NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0/is ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio [HR] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% [REFs], whereas the addition of platinum increases pCR rates to approximately 50-55%.
The KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC.
Despite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial:
1. Do all patients require the full 6 months of NACT as per KEYNOTE-522 or is there a subgroup of patients who are sufficiently treated with 12 weeks of NACT plus PEM?
2. Can incorporation of ADCs into the KEYNOTE-522 regimen improve response and outcomes in patients without an optimal early response? The outcome of patients with residual disease after 24 weeks of NACT and PEM remains suboptimal and there is an urgent need for more effective strategies. ADCs such as SG have demonstrated superior efficacy compared to standard chemotherapy in metastatic TNBC, resulting in substantially higher response rates and improved progression-free (PFS) and OS. Combination studies of ADCs and immunotherapy in metastatic TNBC have demonstrated significant activity, suggesting possible synergistic activity It is therefore a logical next step to investigate, whether the incorporation of SG in the NACT regimen can improve pCR rates and EFS results in patients who have residual clinical disease after 12 weeks of NACT with CARBO/PAC + PEM.

开始日期2026-01-31

申办/合作机构

Gilead Sciences, Inc.

NCT06462092

/ Recruiting临床1/2期IIT

A Phase I/II Clinical Study of Sacituzumab Govitecan Combined With Intrathecal Chemotherapy for the Treatment of Leptomeningeal Metastases From Her2-negative Breast Cancer

Leptomeningeal metastases (LM) is a lethal complication of malignant tumors, characterized by tumor cell invasion and proliferation within the subarachnoid space. LM from HER2-negative breast cancer remains challenging to treat, with a median overall survival of only 3-6 months despite aggressive therapy. This open-label, uncontrolled Phase I/II clinical study aims to evaluate the safety, feasibility, and potential efficacy of Sacituzumab Govitecan in combination with intrathecal pemetrexed chemotherapy for LM from HER2-negative breast cancer, with the objective of identifying a more effective treatment strategy.

开始日期2026-01-01

申办/合作机构

广州医科大学

NCT07134556

/ Not yet recruiting临床2期

A Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as First-line Therapy for PD-L1 Positive Advanced Triple-negative Breast Cancer

The ADJUNCT is a single-arm, phase II clinical trial to evaluate the safety and efficacy of the combination of zimberelimab, domvanalimab and sacituzumab govitecan as first-line therapy for patients with PD-L1 positive advanced or metastatic triple-negative breast cancer.

开始日期2025-12-08

申办/合作机构

Medica Scientia Innovation Research SL

100 项与戈沙妥组单抗相关的临床结果

登录后查看更多信息

100 项与戈沙妥组单抗相关的转化医学

登录后查看更多信息

100 项与戈沙妥组单抗相关的专利（医药）

登录后查看更多信息

2,046

项与戈沙妥组单抗相关的文献（医药）

2025-12-02·Expert Opinion On Drug Safety

Mining and influencing factors analysis of sacituzumab govitecan adverse drug event based on FAERS database

Article

作者: Liu, Xiaobo ; Fan, Hao ; Hua, Peng ; Wu, Xuejiao ; Duan, Xueyu ; Yang, Liu ; Wu, Shilin ; Zhang, Dingcai

OBJECTIVE:

Utilizing the FAERS database, this study aims to analyze the ADE signals of sacituzumab govitecan to provide references for clinical safety.

METHODS:

By searching the US FAERS database, we applied Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods to analyze ADE reports for sacituzumab govitecan from Q2 2020 to Q4 2023, covering 15 quarters.

RESULTS:

The total number of reports with sacituzumab govitecan as the first suspicion was 2854. A total of 139 signals involving 26 SOCs were obtained. The most reported were general disorders and administration site conditions (2,307 cases, 25.66%), followed by gastrointestinal disorders (1,125 cases, 12.52%), and investigations (810 cases, 9.01%). Frequent ADEs included sepsis and COVID-19 were not listed in the prescribing information. The signal strength analysis highlighted conditions like cholestasis and epilepsy not mentioned in the prescribing information. Furthermore, an analysis of influencing factors revealed differences in infections and infestations by gender and nationality (p < 0.05), and in gastrointestinal disorders and blood and lymphatic system disorders by gender, treatment duration, and nationality (p < 0.05).

CONCLUSIONS:

Common ADEs generally correspond with the prescribing information. Clinicians should be vigilant regarding unlisted ADEs about sacituzumab govitecan, and close monitoring of laboratory indicators ensure patient medication safety.

2025-12-01·BREAST CANCER RESEARCH AND TREATMENT

Evaluation of efficacy and safety of sequential antibody drug conjugates (ADCs) in human epidermal growth factor 2 (HER2)-negative metastatic breast cancer

Article

作者: Bansal, Rani ; Erkanli, Alaattin ; Yang, Lexie Zidanyue ; Moore, Heather ; Anders, Carey ; Nezirevic, Sara ; Dent, Susan

Abstract:

Purpose:

Limited data is available assessing sequencing of antibody drug conjugates (ADCs) in patients with hormone receptor-positive (HR +), human epidermal growth factor 2 (HER2)-negative, HER2-low, and triple-negative metastatic breast cancer (MBC), including patients with brain metastases (BrM) or leptomeningeal disease (LMD). This study assesses the efficacy and safety of sequential sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) in MBC and impact on chemotherapy (CTX).

Methods:

This is a single-center, retrospective, cohort study in adult patients with HR + , HER2-negative, or low MBC who received T-DXd and/or SG.

Results:

A total of 112 patients were divided into three cohorts: ADCs given sequentially (cohort A), ADC then CTX (cohort B), or CTX between ADCs (cohort C). The median progression-free survival (mPFS) in cohort A was 4.5 months for SG before T-DXd and 3.1 months for T-DXd before SG. In cohort B, mPFS was 3.1 months for CTX following T-DXd. For CTX following SG, mPFS for CTX was 2.5 months. In patients who received both ADCs, PFS was 2.1 months. In cohort C, mPFS for SG following T-DXd and CTX was 2.1 months and 3.3 months for T-DXd following SG and CTX. The mPFS for ADC1 was longer than ADC2 (5.5 months SG, 3.4 months T-DXd). Those with BrM and/or LMD demonstrated stable disease.

Conclusion:

Sequential administration of ADCs results in a shorter PFS. CTX efficacy is impacted by prior ADC administration. Outcomes for patients with BrM and LMD do not differ for those without recurrence to the brain.

2025-12-01·Oncology and Therapy

Application and Progress of Antibody-Drug Conjugates (ADCs) in the Treatment of Metastatic Triple-Negative Breast Cancer

Review

作者: Chen, Chao ; Xie, Banghong ; Huang, Weiwei ; Liu, Jian ; Wang, Lili ; Cai, Haolin ; Chen, Mulan ; Wu, Fan

Metastatic triple-negative breast cancer (TNBC) lacks actionable targets, and chemotherapy yields median progression-free survival (mPFS) of 4.6-9.7 months and median overall survival (mOS) of 12.6-26.3 months. Immune checkpoint inhibitors (ICIs) and poly (ADP-ribose) polymerase (PARP) inhibitors only help subsets (objective response rate [ORR] of ~ 5% and ~ 12%, respectively). Antibody-drug conjugates (ADCs) have emerged as a leading therapeutic strategy: sacituzumab govitecan extended mPFS to 5.6 months (ASCENT trial), SKB264 to 6.7 months, and datopotamab deruxtecan achieved an ORR of 79%. In Human epidermal growth factor receptor 2 (HER2)-low TNBC, trastuzumab deruxtecan prolonged OS to 18.2 months, while disitamab vedotin and SHR-A1811 achieved ORRs of 26% and 60%, respectively. ADCs targeting Human epidermal growth factor receptor 3 (HER3)-, Nectin-4-, LIV-1- and folate receptor α (FRα) showed responses in 22%-54% of cases. Resistance can arise via antigen loss, endocytic defects, lysosomal failure, and efflux pumps. Bispecific ADCs, linker optimization, and combination regimens (ICI, PARPi) are under investigation. Future efforts will focus on targeting epidermal growth factor receptor (EGFR) and FRα and on developing multimodal immunovascular strategies to sustain clinical benefit.

1,532

项与戈沙妥组单抗相关的新闻（医药）

2025-12-08

·药新谈

2025年国家医保药品目录深度分析：结构变革、产业影响与未来趋势

点击卡片一键关注关注后发送“加群”，邀请你免费加入医药交流群！目录整体结构分析数据驱动的全景透视根据《2025年国家医保药品目录》官方文件，目录构成如下： · 西药部分：1446个（甲类393个，乙类1053个） · 中成药部分：1335个（含民族药95个，甲类246个，乙类1089个） · 协议期内谈判药品部分：472个（西药411个，中成药61个，均按乙类管理） · 中药饮片部分：892个可支付品种+负面清单 · 总计：3253个药品（较2024年增加114个） PS：如有需要《国家基本医疗保险、生育保险和工伤保险药品目录》以及《商业健康保险创新药品目录》（2025年）PDF~，可以关注下方【药新谈】公众号，发送关键词“1207”方可获取！品类分布特点： 1. 西药占比55.4%，中成药占比41.0%，谈判药品占比14.5%（部分与西药/中成药重叠计算） 2. 乙类药品占据主导地位（约75.8%），体现“保基本”原则下的共付机制 3. 谈判药品全部按乙类支付，彰显医保对高价创新药的审慎准入态度 2025版目录核心调整四大结构性变革（一）新增药品分析：聚焦临床价值与创新性新增114个药品中：创新药占比43.9%，其中50个为一类创新药（化学药31个，生物药19个） 1、治疗领域集中度 · 抗肿瘤药：38个（33.3%） · 罕见病用药：22个（19.3%） · 慢性病用药：28个（24.6%） · 抗感染/其他：26个（22.8%） 2、标志性新增品种 · 三阴乳腺癌新药：Sacituzumab govitecan（首个TROP-2 ADC） · 胰腺癌靶向药：Ivosidenib（IDH1突变） · 地中海贫血创新疗法：Luspatercept（首个红细胞成熟剂） · 阿尔茨海默病新药：Lecanemab（β淀粉样蛋白抗体）（二）支付范围优化：精准满足临床需求 1. 适应症限制精细化：如PD-1抑制剂新增一线胃癌、肝癌适应症 2. 用药顺序明确化：如GLP-1受体激动剂限制“二甲双胍治疗不佳后使用” 3. 儿童用药扩容：新增17个儿童专用或儿童适应症药品（三）谈判机制成熟化成功率创新高：88%（2024年为76%）平均降幅理性：61.2%（较2024年的64.7%略有下降）续约规则优化：对销售额未达预期的品种给予更温和降价首版商保创新药目录的深层意义（一）19个入选产品的构成分析类别数量代表品种核心特征细胞与基因治疗 6 CAR-T（阿基仑赛等）、基因疗法单次治疗费用＞50万元罕见病高值药 5 戈谢病酶替代疗法、神经母细胞瘤抗体年费用 30-100万元前沿肿瘤免疫 4 双特异性抗体、新一代ADC 年费用＞20万元神经退行性疾病 2 阿尔茨海默病新药年费用＞10万元其他高创新性 2 创新型糖尿病疗法等临床价值明确但价格高（二）商保目录的三大机会 1. 支付机制创新：探索“医保+商保”分层支付，缓解基金压力 2. 市场准入加速：商保覆盖可作为医院准入的“信用背书” 3. 患者可及性提升：为无法进入医保的高值药提供支付路径国家医保支持方向的五大变化趋势（一）从“广覆盖”到“精准保障” 数据佐证：新增药品中，针对明确生物标志物的靶向药占比从2020年的35%提升至2025年的58% 政策意图：避免无效用药，提升基金使用效率（二）从“价格导向”到“价值导向” 谈判逻辑转变：对真正突破性创新药（如CAR-T）给予更高支付标准证据要求提升：需提供真实世界数据、药物经济学评价（三）罕见病保障制度化突破数量增长：罕见病用药从2019年的30个增至2025年的89个机制创新：探索“国家谈判+专项基金”模式（四）中医药支持结构化调整数量稳定：中成药总数1335个，新增以临床证据充分的品种为主支付限制：对“含天然麝香、牛黄”的品种不予支付，推动人工替代（五）儿童用药保障显著增强专用标识：新增17个儿童适用药品，其中5个为儿童专用剂型政策倾斜：儿童药谈判成功率92%，高于平均水平对产业链各环节的深度影响（一）对药厂研发方向的革命性影响 1. 靶点选择聚焦化：同质化靶点（如PD-1）已基本关闭准入窗口 First-in-class、突破性疗法获得溢价空间 2. 临床开发策略转变：需从Ⅰ期临床就规划医保准入路径真实世界研究成为谈判必备证据 3. 定价策略重构：中国市场价格需参考全球价格体系 “高开高走”模式难以为继，需合理定价（二）对医院与临床医生的双重影响积极影响治疗选择增加：特别是肿瘤、罕见病领域临床指南更新加速：2025版CSCO指南已同步更新32个医保新增方案挑战合理用药压力增大：需严格遵循支付限制条件药占比考核复杂化：高值创新药使用需平衡指标压力处方习惯改变：从“经验用药”转向“证据用药” （三）对代理商/医药代表的生存环境剧变传统模式危机 1. 带金销售空间归零：反腐高压+医保智能监控 2. 准入价值弱化：国家谈判直接决定进院资格 3. 客情关系贬值：医生处方权受医保规则严格约束新兴机会领域 1. 创新药专业化推广：要求代表具备医学背景，能解读临床数据需协助医生完成用药申请、患者教育等 2. 罕见病/专科药服务：建立患者援助项目（PAP）管理能力提供用药随访、不良反应监测服务 3. 商保衔接服务：帮助患者办理商保理赔协助医院建立“双通道”药房管理流程（四）对患者的实质性利好 1. 经济负担降低：新增肿瘤药平均降价65%，患者年自付从15-30万元降至3-8万元罕见病药纳入后，患者自付比例从100%降至30%以下 2. 治疗可及性提升：三阴乳腺癌患者：从无靶向药到有医保覆盖的ADC药物地中海贫血患者：从依赖输血到有口服祛铁剂+创新疗法 3. 用药便利性改善： “双通道”药房扩大至全国85%的县级区域电子处方流转平台实现“处方-医保结算-配送”一站式服务代理商/医药代表的转型生存指南（一）能力重构：从“销售员”到“医疗合作伙伴” 必须掌握的六大核心能力： 1. 医学知识体系：能理解药物作用机制、临床数据 2. 医保政策解读：熟悉本地支付细则、经办流程 3. 患者服务能力：协助用药指导、不良反应管理 4. 数据工具应用：使用CRM、医学文献数据库 5. 跨部门协作：连接药厂、医院、药店、保险公司 6. 合规风险防控：严格避免任何违规推广行为（二）业务模式创新：四大转型路径路径1：专注高壁垒专科领域 · 选择肿瘤、罕见病、自身免疫等专科领域 · 建立专家网络，提供学术会议、病例讨论等增值服务 · 成功案例：某代理商转型肿瘤药后，人均单产提升300% 路径2：打造“医保+商保”衔接服务 · 培训团队掌握商业保险理赔流程 · 与保险公司合作开发专属健康险产品 · 数据支撑：商保目录药品在试点城市报销比例已达50-70% 路径3：建设数字化患者管理平台 · 开发用药提醒、随访问卷等工具 · 收集真实世界数据反哺药厂研发 · 行业趋势：74%的药厂已投资数字化患者支持项目路径4：转型为CSO（合同销售组织） · 轻资产运营，专注于专业化推广服务 · 按服务效果（如患者依从性提升）收取费用 · 市场空间：中国CSO市场规模年增长率＞25% （三）组织架构调整建议传统架构→ 转型后架构 │ │ ├─销售部─────→├─医学事务部（负责学术推广） ├─市场部─────→├─市场准入部（负责医保/商保对接） └─商务部─────→├─患者服务部（负责用药支持） └─数据分析部（负责效果评估）（四）短期行动清单（2026年必须完成） 1. 全员医保政策培训：通过国家医保局在线平台完成认证 2. 客户分层管理： · A类客户（重点专家）：提供最新临床数据解读 · B类客户（普通医生）：培训医保合理使用规则 · C类客户（基层医生）：普及基本用药知识 3. 工具包升级：开发“医保用药指南”小程序制作“患者自付计算器” 4. 合规体系建立：所有推广活动线上留痕费用报销100%合规凭证前瞻展望：2026-2030年医保改革趋势（一）支付方式进一步精细化 DRG/DIP全面覆盖：2025年底前所有统筹地区实施按疗效付费试点：对部分高值药探索“治愈付费” 年度支出上限：可能针对某些病种设置医保支付上限（二）创新药准入加速但门槛提高预测数据： 2026年医保谈判预计新增100-120个药品其中一类创新药占比将超过50% 但要求提供更严格的卫生经济学证据（三）“基本医保+商保+医疗救助”三层保障体系成熟商保作用扩大：预计2027年商保目录将扩展至50-80个药品患者援助项目规范化：药厂PAP项目将与医保衔接（四）数字化监管全面升级智能监控系统：覆盖90%以上定点医疗机构大数据反欺诈：利用AI识别不合理用药模式在变革中寻找确定性 2025年医保目录的发布，标志着中国医药保障体系进入了 “精准保障、价值医疗” 的新阶段。对于代理商和医药代表而言，这既是传统模式终结的“哀歌”，更是专业化转型的“序曲”。生存法则已重新定义： · 过去靠关系，现在靠专业 · 过去靠客情，现在靠服务 · 过去靠信息差，现在靠价值创造那些能够快速适应变化、重构自身能力、在医保与商保的缝隙中找到新定位的企业与个人，不仅不会被淘汰，反而将在中国医药行业高质量发展的浪潮中，获得前所未有的发展机遇。最终赢家，将是那些真正理解“以患者为中心”、能够为医疗系统提供可持续价值的行业参与者。这场变革没有旁观者，只有早转型者与晚淘汰者之分。现在，就是做出选择的时刻。我是医药销售行业21年连续创业者跨界医药和功能性食品关注“谢心普a”视频号：日常更新干货视频，每周五下午15:30直播，内容均为当下医药市场的热点话题及干货，人人都有免费解答疑虑的机会，让我们一起面对行业变革，寻找新的掘金机会。更多社群，欢迎医药同行加入，加群方式：向【药新谈】公众号发送关键词“加群”即可~ 药新谈公众号是医药人学习分享社区，为医药行业中小企业、创业者以及代理商等人群学习赋能。作者观点和案例仅供学习方法使用。本文版权归药新谈公众号所有，未经授权，禁止转载引用

2025-12-08

·龙谈价值2023

恒瑞，龙头的底蕴

大家好，我是龙哥。和大家聊聊上周五参加恒瑞医药第三届研发日的情况，恒瑞医药一共举办了3次研发日，分别是在2021年10月15日、2023年11月16日、2025年12月5日，每隔两年举办一次，这里大家可以对照我们在2023年11月参加恒瑞医药第二届研发日的文章《巨头盛会》来看看恒瑞这两年的一些变化。 1、技术平台布局恒瑞医药的技术平台覆盖小分子、PROTAC、ADC、单抗、融合蛋白、双抗/多抗、多肽、小核酸、核药等全球主流的药物分子形式，并在其中多个领域为国内领先水平。例如在ADC领域，恒瑞医药目前有1款HER2-ADC产品获批，合计14款ADC产品在临床阶段，其中包括Claudin18.2-ADC、HER3-ADC、Nectin4-ADC、CD79b-ADC、TROP2-ADC（可能暂停）等5款ADC药物被推进到III期临床阶段，还有多款ADC、双抗ADC处于Ib/II期临床阶段。在小核酸领域，连山总在研发日上敢于喊出“在小核酸领域的布局不会落后于中国任何一家公司”，恒瑞医药目前有5款小核酸药物处于临床阶段，前两周写到国内在小核酸布局较为领先的石药集团也是有5款分子处于临床阶段。 2、疾病领域布局从2023年恒瑞医药聚焦到肿瘤、代谢、自免呼吸这三大领域、并表示未来拓展中枢神经领域以来，我们看到近两年恒瑞医药新进临床的项目几乎全部围绕这四大疾病领域，在这四大疾病领域以外只有1-2个新项目进入临床，恒瑞对产品组合的定位为“肿瘤+慢病双轮驱动加速转型”。公司在今年的研发日上提出了“从BIC到BID”的概念，目标不再是聚焦于单个靶点的BIC药物或疗法，而是针对一个疾病领域进行全面、广泛的布局，实现在整个疾病领域最佳的产品组合帮助患者最大化获益，这个策略看起来比较简单，但实际上在全球市场来看，能有这样广泛的管线布局、较低的临床成本和较高的临床效率，也仅有极少数公司能有条件去做这样的布局。例如恒瑞在乳腺癌领域的一站式布局：恒瑞医药拥有最全面的技术平台布局，并在此基础上进行一系列的排列组合联用探索。作为行业里跟踪恒瑞医药研发管线非常紧密的投资人，我们非常直观的感受到恒瑞医药的“工具箱”在肿瘤创新疗法开发中的意义，其可以快速的将“理论上的”潜在联用疗法进行5-10个不同疗法的排列组合，例如IO+小分子、IO+双抗、IO+ADC、TCE+ADC、双抗+ADC、双抗+小分子、小分子+ADC、小分子+PROTAC、小分子+核药、IO+小分子+ADC。你只管天马行空的想象潜在联合疗法，恒瑞医药自会在临床试验帮你验证。糖尿病代谢领域是恒瑞医药近年除肿瘤外创新药密集上市的最重要疾病领域，2021年以来有DPP-4、SGLT-2、DPP4/二甲双胍复方、SGLT-2/二甲双胍复方、DPP-4/SGLT-2/二甲双胍三联复方等5款新药获批，其中HR20031恒格列净瑞格列汀二甲双胍缓释片为全球首个该靶点的三联复方制剂。在全球大火的GLP-1药物领域，恒瑞医药的布局也是国内的绝对龙头，除了首个国内自主研发的GLP-1双靶点激动剂HRS9531已经申报上市外，恒瑞还开发了口服GLP-1（III期临床）、长效胰岛素/GLP-1复方制剂（III期临床）、口服GLP-1/GIPR（II期临床）、GLP-1/GIPR/GCGR（I期临床），以及下一代管线周口服、月注射、Amylin、siRNA等。心血管领域是2024年以来恒瑞医药最重点布局的疾病领域之一，2024年以来恒瑞医药有8个心血管领域的新分子进入I/II期临床，3个项目进入III期临床，1个项目（PCSK9单抗）获批上市。 3、国内创新药临床及商业化恒瑞医药2000多人的临床团队，每月管理临床试验患者数量从2023年的约17000名临床受试者到现在的30000+临床受试者，临床效率仍在提升。SHR-A1811瑞康曲妥珠单抗在2020年7月首次拿到临床批件，用时4年在2024年9月提交上市申请并纳入优先审评，到今年5月仅用时8个月就完成审批、成功获批上市。HRS9531 GLP-1/GIPR在2021年10月26日首次获批I期临床，2025年9月1日即申报上市，IND到NDA仅用时3年零10个月。从管线布局到商业化，还有一段很长的距离，恒瑞医药目前在肿瘤领域的院内市场市占率大概是5.7%，但在其他重点疾病领域的市占率还是很低，如心血管代谢的市占率1.9%，与排名第一的阿斯利康的份额相差十倍；自免的市占率更是只有0.2%，与排名第一的诺华相差160倍，恒瑞在自免呼吸领域的管线布局在中国市场来说已经是非常全面和较为领先，只是这两年恒瑞医药的自免创新药管线才刚开始进入商业化阶段，公司希望自免成为继肿瘤、糖尿病代谢后的恒瑞又一重点领域。以上份额是基于院内市场的数据，实际上院内市场是恒瑞医药竞争优势最强的细分市场，在院外还有广阔的市场，而院外市场恒瑞医药与MNC的差距更大，因此恒瑞医药也强调了响应国家慢病管理号召、深耕广阔市场、提高患者可及性。 4、国际化遥想2023年的研发日，恒瑞医药的出海正处于转型初见成效的阶段，当时的定位是“立足中国、放眼全球”，彼时刚与德国默克签订了14亿欧元的BD交易，拿到1.6亿欧元的首付款。后续两年恒瑞医药的BD交易更进一步，与默沙东、GSK等公司达成了可圈可点的合作授权，BD已经成为恒瑞业务增长的重要驱动力之一。2023年恒瑞的BD收入占比1.2%，2024年BD收入占比9.6%，2025年预计BD收入超过60亿、收入占比超过18%，利润占比则是还要显著高于收入占比。恒瑞医药今年新建一家波士顿研发中心，目前在海外有美国、瑞士、澳洲的4个研发中心，并新任命了全球商业化负责人，短中期以BD授权的方式进入全球市场、达到海外业务的财务回报，中长期恒瑞的目标依然是推进产品海外自主上市和全球化运营。今年的研发日，恒瑞医药还邀请了两家海外合作方的高管来分享，分别是GSK的BD总，以及与恒瑞做GLP-1产品组合Newco的Kailera的CEO。 GSK分享的内容里几页重要的PPT我这里都放一下，大家由此可以感受一下GSK这家代表欧洲老牌药企的MNC是如何看到中国创新药产业的发展以及恒瑞医药的优势。 GSK在2023年以来的重点合作方目前包括恒瑞、翰森、映恩、药明、泽安等公司，其中自翰森引进了B7-H3 ADC和B7-H4 ADC，自恒瑞医药引进了PDE3/4+11款可选分子、以及收购了恒瑞Newco授权的长效TSLP单抗，自映恩生物引进了CDH17 ADC。其看到了中国创新药产业的蓬勃发展，全球创新药行业来自中国市场的BD交易占比在近年大幅提升（图中可以看出来自欧洲和日本的占比下降最为明显），也看到了恒瑞的价值——重点管线与GSK优势领域的较高重合度、30年时间从仿制药企业成长为“big pharma”、较高的临床转化效率。另一位合作方Kailera给出了GLP-1系列海外项目的临床规划和上市时间表，其预计即将启动GLP-1/GIP的全球III期临床（此前10月刚融资6亿美元），且预计2029年获批上市，另外其预计口服的GLP-1/GIP在2030年上市，口服GLP-1预计2031年上市。 ...... 总体来看这次恒瑞的研发日还是内容非常丰富的，日常的投研经常会由于看的太细致而纠结于某个管线、某个靶点的研究，甚至有些投资人可能会觉得各家pharma之间的差别并不大。而这类研发日可以帮助我们跳脱出这种局限性，更加全面、深刻的更新公司各方面的发展和变化。 ...... 近期重点文章：一年一度，创新药最重要的事 2025年创新药融资数据更新医疗数据看的人眼前一黑创新器械出海先锋国内外两大重要医药政策风险提示：本文仅讨论行业/公司经营情况，投资需综合考虑公司经营、估值、管理层等多方面因素，建议读者审慎参考，本文不作为投资依据，不建议大家根据本文做出投资计划。

抗体药物偶联物蛋白降解靶向嵌合体临床3期临床结果引进/卖出

2025-12-08

·GlobeNewswire-Health Care

Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement

Dec. 04, 2025 -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicle™-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026. “We are pleased to partner with Royalty Pharma, whose investment recognizes the value and potential of tividenofusp alfa for the Hunter community and supports our ability more broadly to realize the promise of the TransportVehicle platform,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “With these additional funds, we are well positioned to advance our development programs as we prepare for the launch of tividenofusp alfa, unlocking broad opportunities across serious diseases.” “We are delighted to partner with Denali and acquire a royalty on tividenofusp alfa, an innovative therapy that addresses a significant unmet need in the cognitive and physical manifestations of Hunter syndrome,” said Pablo Legorreta, Chief Executive Officer and Chairman of the Board of Royalty Pharma. “Denali’s technology platform delivers therapeutics across the blood-brain barrier and is a promising new approach to brain diseases. We are thrilled to establish a relationship with Denali and believe tividenofusp alfa is a potential practice-changing therapy that could transform the lives of patients with Hunter syndrome.” The transaction is subject to various closing conditions, including Denali achieving U.S. FDA accelerated approval of tividenofusp alfa. At the closing, Royalty Pharma will make an initial payment of $200 million and Royalty Pharma will be obligated to make an additional payment of $75 million upon achieving European Medicines Agency (EMA) approval of tividenofusp alfa by December 31, 2029. In exchange, Royalty Pharma will receive a 9.25% royalty on worldwide net sales of tividenofusp alfa from Denali. The royalty payments to Royalty Pharma will cease upon reaching a multiple of 3.0x, or 2.5x if achieved by the first quarter of 2039. Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its proprietary TransportVehicle™ platform. With a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform the lives of people living with neurodegenerative, lysosomal storage and other serious diseases. Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta and Alyftrek, GSK’s Trelegy, Roche’s Evrysdi, Johnson & Johnson’s Tremfya, Biogen’s Tysabri and Spinraza, Servier’s Voranigo, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Pfizer’s Nurtec ODT, and Gilead’s Trodelvy, and 18 development-stage product candidates. The content above comes from the network. if any infringement, please contact us to modify.

100 项与戈沙妥组单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	戈沙妥组单抗	L01	DB12893

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
转移性三阴性乳腺癌	欧盟	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	冰岛	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	列支敦士登	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	挪威	Gilead Sciences Ireland UC	2021-11-22
乳腺癌	瑞士	Gilead Sciences, Inc.	2021-09-09
HR阳性/HER2阴性乳腺癌	澳大利亚	Gilead Sciences Pty Ltd.	2021-09-06
尿路上皮癌	美国	Gilead Sciences, Inc.	2021-04-13
三阴性乳腺癌	美国	Gilead Sciences, Inc.	2020-04-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
转移性乳腺癌	申请上市	中国	云顶药业（苏州）有限公司	2021-05-17
广泛期小细胞肺癌	临床3期	美国	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	中国	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	日本	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	阿根廷	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	澳大利亚	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	比利时	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	巴西	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	加拿大	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	法国	Gilead Sciences, Inc.	2025-04-04

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05382299 (ASCENT-03, Pubmed \| N Engl J Med)	临床3期	三阴性乳腺癌	558	Sacituzumab govitecan	鏇繭觸願蓋夢衊鑰齋餘(齋蓋選膚蓋蓋遞醖鏇積) = 餘繭積廠鬱糧夢構餘憲夢齋製願膚醖艱顧鹽糧 (壓膚膚繭鏇齋簾淵簾顧 ) 更多	积极	2025-11-13
				Chemotherapy (paclitaxel, nanoparticle albumin-bound paclitaxel, or gemcitabine plus carboplatin)	鏇繭觸願蓋夢衊鑰齋餘(齋蓋選膚蓋蓋遞醖鏇積) = 構壓夢積遞窪構觸獵觸夢齋製願膚醖艱顧鹽糧 (壓膚膚繭鏇齋簾淵簾顧 ) 更多
NCT05382299 (ASCENT-03, N Engl J Med \| Company_Website \| ESMO2025) 人工标引	临床3期	三阴性乳腺癌一线 HER2 Negative \| PR Negative \| ER Negative	558	Sacituzumab govitecan	壓範網遞夢積淵顧膚顧(觸廠艱醖蓋夢醖窪顧衊) = 齋糧膚構憲簾鑰醖鏇膚糧獵鬱鹽觸壓蓋構襯糧 (簾積艱繭糧遞廠齋築鏇, 8.1 ~ 11.1) 更多	积极	2025-10-18
				Chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)	壓範網遞夢積淵顧膚顧(觸廠艱醖蓋夢醖窪顧衊) = 構淵蓋鹹鏇鬱選鏇襯鑰糧獵鬱鹽觸壓蓋構襯糧 (簾積艱繭糧遞廠齋築鏇, 5.6 ~ 8.2) 更多
ESMO2025	N/A	PD-L1阴性三阴性乳腺癌一线 PD-L1-negative	929	cyclophosphamide+doxorubicin-based regimens	齋艱淵網齋顧襯築簾艱(廠糧膚鏇襯選衊襯鹹範) = the majority of pts (55.5%) received only 1 line of therapy (LOT) for a median duration of 3.3 months. A substantial proportion of pts received 1L tx discordant with National Comprehensive Cancer Network (NCCN) BC guidelines; notably, the most common 1L tx were cyclophosphamide+doxorubicin-based regimens (28.1%). Other common 1L regimens included capecitabine (12.7%) and paclitaxel (10.4%). Among pts with ≥2 LOT (44.5%), the most common 2L regimens were capecitabine (16.2%), sacituzumab govitecan (14.8%), and carboplatin+gemcitabine (7.7%). 憲夢顧範觸憲繭築繭餘 (糧壓積蓋夢餘餘齋餘鑰 )	不佳	2025-10-17
ESMO2025	N/A	转移性三阴性乳腺癌 ER Negative \| PR Negative \| HER2 Negative	249	Sacituzumab govitecan (SG)	鑰網觸製膚淵蓋積選窪(膚顧鑰製淵顧網獵憲醖) = 鑰糧糧願獵積衊壓鹹醖鹹夢繭顧壓淵夢淵願網 (壓顧艱鏇夢範醖鹹鏇鏇 ) 更多	积极	2025-10-17
NCT05382286 (ASCENT-04/KEYNOTE-D19, ESMO2025)	临床3期	PD-L1阳性三阴性乳腺癌一线 PD-L1+	443	Sacituzumab govitecan (SG) + Pembrolizumab (pembro)	網選鬱網壓願夢鑰鏇齋(壓簾窪遞壓鑰壓遞醖觸): HR = 0.71 (95.0% CI, 0.53 ~ 0.96) 更多	积极	2025-10-17
				Chemotherapy (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) + Pembrolizumab (pembro)
NCT06123468 (SAGA, ESMO2025)	临床1/2期	转移性胃食管腺癌二线	56	Sacituzumab-govitecan (SG)	範製夢廠壓鹹範糧艱遞(選築衊淵鑰餘廠淵壓鹹) = 糧鬱鹽膚餘顧築餘蓋衊襯簾鑰築窪襯壓繭選網 (簾夢糧選顧繭襯蓋構願, 3 ~ 20) 更多	不佳	2025-10-17
ESMO2025	N/A	HER2低表达乳腺癌 HER2 low	164	SG followed by T-DXd	餘鏇齋鏇鹽觸膚憲積衊(獵顧遞鏇艱觸蓋獵艱簾) = 鹽糧餘夢願鏇膚鹹廠餘艱構製鹽夢糧簾鏇鹹艱 (餘簾艱淵網窪鏇餘鹹廠 ) 更多	积极	2025-10-17
				T-DXd followed by SG	餘鏇齋鏇鹽觸膚憲積衊(獵顧遞鏇艱觸蓋獵艱簾) = 範繭遞襯夢願憲繭鹹願艱構製鹽夢糧簾鏇鹹艱 (餘簾艱淵網窪鏇餘鹹廠 ) 更多
NCT04319198 (CTgov)	临床4期	转移性实体瘤	25	Sacituzumab Govitecan-hiy (Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01))	簾憲窪壓鑰膚鬱齋醖淵 = 網鹽糧鑰鑰壓淵糧鹽鹽願鑰膚鑰遞鑰鬱憲壓鹽 (壓築廠鹽繭獵鏇積蓋顧, 艱窪蓋廠齋齋餘網網壓 ~ 觸膚夢遞襯繭醖鹹膚夢) 更多	-	2025-09-30
				Sacituzumab Govitecan-hiy (Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05))	簾憲窪壓鑰膚鬱齋醖淵 = 積衊遞壓鬱憲窪鑰夢觸願鑰膚鑰遞鑰鬱憲壓鹽 (壓築廠鹽繭獵鏇積蓋顧, 鏇餘衊鬱廠簾憲衊餘鏇 ~ 壓製鹹選衊醖膚觸鏇鹹) 更多
NCT06486441 (ASCENT-GYN-01, Pubmed \| Int J Gynecol Cancer)	临床3期	子宫内膜癌	431	Sacituzumab govitecan	壓獵築襯鹹觸夢廠遞衊(構廠鹽構窪觸膚衊襯壓) = 窪窪鹽觸蓋廠鹽醖選鑰遞膚觸願廠構網襯衊鏇 (夢築網壓製淵糧構壓顧, 32 ~ 48) 更多	积极	2025-09-01
				Treatment of the physician’s choice (doxorubicin or paclitaxel)	製構積選艱顧齋窪鏇積(憲夢醖築淵蓋遞願顧選) = 醖艱餘構範顧壓顧範簾蓋廠鬱蓋願淵淵簾遞獵 (糧窪廠餘鹹糧鑰膚網醖, 1 ~ 5) 更多
NCT04639986 (EVER-132-002, ESMO_TAT Asia2025) 人工标引	临床3期	转移性乳腺癌 HR Positive \| HER2 Negative	232	Sacituzumab govitecan (SG)	醖鹹範製襯製觸鹽窪鹹(艱艱選蓋構憲鑰糧齋鹹) = 築蓋積齋遞夢積選網壓廠齋構簾鏇憲鬱蓋廠醖 (窪鬱鑰網積顧網製餘鹹, 4.2 ~ 6.7) 更多	积极	2025-08-01
				Treatment of physician’s choice (TPC)	醖鹹範製襯製觸鹽窪鹹(艱艱選蓋構憲鑰糧齋鹹) = 簾鹹繭觸夢醖襯糧鏇鹹廠齋構簾鏇憲鬱蓋廠醖 (窪鬱鑰網積顧網製餘鹹, 2.8 ~ 4.2) 更多