A Randomized Phase II Trial of Sacituzumab Govitecan (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy

This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving sacituzumab govitecan and bevacizumab may kill more tumor cells than standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with recurrent platinum-sensitive ovarian cancers that have BRCA1/2 mutations or homologous recombination deficiency.

开始日期2026-09-10

申办/合作机构

National Cancer Institute

NCT07393555

/ Not yet recruiting临床2期IIT

A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

This phase II Expanded Lung-MAP treatment trial compares how well sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan in combination with ivonescimab works in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or is stage IV and has a change in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. This type of gene change is called an actionable genomic alteration (AGA), which means certain treatments can target the change to fight the cancer. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a toxic drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Ivonescimab is a bispecific antibody that can bind to two different antigens at the same time. It binds to programmed cell death protein 1 (PD1), a protein found on the surface of T cells (a type of white blood cell) and vascular endothelial growth factor (VEGF), a protein found on the surface of tumor cells. Ivonescimab may strengthen the immune system and interfere with the ability of tumor cells to grow and spread. Giving a combination of sacituzumab govitecan and ivonescimab work better than either drug alone, and sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan and ivonescimab together may work better than standard treatments at shrinking NSCLC with an AGA.

开始日期2026-08-07

申办/合作机构

SWOG

[+1]

NCT07367178

/ Not yet recruiting临床2期

Phase II Study to Improve Sacituzumab Govitecan Tolerance With Atropine in Patients With Advanced Triple-Negative and Hormone Receptor-Positive/HER2-Negative Breast Cancer

The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) or hormone receptor-positive/HER2-negative (HR(+)/HER2-) treated with sacituzumab govitecan.

开始日期2026-07-01

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

2,335

项与戈沙妥组单抗相关的文献（医药）

2026-07-15·BIOCONJUGATE CHEMISTRY

Rapid and Efficient Antibody–Drug Conjugate Design Using Mechanistic Bottom-Up Modeling from In Vitro to Human

Article

作者: Sweeney-Lasch, Stanley ; Kolmar, Harald ; Kahl, Jan-Philip ; Lindroos, Tatu ; Hecht, Stefan ; Anderl, Jan ; Stein, Judith ; Kaempffe, Anna ; Krug, Michael

Antibody-drug conjugates (ADCs) are complex molecules, and many fail clinically despite promising preclinical data. Here, a modular, bottom-up modeling strategy employing mechanistic PK-PD models was developed to translate ADC efficacy and toxicity from bench to bedside and to guide ADC design. The models handle various antigens, payloads, and ADCs, validated using six ADCs (Enhertu, Kadcyla, Trodelvy, RC48, RN927C, and Datroway). Using determined cellular distribution of payloads/ADCs, payload killing parameters, and systemic parameters (assay volume, cell doubling time), ADC in vitro potency was predicted with 94.64% accuracy within a 2-fold range. Incorporating ADC and payload pharmacokinetic parameters enables prediction of in vivo efficacy comparable to cell line- and patient-derived xenograft data from the literature. Scaling parameters from mouse to human (PK, tumor volume, and tumor doubling time) led to the reproduction of clinical efficacy trends. Beyond efficacy, the approach predicts key hematologic toxicities such as neutropenia and thrombocytopenia, demonstrated for Kadcyla and Enhertu. Application to the clinically failed RN927C demonstrated how our modeling approach could have flagged issues and enabled suggestions for design modifications to widen the therapeutic window and prevent the clinical failure. In conclusion, our presented modeling strategy delivers accurate efficacy and toxicity translation from in vitro to humans utilizing easily accessible parameters as the foundation and deepens understanding of ADCs and their individual components, thereby supporting ADC design and candidate and patient selection and accelerating ADC development.

2026-07-01·iScience

The WEE1 inhibitor azenosertib broadly enhances efficacy of antibody-drug conjugates with topoisomerase I and microtubule inhibitor payloads

Article

作者: Chung, Heekyung ; Guo, Xiao ; Meric-Bernstam, Funda ; Cabrera, Erika ; Lackner, Mark R ; Harismendy, Olivier ; Lee, Catherine ; Kim, Doris ; Ma, Jianhui

Antibody-drug conjugates (ADCs) have transformed targeted cancer therapy, yet strategies to overcome resistance and enhance efficacy remain needed. Since ADCs exert anti-tumor effects via DNA damage or mitotic disruption, combining them with WEE1 inhibitors represents a rational approach. We investigated the selective WEE1 inhibitor azenosertib in combination with ADCs carrying topoisomerase I inhibitor (TOP1i) or microtubule inhibitor (MTI) payloads. Azenosertib enhanced the activity of free TOP1i agents and TOP1i-based ADCs (trastuzumab deruxtecan [T-DXd] and sacituzumab govitecan), increasing DNA damage and apoptosis, and extended the duration of response while overcoming T-DXd resistance in patient-derived xenografts. Synergistic effects were also observed with MTI agents and MTI-based ADCs (mirvetuximab soravtansine, tisotumab vedotin, and enfortumab vedotin), associated with exacerbated mitotic defects and prolonged mitotic arrest. All combinations enhanced efficacy and were well tolerated in vivo. These findings position azenosertib as a broadly applicable enhancer of cytotoxic-payload ADCs, offering a promising strategy for patients with advanced solid tumors.

2026-07-01·INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS

Multicenter Retrospective Analysis of the Safety and Efficacy of Sacituzumab Govitecan Combined With Radiation Therapy: The French ATTENTION Study

Article

作者: Boudabous, Hanene ; Toledano, Alain ; Durdux, Catherine ; Spano, Jean-Philippe ; Alati, Aurelia ; Assaf, Elias ; Scher, Nathaniel ; Mavrikios, Antoine ; Belkacemi, Yazid ; Debbi, Kamel ; Meynard, Claire ; Huguet, Florence ; Bennassi, Alexander ; Quero, Laurent ; Medioni, Jacques ; Gligorov, Joseph ; Chargari, Cyrus ; Benderra, Marc-Antoine

PURPOSE:

Based on the results of the ASCENT trial, sacituzumab govitecan (SG) has been approved for the treatment of breast cancer. With the expanding indications across multiple cancers, data on its combination with radiation therapy (RT) are needed.

METHODS AND MATERIALS:

ATTENTION is a retrospective multicenter study from 6 French institutions. Eligibility criteria included patients with breast cancer who received RT and SG between September 2021 and January 2025. Concomitant treatment was defined as RT administered within 4 days before or after SG administration. Data were collected through an online questionnaire and centralized after medical record review, and protocol validation by the local ethics committee. The primary endpoint was safety profiles according to the Common Terminology Criteria for Adverse Events, version 5.0. Secondary endpoints included treatment response, evaluated according to Response Evaluation Criteria in Solid Tumors, version 1.1 criteria and/or clinical symptom improvement. Assessment was performed 4-12 weeks after RT.

RESULTS:

Fifty-five patients (63 lesions) were included. The median age was 56 years (37-82). SG and RT were administered concurrently in 37 lesions (median, 3 days), sequentially in 26 lesions (median, 10 days). Subtypes included human epidermal growth factor receptor 2 (HER2)-/hormone receptors (HR)- (30%), HER2-/HR+ (27%), HER2-low/HR+ (24%), HER2-low/HR- (18%), and HER2+ (2%). SG was given as second-line in 16%, and ≥ fourth-line in 54%. RT was symptomatic in 57% and for progression in 43%, mostly targeting bone (49%) and brain (32%), using 3D conformal RT (52%), stereotactic body RT (40%), or intensity modulated RT (8%). With a median follow-up of 7.9 months (1.7-35.4), RT-related toxicities of grade 1-2 occurred in 17 cases (27%), (3 dermatitis, 4 esophagitis, and 1 brain radionecrosis). No grade ≥ 3 toxicity occurred with concomitant SG. The overall response rate was 25% complete and 80% partial responses. Median overall survival was 12.9 months (95% CI, 7.97-17.77).

CONCLUSIONS:

ATTENTION is the largest study that confirms the feasibility and promising efficacy of concurrent treatment, pending confirmation in prospective trials.

2,514

项与戈沙妥组单抗相关的新闻（医药）

2026-07-27

·BioSpace

CHMP Recommends Gilead’s Trodelvy® Plus Keytruda® in PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer

– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union – – ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10). The European Commission decision on this indication is anticipated later in 2026. Metastatic TNBC is an aggressive form of breast cancer that is associated with rapid disease progression and poor prognosis. Approximately 40% of metastatic TNBC tumors are PD-L1 positive. These tumors are considered more aggressive and associated with shorter survival, creating urgency to initiate treatment with effective regimens as soon as possible. For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment. “People with metastatic triple-negative breast cancer need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1,” said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and Investigator of the ASCENT-04 study. “This positive opinion is welcome news for our patients and the entire clinical community. If authorized, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status.” The CHMP’s recommendation is based on data from the Phase 3 ASCENT-04 study/KEYNOTE-D19 which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy plus Keytruda versus the combination of standard of care chemotherapy plus Keytruda as a first-line treatment in PD-L1 positive patients. In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% reduced risk of disease progression or death in patients with PD-L1 positive metastatic TNBC. The ASCENT-04/KEYNOTE-D19 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. “Building on our established leadership in metastatic TNBC, this positive opinion reinforces our commitment to the breast cancer community,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “People with metastatic TNBC desperately need new options as early as possible. This positive opinion, coupled with the recent EMA approval of Trodelvy monotherapy, is an important step in changing outcomes for these patients.” The European Commission has approved the use of Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. The U.S. Food and Drug Administration (FDA) has approved Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC. Trodelvy is approved for: either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. KEYTRUDA® and KEYTRUDA QLEX™ are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC. Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is globally approved for use in certain patients with metastatic TNBC and pre-treated HR+HER2- metastatic breast cancer. Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression, including in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. The content above comes from the network. if any infringement, please contact us to modify.

临床结果上市批准抗体药物偶联物

2026-07-27

·馨的日志

全球药品注册与前沿发展动态｜7月23日-27日

全球药品注册与研发日报 Global Pharmaceutical Registration & R&D Daily Report 2026年7月27日（星期一）覆盖周期：2026年7月23日— 7月27日（培训期间没更新，补追7月23-24日周四至周五期间重要动态）报告生成日期：2026年7月27日 09:00 信息来源：各国药监局官网、专业媒体公开报道本报告仅供参考，不构成任何投资或注册决策建议一、本期核心事件/头条新闻 ▶ FDA批准首个眼科贝伐珠单抗LYTENAVA用于湿性AMD 2026年7月24日，Outlook Therapeutics宣布FDA批准LYTENAVA（bevacizumab-vikg）用于治疗湿性年龄相关性黄斑变性（wet AMD），成为首个且唯一获FDA批准的眼科用贝伐珠单抗。该产品享有BPCIA法案下预计12年的市场独占期，美国视网膜市场规模约85亿美元。 ▶ EMA CHMP 7月会议推荐12种新药批准 —— Susvimo、Icotyde等里程碑产品 2026年7月20-23日EMA CHMP会议共推荐12种新药批准，包括Susvimo（首个眼内可再填充植入体，治疗湿性AMD）、Icotyde（首个口服IL-23受体抑制剂治疗银屑病）、三款降脂药物（Lyrokaul/Evlarco/Ubeslo）等。同时3款药物被否定（KemSu/Meplyffa/Qezzaqar），Tavneos仍维持撤销建议。8个适应症扩展推荐，涵盖Enhertu、Trodelvy等多款重磅药。 ▶ Revolution Medicines daraxonrasib胰腺癌NDA获FDA受理 —— OS近乎翻倍 2026年7月22日，Revolution Medicines宣布daraxonrasib（口服RAS(ON)多选择性抑制剂）治疗转移性胰腺癌的NDA获FDA受理。III期RASolute 302试验中位OS 13.2月 vs 化疗6.6月（HR=0.40），PFS 7.3 vs 3.5月（HR=0.45），堪称胰腺癌治疗的里程碑突破。二、药品注册动态2.1 中国 NMPA/CDE 动态日期机构/企业药品名称关键内容 7月21日 NMPA 选择性食欲素2型受体激动剂（发作性睡病）全球首款同步研发的新靶点创新药在中国首报首发获批，用于16岁以上1型发作性睡病。该药获CDE突破性治疗+优先审评"双重加速通道"，中美日欧同步申报，中国率先获批。 7月23日海思科 HSK39297（琥珀酸思普可泮片） NMPA批准海思科1类创新药HSK39297用于阵发性睡眠性血红蛋白尿症（PNH），为全球首个每日一次口服补体B因子（CFB）抑制剂，通过优先审评程序获批。 7月17日 CDE 安尼妥单抗（KN026） CDE将安尼妥单抗（HER2双抗）2项乳腺癌适应症纳入优先审评：一线治疗HER2+转移性乳腺癌、新辅助治疗早期/局晚期HER2+乳腺癌。该药已于5月获批用于胃癌。 7月15日 CDE突破性治疗 CM512注射液（康诺亚）康诺亚CM512（TSLP×IL-13双阻断剂）纳入突破性治疗品种，用于慢性鼻窦炎伴鼻息肉（CRSwNP），为全球首款IgG-like长效TSLP/IL-13双抗。 7月14日 CDE突破性治疗 TRD205（AT2R拮抗剂）中国生物制药/北京泰德TRD205纳入突破性治疗，用于外周镇痛，系AI辅助药物发现平台开发的高选择性AT2R拮抗剂。 7月24日 NMPA 酒石酸长春瑞滨软胶囊（人福医药）人福医药全资子公司武汉普克获酒石酸长春瑞滨软胶囊药品注册证书，用于NSCLC和转移性乳腺癌。 7月25日 NMPA 达芦那韦片（艾迪药业）艾迪药业达芦那韦片首仿获批（抗HIV药物），实现非核苷逆转录酶抑制剂、整合酶抑制剂、蛋白酶抑制剂三大主流抗艾靶点全覆盖。 7月25日 NMPA 科源制药3个新产品科源制药全资子公司力诺制药获3个药品注册证书，制剂产品线持续扩容。2.2 美国 FDA 动态日期类型药品名称企业适应症关键内容 7月24日 FDA批准 LYTENAVA（bevacizumab-vikg） Outlook Therapeutics wet AMD 首个FDA批准的眼科用贝伐珠单抗，专门用于眼部疾病治疗，BPCIA下12年市场独占期。 7月22日 FDA批准 Jideytro（zidesamtinib） GSK（收购Nuvalent，106亿美元） ROS1+ NSCLC 下一代ROS1抑制剂，高度选择性、覆盖多种耐药突变、穿透血脑屏障。ORR 44%。 7月22日 FDA受理NDA Daraxonrasib（RAS(ON)抑制剂） Revolution Medicines 转移性胰腺癌 III期RASolute 302：OS 13.2 vs 6.6月（HR=0.40），PFS 7.3 vs 3.5月（HR=0.45）。获FDA CNPV优先审评。 7月24日 FDA批准 Tylenol with Naproxen（对乙酰氨基酚+萘普生钠） Kenvue 短期疼痛缓解首个非处方固定剂量复方对乙酰氨基酚/萘普生钠镇痛片，12小时止痛效果。 7月14日 FDA批准 Revtorpyk（gedatolisib） Celcuity HR+HER2-乳腺癌多靶点PAM抑制剂，联合fulvestrant±palbociclib治疗PIK3CA野生型乳腺癌。 7月14日 FDA传统批准 Retevmo（selpercatinib）礼来 RET融合+实体瘤从加速批准转为传统批准，覆盖成人和2岁以上儿童RET融合阳性实体瘤。7月PDUFA审评日历（未来30天）日期企业药品适应症 7月29日 Capricor Deramiocel 杜氏肌营养不良症 7月30日 Viatris 低剂量雌激素周贴片更年期综合征 8月5日 Moderna mRNA-1010 流感疫苗 8月13日 Lantheus MK-6240 PET显像剂 8月17日 BMY/BNTX/CTMX/EVAX/RARE等多项密集决策周（6项） 8月24日吉利德/Jazz/Oncopeptides等多项密集决策周（5项）2.3 欧盟 EMA / 日本 PMDA 动态EMA CHMP 7月会议（7月20-23日，结果7月24日发布）药品/项目适应症关键内容 Susvimo（rabinizumab）治疗湿性AMD 首个在欧盟获批的眼内可再填充植入体，每6个月补充一次 Icotyde（icotrokinra）中重度斑块状银屑病首个口服IL-23受体抑制剂，12岁以上青少年及成人 Lyrokaul（lerodalcibep）高胆固醇血症患者可自行注射，每月一次 Evlarco（obicetrapib/ezetimibe）高胆固醇血症口服复方降脂药 Lynavoy（linerixibat）原发性胆汁性胆管炎瘙痒首个针对胆汁淤积性瘙痒的治疗药物 Nezglyal（leriglitazone）脑性肾上腺脑白质营养不良罕见病，特殊情况批准 Zokovea（ensitrelvir） COVID-19暴露后预防抗病毒药物 Enhertu扩展 HER2-low乳腺癌等新增适应症推荐 Trodelvy扩展 TNBC等新增适应症推荐 EMA负面意见（3项）：KemSu（舒芬太尼/氯胺酮）儿童急性疼痛被否；Meplyffa（arimoclomol）尼曼-匹克病C型被否；Qezzaqar（catequentinib）软组织肉瘤被否。 EMA加速审评：Revolution Medicines daraxonrasib胰腺癌进入EMA分阶段审评程序。 EMA药物警戒：Tavneos（avacopan）撤销上市许可建议维持（7月16日HPRA发布）。 EMA女性健康倡议：7月2日启动妇女健康药物加速行动。PMDA动态日期事项关键内容 7月22日复宏汉霖HLX43获PMDA临床默示许可 PD-1/VEGF双抗治疗鳞状NSCLC国际多中心2/3期临床在日本获批开展 7月7日 ICH E11A儿科药物开发外推指南发布日本正式发布ICH E11A指导原则日文版 7月14日药品安全信息第430号发布含多潘立酮等药品安全性更新2.4 国际组织及其他国家注册动态各国注册法规/指南更新国家/地区法规更新关键内容中国《药品管理法实施条例》5月15日施行固化突破性治疗、优先审评、附条件批准四大绿色通道；儿童药≤2年、罕见病≤7年市场独占期；eCTD V3.2.2自3月1日全面实施；ICH M13A、E6(R3)等指导原则落地。 PIC/S Annex 15修订概念文件（7月16日勘误）范围扩展至API生产商，考虑ICH Q9(R1)质量风险管理更新。Annex 6（医用气体）2月发布概念文件。哈萨克斯坦申请加入PIC/S。约旦完成首次PIC/S GMP检查（合规结论）。 EAEU 统一药品市场正式启动 2026年1月1日起所有新药按EAEU规则注册。过渡措施延至2027年12月31日。哈萨克斯坦为战略门户（85%进口药品）。乌兹别克斯坦第3806号循证医学评估令生效 2026年7月生效，引入基于国际科学证据的疗效评估分类（1/2/3类），影响新注册和续期。第738号决议2月26日生效，强制IP合规评估。第3848号ICH对齐指令已注册。哈萨克斯坦一站式注册试点延至2026年底 100个工作日内完成复合注册。讨论加速审评机制——对已在FDA/EMA/PMDA等获批的产品简化认可。沙特阿拉伯 RAID计划7月2日生效 SFDA研究用新药（RAID）认定计划正式实施，加速创新药发展。2月批准OneSource-Hikma semaglutide仿制药（首个GLP-1仿制药）。蒙古国国家药品参比实验室启用 6月16日世界银行资助的国家药品参比实验室正式启用，年检测4000-5000份样品，加强药品质量控制。土库曼斯坦药物警戒指南更新非EAEU成员国，按本国药事法监管。注册有效期5年，续期3-4个月。需提供俄语/土库曼语/英语说明书和标签。药品拒绝注册/撤销公示汇总机构药品/项目申请人拒绝原因 EMA CHMP 7月 3款 KemSu（儿童止痛）、Meplyffa（尼曼-匹克病）、Qezzaqar（软组织肉瘤）疗效-风险平衡无法建立，临床数据不充分 FDA TAZVERIK（tazemetostat）撤市 Epizyme/益普生确证性试验中继发性恶性肿瘤发生率升高，6月已正式撤市 FDA（2026以来） Anaphylm（肾上腺素舌下膜剂） Aquestive 人为因素验证测试瑕疵（包装开启困难） FDA（2026以来） Saphnelo SC（阿伏利尤单抗自行注射）阿斯利康 CMC/生产质量控制问题 FDA（2026以来） Reproxalap干眼症（第3次CRL） Aldeyra 疗效证据充分性和一致性不足WHO预认证动态机构事项关键内容 WHO PQ 2026年3月完成第150次评估会议 25年预认证历史：超过1060种药品、30种生物制品、240种原料药获得PQ。全球CRP合作注册程序支持超过1350项国家注册。 WHO PQ扩展首次邀请SUD药物提交PQ申请 5月22日首次邀请阿片类药物依赖治疗药物（美沙酮、丁丙诺啡、纳洛酮）提交PQ申请。WHO阿片类药物依赖治疗指南预计2026年底/2027年初更新。 WHO PQ Coartem Baby疟疾治疗预认证 4月24日首个针对新生儿和低体重婴幼儿（2-5kg）的抗疟药物获得WHO PQ。三、医药研发进展与突破3.1 临床突破日期药物/方案适应症关键结果 7月23日礼来Retatrutide（GIP/GLP-1/GCGR三靶点激动剂）肥胖症 TRIUMPH-2（糖尿病+肥胖）：减重20.8%；TRIUMPH-3（心血管+重度肥胖）：减重22.6%。计划2027Q1申报BLA。 7月23日强生Tecvayli+Talvey双抗组合复发/难治多发性骨髓瘤 MonumenTAL-6 III期：降低疾病进展或死亡风险89%（HR=0.11），死亡风险降低62%（HR=0.38）。 7月22日 Revolution Medicines daraxonrasib 胰腺癌 RASolute 302 III期：OS 13.2 vs 6.6月（HR=0.40），PFS 7.3 vs 3.5月（HR=0.45）。NDA获FDA受理+EMA分阶段审评。 7月22日 GSK zidesamtinib（Jideytro） ROS1+ NSCLC FDA批准。ROS1选择性抑制剂，ORR 44%，脑转移和耐药突变患者均有效。106亿美元收购Nuvalent获得。 7月中旬科伦博泰sac-TMT（TROP2 ADC）+ Keytruda PD-L1阴性NSCLC OptiTROP-Lung06 III期：PFS达到主要终点，全球首个ADC+IO在PD-L1阴性nsNSCLC一线阳性III期。 7月中旬华海生物HBI-8000+纳武利尤单抗晚期黑色素瘤全球III期：PFS 11.7 vs 7.4月（改善58%），有望成为新一线方案。 7月上旬罗氏divarasib KRAS G12C NSCLC Krascendo 1 III期：头对头击败一代KRAS G12C抑制剂，PFS和OS双重统计学显著获益。3.2 重要交易与合作日期合作方项目交易条款概要 7月22日齐鲁制药-同源康医药 TY-9591（EGFR-TKI）肺癌首付款7亿元（3亿现金+4亿H股认购），潜在总对价超27亿元（含20.6亿里程碑）。齐鲁获中国独家商业化权。 7月14日迪哲医药-阿斯利康舒沃哲®（EGFR exon20ins TKI）首付款6亿美元（创国产小分子出海首付纪录），总金额最高15亿美元+双位数销售分成。 7月14日翰森制药-Avere HS-20118（口服IL-23环肽）首付款1.2亿美元，里程碑最高21.8亿美元，翰森持Avere合并后30-40%股权。 7月1日 AlzeCure-QuantumCell ACD856（Trk-PAM阿尔茨海默病）首付1200万美元（含500万股权溢价30%），里程碑超22亿美元。Ib期耐受性良好。 7月1日石药巨石生物-阿斯利康肝外递送siRNA候选药物首付3000万美元，双靶点里程碑最高5.4亿+12亿美元。3.3 热门靶点与前沿技术 ● RAS通路 Daraxonrasib胰腺癌III期阳性提交NDA；Erasca ERAS-0015泛RAS分子胶I期积极；pan-KRAS时代开启（恒瑞HRS-2329、和誉ABSK211等）。 ● ADC+IO联合科伦博泰sac-TMT+K药PD-L1阴性NSCLC III期阳性；第一三共Enhertu适应症扩展。B7-H3 ADC（翰森HS-20093）SCLC III期OS阳性。 ● GLP-1/多重激动剂礼来Retatrutide III期集齐5项阳性（减重22.6%）；口服orforglipron已获批；GLP-1仿制药赛道拥挤（沙特首个semaglutide仿制药获批）。 ● 双特异性抗体强生Tecvayli+Talvey MM III期阳性（89%风险降幅）；Icotyde口服IL-23R抑制剂获CHMP推荐。国产HER2双抗KN026乳腺癌优先审评。 ● 基因治疗/CGT CDE发布2026年版CGT指导原则；CAR-T、Treg细胞疗法持续突破；全球首款口服ASO疗法Tryngolza已获批。四、国际注册策略启示与建议5.1 主流市场（FDA/EMA/PIC/S/WHO PQ）注册策略启示 ■ FDA单臂研究趋势强化 2026年2月FDA宣布一项充分对照试验+确证性证据作为新药审批标准。约60%的FIC药物在近五年基于单臂获批。建议企业早期与FDA沟通，战略性地构建"确证性证据包"，不局限于多个试验。 ■ FDA CNPV优先审评试点 Daraxonrasib成为CNPV试点项目首批入选药物。建议符合国家优先健康需求的创新药积极申请该试点，加速审评。 ■ EMA分阶段审评常态化 Daraxonrasib接受EMA分阶段审评，允许数据逐步提交。建议有重大未满足需求的产品利用这一路径加速欧盟上市。 ■ PIC/S Annex 15修订影响 Annex 15范围扩展至API生产商，考虑ICH Q9(R1)质量风险管理。建议原料药和制剂企业提前评估新版要求对验证策略的影响。哈萨克斯坦、约旦等新兴PIC/S成员国的加入意味着PIC/S标准正在全球扩展。 ■ WHO PQ扩展至SUD药物 WHO首次邀请物质使用障碍治疗药物申请PQ。建议有美沙酮、丁丙诺啡、纳洛酮等产品的企业抓住这一新窗口获取PQ资格。 ■ EMA CHMP拒绝案例警示 7月3款药被否：缺乏对照组的单臂试验设计（Yartemlea/Xervyteg）和数据完整性问题（Tacquell）是主要拒因。建议使用单臂试验支持上市时，确保数据完整性、制造质量可控，并准备充分的后续确证计划。5.2 非主流市场（中亚、西亚、东南亚、蒙古等）注册策略建议 ■ 乌兹别克斯坦：循证医学评估时代来临第3806号令要求基于国际科学证据进行疗效评估。原研药：确保Module 5临床数据引用国际公认期刊。仿制药：确认参比制剂和活性成分有充分的国际文献支持。续期产品：早期评估疗效证据差距。第738号决议强制IP合规评估，建议提前完成商标/专利检索。 ■ 哈萨克斯坦：100天注册试点+PIC/S申请一站式注册试点延至年底（100个工作日）。讨论加速认可FDA/EMA等审评结果。哈萨克斯坦已申请PIC/S成员。建议已有FDA/EMA批准的仿制药和创新药利用简化通道进入哈萨克市场。 ■ EAEU统一市场：窗口期策略 2026年1月起新药按EAEU规则注册。国家注册证书到期后须转为EAEU注册（延至2027年底）。建议尽早通过MRP程序进入EAEU市场，以哈萨克斯坦为门户辐射中亚。 ■ 沙特阿拉伯：RAID计划+GLP-1仿制药市场 RAID计划7月2日生效——创新药可获SFDA优先审评。SFDA eSDR全面电子化，需按eCTD格式提交。GLP-1仿制药市场快速增长（首个semaglutide仿制药已获批）。建议仿制药企关注GLP-1专利到期后的SFDA注册机会。 ■ 土库曼斯坦：独立注册路径非EAEU成员国，独立注册体系（5年有效期，续期3-4月）。需CPP、GMP证书、PSUR、样品检测。标签和说明书需提供土库曼语/俄语/英语。建议提前规划翻译和样品准备，预留3-4个月审评周期。 ■ 蒙古：质量控制升级国家药品参比实验室启用（年检测4000-5000份），药品质量审查全面加强。建议出口蒙古的企业提前进行自主质量检测，确保符合升级后的质量标准。 ■ 东南亚：越南ACTD/ACTR全面实施越南2026药品法全面实施ACTD/ACTR格式要求。建议出口东南亚的企业统一按ACTD/eCTD双轨准备，提高申报效率。5.3 跨市场趋势与风险预警 ● 全球注册标准趋同化 ICH E6(R3)、M13A、M11等指导原则在全球加速落地。eCTD全面实施（中国3月、沙特SDR、新加坡eCTD）。建议企业统一按ICH-CTD/eCTD标准准备全球申报资料，实现"一套数据，多国申报"。 ● 拒绝注册风险上升 2026年以来国内外新药被拒/撤市显著增多（FDA多个CRL、EMA 3款被否、NMPA仿制药集中拒批）。监管全面趋严，"临床价值"导向强化——单臂试验需要更强确证证据，仿制药审评标准提升。 ● 中亚市场门槛提升乌兹别克斯坦引入循证医学评估和IP合规审查，哈萨克斯坦加速审评但标准化要求提高。中亚市场正在从"低门槛准入"向"国际标准对齐"转型，企业注册策略需要相应升级。 ● GLP-1赛道竞争白热化礼来Retatrutide 5项III期全阳性、口服orforglipron已获批、沙特semaglutide仿制药获批。GLP-1及其多重激动剂在全球范围内的注册竞争将进入白热化阶段，建议关注差异化和联合用药策略。 ● RAS靶向治疗迎来拐点 Daraxonrasib胰腺癌III期阳性已提交NDA，Divarasib头对头击败一代KRAS G12C抑制剂，泛RAS分子胶I期积极。RAS靶向治疗经过40年攻坚即将进入临床，建议关注伴随诊断和精准患者分层策略。五、本期总结与展望 2026年7月最后一周，全球药品注册与研发领域呈现以下核心特征：一、监管层面：全球注册标准加速对齐。EMA CHMP 7月会议创纪录推荐12种新药批准，涵盖眼科植入体、口服IL-23抑制剂、降脂新药等；FDA批准首个眼科贝伐珠单抗和首个ROS1新一代抑制剂；NMPA实现全球首款同步研发新药（发作性睡病）首报首发，凸显中国审评的国际竞争力。PIC/S Annex 15/6修订、中国eCTD全面实施、乌兹别克斯坦引入循证医学评估、沙特RAID计划启动——全球药品注册管理的标准化、数字化、循证化趋势不可逆转。二、研发突破：胰腺癌治疗迎来里程碑。Revolution Medicines daraxonrasib将胰腺癌患者中位OS从6.6月提升至13.2月（翻倍），NDA已获FDA受理，有望成为RAS靶向治疗胰腺癌的首个标准疗法。礼来Retatrutide集齐5项III期阳性（最高减重22.6%），GLP-1/GIP/GCGR三靶点赛道格局确立。强生Tecvayli+Talvey双抗组合89%风险降幅刷新多发性骨髓瘤治疗标准。三、BD交易活跃：中国药企出海深化。齐鲁-同源康27亿元人民币、迪哲-AZ 6亿美元首付（创国产小分子首付纪录）、翰森-Avere 1.2亿美元首付——中国创新药的全球价值正在被跨国药企认可。但石药-AZ的siRNA合作、翰森对外授权等表明，License-out仍是国内Biotech的核心变现路径。四、注册策略启示：非主流市场门槛提升。乌兹别克斯坦、哈萨克斯坦、蒙古等中亚国家纷纷升级注册标准和检测能力，EAEU统一市场全面运行。"低门槛准入"时代结束，"国际标准对齐"时代来临。建议企业在布局中亚市场时，提前准备ICH-CTD格式的完整申报资料，并关注当地的循证医学评估和IP合规新规。展望未来一周（7月27日-8月2日）：FDA PDUFA焦点为Capricor Deramiocel（7/29）、Viatris雌激素贴片（7/30）；EMA CHMP会议后续的欧盟委员会决策将陆续批准7月推荐的12款新药。建议持续关注Revolution Medicines daraxonrasib的FDA审评进展和礼来Retatrutide的BLA准备。本报告基于公开可检索的监管机构和专业媒体信息编制，仅供一般参考。免责声明本报告信息来源包括各国药监局官方网站（FDA、EMA、NMPA/CDE、PMDA、SFDA等）、世界卫生组织（WHO）、PIC/S、Xinhua News、PRNewswire、GlobeNewswire、医药魔方、识林、药时代等公开专业媒体。报告内容仅供行业研究参考，不构成任何投资建议、注册决策建议或法律意见。报告中的信息可能因时效性原因而不完整或存在偏差。建议读者在做出任何注册策略或投资决策前，咨询专业监管事务顾问或法律顾问。报告生成日期：2026年7月27日报告覆盖周期：2026年7月23日-7月27日

2026-07-27

·癌度

《癌度快报》2026年7月27日：国产HER2 双抗 ADC 第 3 次纳入突破性疗法，HER2 低表达乳腺癌 ORR 达 53%!

一、新药快讯 1、 IPH4502 完成 1 期剂量递增，Nectin-4 靶向 ADC 在 Padcev 耐药患者中仍有效！近日，Innate Pharma 公司宣布，其 Nectin-4 靶向抗体偶联药物（ADC）IPH4502 完成 1 期临床剂量递增阶段，共入组 76 例晚期实体瘤患者（尿路上皮癌、非小细胞肺癌、头颈鳞癌等）。初步数据显示安全性良好，血液学毒性有限；在既往接受过 Padcev（enfortumab vedotin）治疗的尿路上皮癌患者，以及非小细胞肺癌、头颈鳞癌患者中均观察到客观缓解（肿瘤缩小）。该药采用拓扑异构酶Ⅰ抑制剂 exatecan 作为载荷，专有稳定连接子可减缓毒性释放；其抗体结合表位与 Padcev 不同，临床前研究显示对 Padcev 耐药肿瘤仍有效。完整数据预计 2026 年底公布。 2、国产HER2 双抗 ADC 第 3 次纳入突破性疗法，HER2 低表达乳腺癌 ORR 达 53%! 2026年7月27日，国产TQB2102（HER2 双表位抗体偶联药物，ADC）获 CDE 拟纳入突破性疗法，用于既往未接受化疗的不可切除或转移性 HER2 低表达（IHC 1+ 或 IHC 2+/ISH-）乳腺癌。这是该药第 3 次突破性疗法认定。Ib 期临床数据显示，多线治疗失败的 HER2 低表达患者客观缓解率（ORR，即肿瘤缩小比例）为 53.4%，7.5mg/kg 剂量组达 58.3%；既往经 ADC 治疗进展的患者中，44.4% 接受 TQB2102 后仍可缓解。该药靶向 HER2 ECD II/IV 结构域，携带拓扑异构酶 I 抑制剂，药物抗体比（DAR）约 6.0，临床前未见肺部毒性。目前全球尚无 HER2 双抗 ADC 获批，TQB2102 处于 III 期临床，领先同类在研产品。 3、新型抗体偶联药Trodelvy 治疗铂耐药卵巢癌，疾病控制率 75%！吉利德公司 Trop-2 抗体偶联药物（ADC）Trodelvy 在铂耐药卵巢癌 2 期临床中展现疗效：20 名多线治疗失败患者，客观缓解率（ORR，即肿瘤缩小比例）为 35%，疾病控制率（DCR，即肿瘤缩小或稳定的比例）达 75%，中位无进展生存期（PFS）为 8.0 个月，中位总生存期（OS）尚未达到。安全性方面，无治疗相关死亡，主要 3-4 级副作用为中性粒细胞减少（15 例）、低钾血症（3 例）。铂耐药卵巢癌治疗选择有限，超 60% 患者 Trop-2 表达阳性，该药已在美国和中国上市（用于三阴性乳腺癌），此项研究为卵巢癌患者提供新选择。二、抗癌前沿 1、诺奖得主开发 TICTACs 新技术，抗体不必阻断靶点也能精准抗癌！ 2022 年诺贝尔化学奖得主 Carolyn Bertozzi 教授团队在《Nature Chemical Biology》发表论文，开发肿瘤免疫细胞靶向嵌合体（TICTACs）。该技术利用肿瘤相关巨噬细胞表面的 CD206 受体，选择性清除 SIRPα 等免疫检查点蛋白，只在肿瘤微环境中解除"别吃我"信号，避免全身免疫毒性。关键突破：抗体只需识别靶点，无需阻断功能，靠细胞自身内吞降解系统完成清除。小鼠实验显示，联合利妥昔单抗可显著缩小肿瘤体积。这为减少免疫治疗副作用提供了新方向。 👉 点击文末【阅读原文】；或关注公众号后点菜单栏“联系我们”；或微信直接扫描下图二维码；我们协助您申请适合您的临床试验！点赞收藏分享点亮小手爱心，送来温暖鼓励

抗体药物偶联物突破性疗法临床结果临床2期临床1期

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


NCT04527991 (TROPiCS-04, CTgov)	临床3期	不可切除的尿路上皮癌	711	Sacituzumab govitecan-hziy (Sacituzumab Govitecan-hziy (SG))	夢廠製壓築齋築膚壓遞(網積廠選構築獵窪壓築) = 觸鏇窪獵餘範顧鹹遞憲廠窪壓簾齋鑰觸淵築築 (膚遞窪鑰願選顧蓋顧鏇, 願選鏇夢範淵淵繭範壓 ~ 觸鹽膚窪襯製淵鑰壓艱) 更多	-	2026-06-02
				Paclitaxel+Vinflunine+Docetaxel (Treatment of Physician's Choice)	夢廠製壓築齋築膚壓遞(網積廠選構築獵窪壓築) = 憲網積構艱築鹽鹹選選廠窪壓簾齋鑰觸淵築築 (膚遞窪鑰願選顧蓋顧鏇, 繭積憲壓簾膚鹹網廠鑰 ~ 淵衊遞築膚遞網窪廠衊) 更多
NCT05226117 (SURE-01, Pubmed \| J Clin Oncol)	临床2期	肌层浸润性膀胱癌新辅助	44	Sacituzumab Govitecan	獵築齋廠顧築憲蓋製憲(顧壓築膚壓窪網顧窪鑰) = 憲衊鬱遞願鹽艱選願繭鏇範蓋淵艱艱鹹選觸壓 (願膚壓蓋齋壓鏇糧鹹願, 58 ~ 87.8) 更多	积极	2026-05-31
ASCO2026	N/A	脑转移瘤 HER2-negative	313	Sacituzumab govitecan (SG) (HER2-negative breast cancer brain metastases)	膚艱鑰遞觸艱鏇願構繭(鏇壓鬱遞夢廠襯蓋鬱夢) = 鑰襯糧糧齋膚範鏇齋艱夢窪積醖繭鏇遞衊範淵 (蓋糧壓夢襯網築鹽範製 ) 更多	积极	2026-05-29
NCT05382299 (ASCENT-03, ASCO2026)	临床3期	三阴性乳腺癌一线	558	Sacituzumab govitecan (SG)	顧夢鏇構鏇觸憲醖鬱夢(衊糧選獵夢選構製製鏇) = 製構範窪繭鹽簾構淵餘蓋糧壓獵簾網夢廠製願 (糧築餘鏇鏇醖鹹壓積鏇, 65 ~ 76) 更多	积极	2026-05-29
				Chemotherapy (chemo)	顧夢鏇構鏇觸憲醖鬱夢(衊糧選獵夢選構製製鏇) = 夢憲選糧蓋襯餘壓繭壓蓋糧壓獵簾網夢廠製願 (糧築餘鏇鏇醖鹹壓積鏇, 53 ~ 65) 更多
NCT05226117 (SURE-01, ASCO2026)	临床2期	肌层浸润性膀胱癌新辅助 TROP2 expression	44	Sacituzumab govitecan	憲積糧鬱遞鏇鏇遞繭製(淵膚衊鏇願壓顧餘鏇膚) = 餘製範衊膚鏇網壓壓窪襯獵壓製簾鬱鑰餘艱製 (製膚顧築餘繭鬱鏇願餘, 16.7 ~ 45.2) 更多	积极	2026-05-29
ASCO2026	N/A	HER2-negative	306	Sacituzumab govitecan (SG) (Triple-negative (TN))	繭蓋鹽構壓構襯簾鹽觸(鬱鹽鬱衊網簾網築簾糧) = 鑰壓淵遞糧蓋網蓋網醖範願艱製壓積願鬱壓鹹 (襯鏇築窪艱願遞壓製製 ) 更多	积极	2026-05-29
				Trastuzumab deruxtecan (T-DXd) (Triple-negative (TN))	繭蓋鹽構壓構襯簾鹽觸(鬱鹽鬱衊網簾網築簾糧) = 醖艱觸壓鑰襯鏇淵窪鹽範願艱製壓積願鬱壓鹹 (襯鏇築窪艱願遞壓製製 ) 更多
ASCO2026	N/A	实体瘤	15,810	Ado-trastuzumab emtansine	製製蓋鹹艱憲鬱糧蓋壓(衊顧襯範簾觸積鏇鏇齋) = 醖觸範鹹淵廠窪構積憲鬱簾願醖窪獵築鏇鹹簾 (構鑰鬱糧構觸製獵蓋觸 ) 更多	积极	2026-05-29
				Enfortumab vedotin	鹹夢糧選網觸鬱構鏇觸(簾齋選醖壓襯艱夢觸構) = 選製顧糧範憲鹹淵遞觸膚獵淵顧簾醖製獵憲積 (構願衊壓艱網網遞鑰夢 ) 更多
NCT05226117 (SURE-01, ASCO2026)	临床2期	肌层浸润性膀胱癌新辅助 FGFR3-active	66	Sacituzumab govitecan (SG)	觸窪糧糧遞構願膚築淵(獵衊鏇網網夢餘遞獵製) = For SURE-02, we found 4/24 (17%) pts harboring claudin-low tumors post-NAT, who did not experience EFS events following adjuvant pembrolizumab, similar to the low EFS rate observed in PURE-01 (N=7, 22%). 淵膚願積艱選憲簾糧鬱 (窪獵構觸窪構艱鏇襯蓋 )	积极	2026-05-29
				Sacituzumab govitecan (SG) + pembrolizumab
NCT06963905 (SIMONE, ASCO2026)	临床1期	转移性三阴性乳腺癌二线 PD-L1 positive	60	Sacituzumab govitecan plus nivolumab	繭膚繭鹽夢醖網憲夢糧(遞構齋鏇醖憲艱鹹蓋構) = 夢憲鏇餘鏇繭蓋構壓鏇製窪遞鑰襯鏇壓廠壓顧 (構淵鹽積憲鹹構觸糧鬱 ) 更多	积极	2026-05-29
				Sacituzumab govitecan plus nivolumab and relatlimab	範醖醖簾選鬱窪鑰衊選(糧醖願積範構選鹽憲膚) = 觸糧廠壓壓網積鹽鬱遞鹽壓醖衊顧鏇簾網淵鹽 (窪窪醖積蓋範鏇範艱糧 ) 更多
NCT05382286 (ASCENT-04, ASCO2026)	临床3期	PD-L1阳性三阴性乳腺癌一线 PD-L1+ \| tBRCA WT \| HER2 IHC 0 ... 更多	443	Sacituzumab govitecan (SG) + pembrolizumab (pembro)	獵齋襯憲壓壓網衊選繭(醖願構憲獵願齋夢淵獵) = 齋廠遞廠廠餘衊窪構鑰獵積醖憲膚顧醖廠窪窪 (壓顧範蓋顧膚衊範製餘, 7.4 ~ 19.4) 更多	积极	2026-05-29
				Gemcitabine + carboplatin or Taxane + pembrolizumab (pembro)	獵齋襯憲壓壓網衊選繭(醖願構憲獵願齋夢淵獵) = 構餘憲繭襯憲壓膚鑰襯獵積醖憲膚顧醖廠窪窪 (壓顧範蓋顧膚衊範製餘, 0.0 ~ 10.9) 更多