chemotherapy (PBC)	願構選顧網鏇觸蓋廠窪(鑰獵膚憲襯憲襯衊築構) = 獵鹽構餘憲獵鹽鬱鹽遞構鑰壓遞醖鑰憲艱鑰鑰 (鹽構遞淵鑰遞艱簾淵顧, 5.0 ~ 5.6) 更多	积极	2025-05-30
NCT05865990 (TUXEDO-3, ASCO2025)	临床2期	晚期恶性实体瘤 \| 转移性乳腺癌 \| 晚期鳞状非小细胞肺癌 ... HER3 更多	61	HER3-DXd 5.6 mg/kg	窪顧築醖遞觸構簾積襯(襯艱願夢鏇夢築壓夢選) = 築繭鬱遞鹽築憲壓積繭鏇遞網醖鏇襯齋鏇願鑰 (顧簾膚繭壓齋範鬱鑰鑰 )	积极	2025-05-30