Last update 01 Nov 2024

Bevacizumab biosimilar(Shanghai Huaaotai)

Last update 01 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Bevacizumab Biosimilar (Shanghai Huaaotai Biopharmaceutical Co., Ltd.), 贝伐珠单抗生物类似药（Shanghai Huaaotai Biopharmaceutical Co., Ltd.）, 重组人源化抗血管内皮生长因子 (VEGF)单抗 (上海华奥泰生物)

+ [2]

Target

VEGF-A

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors), Angiogenesis inhibitors

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases

Active Indication

Advanced Lung Non-Small Cell CarcinomaMetastatic Colorectal CarcinomaNon-Small Cell Lung Cancer+ [1]

Inactive Indication

GliomaOvarian CancerRenal Cell Carcinoma

Originator Organization

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

Active Organization

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

Huabo Biopharm Co Ltd.

Inactive Organization

Shanghai Junshi Biosciences Co., Ltd.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 41637L

The sequence is quoted from: *****

Sequence Code 41632H

The sequence is quoted from: *****

Clinical Trials associated with Bevacizumab biosimilar(Shanghai Huaaotai)

CTR20202435 / RecruitingPhase 3

重组人源化抗血管内皮生长因子单克隆抗体注射液（HOT-1010）对比贝伐珠单抗联合卡铂/紫杉醇治疗晚期、转移性或复发性非鳞状细胞非小细胞肺癌的多中心、随机、双盲、平行阳性对照的有效性和安全性的Ⅲ期临床研究

[Translation] A phase III clinical study on the efficacy and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection (HOT-1010) versus bevacizumab combined with carboplatin/paclitaxel in the treatment of advanced, metastatic or recurrent non-squamous non-small cell lung cancer: a multicenter, randomized, double-blind, parallel positive control

主要目的：比较HOT-1010联合紫杉醇/卡铂与贝伐珠单抗联合紫杉醇/卡铂治疗晚期、转移性或复发性非鳞状细胞非小细胞肺癌受试者的第18周客观缓解率(ORR18：使用独立影像评估)。次要目的：比较HOT-1010联合紫杉醇/卡铂与贝伐珠单抗联合紫杉醇/卡铂治疗晚期、转移性或复发性非鳞状细胞非小细胞肺癌受试者的第24周客观缓解率(ORR24)、缓解持续时间（DOR）、无进展生存期（PFS）、疾病控制率（DCR）、总生存期（OS）和1年生存率（OSR1年）、2年生存率（OSR2年）等。

[Translation]

Primary objective: To compare the objective response rate at week 18 (ORR18: using independent imaging assessment) between HOT-1010 combined with paclitaxel/carboplatin and bevacizumab combined with paclitaxel/carboplatin in subjects with advanced, metastatic, or recurrent non-squamous non-small cell lung cancer. Secondary objective: To compare the objective response rate at week 24 (ORR24), duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), 1-year survival rate (OSR1 year), 2-year survival rate (OSR2 years), etc. between HOT-1010 combined with paclitaxel/carboplatin and bevacizumab combined with paclitaxel/carboplatin in subjects with advanced, metastatic, or recurrent non-squamous non-small cell lung cancer.

Start Date16 Mar 2021

Sponsor / Collaborator

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

CTR20181610 / CompletedPhase 1

比较HOT-1010与贝伐珠单抗在健康男性受试者中药代动力学特性、安全性、耐受性和免疫原性的临床研究

[Translation] A clinical study comparing the pharmacokinetic properties, safety, tolerability and immunogenicity of HOT-1010 and bevacizumab in healthy male subjects

主要研究目的：评价HOT-1010（重组人源化抗血管内皮生长因子单克隆抗体注射液）与贝伐珠单抗在健康男性受试者单次静脉给药的药代动力学（PK）相似性。次要研究目的：评价HOT-1010与贝伐珠单抗在健康男性受试者单次静脉给药的药代动力学特征、安全性、耐受性及免疫原性。

[Translation]

The primary study objective is to evaluate the pharmacokinetic (PK) similarity of HOT-1010 (recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection) and bevacizumab in healthy male subjects after a single intravenous administration. The secondary study objective is to evaluate the pharmacokinetic characteristics, safety, tolerability and immunogenicity of HOT-1010 and bevacizumab in healthy male subjects after a single intravenous administration.

Start Date06 Jun 2019

Sponsor / Collaborator

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Bevacizumab biosimilar(Shanghai Huaaotai)

100 Translational Medicine associated with Bevacizumab biosimilar(Shanghai Huaaotai)

100 Patents (Medical) associated with Bevacizumab biosimilar(Shanghai Huaaotai)

Literatures (Medical) associated with Bevacizumab biosimilar(Shanghai Huaaotai)

Frontiers in PharmacologyQ2 · MEDICINE

A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male Subjects

Q2 · MEDICINE

ArticleOA

Author: Li, Zhenni ; Shi, Yunfei ; Zhang, Jisheng ; Wang, Jiakun ; Tang, Yuan ; Zhang, Lin ; Que, Linling ; Yang, Yongmin ; Qian, Zhenzhong ; Chu, Nannan ; Huang, Kai ; Chen, Yuanxin ; Qin, Wei ; Zhu, Xiangyang ; Ding, Ying ; He, Qing ; Gu, Xianghong

Objective: This study was conducted to compare the pharmacokinetics, safety and immunogenicity of HOT-1010 with bevacizumab (Avastin®) in Chinese healthy male subjects.Methods: A single-center, randomized, double-blind, single-dose, parallel trial was performed in 84 Chinese healthy male subjects who randomly (1:1) received a single intravenous infusion of 1 mg/kg HOT-1010 or Avastin® for 90 min and followed up for 85 days. Serum concentrations of bevacizumab were analyzed by enzyme-linked immunosorbent assay. Primary pharmacokinetic parameters, Cmax, AUC0-t and AUC0-∞, were calculated and evaluated the bioequivalence between HOT-1010 and Avastin®, the safety and immunogenicity of investigational drugs were also assessed.Results: A total of 82 subjects completed the study. The 90% Confidence Intervals for geometric mean ratios of Cmax, AUC0-t and AUC0-∞ were 91.81–103.64%, 85.19–95.39% and 85.04–95.36%, which were all within the bioequivalence margin. Treatment-emergent adverse events were reported in 27 (65.9%) subjects in HOT-1010 group and 23 (56.1%) subjects in Avastin® group. Most TEAEs were mild or moderate. No TEAEs, Serious Adverse Events or deaths leading to discontinuation was reported. Subjects were all tested negative for Anti-drug Antibody.Conclusion: HOT-1010 exhibited the similar pharmacokinetics, safety and immunogenicity profiles of bevacizumab (Avastin®) in Chinese healthy male subjects.Clinical Trial Registration:http://www.chinadrugtrials.org.cn/index.html, CTR20181610.

100 Deals associated with Bevacizumab biosimilar(Shanghai Huaaotai)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	19 Aug 2022
Metastatic Colorectal Carcinoma	Phase 3	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	19 Aug 2022
Non-squamous non-small cell lung cancer	Phase 3	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	16 Mar 2021
Non-Small Cell Lung Cancer	Preclinical	CN	Shanghai Junshi Biosciences Co., Ltd.	24 Jun 2019
Glioma	Discovery	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	07 Mar 2013
Ovarian Cancer	Discovery	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	07 Mar 2013
Renal Cell Carcinoma	Discovery	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	07 Mar 2013

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