A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, SINGLE-DOSE, CROSS-OVER STUDY TO ESTIMATE THE ABSOLUTE BIOAVAILABILITY OF VEPDEGESTRANT (ARV-471, PF-07850327) FOLLOWING ORAL AND INTRAVENOUS DOSING OF THE DRUG TO HEALTHY PARTICIPANTS

The purpose of this study is to learn how much of the study medicine called Vepdegestrant will reach the bloodstream when given orally compared to given intravenously.
This study is seeking participants who:
* are healthy males and healthy females who cannot have children.
* are 18 years or older.
* are healthy as decided by medical tests.
* have a body mass index (BMI) of 16 to 32 kilogram per meter squared.
* have a total body weight of more than 45 kilograms (99 pounds).
In Period 1, all participants will receive one dose of Vepdegestrant by IV. In Period 2, all participants will receive one dose of Vepdegestrant by mouth following a high-fat breakfast. The levels of Vepdegestrant in Period 1 will be compared to the levels of Vepdegestrant in Period 2 and the bioavailablility of the oral formulation of Vepdegestrant will be determined.
The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit for 9 days (8 nights) during each period. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time.

开始日期2025-04-03

申办/合作机构

Pfizer Inc.

[+1]

CTR20242782

/ Active, not recruiting临床2期

一项在 18 岁及以上 ER+/HER2- 晚期或转移性乳腺癌研究参与者中评估口服蛋白水解靶向嵌合体 Vepdegestrant（ARV-471/PF-07850327）联合 PF-07220060 治疗的耐受性、PK 和抗肿瘤活性的开放标签、干预性的安全有效性 Ib/II 期研究

II期主要目的：1. 评估 Vepdegestrant 联合 PF-07220060 治疗的临床抗肿瘤活性。II期次要目的：1. 确定 Vepdegestrant 联合 PF-07220060 治疗的其他抗肿瘤活性结局。2. 进一步评价 Vepdegestrant 与 PF-07220060 联合用药的总体安全性特征和耐受性。3. 评价 Vepdegestrant 与 PF-07220060 联合给药时，Vepdegestrant、ARV-473 和 PF-07220060 的血浆药物暴露量。4. 评估治疗后血浆 ctDNA 相对于基线水平的变化。II期探索性目的：1. 探索 PF-07220060 联合 Vepdegestrant 治疗对患者报告的症状和健康相关生命质量的影响。2. 了解乳腺癌的肿瘤生物学，确定潜在的敏感性和/或耐药性机制。3. 评价分子定义的研究参与者人群中突变状态与应答之间的关系。4. 探索药物基因组学对 PF-07220060 血浆药物暴露量的影响。

开始日期2024-11-18

申办/合作机构

Pfizer Inc.

[+2]

NCT06645938

/ Completed临床1期

A PHASE I, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-TREATMENT, 2-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF AN VARIANT (HIGH HARDNESS) TABLET OF VEPDEGESTRANT (ARV-471, PF-07850327) RELATIVE TO THE REGISTRATIONAL TABLET

The purpose of the study is to compare the amount vepdegestrant available from two different tablet formulations under fed conditions in healthy adult participants; 200 mg vepdegestrant alternative tablet formulation compared to 200 mg vepdegestrant standard tablet formulation.
This study is seeking male or female participants of non-childbearing potential age who:
* are 18 years or older
* are healthy as decided by medical tests.
* have a Body mass index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (99 pounds).
All participants will be put into groups to receive one of the 2 treatments in each period. This study will consist of 2 treatment sequences:
* Sequence 1: Single 200 mg dose of vepdegestrant registrational tablet in Period 1, followed by a single 200 mg dose of vepdegestrant variant tablet in Period 2.
* Sequence 2: Single 200 mg dose of vepdegestrant variant tablet in Period 1, followed by a single 200 mg dose of vepdegestrant registrational tablet in Period 2.
Participants will be in the study for about 11 weeks.

开始日期2024-10-16

申办/合作机构

Pfizer Inc.

[+1]

100 项与 Vepdegestrant 相关的临床结果

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100 项与 Vepdegestrant 相关的转化医学

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100 项与 Vepdegestrant 相关的专利（医药）

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项与 Vepdegestrant 相关的文献（医药）

2025-08-07·NEW ENGLAND JOURNAL OF MEDICINE

Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer

Article

作者: Hu, Xichun ; Parameswaran, Janaki ; Mouret-Reynier, Marie-Ange ; Jerzak, Katarzyna J. ; Lu, Dongrui R ; Patsouris, Anne ; Zhi, Xin ; Valota, Olga ; Cui, Jiuwei ; Guarneri, Valentina ; Sezer, Ahmet ; De Laurentiis, Michelino ; Jhaveri, Komal ; Fontana, Andrea ; Yoshinami, Tetsuhiro ; Martignoni, Marcella ; Cil, Timucin ; Zamagni, Claudio ; Molckovsky, Andrea ; Ladoire, Sylvain ; Hamilton, Erika P. ; Rodriguez-Lescure, Alvaro ; Zhang, Yongqiang ; Fuentes, Christian ; Demirci, Umut ; Campone, Mario ; Cazzaniga, Marina

BACKGROUND:

Vepdegestrant is an oral proteolysis-targeting chimera (PROTAC) estrogen receptor (ER) degrader that directly harnesses the ubiquitin-proteasome system.

METHODS:

In this phase 3, open-label, randomized trial, we enrolled patients with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who had received one previous line of cyclin-dependent kinase 4 and 6 inhibitor therapy plus one line of endocrine therapy (and up to one additional line of endocrine therapy). Patients were randomly assigned in a 1:1 ratio to receive vepdegestrant at a dose of 200 mg orally once every day of each 28-day cycle or fulvestrant at a dose of 500 mg, administered intramuscularly, on day 1 and day 15 of cycle 1 and on day 1 of subsequent cycles, with randomization stratified according to ESR1-mutation status and presence or absence of visceral disease. The primary end point was progression-free survival as assessed by blinded independent central review among the patients with ESR1 mutations and among all the patients who underwent randomization. Progression-free survival was estimated with Kaplan-Meier methods and hazard ratios with a stratified Cox proportional-hazards model.

RESULTS:

A total of 624 patients underwent randomization; 313 were assigned to receive vepdegestrant, and 311 to receive fulvestrant. Among the 270 patients with ESR1 mutations, the median progression-free survival was 5.0 months (95% confidence interval [CI], 3.7 to 7.4) with vepdegestrant and 2.1 months (95% CI, 1.9 to 3.5) with fulvestrant (hazard ratio, 0.58 [95% CI, 0.43 to 0.78]; P<0.001). Among all the patients, the median progression-free survival was 3.8 months (95% CI, 3.7 to 5.3) with vepdegestrant and 3.6 months (95% CI, 2.6 to 4.0) with fulvestrant (hazard ratio, 0.83 [95% CI, 0.69 to 1.01]; P = 0.07). Adverse events of grade 3 or higher occurred in 23.4% of the patients in the vepdegestrant group and in 17.6% of the patients in the fulvestrant group. Adverse events led to treatment discontinuation in 2.9% and 0.7% of the patients, respectively.

CONCLUSIONS:

Among patients with ER-positive, HER2-negative advanced breast cancer, vepdegestrant was associated with significantly longer progression-free survival than fulvestrant in the subgroup with ESR1 mutations but not in the full patient population. (Funded by Pfizer and Arvinas Estrogen Receptor; VERITAC-2 ClinicalTrials.gov number, NCT05654623.).

2025-08-01·MOLECULAR DIVERSITY

AI-DPAPT: a machine learning framework for predicting PROTAC activity

Article

作者: Alshammari, Bahaa ; Alqarni, Saad ; Kassab, Shaymaa E. ; Abouzied, Amr S. ; Kari, Hayam ; Abouzied, Amr S ; Huwaimel, Bader ; Kassab, Shaymaa E

Proteolysis Targeting Chimeras are part of targeted protein degradation (TPD) techniques, which are significant for pharmacological and therapy development. Small-molecule interaction with the targeted protein is a complicated endeavor and a challenge to predict the proteins accurately. This study used machine learning algorithms and molecular fingerprinting techniques to build an AI-powered PROTAC Activity Prediction Tool that could predict PROTAC activity by examining chemical structures. The chemical structures of a diverse set of PROTAC drugs and their corresponding activities are selected as a dataset for training the tool. The processes used in this study included data preparation, feature extraction, and model training. Further, evaluation was done for the performance of the various classifiers, such as AdaBoost, Support Vector Machine, Random Forest, Gradient Boosting, and Multi-Layer Perceptron. The findings show that the methods selected here depict accurate PROTAC activities. All the models in this study showed an ROC curve better than 0.9, while the random forest on the test set of the AI-DPAPT had an area under the curve score of 0.97, thus showing accurate results. Furthermore, the study revealed significant insights into the molecular features that can influence the functions of the PROTAC. These findings can potentially increase the understanding of the structure-activity correlations involved in the TPD. Overall, the investigation contributes to computational drug development by introducing this platform powered by artificial intelligence that predicts the function of PROTAC. In addition, it sped up the processes of identifying and improving previously unknown medications. The AI-DPAPT platform can be accessed online using a web server at https://ai-protac.streamlit.app/ .

2025-06-01·EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

A comprehensive mechanistic investigation of factors affecting intestinal absorption and bioavailability of two PROTACs in rats

Article

作者: Dahlgren, David ; Koziolek, Mirko ; Borchardt, Thomas ; Arendt, Nathalie ; Sjöblom, Markus ; Indulkar, Anura ; Hedeland, Mikael ; Niessen, Janis ; Dubbelboer, Ilse R ; Lennernäs, Hans

AIM:

Proteolysis targeting chimeras (PROTACs) exhibit a unique and promising pharmacology. However, this comes with molecular properties exceeding the 'drug-like' rule of five chemical space, which often limits gastrointestinal absorption. This in vivo study aimed to investigate the contribution of luminal and plasma stability, intestinal effective permeability, P-glycoprotein (P-gp) efflux, and bile excretion, on the rat intestinal absorption and systemic exposure of two PROTACs, ARV-110 (812 Da, LogD_7.4 4.8) and ARV-471 (724 Da, LogD_7.4 4.6).

METHODS:

Luminal stability and effective intestinal permeability were determined directly from luminal disappearance using single-pass intestinal perfusion, with and without a protease inhibitor, or a P-gp/Cytochrome P450 CYP3A inhibitor (ketoconazole) in rats. Plasma stability was tested by in vitro incubations. Intestinal absorption, systemic exposure, and biliary excretion were examined after intraduodenal and intravenous dosing with ketoconazole or the P-gp selective inhibitor (encequidar).

RESULTS AND DISCUSSION:

Both PROTACs were degraded in the intestinal lumen and in plasma by peptidases. The intestinal effective permeability in rats was moderate for ARV-110 (0.62 × 10^-4 cm/s) and low for ARV-471 (0.23 × 10^-4 cm/s). P-gp inhibition increased the permeability 1.6- and 2.3-fold for ARV-110 and ARV-471, respectively. After intraduodenal dosing with the P-gp inhibitors a corresponding increase in systemic exposure was observed for both PROTACs. There was only a minor difference in the increased systemic exposure induced by the two inhibitors, suggesting that the mechanisms were primarily P-gp inhibition, rather than gut-wall and hepatic extraction. Biliary excretion was a minor pathway and did not affect the absorption and systemic exposure of the PROTACs to a large extent.

CONCLUSION:

In the rat, ARV-110 and ARV-471 were enzymatically degraded in the intestinal lumen and in plasma, and their intestinal permeability and systemic exposure seem to be reduced due to P-gp efflux.

316

项与 Vepdegestrant 相关的新闻（医药）

2025-08-11

·药明康德

明星PROTAC®分子上市申请获FDA受理！

Arvinas与辉瑞（Pfizer）日前宣布，美国FDA已受理其为vepdegestrant所递交的新药申请（NDA），用于治疗既往接受过内分泌治疗的、雌激素受体阳性（ER+）/人表皮生长因子受体2阴性（HER2-）且伴有ESR1突变的晚期或转移性乳腺癌患者。该申请的PDUFA日期为2026年6月5日。根据新闻稿，vepdegestrant是首个在乳腺癌患者中展现临床获益的PROTAC®疗法；若获批，该疗法将成为首个获美国FDA批准的PROTAC®雌激素受体降解剂。这次vepdegestrant上市申请的递交，主要基于VERITAC-2临床3期试验的积极结果。分析显示，在携带ESR1突变的激素受体（HR）阳性、HER2阴性乳腺癌患者群体中，vepdegestrant与活性对照相比，为患者的无进展生存期（PFS）带来统计学显著并具有临床意义的改善。这些患者在此前接受CDK4/6抑制剂和内分泌治疗后疾病出现进展。在携带ESR1突变的患者群体中，疾病进展或死亡风险降低43%（HR=0.57；95% CI：0.42–0.77，P<0.001），vepdegestrant组患者的PFS达5.0个月，对照组患者则仅有2.1个月。在携带ESR1突变的所有患者亚群当中，vepdegestrant的获益情形一致。 Vepdegestrant是一款潜在“first-in-class”的口服PROTAC®降解剂，利用人体天然的蛋白质降解系统特异性地靶向并降解雌激素受体。它已经获得美国FDA授予的突破性疗法认定，用于治疗经治ER阳性、HER2阴性乳腺癌。参考资料： [1] Arvinas Announces FDA Acceptance of the New Drug Application for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer. Retrieved August 11, 2025 from https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-acceptance-new-drug-application [2] Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer. Retrieved June 6, 2025 from https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-submission-new-drug-application-us-fda 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

蛋白降解靶向嵌合体突破性疗法临床结果临床3期

2025-08-11

·Pharmaceutical Technology

FDA gives Arvinas and Pfizer’s vepdegestrant NDA for breast cancer

The NDA submission was based on results from the VERITAC-2 clinical trial. Credit: Gorodenkoff/Shutterstock.com. Arvinas, in collaboration with Pfizer, has announced new drug application (NDA) acceptance for vepdegestrant from the US Food and Drug Administration (FDA) to treat breast cancer. The treatment is aimed at patients with oestrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), oestrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have previously undergone endocrine-based therapy. The Prescription Drug User Fee Act (PDUFA) action date is set for 5 June 2026. Vepdegestrant is an investigational, oral bioavailable PROteolysis TArgeting Chimera (PROTAC) medication designed to degrade oestrogen receptors. It is being developed collaboratively by Arvinas and Pfizer as a potential monotherapy option. The submission was based on results from VERITAC-2, a randomised, global Phase III study that compared vepdegestrant against fulvestrant. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Patients were randomly assigned in a 1:1 ratio to receive either vepdegestrant, administered orally once daily on a continuous 28-day schedule, or fulvestrant, which was given intramuscularly. 43% of the patients in the trial had detectable ESR1 mutations. Progression-free survival (PFS), measured both in patients with ESR1 mutations and across all trial participants, served as the primary endpoint evaluated through blinded independent central review. Overall survival (OS) remains an important secondary endpoint. Arvinas chairperson, CEO and president John Houston stated: “Patients often face limited treatment options after first-line treatment and vepdegestrant demonstrated improved progression-free survival in patients with ESR1-mutated ER+/HER2- advanced breast cancer. “With the efficacy and favourable tolerability seen in VERITAC-2, we believe vepdegestrant, if approved, has potential to be a best-in-class treatment option for patients in the second-line ESR1-mutant setting.” In August 2025, Pfizer raised its full-year profit forecast , driven by robust sales of its heart disease medication Vyndaqel (tafamidis) and the blood thinner Eliquis (apixaban), among other products. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

临床3期临床结果申请上市

2025-08-10

·药事纵横

130亿美元弹药就绪！辉瑞2025H1业绩暗藏“钞能力”

导读当跨国药企集体穿越专利悬崖风暴，辉瑞用一份“稳中藏锋”的半年报展现了老牌巨头的韧性。2025上半年总营收283.67亿美元，同比微增1%的背后，暗藏关键业务线的剧烈分化：肿瘤板块扛起增长大旗，ADC产品以15亿美元收入成为新引擎，而初级护理业务8%的滑坡则敲响转型警钟。更值得关注的是，手握430亿美金收购Seagen的整合红利尚未完全释放，130亿美元BD弹药已蓄势待发。这家曾被质疑“后新冠时代增长乏力”的药企，正用一场精密的战略卡位战，向市场证明大象也能起舞。肿瘤业务：ADC 与双抗引领增长肿瘤业务作为辉瑞业绩增长的关键驱动力，在 2025H1 表现卓越，实现了 81.45 亿美元的收入，同比增长 9% 。这一增长主要得益于 ADC 产品的强劲表现以及双抗药物的崭露头角。 ADC 产品无疑是肿瘤业务增长的核心动力。全球首个 Nectin-4 ADC 药物 Padcev，凭借其独特的作用机制和显著的临床疗效，上半年收入飙升 32%，达到 9.67 亿美元，成为肿瘤板块最大的增长极。其成功不仅源于单药治疗的有效性，更在于与帕博利珠单抗等药物的联合治疗方案，显著延长了尿路上皮癌患者的生存期，推动其市场份额不断扩大。Adcetris 和 Tivdak 同样表现出色。Adcetris 作为全球首个 CD30 ADC 药物，尽管销售额同比下降 12%，仍贡献了 4.72 亿美元的收入。Tivdak 作为全球首个组织因子（TF）ADC 药物，收入同比增长 31%，达到0.79 亿美元。这些 ADC 药物的优异表现，充分证明了辉瑞在 ADC 领域的技术实力和创新能力。 CD3/BCMA 双抗Elrexfio 在多发性骨髓瘤治疗领域展现出巨大潜力。作为 2023 年获批上市的新药，Elrexfio 在上市首年便取得了 1.45 亿美元的销售收入，且在日本等新市场占据领先份额。其通过同时靶向表达 B 细胞成熟抗原（BCMA）的多发性骨髓瘤细胞和表达 CD3 的 T 细胞，激活 T 细胞对肿瘤细胞的杀伤作用，为多发性骨髓瘤患者提供了新的治疗选择。随着临床应用的推广和适应症的扩展，Elrexfio 有望成为 BCMA 双抗的标准疗法，进一步推动肿瘤业务的增长。洛拉替尼和恩扎卢胺等传统肿瘤药物也持续为业务增长贡献力量。洛拉替尼作为第三代 ALK 抑制剂，上半年销售额增长 42%，达到 4.73 亿美元。其能够有效抑制 ALK 阳性非小细胞肺癌患者的肿瘤生长，且对脑转移患者具有较好的疗效。恩扎卢胺作为雄激素受体信号抑制剂，收入增长 12%，达到 10.23 亿美元，在前列腺癌治疗领域保持着稳定的市场地位。传统业务：危机与希望并存初级护理板块在 2025H1 面临营收下滑的挑战，收入为 112.36 亿美元，同比下降 8% 。这一下滑趋势反映出辉瑞在传统业务领域面临的严峻考验，尤其是两大现金牛产品 Eliquis 和 Prevnar 系列，增长停滞的问题愈发凸显。 Eliquis 作为重磅抗凝药，在初级护理业务中占据重要地位，2025H1 销售额达到 39.26 亿美元。然而，其将于 2026 年面临专利到期的困境，一旦专利到期，仿制药的竞争将不可避免，这将对Eliquis 的市场份额和销售额产生巨大冲击。届时，辉瑞需要凭借有效的市场策略和产品创新，来应对仿制药的竞争压力，维持其在抗凝药市场的地位。Prevnar 系列肺炎球菌疫苗同样面临增长瓶颈，2025H1 销售额为 30.43 亿美元，增长停滞。随着市场竞争的加剧和疫苗技术的不断发展，Prevnar系列需要加快升级换代和拓展新适应症的步伐，以满足市场需求，重新激发增长动力。在传统业务整体承压的情况下，偏头痛新药 Nurtec ODT/Vydura 和 RSV 疫苗 Abrysvo 成为亮点。Nurtec ODT/Vydura 作为辉瑞斥资 116 亿美元收购 Biohaven 公司获得的产品，在 2025H1 贡献了 6.07 亿美元收入，同比增长 14% 。其通过特异性阻断降钙素基因相关肽（CGRP）受体，有效缓解偏头痛症状，为偏头痛患者提供了新的治疗选择。RSV 疫苗 Abrysvo 在 2023 年上市后，迅速获得市场认可，2025H1 创收 2.74 亿美元，同比增长 36% 。尽管受到美国疾控中心调整推荐接种人群和疫苗安全性问题的影响，其市场前景仍值得期待。未来，随着市场推广的深入和接种人群的逐渐扩大，Abrysvo 有望进一步提升销售额，成为初级护理业务的重要增长点。并购成效：Seagen 资产释放红利 2023 年底，辉瑞以 430 亿美元收购 Seagen，这一重磅交易在 2025H1 展现出显著的协同效应，收购资产合计创收 17.52 亿美元，成为辉瑞业绩增长的重要支撑。在这些收购资产中，ADC 产品占据主导地位，合计收入约 15.18 亿美元。Padcev 作为全球首个 Nectin-4 ADC 药物，凭借其在尿路上皮癌治疗领域的卓越表现，上半年收入达到9.67 亿美元，同比增长 32% 。其成功不仅源于单药治疗的有效性，更在于与帕博利珠单抗等药物的联合治疗方案，显著延长了尿路上皮癌患者的生存期，推动其市场份额不断扩大。Adcetris 尽管销售额同比下降 12%，仍贡献了 4.72 亿美元的收入，作为全球首个 CD30 ADC 药物，其在经典型霍奇金淋巴瘤等适应症上的治疗地位依然稳固。Tivdak 作为全球首个组织因子（TF）ADC 药物，收入同比增长 31%，达到0.79 亿美元，在复发性或转移性宫颈癌治疗中显示出良好的疗效。 Seagen 的产品管线进一步丰富了辉瑞的肿瘤矩阵，形成了 ADC、双抗、小分子药物协同发展的格局。这种协同效应不仅有助于辉瑞在现有肿瘤治疗领域巩固优势，还为其开拓新的治疗领域和市场提供了有力支持。通过整合 Seagen 的技术和资源，辉瑞能够加速研发进程，推出更多创新的肿瘤治疗方案，满足患者的多样化需求。 BD 战略：130 亿弹药的未来投向在业务拓展与创新布局的战略规划下，辉瑞展现出积极进取的态势。5 月 20 日，辉瑞与三生制药达成重磅合作，以高达 60.5 亿美元的总交易额，获得三生制药自主研发的 PD-1/VEGF 双抗 SSGJ-707 在全球（不包括中国内地）的开发、生产及商业化权利。这一合作不仅体现了辉瑞对双抗药物前景的高度认可，更凸显了其在肿瘤免疫联合治疗领域的战略布局。SSGJ-707 基于三生制药的 CLF2 专利平台开发，已获得中国国家药品监督管理局药品审评中心（CDE）突破性治疗药物认定，在一线治疗 PD-L1 表达阳性的局部晚期或转移性非小细胞肺癌的 III 期临床研究中展现出巨大潜力。辉瑞计划全面规划其 III 期开发机会，并探索与旗下 ADC 药物的联用方案，有望为肿瘤患者带来更有效的治疗选择。辉瑞明确将 “并购扩张” 列为核心增长引擎，彰显其通过外部资源整合推动业务增长的决心。在生物制药领域，并购是获取新技术、新产品和新市场的重要途径。辉瑞凭借雄厚的资金实力和广泛的行业影响力，积极寻找具有潜力的并购目标。通过并购，辉瑞能够快速扩充产品线，填补研发管线的空白，增强在肿瘤、疫苗、免疫等核心治疗领域的竞争力。例如，收购 Seagen 使其在 ADC 领域实现了跨越式发展，迅速提升了在肿瘤治疗市场的地位。展望未来，辉瑞将 PROTAC 技术平台、新型 ADC 靶点、肿瘤免疫联合疗法列为重点发展方向，这些领域代表了生物医药行业的前沿趋势，具有巨大的发展潜力。PROTAC 技术作为一种新兴的靶向蛋白降解策略，能够特异性降解致病蛋白，为攻克 “不可成药” 靶点提供了新的解决方案。辉瑞与 Arvinas 联合开发的 Vepdegestrant 已申报上市，有望成为全球首个问世的 PROTAC 药物，为乳腺癌治疗带来新的突破。新型 ADC 靶点的探索和开发，将进一步拓展 ADC 药物的应用范围，提高癌症治疗的精准性和有效性。肿瘤免疫联合疗法通过整合多种治疗手段，能够激活患者自身的免疫系统，实现对肿瘤细胞的协同杀伤，成为未来肿瘤治疗的重要发展方向。辉瑞在这些领域的提前布局，将有助于其在激烈的市场竞争中抢占先机，持续引领生物医药行业的发展潮流。最后当Albert Bourla在财报中强调“为未来十年奠基”时，辉瑞已悄然完成战术切换：从依赖新冠产品的非常态增长，转向以ADC为矛、BD为盾的长期作战模式。15亿美元ADC收入的背后，是430亿美金并购的精准拆弹；130亿美元弹药的部署，则是对创新荒漠的未雨绸缪。尽管Eliquis专利倒计时的阴影仍在，但PROTAC药物的破局、双抗产品的爆发、以及对中国创新药企的深度捆绑，无不揭示着这家巨头的野心——它要的不仅是穿越周期，更是重新定义制药巨头的进化法则。大象转身虽缓，落子却招招致命。药事纵横投稿须知：稿费已上调，欢迎投稿

抗体药物偶联物并购申请上市免疫疗法财报

100 项与 Vepdegestrant 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
ER阳性/HER2阴性/ESR1突变乳腺癌	申请上市	美国	Arvinas, Inc.	2025-06-06
ER阳性/HER2阴性乳腺癌	临床3期	美国	Arvinas Estrogen Receptor, Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	美国	Pfizer Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	中国	Pfizer Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	中国	Arvinas Estrogen Receptor, Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	日本	Pfizer Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	日本	Arvinas Estrogen Receptor, Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	阿根廷	Pfizer Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	阿根廷	Arvinas Estrogen Receptor, Inc.	2023-03-03
ER阳性/HER2阴性乳腺癌	临床3期	澳大利亚	Arvinas Estrogen Receptor, Inc.	2023-03-03

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临床结果

适应症

分期

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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


NCT05654623 (VERITAC-2, Pubmed \| N Engl J Med)	临床3期	晚期乳腺癌	624	Vepdegestrant 200 mg	鏇網範鹽廠窪夢鹽構鑰(範選膚餘齋顧網觸製憲) = in 2.9% and 0.7% of the patients, respectively 網鑰鏇餘壓淵襯醖餘鑰 (艱構鹹鏇鬱餘繭鹹範願 ) 更多	积极	2025-05-31
				Fulvestrant 500 mg
NCT05654623 (VERITAC-2, ASCO2025 \| Company_Website) 人工标引	临床3期	ER阳性/HER2阴性乳腺癌 ER Positive \| HER2 Negative	624	Vepdegestrant	鹽鏇餘製遞鏇憲衊艱衊(遞構製顧鹽齋獵鬱糧鬱) = 蓋艱夢襯憲製積鹽鏇觸鑰網蓋窪鑰鑰願顧膚鬱 (鏇製鹹願構膚齋糧蓋艱, 3.6–5.3) 更多	积极	2025-05-30
				fulvestrant	鹽鏇餘製遞鏇憲衊艱衊(遞構製顧鹽齋獵鬱糧鬱) = 遞夢餘蓋製網餘膚窪壓鑰網蓋窪鑰鑰願顧膚鬱 (鏇製鹹願構膚齋糧蓋艱, 2.2–3.8) 更多
NCT05654623 (VERITAC-2, Company_Website) 人工标引	临床3期	ER阳性/HER2阴性乳腺癌 ESR1 Mutation	-	Vepdegestrant (ESR1 mutant)	膚築蓋鏇壓齋鹹獵淵憲(觸淵製鏇網糧鏇壓襯壓) = The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population. 襯艱顧糧衊遞繭積鏇憲 (夢齋鏇鏇鹹遞顧襯構鹹 )	不佳	2025-03-11
				fulvestrant (ESR1 mutant)
NCT05548127 (TACTIVE-U, GlobeNewswire) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌三线	16	Vepdegestrant + Abemaciclib	鏇窪餘夢構簾餘鏇鹹糧(廠艱遞顧繭繭淵鏇齋簾) = None 範顧觸製構艱憲夢憲糧 (壓觸憲遞遞築鹹鬱鑰襯 ) 更多	积极	2024-12-10
				Vepdegestrant + Abemaciclib (mutant ESR1)
NCT05463952 (Pubmed \| Int J Clin Oncol)	临床1期	局部晚期不能切除的乳腺癌 \| 乳腺癌 \| ER阳性乳腺癌 ... estrogen receptor (ER) 更多	6	Vepdegestrant 200 mg QD	蓋憲範襯襯醖積淵積夢(糧憲鏇獵鏇鬱鹽鬱壓鏇) = Four (66.7%) patients experienced adverse events; none led to dose reduction or discontinuation 遞糧顧鹽淵膚網積築艱 (壓糧顧艱壓醖窪鹹鏇憲 ) 更多	-	2024-11-20
NCT05463952 (CTgov)	临床1期	局部晚期不能切除的乳腺癌 \| 乳腺癌 \| ER阳性乳腺癌 ... 更多	6	ARV-471	觸顧遞選願鬱衊襯遞襯 = 獵觸獵膚簾築網膚糧築繭選廠夢鏇窪醖鏇衊夢 (淵醖獵製衊構構襯鑰艱, 鑰鏇壓餘築襯選襯鹽鬱 ~ 鬱製範廠鹹膚構構糧顧) 更多	-	2024-09-23
NCT05538312 (CTgov)	临床1期	-	12	ARV-471 (Period 1: ARV-471 200 mg)	鹽鏇顧鹽窪襯夢鬱選網(壓遞鑰餘齋願網糧醖鏇) = 餘壓衊憲糧網鹹選築廠襯餘鏇願選鏇鹹鬱艱齋 (淵觸夢獵簾製衊襯積範, 23) 更多	-	2024-09-23
				Itraconazole+ARV-471 (Period 2: ARV-471 200 mg + Itraconazole 200 mg)	鹽鏇顧鹽窪襯夢鬱選網(壓遞鑰餘齋願網糧醖鏇) = 膚鹽觸憲壓選獵積醖壓襯餘鏇願選鏇鹹鬱艱齋 (淵觸夢獵簾製衊襯積範, 24) 更多
NCT05673889 (CTgov)	临床1期	-	24	Dabigatran (Period 1: Dabigatran 75 mg)	選顧鑰獵淵艱鏇衊醖獵(廠鏇夢製壓襯顧鑰蓋積) = 選構鹽醖衊繭獵膚壓繭網繭繭餘夢顧憲憲觸壓 (選淵夢選襯觸窪夢鏇鹽, 94) 更多	-	2024-08-16
				ARV-471+Dabigatran (Period 2: Dabigatran 75 mg + ARV-471 200 mg)	選顧鑰獵淵艱鏇衊醖獵(廠鏇夢製壓襯顧鑰蓋積) = 齋鹽範壓網蓋膚願願蓋網繭繭餘夢顧憲憲觸壓 (選淵夢選襯觸窪夢鏇鹽, 66) 更多
NCT05652660 (CTgov)	临床1期	-	12	Rosuvastatin (Period 1: Rosuvastatin)	夢範遞餘齋糧襯顧餘獵(襯獵鹽壓遞廠範醖鹽襯) = 鏇鬱繭鬱窪齋鑰衊獵構蓋鏇積窪淵窪壓蓋艱繭 (顧艱齋壓鏇鏇製壓製網, 53) 更多	-	2024-07-26
				Rosuvastatin+ARV-471 (Period 2: ARV-471 + Rosuvastatin)	夢範遞餘齋糧襯顧餘獵(襯獵鹽壓遞廠範醖鹽襯) = 鏇壓餘範築鹽鬱網餘願蓋鏇積窪淵窪壓蓋艱繭 (顧艱齋壓鏇鏇製壓製網, 48) 更多
NCT04072952 (ESMO_BC2024) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌 HER2 Negative \| ER Positive \| ESR1 Mutation	46	Vepdegestrant+palbociclib (Total)	觸淵顧鬱築簾鬱衊積窪(製鏇獵簾夢餘遞廠襯簾) = ≥10% to either vepdegestrant or palbo were neutropenia (91%) and decreased white blood cell count (15%). 憲窪廠鏇積製顧構齋鏇 (齋鬱鬱壓窪壓廠壓齋壓 )	积极	2024-05-16
				Vepdegestrant+palbociclib (Mutant ESR1)