更新于：2024-11-01

Perivascular epithelioid cell tumour

血管周围上皮样细胞肿瘤

更新于：2024-11-01

基本信息

别名

CCMMT、Clear Cell Myomelanocytic Tumor、Clear Cell Myomelanocytic Tumor of the Falciform Ligament/Ligamentum Teres

+ [32]

简介

A family of mesenchymal tumors composed of histologically and immunohistochemically distinctive perivascular epithelioid cells. These cells do not have a normal anatomic homolog. (From Fletcher CDM, et. al., World Health Organization Classification of Tumors: Pathology and Genetics of Tumors of Soft Tissue and Bone, 2002).

关联

项与血管周围上皮样细胞肿瘤相关的药物

Sirolimus Albumin-Bound

西罗莫司(白蛋白结合型)

靶点

MUT x mTOR

作用机制

MUT刺激剂 [+3]

在研机构

Aadi Bioscience, Inc. [+5]

原研机构

Abraxis BioScience, Inc.

在研适应症

血管周围上皮样细胞肿瘤 [+19]

非在研适应症

晚期肉瘤 [+16]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2021-11-22

Nivolumab

纳武利尤单抗

靶点

PD-1

作用机制

PD-1抑制剂

在研机构

Ono Pharmaceutical Co., Ltd. [+21]

原研机构

Ono Pharmaceutical Co., Ltd. [+1]

在研适应症

皮肤肿瘤 [+459]

非在研适应症

异戊酸血症 [+83]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2014-07-04

Ipilimumab

伊匹木单抗

靶点

CTLA4

作用机制

CTLA4抑制剂

在研机构

Bristol Myers Squibb Co. [+11]

原研机构

Bristol Myers Squibb Co.

在研适应症

不能切除的食管鳞状细胞癌 [+287]

非在研适应症

复发性急性淋巴细胞白血病 [+97]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2011-03-25

111

项与血管周围上皮样细胞肿瘤相关的临床试验

NCT06453642 / RecruitingN/A

Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)

The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.

开始日期2024-09-01

申办/合作机构

Fluidx Medical Technology LLC

[+1]

ChiCTR2400086579 / RecruitingN/AIIT

Pilot study on the feasibility of medical Tai Chi exercise prescription to improve exercise capacity and quality of life in patients with lymphangioleiomyomatosis

开始日期2024-06-28

申办/合作机构-

NCT06405997 / RecruitingN/AIIT

The Genotype and Phenotype of Lymphangioleiomyomatosis

This study aims to differentiate between sporadic Lymphangioleiomyomatosis and Tuberous Sclerosis Complex-associated Lymphangioleiomyomatosis.

开始日期2024-05-10

申办/合作机构

National Taiwan University Hospital

100 项与血管周围上皮样细胞肿瘤相关的临床结果

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100 项与血管周围上皮样细胞肿瘤相关的转化医学

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0 项与血管周围上皮样细胞肿瘤相关的专利（医药）

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7,918

项与血管周围上皮样细胞肿瘤相关的文献（医药）

2025-04-01·DEN Open

A diminutive perivascular epithelioid cell tumor in the colon

作者: Sano, Yasushi ; Sano, Wataru ; Iwatate, Mineo ; Fujimori, Takahiro ; Hirata, Daizen ; Fujita, Mikio ; Sugimura, Naoki ; Hattori, Santa

AbstractPerivascular epithelioid cell tumor (PEComa) is a rare mesenchymal tumor. Some papers have reported that colonoscopy could be used to treat PEComa with a predominantly pedunculated polyp, whereas surgical intervention is often required for cases with submucosal‐type tumors. These findings suggest that the morphology of PEComa changes dramatically with disease progression. Because of the rapid progression of PEComa, endoscopic treatment remains challenging, and early‐stage PEComa morphology is not well understood. A 64‐year‐old man presented to our hospital for a follow‐up colonoscopy after undergoing multiple polypectomies. He had a medical history of colorectal adenoma and prostate cancer. A 4‐mm pale blue elevated but not pedunculated lesion was observed in the transverse colon, an area where he had not had polyps previously. Since no epithelial change was observed, the presence of a submucosal tumor, such as a gastrointestinal stromal tumor, was suspected. Cold snare polypectomy was performed, and the lesion was completely resected. Histological evaluation using hematoxylin and eosin staining identified that the submucosal tumor included thickened vascular walls and adipose tissue. Although fragmented due to significant degeneration, spindle‐shaped cells staining positive for smooth muscle actin were observed within and surrounding the unstructured hyalinized tissue with calcifications. Based on these findings, the lesion was diagnosed as angiomyolipoma, a subtype of PEComa. Complete resection was confirmed by histopathology. To our knowledge, this PEComa is the smallest of any PEComa reported in the literature. Our finding provides valuable insights into the very early stage of colorectal PEComas.

2024-12-18·Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences

[Clinical diagnosis and treatment of renal angiomyolipoma with inferior vena cava tumor thrombus].

Article

作者: Wang, Guoliang ; Zhang, Shudong ; Zhang, Fan ; Ye, Jianfei ; Liu, Zhuo ; Deng, Shaohui ; Chen, Kewei

OBJECTIVETo summarize the clinical characteristics of patients with renal angiomyolipoma (RAML) combined with inferior vena cava (IVC) tumor thrombus, and to explore the feasibility of partial nephrectomy and thrombectomy in this series of patients.METHODSThe clinical data of patients diagnosed with RAML combined with IVC tumor thrombus in the Department of Urology of the Peking University Third Hospital from April 2014 to March 2023 were retrospectively analyzed, and demographic and perioperative data of RAML patients with IVC tumor thrombus were recorded and collected from Electronic Medical Record System, including age, gender, surgical methods, and follow-up time, etc. The clinical characteristics between classic angiomyolipoma (CAML) patients with IVC tumor thrombus and epithelioid angiomyolipoma (EAML) patients with IVC tumor thrombus were compared to determine the clinical characteristics of these patients.RESULTSA total of 11 patients were included in this study, including 7 patients with CAML with IVC tumor thrombus and 4 patients with EAML with IVC tumor thrombus. There were 9 females (9/11, 81.8%) and 2 males (2/11, 18.2%), with an average age of (44.0±17.1) years. 9 patients (9/11, 81.8%) experienced clinical symptoms, including local symptoms including abdominal pain, hematuria, abdominal masses, and systemic symptoms including weight loss and fever; 2 patients (2/11, 18.2%) with RAML and IVC tumor thrombus did not show clinical symptoms, which were discovered by physical examination. Among the 11 patients, 10 underwent radical nephrectomy with thrombectomy, of whom, 3 underwent open surgery (3/10, 30.0%), 2 underwent laparoscopic surgery (2/10, 20.0%), and 5 underwent robot-assisted laparoscopic surgery (5/10, 50.0%). In addition, 1 patient underwent open partial nephrectomy and thrombectomy. The patients with EAML combined with IVC tumor thrombus had a higher proportion of systemic clinical symptoms (100% vs. 0%, P=0.003), more intraoperative bleeding [400 (240, 3 050) mL vs. 50 (50, 300) mL, P =0.036], and a higher proportion of tumor necrosis (75% vs. 0%, P=0.024) compared to the patients with CAML combined with IVC tumor thrombus. However, there was no statistically significant difference in operation time [(415.8±201.2) min vs. (226.0±87.3) min, P=0.053] between the two groups.CONCLUSIONCompared with the patients with CAML and IVC tumor thrombus, the patients with EAML and IVC tumor thrombus had a higher rate of systemic symptoms and tumor necrosis. In addition, in the selected patients with CAML with IVC tumor thrombus, partial nephrectomy and tumor thrombectomy could be performed to better preserve renal function.

2024-12-01·European Journal of Radiology

MRI quantitative T1 and T2 mapping of the renal cortex: Assessment of normal values and potential usefulness for renal masses at 3 T

Article

作者: Ohana, Mickael ; Henry, Remy ; Moliére, Sébastien ; Brandhuber, Laurent ; Labani, Aissam ; Goetsch, Thibaut ; Roy, Catherine

PURPOSEThe purpose of this monocentric retrospective study consisted in exploring the potential improvement of the assessment of renal masses on MRI by using the T1 (T1m) and T2 (T2m) mapping relaxation times.MATERIALS AND METHODSWe recorded the renal cortex values of 125 patients with normal kidneys (reference group) and 75 patients with renal masses on a clinical 3 T MR unit using T1m and T2m sequences. For the quantitative evaluation, measurements were performed by delineating ROIs on T1m and T2m sequences in renal cortex of the reference group and in renal masses. Interobserver agreement for the qualitative analysis of image quality was assessed using quadratic Cohen's weighted kappa statistics (k). Student's paired t-test and non-parametric Kruskal-Wallis test were used to compare our datasets in terms of T1m and T2m values.RESULTSFor the cohort of reference group, mean renal cortex T1m and T2m values were 1,529 ± 83 ms and 98 ± 7 ms, respectively. No statistically significant differences were found for T1m and T2m in the reference group regardless of age, gender or eGRF categories. For the group with renal masses, mean T1m and T2m values were 1,667 ± 87 ms and 105 ± 8 ms; 1,621 ± 96 ms and 117 ± 6 ms, and 1,530 ± 62 ms and 85 ± 4 ms for renal cell carcinomas, angiomyolipomas, and oncocytomas, respectively. For T1m values, there was no significant difference (p = 0.37) among the three types of renal masses. Among histological subtypes we have found: RCC versus angiomyolipoma (p = 0.25), RCC versus oncocytoma (p = 0.15), and oncocytoma versus angiomyolipoma (p = 0.47). However, we have found a statistically significant difference for the T2m value (p = 0.0005). Among histological subtypes, only T2m values were statistically significant for each combination: RCC versus angiomyolipoma (p = 0.012), RCC versus oncocytoma (p = 0.0002), and oncocytoma versus angiomyolipoma (p = 0.003).CONCLUSIONAs this is the largest normal patient cohort, the T1m and T2m values recorded could be proposed as reference values and can play a role in the differential diagnosis between benign and malignant renal tumoral masses.

项与血管周围上皮样细胞肿瘤相关的新闻（医药）

2024-10-30

·PRNewswire

Aadi Bioscience to Report Third Quarter 2024 Results and Corporate Update

LOS ANGELES, Oct. 30, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI) today announced that it will report third quarter 2024 financial results and provide recent corporate updates on Wednesday, November 6, 2024. These results will be available under the "Investors & News" page of the Aadi Bioscience website at aadibio.com. About Aadi Bioscience Aadi is a precision oncology company focused on the commercialization of FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). More information on the Company is available on the Aadi website at and connect with us on Twitter and LinkedIn. Contact: [email protected] SOURCE Aadi Bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报

2024-09-03

·安斯泰来中国

欧盟批准安斯泰来备思复（维恩妥尤单抗）联合可瑞达（帕博利珠单抗）用于一线治疗晚期尿路上皮癌

- 此次获批为近40年来，首个在晚期尿路上皮癌中被证实疗效优于标准治疗含铂化疗的治疗方案 - 欧洲市场授权是基于全球III期研究EV-302的总生存期和无进展生存期的积极结果东京，2024年8月27日 – 安斯泰来制药集团（TSE：4503，总裁兼首席执行官：冈村直树，“安斯泰来”）今日宣布，欧盟委员会已经批准备思复（维恩妥尤单抗，一种抗体-药物偶联物[ADC]）的上市申请，联合可瑞达（帕博利珠单抗，一种PD-1抑制剂）用于一线治疗耐受含铂化疗、不可切除或转移性尿路上皮癌（lam/mUC）成年患者。此次批准是基于全球III期研究EV-302（也被称为KEYNOTE-A39）的结果，研究显示与含铂化疗相比，维恩妥尤单抗联合帕博利珠单抗的中位总生存期几乎翻倍，并且显著延长了无进展生存期。英国巴茨癌症研究所生物医学研究中心 Thomas Powles博士 “晚期尿路上皮癌通常是致命的。拥有一种有效的新一线治疗方案，为该疾病的管理开启了一个期待已久的新篇章。在III期临床试验中，与含铂化疗相比维恩妥尤单抗联合帕博利珠单抗治疗显著延长了总生存期和无进展生存期。我期待着看到该新一线治疗方案，在临床实践中得到应用。” 世界膀胱癌患者联盟执行董事 Alex Filicevas “据报告显示，欧洲的膀胱癌新发病率为全球最高，但人们对该疾病的认知仍然不足，这导致很多患者在疾病晚期才得到正确诊断。目前迫切需要新的治疗选择来改善膀胱癌患者的治疗结果，并为整个患者群体的未来带来希望。” 安斯泰来高级副总裁兼肿瘤学领域开发负责人、医学博士、公共卫生硕士 Ahsan Arozullah “根据最新更新的欧洲临床指南，我们很高兴欧盟委员会批准将维恩妥尤单抗联合帕博利珠单抗作为一线治疗方案，用于治疗不可切除或转移性尿路上皮癌患者。这一批准证明了我们与临床试验研究人员、研究参与者及其家属以及更广泛的膀胱癌社区之间持续的合作伙伴关系。我们期待整个欧盟的患者能在治疗旅程的早期阶段获益于该联合治疗方案。” 在欧盟膀胱癌是排名第五位的常见癌症，2每年有超过165,000例新诊断病例，夺去了超过50,000人的生命。3由于诊断延迟，许多患者在晚期或转移阶段才被诊断，因此生存结果堪忧。45 3期临床研究EV-302探索了维恩妥尤单抗联合帕博利珠单抗在既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者中的有效性和安全性。研究数据显示联合治疗组的中位总生存期为31.5个月（95% CI：25.4-NR），含铂化疗组的中位总生存期为16.1个月（95% CI：13.9-18.3），即与化疗组相比，联合治疗组患者的死亡风险降低了53%（HR=0.47；95% CI：0.38-0.58；P<0.00001）。联合治疗组的中位无进展生存期为12.5个月（95% CI：10.4-16.6），含铂化疗组的无进展生存期为6.3个月（95% CI：6.2-6.5），即与化疗组相比，联合治疗组患者的肿瘤进展或死亡的风险降低了55%（HR=0.45；95% CI：[0.38-0.54]；P<0.00001）。在EV-302研究中，大约30%的患者在完成化疗后继续接受avelumab（一种PD-L1抑制剂）作为维持治疗，即目前真实世界的临床实践。1该研究结果在2023年欧洲医学肿瘤学会（ESMO）大会上展示，并在《新英格兰医学杂志》上发表。1 欧洲市场授权在所有27个欧盟成员国以及冰岛、列支敦士登和挪威有效，并且与欧洲肿瘤内科学会和欧洲泌尿外科协会最近更新的临床指南相一致，推荐将维恩妥尤单抗联合帕博利珠单抗作为局部晚期或转移性尿路上皮癌的一线治疗。67安斯泰来正在与欧盟各地的监管当局和卫生技术评估机构紧密合作，以确保能从这一组合治疗中受益的患者尽快可及该治疗方案。这次批准之前，美国食品药品监督管理局（FDA）已经在2023年12月批准维恩妥尤单抗联合帕博利珠单抗用于治疗局部晚期或转移性尿路上皮癌（la/mUC）成人患者；欧盟在2022年4月批准维恩妥尤单抗作为单药治疗，用于治疗既往接受含铂化疗和程序性死亡受体-1（PD-1）或程序性死亡配体-1（PD-L1）抑制剂的成人la/mUC患者。89 安斯泰来已经在2024财年（截止于2025年3月31日）的财务预测中，体现了这一结果带来的影响。有关更多信息，请参见2024年7月29日发布的新闻稿“安斯泰来收到欧洲药品管理局人用药品委员会对PADCEV™（维恩妥尤单抗）联合KEYTRUDA®（帕博利珠单抗）用于一线治疗晚期膀胱癌的积极意见”。向下滑动查看更多▼ 关于EV-302 EV-302试验是一项开放标签、随机、对照3期试验，用于评估维恩妥尤单抗与帕博利珠单抗联合用药与含铂化疗相比对既往未经治疗的局部晚期或转移性尿路上皮癌患者的疗效。该试验招募了886名既往未经治疗的局部晚期或转移性尿路上皮癌且能耐受含铂化疗的患者，无论其PD-L1表达。患者随机接受维恩妥尤单抗与帕博利珠单抗联合用药治疗或含铂化疗。该试验的双重主要终点是总生存期和无进展生存期（根据实体瘤疗效评价标准1.1（RECIST v1.1），经盲态独立中心阅片（BICR）确定）。次要终点包括根据实体瘤疗效评价标准1.1经盲态独立中心阅片的客观缓解率和缓解时间，以及安全性。1 与维恩妥尤单抗与帕博利珠单抗联合用药治疗相关的最常见（≥3%）的3级或以上级别不良事件，包括皮疹、血糖升高、中性粒细胞降低、周围神经病变、腹泻和贫血。EV-302研究的安全性结果与之前EV-103研究中顺铂不耐受的la/mUC患者使用该联合疗法的安全性结果一致。没有发现新的安全性问题。1 EV-302试验是评估该联合疗法在治疗尿路上皮癌和其他实体瘤的多个阶段疗效的全面计划的一部分。EV-302试验结果已于2023年10月在2023年欧洲肿瘤内科学会（ESMO）大会上展示，并在《新英格兰医学杂志》上发表。1 访问https://clinicaltrials.gov 了解关于EV-302研究(NCT04223856)的更多信息。关于膀胱癌和尿路上皮癌尿路上皮癌或膀胱癌源于尿路上皮细胞，这些细胞分布在尿道、膀胱、输尿管、肾盂及一些其他器官中。10尿路上皮癌占所有膀胱癌病例的90%，也会发生在肾盂、输尿管和尿道。1112如果肿瘤无法通过外科手术治疗，称其为不可切除疾病。13如果肿瘤已经扩散到周边器官或肌肉，则其被称为局部晚期疾病。14如果肿瘤已经扩散到身体其他部位，则其被称为转移性疾病。15约有12%的病例在确诊时即为局部晚期或转移性尿路上皮癌。4 全球每年约有614,000例新诊断膀胱癌病例，导致220,000例死亡。16在欧洲，膀胱癌是第五位常见癌症，每年有超过165,000人被诊断为膀胱癌。2,3持续治疗以及监测使膀胱癌成为治疗成本昂贵的癌症之一，与其他恶性肿瘤相比，成本最高。17 关于备思复（维恩妥尤单抗）备思复（维恩妥尤单抗）是直接作用于Nectin-4（位于细胞表面的一种蛋白，在膀胱癌中高度表达）的一种同类首创的抗体-药物偶联物（ADC）。7,18非临床数据显示，维恩妥尤单抗通过与表达Nectin-4蛋白的细胞结合，然后将抗肿瘤成分单甲基澳瑞他汀E（MMAE）内化并释放到细胞中，导致细胞停止增殖（细胞周期阻滞）和程序性细胞死亡（凋亡）来发挥其抗癌活性。7 备思复（维恩妥尤单抗）目前在欧盟被批准作为单药治疗，用于治疗既往接受过含铂化疗和程序性死亡受体-1（PD-1）或程序性死亡配体1（PD-L1）抑制剂的la/mUC成年患者；联合可瑞达（帕博利珠单抗）用于一线治疗耐受含铂化疗、不可切除或转移性尿路上皮癌（lam/UC）成年患者。7 进行中的研究 EV-302临床试验（NCT04223856）是一项开放标签、随机、对照的3期临床试验，旨在评估维恩妥尤单抗与帕博利珠单抗联合用药与含铂化疗相比，在耐受含顺铂或卡铂治疗的、既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者中的疗效，无论其PD-L1表达。 EV-103临床试验（NCT03288545）是一项正在进行中的多队列、开放标签、多中心1b/2期临床试验，旨在研究维恩妥尤单抗单药或与帕博利珠单抗联合用药和/或化疗用于一线或二线治疗患有局部晚期或转移性尿路上皮癌及肌层浸润性膀胱癌（MIBC）患者的疗效。目前安斯泰来正在一项全面计划中开展对维恩妥尤单抗与帕博利珠单抗联合用药治疗多阶段尿路上皮癌的研究，其中包括肌层浸润性膀胱癌的两项3期临床试验EV-304（NCT04700124，也被称为KEYNOTE-B15试验）和EV-303（NCT03924895, 也被称为KEYNOTE-905试验）。维恩妥尤单抗与帕博利珠单抗联合用于二线尿路上皮癌和肌层浸润性膀胱癌（MIBC）的安全性和疗效尚未证实。 EV-203临床试验（NCT04995419）是一项在中国开展的多中心、II期单臂桥接研究，旨在评估维恩妥尤单抗在中国患者中的有效性、安全性和药代动力学特征。该研究共入组40例患者。 EV-104试验（NCT05014139）是一项1期研究，探索在非肌层浸润性膀胱癌（NMIBC）患者中使用维恩妥尤单抗。该研究将分为两部分进行，评估维恩妥尤单抗作为术后单药治疗时的剂量递增和剂量扩展。 EV-202试验（NCT04225117）是一项正在进行中的多队列、开放标签、多中心2期临床试验，旨在研究维恩妥尤单抗单独用药对既往接受过治疗的晚期实体瘤患者的疗效。该试验还有一个队列，旨在研究维恩妥尤单抗与帕博利珠单抗联合用药治疗既往未经治疗的复发转移的头颈部鳞状细胞癌患者。重要的安全性信息关于维恩妥尤单抗重要安全性信息，请访问https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf 关于安斯泰来安斯泰来制药集团是一家制药企业，业务遍及全球70多个国家和地区。目前，我们正在推进“焦点领域”研究策略（Focus Area Approach），旨在通过聚焦生理机制和治疗手段，确定持续研发新药的机会，解决尚未被满足的医疗需求。与此同时，我们正在将目光投向处方药以外的业务领域，将我们的专业技能和知识与不同领域外部合作伙伴的尖端技术相结合，打造Rx+®医疗解决方案。通过这些努力，安斯泰来立志处于不断变化的医疗行业的最前沿，将科学的进步转变为患者的价值。欲了解更多信息，请访问我们的网站https://www.astellas.com/en。关于安斯泰来、辉瑞与默克的合作安斯泰来和辉瑞与默沙东公司共同签署了一项临床合作协议，以评估安斯泰来和辉瑞的维恩妥尤单抗联合默沙东公司的帕博利珠单抗联合用药治疗既往未经治疗的转移性尿路上皮癌患者的疗效。KEYTRUDA是Merck Sharp & Dohme Corp. 的注册商标，该公司是美国新泽西州拉韦市 Merck & Co., Inc. 的子公司。安斯泰来警戒声明本新闻稿中，有关当前计划、估计、战略和信念以及其他非历史事实的陈述，均为关于安斯泰来未来表现的前瞻性陈述。这些陈述是根据管理层结合当前可获得的信息而形成的当前假设和信念得出的，并涉及已知和未知的风险与不确定性。许多因素可能导致实际结果与前瞻性陈述中讨论的结果产生重大差异。这些因素包括但不限于：（i）与制药市场有关的一般经济条件和法律法规的变化，（ii）货币汇率波动，（iii）新产品上市的延迟，（iv）安斯泰来无法有效地销售现有产品和新产品，（v）安斯泰来无法继续有效地研究和开发在竞争激烈的市场中被客户接受的产品，以及（vi）第三方侵犯安斯泰来的知识产权。本新闻稿中包含的有关药品（包括当前正在开发的产品）的信息并不构成广告或医疗建议。 1.本文翻译自安斯泰来全球新闻稿，原文链接为：https://www.astellas.com/en/news/29371 2.本文所涉及的药品为研究中的药品，尚未在中国获批适应症, 安斯泰来中国不推荐任何未获批的药品使用（除中国大陆已获批的特殊地域外）。 3.本文旨在传递医药前沿信息，不构成对任何药物或诊疗方案的推荐或推广。 4.如您想了解更多疾病知识或药品、诊疗相关信息，请咨询医疗卫生专业人士。参考文献： [1] Powles T, et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med. 2024;390:875-888. [2] International Agency for Research on Cancer. Global Cancer Observatory. WHO Europe Region (EURO) Factsheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/994-who-europe-euro-fact-sheet.pdf. Last accessed: August 2024. [3] International Agency for Research on Cancer. Global Cancer Observatory. Cancer Today: 2022. Available at: https://gco.iarc.who.int. Last accessed: August 2024. [4] National Cancer Institute. Cancer stat facts: bladder cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Last accessed: August 2024. [5] National Cancer Institute. Bladder Cancer Prognosis and Survival Rates. Available at: https://www.cancer.gov/types/bladder/survival. Last accessed: August 2024. [6] Powles T, et al. ESMO Clinical Practice Guideline interim update on first-line therapy in advanced urothelial carcinoma. Annals of Oncology. 2024;35(6):485-490. [7] Masson-Lecomte A, et al. EAU guidelines on upper urinary tract urothelial carcinoma. (April 2024) Available at: https://uroweb.org/guidelines/upper-urinary-tract-urothelial-cell-carcinoma. Last accessed: August 2024. [8] U.S. Food & Drug Administration. FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic-urothelial-cancer. Last accessed: August 2024. [9] European Medicines Agency. PADCEV EMA SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf. Last accessed: August 2024. [10] National Cancer Institute. What is bladder cancer? (February 2023) Available at: https://www.cancer.gov/types/bladder. Last accessed: August 2024. [11] Leow JJ, et al. Optimal management of upper tract urothelial carcinoma: Current perspectives. Onco Targets Ther. 2020;13:1-15. [12] Petros FG. Epidemiology, clinical presentation, and evaluation of upper-tract urothelial carcinoma. Transl Androl Urol. 2020;9(4):1794-8. [13] National Cancer Institute. NCI dictionary of cancer terms: Unresectable. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/unresectable. Last accessed: August 2024. [14] National Cancer Institute. NCI dictionary of cancer terms: Locally advanced cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/locally-advanced-cancer. Last accessed: August 2024. [15] American Cancer Society. If you have bladder cancer. (March 2024). Available at: https://www.cancer.org/cancer/types/bladder-cancer/if-you-have-bladder-cancer.html. Last accessed: August 2024. [16] International Agency for Research on Cancer. Global Cancer Observatory. Bladder Factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf. Last accessed: August 2024. [17] Aly A, et al. The Real-World Lifetime Economic Burden of Urothelial Carcinoma by Stage at Diagnosis. J Clin Pathw. 2020;6(4):51-60. [18] Challita-Eid PM, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res. 2016;76(10):3003-13. 向下划动查看更多 ▼

临床3期AHA会议临床结果抗体药物偶联物申请上市

2024-09-01

·赛柏蓝

139家药企裁员（附名单）

作者 | 陈芋来源 | 赛柏蓝 139家药企减员，一批药企精简研发团队。 01 139家药企减员略超上年同期水平据不完全统计，截至8月末，今年已有139家医药企业宣布了人员裁撤或工厂、管线关闭计划（文末附完整名单，每月按次统计后累加，未去重，下同）。分月度来看，自7月起，减员的企业数量有所增加，7月、8月宣布减员的企业分别达到19家、23家，分别是6月——即目前为止全年最低水平的2.4倍、2.9倍。此外，今年7月、8月公布减员计划的企业数量较上年同期也略有上升，截至目前，今年前8个月宣布减员的企业总数比2023年同期多10家。除5月以外，今年各月度公布人员、管线精简计划的企业数量变动情况与上年度基本一致，据此推测，9月、10月相关消息或将有所减少，直至年底迎来第四季的减员小高峰。 02 研发团队成“重灾区” 有药企裁研发为商业化“腾空间” 从近期公布了裁撤详细情况的企业来看，研发成了首当其冲的岗位。例如，FDA批准的首款用于治疗成人晚期恶性PEComa（局部晚期不可切除性/转移性恶性血管周上皮样细胞肿瘤）药物Fyarro，近期在实体瘤二期试验中表现不佳，未达到关键目标。作为生产企业Aadi Bioscience目前唯一研发中的药物，Fyarro的试验失败给Aadi带来了较大冲击，一方面Aadi终止了该项试验，另一方面，其80%的研发团队将被裁撤。 Fyarro在神经内分泌肿瘤和子宫内膜癌研究还将继续。截至6月底，Aadi还有7860万美元资金，预计可持续到2025年年底，而随着此次管道和员工数量调整，Aadi预计其现金流“至少”能延长到2026年下半年。由于临床失败裁撤研发团队听起来理所应当，但一些研发表现较好的药企也在精简对应岗位。 8月中旬，融资总额近6亿的酶促DNA合成先驱企业Ansa Biotechnologies表示其解雇了“团队中的一些重要成员”，主要来自其研发团队。今年7月，Ansa才召开了首个产品发布会——去年3月，Ansa宣布其成功从头合成了1005个碱基的DNA序列。据报道，这是目前世界上单次合成最长的DNA寡核苷酸，成为合成生物学领域的重大里程碑。而此次研发团队精简主要是为其商务业务新团队“腾出空间”，Ansa表示这是“从一家专注于研发的初创企业向一家商业企业转型的重要部分”。药企裁撤研发团队并非国外前沿中小型企业的独特现象。今年第一季度，贝达药业也展开了一场较大规模的人员调整，其中就涉及大量研发部门员工。对药企而言，精简研发团队能在短期内控制成本，通过减少自研投入、从外部引进研发成果也在一定程度上分散了风险。各家药企重点精简的团队部门根据当前业务重点、资金情况、市场环境和战略方向等各有侧重，例如拜耳今年的裁员就瞄准了管理层，总体来看，通过精简人员和管线来应对市场变化、降低成本、提高效率是近年药企的共同策略。 END 内容沟通：郑瑶（13810174402）医药代理商产品交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

寡核苷酸高管变更