优替德隆(Utidelone) - 药物靶点：Tubulin_在研适应症：复发性乳腺癌，转移性乳腺癌，局部晚期非小细胞肺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Depoxythilone、Desoxyepothilone B、Epothilone D

+ [7]

靶点

Tubulin

作用机制

微管蛋白抑制剂、有丝分裂抑制剂、微管蛋白聚合促进剂

治疗领域

肿瘤皮肤和肌肉骨骼疾病呼吸系统疾病+ [5]

在研适应症

复发性乳腺癌转移性乳腺癌局部晚期非小细胞肺癌+ [20]

非在研适应症

原研机构

在研机构

+ [1]

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2021-03-11),

复发性乳腺癌转移性乳腺癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)、特殊审批 (中国)

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结构

分子式C27H41NO5S

InChIKeyXOZIUKBZLSUILX-GIQCAXHBSA-N

CAS号189453-10-9

关联

45

项与优替德隆相关的临床试验

NCT06683703 / Not yet recruiting临床2期

Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.

This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases.
The main objective of the first stage was to determine the combined dose of the first stage and the second stage, and to compare the intracranial efficacy of the two treatment groups. Secondary objectives were to compare other intracranial efficacy, systemic efficacy, safety and tolerability between the two treatment groups.In the second stage, the main purpose was to evaluate the intracranial efficacy of Utidelone combined with Bevacizumab in patients, and the secondary purpose was to evaluate the other intracranial efficacy, systemic efficacy, safety and tolerability of Utidelone combined with Bevacizumab in patients, and to explore the improvement of patients' quality of life.

开始日期2024-12-01

申办/合作机构

北京华昊中天生物医药股份有限公司

NCT06510465 / Not yet recruiting临床2期IIT

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study

This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.

开始日期2024-08-01

申办/合作机构

上海交通大学医学院附属仁济医院

NCT06598046 / Recruiting临床2期IIT

A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of Triple-negative Advanced Breast Cancer.

This study aims to explore the efficacy and safety of the combination therapy of utidelone and capecitabine in the treatment of brain metastases from triple-negative advanced breast cancer, and to search for systemic treatment for brain metastases from triple-negative advanced breast cancer cases.

开始日期2024-06-19

申办/合作机构

河南省肿瘤医院

100 项与优替德隆相关的临床结果

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100 项与优替德隆相关的转化医学

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100 项与优替德隆相关的专利（医药）

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98

项与优替德隆相关的文献（医药）

2024-10-18·ANTI-CANCER DRUGS

Utidelone plus pembrolizumab as the fourth-line combination treatment in non-small cell lung cancer with EGFR mutation: a case report.

Article

作者: Fang, Henghu ; Zhu, Qi ; Han, Qing ; Wu, Shanshan ; Guan, Gaowa ; Yang, Wei ; Li, Jingjiao ; Wen, Juyi ; Zhao, Rugang ; Zheng, Wei ; Lu, Zejun

Utidelone is an ebomycin derivative chemotherapeutic drug, which can promote tubulin polymerization and stabilize microtubule structure, so as to induce apoptosis. The drug is an innovative drug independently developed by China with independent intellectual property rights. Phase II clinical trials for advanced breast cancer are being approved by National Medical Products Administration for the treatment of advanced breast cancer. However, there is no report on the application in non-small cell lung cancer (NSCLC) patients with the epidermal growth factor receptor (EGFR) mutation. This case is a patient with EGFR mutant stage IV NSCLC who has progressed after third-line targeted therapy. The fourth line was treated with utidelone combined with pabolizumab. The patient had progressed after targeted therapy with oxitinib, ametinib, and vometinib. Due to the patient's physical reasons, the traditional platinum drugs were not suitable, so the patient was treated with utidelone combined with pabolizumab. The curative effect was evaluated as SD after two cycles and progesterone receptor after four cycles. At present, it is still in the maintenance of reduction of utidelone combined with pabolizumab, and the tumor continues to shrink. Although peripheral neurotoxicity occurred during treatment, it improved after symptomatic treatment. The treatment of EGFR mutant stage IV NSCLC with utidelone combined with pabolizumab has good effect and mild adverse reactions.

2024-04-01·Cancer pathogenesis and therapy

Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment: A phase 2 clinical trial (BG01-1801)

Article

作者: Chen, Gongyan ; Zhao, Jing ; Shi, Yuankai ; Zhao, Yanqiu ; Lin, Lin

Background:

Chemotherapy remains the standard-of-care for many patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC), but acquired resistance presents challenges. The aim of this open-label, multicenter phase 2 clinical trial was to determine the efficacy and safety of utidelone, a novel genetically engineered epothilone analog and microtubule-stabilizing agent, as a third- or later-line treatment for locally advanced or metastatic NSCLC.

Methods:

Patients who had failed standard second-line treatment (including platinum-containing chemotherapy or targeted therapy) received utidelone (40 mg/m² via intravenous injection daily, day 1-5) every 21 days. The primary endpoint was the objective response rate (ORR). Secondary endpoints were the duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.

Results:

From March 12, 2019 to January 18, 2021, 26 pretreated patients with locally advanced or metastatic NSCLC (100% of patients had received prior platinum and 65.4% patients had received prior taxane treatment) were enrolled (80.8% of patients had adenocarcinoma). At baseline, nine (34.6%) patients had received second-line treatment, 10 (38.5%) patients had received third-line treatment, and seven (26.9%) patients had received fourth- or later-line treatment. By the data cut-off date of August 10, 2021, the median follow-up was 7.49 months (range, 1.4-26.7 months). The ORR was 15.4% (95% confidence interval [CI], 4.4%-34.9%) in the intention-to-treat (ITT) cohort (N = 26) and 19.0% (95% CI, 5.4%-41.9%) in the per-protocol (PP) cohort (N = 21). The disease control rate was 69.2% (95% CI, 48.2%-85.7%) and 81.0% (95% CI, 58.1%-94.6%) in the ITT and PP cohorts, respectively. The median DoR was 4.1 months (95% CI, 3.1-5.1 months) in the ITT cohort. The median PFS was 4.37 months (95% CI, 2.50-5.29 months) in the ITT cohort and 4.37 months (95% CI, 2.50-9.76 months) in the PP cohort. The median OS was not reached, and the 12-month OS rate was 69% (95% CI, 45.1%-84.1%). Grade 3/4 treatment-emergent adverse events occurred in 38.5% of patients, and the most common was peripheral neuropathy (23.1%, all Grade 3), which was manageable with dose modifications.

Conclusions:

In this clinical trial, utidelone showed promising efficacy and had a manageable safety profile. Further clinical studies are warranted to confirm its role in NSCLC treatment.

Trial registration:

No.NCT03693547; https://classic.clinicaltrials.gov.

2023-12-01·Surgery open science

Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study

Article

作者: Xun, Xueqiong ; Zheng, Kai ; Mao, Qing ; Zhang, Fan ; Zhou, Shaoqiang ; Zhao, Jiawen ; Tang, Shicong ; Wang, Xi ; Tang, Baoyan ; Guo, Rong ; Wei, Shanrong ; Li, Xiuqin ; Zhang, Ying ; Bi, Pingping ; Tan, Xin ; Liu, Rui

Background:

The purpose of this study was to compare the efficacy and safety of utidelone plus capecitabine for advanced first-line versus second-line or above therapy in metastatic breast cancer patients who had previously received anthracycline and taxane. At the same time, we compared the efficacy of utidelone plus capecitabine and vinorelbine plus cisplatin in advanced first-line treatment of metastatic breast cancer.

Patients and methods:

A retrospective cohort of 11 patients with metastatic breast cancer previously treated with anthracycline and taxane (including neoadjuvant and adjuvant therapies) for advanced first-line with utidelone plus capecitabine, 32 patients treated with second-line or above, and 60 patients with vinorelbine plus cisplatin between October 2011 and August 2022 was collected. The first and second groups were treated with utidelone plus capecitabine, and the third group was treated with vinorelbine plus cisplatin. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), objective response rate (ORR), and treatment safety.

Results:

By 03/31/2023, median PFS reached 11.70 months (95 % CI 0.093-0.141) in utidelone plus capecitabine group in the advanced first-line therapy, compared to 5.60 months (95 % CI 0.025-0.079) in the second-line or above therapy [HR 0.42, (95 % CI 0.226-0.787), P = 0.0077]. In utidelone plus capecitabine, the median OS was not reached in the advanced first-line therapy, with a mean overall survival of 23.16 months (95 % CI 0.198-0.265); whereas the median OS in the second-line or above therapy was 19.50 months (95 % CI 0.083-0.307), with a mean overall survival of 16.89 months (95 % CI 0.136-0.202) [HR 0.26, (95 % CI 0.098-0.678), P = 0.0495]. The ORR for advanced first-line therapy was 27.27 % (95%CI 0.060, 0.610) compared with 15.63 % (95%CI 0.053, 0.328) for second-line or above. In advanced first-line therapy, utidelone plus capecitabine was superior to vinorelbine plus cisplatin with a median PFS of 6.12 months (95 % CI 0.051-0.072) [HR 0.49, (95 % CI 0.286-0.839), P = 0.0291]. Compared with utidelone plus capecitabine, the median OS in vinorelbine plus cisplatin advanced first-line therapy group was 35.37 months (95 % CI 0.258-0.449), and the mean overall survival was 40.79 months (95 % CI 0.315-0.501) [HR 0.54, (95 % CI 0.188-1.568), P = 0.2587]. The ORR for vinorelbine plus cisplatin was 18.33 % (95 % CI 0.095, 0.304). The most common adverse events in our study were neurological toxicity, hand-foot syndrome, hematological toxicity, gastrointestinal toxicity, and hepatic and renal function abnormalities. There were no deaths due to adverse effects during the utidelone plus capecitabine treatment period.

Conclusions:

In MBC, advanced first-line therapy with utidelone plus capecitabine resulted in more favorable PFS, OS, and ORR than second-line or above therapy. In advanced first-line therapy, utidelone plus capecitabine had superior PFS, and ORR compared with vinorelbine plus cisplatin. This study concludes that utidelone plus capecitabine is a more valuable chemotherapy option in advanced first-line MBC.

83

项与优替德隆相关的新闻（医药）

2024-11-15

·药研网

首付款5000万元！华昊中天与百洋医药就乳腺癌创新药达成合作

2024年11月14日，医药产业化平台青岛百洋医药股份有限公司（简称“百洋医药”）发布公告，全资子公司北京百洋智合医学成果转化服务有限公司与北京华昊中天生物医药股份有限公司（简称“华昊中天”）签订市场推广合作协议。根据协议，百洋医药将获得华昊中天自主研发的1类创新药优替德隆注射液（商品名：优替帝®，以下简称“优替德隆”）在中国大陆地区的独家市场推广权益。百洋医药将向华昊中天支付不可退还的首付款5,000万元人民币；同时根据研发及销售进度，向华昊中天支付研发里程碑及销售里程碑款项。华昊中天将根据年度终端销售额按梯度向百洋医药支付推广服务费。优替德隆是全球唯一基于合成生物学技术研发上市的化疗新分子，属于新一代微管蛋白稳定剂，具有疗效更佳、安全性更优、抗癌谱更广、不易产生耐药性、能够穿透血脑屏障2等多重优势，满足了临床对疗效与安全性并重的实际需求。该药物于2021年3月获得国家药品监督管理局（NMPA）批准上市，并于2023年3月被纳入国家医保药品目录，填补了医保目录内无国产创新微管抑制剂化疗药的空白。在当前人口老龄化趋势加剧、癌症患者群体不断扩大的背景下，随着医保覆盖范围的持续扩大，优替德隆作为对比紫杉类药物具有显著优势的创新药物，其市场前景极为广阔。对于此次合作，华昊中天董事长唐莉表示：“作为一家以合成生物学技术驱动的生物医药公司，华昊中天致力于开发肿瘤创新药，近期也成功登陆港交所。我们非常高兴能与具有优秀商业化能力的百洋医药展开合作，共同将优替德隆这一创新产品惠及更多患者。” End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，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/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 10月 | 20家生物医药裁员汇总 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

疫苗上市批准引进/卖出

2024-11-15

·医药魔方Invest

百洋医药加码肿瘤领域，获华昊中天抗癌新药优替德隆商业化权益

2024年11月14日，医药产业化平台青岛百洋医药股份有限公司（以下简称“百洋医药”，股票代码：301015.SZ）发布公告，全资子公司北京百洋智合医学成果转化服务有限公司与北京华昊中天生物医药股份有限公司（以下简称“华昊中天”，股票代码：2563.HK）签订市场推广合作协议。根据协议，百洋医药将获得华昊中天自主研发的1类创新药优替德隆注射液（商品名：优替帝®，以下简称“优替德隆”）在中国大陆地区的独家市场推广权益。百洋医药将向华昊中天支付不可退还的首付款5,000万元人民币；同时根据研发及销售进度，向华昊中天支付研发里程碑及销售里程碑款项。华昊中天将根据年度终端销售额按梯度向百洋医药支付推广服务费。签约仪式现场优替德隆是唯一由境内企业自主研发的微管抑制剂1类创新药，也是自2010年以来全球唯一获批的具有新型分子结构的微管抑制剂抗肿瘤新药，首个获批适应症用于治疗复发或转移性晚期乳腺癌。乳腺癌作为女性发病率首位的恶性肿瘤，尽管临床治疗取得了一定进展，但患者仍存在复发或转移的风险，晚期乳腺癌的5年生存率仅为28%1。临床研究证实优替德隆使晚期乳腺癌患者实现无进展生存期（PFS）和总生存期（OS）双获益，且安全性更具优势。因此，优替德隆的推出能为晚期乳腺癌患者带来了新的治疗希望。优替德隆是全球唯一基于合成生物学技术研发上市的化疗新分子，属于新一代微管蛋白稳定剂，具有疗效更佳、安全性更优、抗癌谱更广、不易产生耐药性、能够穿透血脑屏障2等多重优势，满足了临床对疗效与安全性并重的实际需求。该药物于2021年3月获得国家药品监督管理局（NMPA）批准上市，并于2023年3月被纳入国家医保药品目录，填补了医保目录内无国产创新微管抑制剂化疗药的空白。在当前人口老龄化趋势加剧、癌症患者群体不断扩大的背景下，随着医保覆盖范围的持续扩大，优替德隆作为对比紫杉类药物具有显著优势的创新药物，其市场前景极为广阔。对于此次合作，华昊中天董事长唐莉表示：“作为一家以合成生物学技术驱动的生物医药公司，华昊中天致力于开发肿瘤创新药，近期也成功登陆港交所。我们非常高兴能与具有优秀商业化能力的百洋医药展开合作，共同将优替德隆这一创新产品惠及更多患者。” 百洋医药董事长付钢表示：“百洋医药始终致力于推动真正能优化医疗场景的产品进入临床场景。作为华昊中天的战略伙伴及IPO发行的基石投资者，百洋医药非常高兴能与华昊中天携手，共同推动这款具有显著临床效益的创新产品广泛应用，为更多患者带来生命的希望与治疗的福音。” 此次合作，百洋医药在肿瘤创新药领域的产品矩阵再度扩容。作为支持源头创新的医药产业化平台，百洋医药积极对外开放自身平台优势，与优质药企合作共推创新产品商业化进程。与此同时，依托大股东的创新协同，百洋医药也正不断引入自主知识产权的创新产品。在外部合作和集团孵化的双重驱动下，百洋医药将不断提升其产业化竞争力，激发强劲增长势能。数据来源：【1】Kimberly D CA, 2022, June 【2】Xu B, et al. Annals of Oncology, 2020, Nov 推荐阅读美元投中国创新药玩法变了 NewCo浪潮背后：美元投中国创新药还赚钱 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

IPO引进/卖出上市批准申请上市

2024-11-14

·氨基观察

礼来替尔泊肽可以预防糖尿病；睿跃生物借壳上市

氨基观察-创新药组原创出品作者 | 黄凯 GLP-1是万能的！ 11月13日，礼来公布SURMOUNT-1研究的3年随访详细结果。数据显示，对于肥胖且合并糖尿病前期的受试者，经替尔泊肽治疗176周，体重最高可减轻约20%，而且进展至2型糖尿病的风险显著降低93%。 Biotech自救进行时。 11月13日，睿跃生物与纳斯达克上市公司Pulmatrix达成合并协议，旨在创建一家美股Biotech，专注于靶向蛋白降解新药开发。基因疗法新里程碑。 11月13日，PTC Therapeutics宣布，美国FDA加速批准基因疗法Kebilidi用于治疗芳香族L-氨基酸脱羧酶缺乏症的儿童和成人患者，无论他们的疾病严重程度为何。这是FDA批准的首个直接注射到大脑的基因疗法。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）普米斯9.5亿美元卖身BioNTech 11月13日，普米斯宣布，BioNTech将以8亿美元预付款收购普米斯100%已发行股本。此外，BioNTech将在普米斯达到双方约定的里程碑条件时，额外支付最高 1.5 亿美元的里程碑付款。 2）百洋医药签订市场推广服务协议 11月14日，百洋医药公告，近日，公司全资子公司北京华昊中天签订了《市场推广服务协议》，约定北京华昊中天指定百洋智合在区域内进行指定产品（优替德隆注射液）的独家市场推广服务。 3）葛兰素史克任命中国区事业部负责人日前，葛兰素史克中国向员工发布一则人事任命通告，宣布傅祁越将于当日起加入GSK 中国特药事业部担任副总裁、抗感染负责人，常驻上海，直接汇报于 GSK 中国特药业务负责人张宁。 / 02 / 资本信息 1）与Pulmatrix合并，睿跃生物借壳上市 11月13日，睿跃生物与纳斯达克上市公司Pulmatrix达成合并协议，旨在创建一家美股Biotech，专注于靶向蛋白降解新药开发。 2）派格生物向港交所递交上市申请 11月13日，据港交所披露易，派格生物递交上市申请。 / 03 / 医药动态 1）万明赛伯G01滴眼液获临床许可 11月14日，据CDE官网，万明赛伯G01滴眼液获临床许可，拟开展治疗青光眼导致的视神经损伤的研究。 2）贝来药业人脐带间充质干细胞注射液获临床许可 11月14日，据CDE官网，贝来药业人脐带间充质干细胞注射液获临床许可，拟开展治疗慢加急性肝衰竭的研究。 3）科兴中维冻干人用狂犬病疫苗（Vero细胞）获临床许可 11月14日，据CDE官网，科兴中维冻干人用狂犬病疫苗（Vero细胞）获临床许可，拟用于狂犬病预防。 4）新樾生物ND-003片获临床许可 11月14日，据CDE官网，新樾生物ND-003片获临床许可，拟开展治疗胃肠道间质瘤的研究。 5）中国生物制药四代EGFR抑制剂获美国临床试验许可 11月14日，中国生物制药发布公告表示，四代EGFR抑制剂TQB3002获美国临床试验许可，即将启动1期临床。 / 04 / 器械跟踪 1）奥林巴斯为苏州新工厂投产做准备 11月14日，奥林巴斯正为苏州新工厂投产做准备，将开始在当地组装在华销售的内窥镜等主力产品。奥林巴斯执行董事、中国业务负责人土屋英尚透露，核心部件将从日本生产后送至苏州的新工厂进行组装。 2）南微医学一次性使用乳头括约肌切开刀获注册许可 11月14日，据NMPA官网，南微医学一次性使用乳头括约肌切开刀获注册许可。 3）海杰亚微波消融仪获注册许可 11月14日，据NMPA官网，海杰亚微波消融仪获注册许可。 4）美敦力脊柱外科手术导航定位系统获注册许可 11月14日，据NMPA官网，美敦力脊柱外科手术导航定位系统获注册许可。 5）半岛医疗皮秒Nd:YAG激光治疗仪获注册许可 11月14日，据NMPA官网，半岛医疗皮秒Nd:YAG激光治疗仪获注册许可。 6）硅基传感持续葡萄糖监测系统获注册许可 11月14日，据NMPA官网，硅基传感持续葡萄糖监测系统获注册许可。 / 05 / 海外药闻 1）礼来替尔泊肽可以预防糖尿病 11月13日，礼来公布SURMOUNT-1研究的3年随访详细结果。数据显示，对于肥胖且合并糖尿病前期的受试者，经替尔泊肽治疗176周，体重最高可减轻约20%，而且进展至2型糖尿病的风险显著降低93%。 20）FDA批准直接注入大脑的基因疗法 11月13日，PTC Therapeutics宣布，美国FDA加速批准基因疗法Kebilidi用于治疗芳香族L-氨基酸脱羧酶缺乏症（AADCD）的儿童和成人患者，无论他们的疾病严重程度为何。这是FDA批准的首个直接注射到大脑的基因疗法。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

高管变更基因疗法引进/卖出疫苗

100 项与优替德隆相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB01873

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性乳腺癌	中国	成都华昊中天药业有限公司	2021-03-11
转移性乳腺癌	中国	成都华昊中天药业有限公司	2021-03-11

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期非小细胞肺癌	临床3期	中国	北京华昊中天生物医药股份有限公司	2023-05-12
HER2 阴性乳腺癌	临床3期	中国	中山大学	2022-03-01
局部晚期乳腺癌	临床3期	中国	成都华昊中天药业有限公司	2022-03-01
局部晚期乳腺癌	临床3期	中国	中山大学	2022-03-01
非小细胞肺癌	临床2期	-	北京华昊中天生物医药股份有限公司	2024-12-01
胆管癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14
食管癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14
肝癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14
胃癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14
宫颈癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14

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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


NCT05700084 (ASCO2024)	临床1期	晚期乳腺癌	5	Utidelone Capsule 50 mg/m2/d-5day	鏇襯夢鬱願鹽觸構觸鹹(鹽醖糧壓製壓壓艱築蓋) = 壓顧艱醖衊獵夢蓋襯築築廠糧襯膚膚壓壓顧願 (壓製鑰餘蓋蓋範壓齋鹽 )	积极	2024-05-24
NCT05700084 (ASCO2024)	临床1期	晚期乳腺癌	5	Utidelone Capsule 75 mg/m2/d-5day	鏇襯夢鬱願鹽觸構觸鹹(鹽醖糧壓製壓壓艱築蓋) = 襯遞憲顧鹽餘繭醖廠繭築廠糧襯膚膚壓壓顧願 (壓製鑰餘蓋蓋範壓齋鹽 ) 更多	积极	2024-05-24
NCT05357417 (U-BOMB, ASCO2024)	临床2期	脑转移瘤 HER2-negative	46	Utidelone plus bevacizumab	鹽襯簾願範蓋襯鑰繭糧(襯齋繭構膚窪獵膚鏇衊) = 範餘鏇鏇築鹹製蓋醖鑰獵繭鏇糧願齋構蓋廠鏇 (築網餘鏇鑰簾壓餘蓋觸, 28.9% ~ 58.9) 更多	积极	2024-05-24
NCT04911907 (NCT04911907, ASCO2024)	临床2期	晚期恶性实体瘤 \| 晚期胃癌一线 HER2 negative	79	Utidelone plus sintilimab and oxaliplatin	壓膚觸窪壓遞壓積鹽繭(繭鬱構鬱簾廠窪構簾願) = Grade 3/4 TRAEs occurred in 27.8% of pts in stage I, and included anemia (13.9%), peripheral neuropathy (11.4%) and neutropenia (7.6%). No treatment-related deaths occurred. Gastric cancer was chosen as the expansion cohort indication. As of February 1st2024, 14 eligible pts with GC with a median age of 57 years (range, 41-69) were enrolled. The median follow-up was 5.5 months (range, 1.0-9.7) and the longest duration of response was 8.0 months. A total of 8 PRs and 3 SDs were achieved in the 11 pts evaluable for efficacy, and 6 pts including the 3 with SD were still receiving treatment. Grade 3/4 TRAEs occurred in 28.6% of pts including diarrhea (14.3%), fatigue (14.3%), neutropenia (14.3%), and vomiting (7.1%). Other AEs were all Grade 1 or 2, with no treatment-related deaths. 齋膚鹽鹽鏇襯構範鑰鏇 (簾夢醖鹹網觸窪範壓壓 ) 更多	积极	2024-05-24
NCT03693547 (BG01-1801, Pubmed) 人工标引	临床2期	转移性非小细胞肺癌 \| 局部晚期非小细胞肺癌	26	at least one dose of utidelone (ITT cohort)	窪餘遞鏇艱淵鬱積糧選(糧襯壓遞窪餘獵築網鑰) = 繭築鑰鹽築憲製鑰醖構鏇憲鬱餘鹽淵蓋遞壓觸 (範顧構構鬱艱鑰衊鏇淵, 4.4 ~ 34.9) 更多	积极	2024-04-01
NCT03693547 (BG01-1801, Pubmed) 人工标引	临床2期	转移性非小细胞肺癌 \| 局部晚期非小细胞肺癌	26	at least two cycles of utidelone (PP cohort)	窪餘遞鏇艱淵鬱積糧選(糧襯壓遞窪餘獵築網鑰) = 蓋築壓蓋觸夢齋鬱鏇顧鏇憲鬱餘鹽淵蓋遞壓觸 (範顧構構鬱艱鑰衊鏇淵, 5.4 ~ 41.9) 更多	积极	2024-04-01
ESMO_ASIA2023	N/A	转移性实体瘤	50	Utidelone	網鑰製衊範鑰製蓋築壓(糧構築範齋積鬱淵鑰艱) = 製淵鑰顧築範夢鹽鏇糧廠糧繭鑰衊築築齋餘網 (鏇選憲糧窪鹹積膚夢鹽 ) 更多	积极	2023-12-02
ChiCTR2200062161 (HX-SARC02, ESMO2023) 人工标引	临床2期	软组织肉瘤	10	Utidelone	襯選遞積鹽願願艱鏇鹽(鹹範艱夢繭窪窪鹹齋顧) = 觸繭鏇窪醖襯鹽窪蓋鹹遞製鑰顧遞鹹憲糧鹽觸 (繭衊淵壓製選齋淵糧範 ) 更多	积极	2023-10-23
IPU (ESMO2023) 人工标引	临床2期	HER2阳性乳腺癌一线 \| 二线 HER2 positive	29	Inetetamab+ pyrotinib+utidelone	艱選淵餘鹹艱餘衊壓積(壓襯膚淵夢鬱窪鏇艱壓) = 構範餘鏇範獵鑰襯糧願網鹽鏇鏇衊夢鹹夢鏇廠 (糧繭艱範築構積積鑰網 ) 更多	积极	2023-10-21
NCT04681287 (ASCO2022) 人工标引	临床2期	晚期 HER2 阳性乳腺癌 HER2 Positive	20	utidelone+camrelizumab+inetetamab	壓壓齋餘糧製夢範鹽繭(鹽顧窪襯憲範獵積選鏇) = 築餘餘艱構齋襯鹹鹽壓膚鹽蓋糧夢築醖夢積遞 (夢鬱構簾衊餘糧窪簾構 ) 更多	积极	2022-06-02
NCT03693547 (ESMO_ELCC2022)	临床2期	晚期非小细胞肺癌二线	26	Utidelone	鏇艱餘憲觸鏇顧衊衊壓(製構願鏇衊壓製鏇醖夢) = 窪繭衊廠獵鏇廠夢鬱積餘襯艱鬱願淵壓淵襯選 (獵網壓夢齋憲鹹繭鹹衊, 4.4 ~ 34.9) 更多	-	2022-04-03
ASCO2006	临床1期	肿瘤	13	KOS-862 (Epothilone D)	鹹襯鏇遞願糧鑰壓齋願(構觸獵鏇遞窪艱選餘糧) = 鏇築衊積選鑰憲襯鑰選蓋淵顧簾淵繭鬱醖範範 (簾製餘遞夢網簾淵窪鬱 )	-	2006-06-20