Delving into the Latest Updates on Bevacizumab biosimilar (Betta Pharma) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Bevacizumab biosimilar

+ [1]

Target

VEGF-A

Mechanism

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

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [4]

Active Indication

Fallopian Tube CarcinomaGlioblastomaOvarian Cancer+ [4]

Inactive Indication

Advanced Lung Non-Squamous Non-Small Cell CarcinomaMetastatic Colorectal CarcinomaRecurrent Lung Non-Squamous Non-Small Cell Carcinoma

Originator Organization

Chinese Academy of Medical Sciences

Active Organization

Betta Pharmaceuticals Co., Ltd.

Inactive Organization

Beijing Mabworks Biotech Co., Ltd.Chinese PLA Academy of Military Medical Sciences

Drug Highest PhaseApproved

First Approval Date

CN (24 Nov 2021),

Colorectal CancerNon-Small Cell Lung Cancer

Regulation-

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Gene Sequence

Sequence Code 41637L

The sequence is quoted from: *****

Sequence Code 41632H

The sequence is quoted from: *****

主要目的：评价MIL60（重组抗人血管内皮生长因子人源化单克隆抗体注射液）与Avastin在健康男性志愿者单次静脉给药的药代动力学（PK）相似性。次要目的：评价MIL60与Avastin在健康男性志愿者单次静脉给药的药代动力学特征、安全性、耐受性和免疫原性。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) similarity of MIL60 (recombinant anti-human vascular endothelial growth factor humanized monoclonal antibody injection) and Avastin in healthy male volunteers after a single intravenous administration. Secondary objective: To evaluate the pharmacokinetic characteristics, safety, tolerability and immunogenicity of MIL60 and Avastin in healthy male volunteers after a single intravenous administration.

Start Date08 Nov 2016

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

[+1]

100 Clinical Results associated with Bevacizumab biosimilar (Betta Pharma)

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100 Translational Medicine associated with Bevacizumab biosimilar (Betta Pharma)

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100 Patents (Medical) associated with Bevacizumab biosimilar (Betta Pharma)

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4

Literatures (Medical) associated with Bevacizumab biosimilar (Betta Pharma)

01 Dec 2021·eClinicalMedicine

Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study

Article

Author: Li, Na ; Yu, Yan ; Yue, Lu ; Feng, Weineng ; Jiang, Ou ; Lv, Dongqing ; Han, Jianguo ; Yang, Shujun ; Fang, Haohui ; Pan, Yueyin ; Zhang, Yu ; Wang, Yang ; Zhao, Min ; Wang, Xiaoshan ; Sun, Sanyuan ; Zhu, Yuxi ; Chen, Qun ; Zhao, Guofang ; Wu, Rong ; Huang, Linian ; Ding, Lieming ; Wang, Kai ; Zhao, Hui ; Zhao, Enfeng ; Zhou, Chengzhi ; Wang, Jie ; Wu, Lin ; Liang, Li ; Wen, Juyi ; Li, Yinyin ; Chen, Yinglan ; Gao, Hongjun ; Zeng, Aiping ; Zang, Aimin ; Li, Gaofeng ; Hong, Wei ; Dai, Zhaoxia ; Wang, Shubin ; Guo, Zhongliang ; Lin, Chuan ; Pan, Hongming ; Su, Yanjun ; Yuan, Xiaobin ; Bao, Yangyi ; Zhang, Guojun ; Zhu, Yulong ; Dong, Xiaorong ; Zhang, Xiaochun ; Li, Wenxin ; Yang, Lei ; Fu, Xiuhua ; Wan, Rui ; Ma, Rui ; Li, Chong ; Duan, Jianchun

BACKGROUNDWe compared the efficacy, safety, and immunogenicity of MIL60 with reference bevacizumab as first-line treatment in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) in this phase 3, randomized, double-blind study.METHODSPatients with untreated advanced or recurrent NSCLC were randomized (1:1 ratio) to receive either MIL60 or bevacizumab in combination with paclitaxel/carboplatin. Patients with non-progressive disease continued maintenance single-agent MIL60 until disease progression, or intolerable toxicity. The primary endpoint was the 12-week objective response rates (ORR12) by independent review committee (IRC) using RECIST 1.1. Bioequivalence was established if the ORR ratio located between 0.75 and 1/0.75. The trial was registered with clinicaltrials.gov (NCT03196986).FINDINGSBetween Aug 23, 2017, and May 8, 2019, 517 patients were randomly assigned to MIL60 group (n=257) and bevacizumab group (n=260). In the full analysis set (FAS) population including all randomized and evaluable patients who received at least one dose of MIL60 or bevacizumab, the ORR12 in MIL60 group and bevacizumab group were 48.6% and 43.1%, respectively. The ORR ratio of these two groups were 1.14 (90% CI 0.97-1.33), which fell within the pre-specified equivalence boundaries (0.75-1/0.75). The median DOR was 5.7 months (95% CI 4.5-6.2) for MIL60 and 5.6 months (95% CI 4.3-6.4) for bevacizumab. No significant difference was noted in median PFS (7.2 vs. 8.1 months; HR 1.01, 95% CI 0.78-1.30, p=0.9606) and OS (19.3 vs. 16.3 months; HR 0.81, 95% CI 0.64-1.02, p=0.0755). Safety and tolerability profiles were similar between the two groups. No patient detected positive for Anti-drug antibody (ADA).INTERPRETATIONThe efficacy, safety and immunogenicity of MIL60 were similar with bevacizumab, providing an alternative treatment option for advanced or recurrent non-squamous NSCLC.FUNDINGThis study was sponsored by Betta Pharmaceutical Co., Ltd.

01 Oct 2018·Cancer Chemotherapy and PharmacologyQ4 · MEDICINE

Tolerance, variability, and pharmacokinetics of bevacizumab biosimilars in Chinese healthy male subjects

Q4 · MEDICINE

Article

Author: Zhang, Hong ; Wang, Jing ; Ding, Yanhua ; Liu, Chengjiao ; Hu, Yue ; Li, Xiaojiao ; Shen, Zhenwei ; Wei, Haijing ; Li, Cuiyun ; Li, Qingmei ; Chen, Guiling ; Zhu, Xiaoxue

OBJECTIVEThe aim of this study was to explore the tolerance, variability, and pharmacokinetics (PK) of bevacizumab biosimilars (MIL60, BAT1706, IBI305) in Chinese healthy male subjects.METHODSThis randomized, double-blind, two-arm, parallel studies included three separate investigations, which were conducted by three sponsors to investigate the bioequivalence of bevacizumab biosimilars (MIL60, BAT1706, IBI305) with that of bevacizumab-EU as a reference drug. Subjects received a single-dose of 1 or 3 mg/kg of the bevacizumab biosimilars or bevacizumab-EU and were followed up for 70-99 days. Serum concentrations of bevacizumab, antidrug antibody (ADA), and neutralizing antibody (NAb) were measured using electrochemiluminescence. In addition, the PK parameters were determined using non-compartmental methods. The safety assessments included adverse events, hematology tests, and biochemistry tests.RESULTSThe three bevacizumab biosimilars exhibited similar PK properties to that of bevacizumab-EU. Bevacizumab demonstrated linear PK properties and a concentration-dependent disposition. When comparing the three biosimilars with bevacizumab-EU, the 90% CIs of the ratios for C_max, AUC_0-t, and AUC_0-∞ were within 80-125%. The inter-CV ranged from 12.6 to 23.3%. Three subjects in the biosimilar groups and bevacizumab-EU were positive for the ADA and negative for the NAb. Treatment-related mild or moderate adverse events were reported in 56-80 and 36-80% of subjects in the biosimilar and bevacizumab treatment arms, respectively.CONCLUSIONSThe bevacizumab biosimilars exhibit similar PK characteristics to that of the reference product bevacizumab-EU. The inter-CV is moderate and less than 25% in all cases. The safety profile was similar among bevacizumab biosimilars and bevacizumab-EU with significant adverse events.

01 May 2014·Cellular & Molecular ImmunologyQ1 · MEDICINE

Potent anti-angiogenesis and anti-tumor activity of a novel human anti-VEGF antibody, MIL60

Q1 · MEDICINE

Article

Author: Qiao, Chunxia ; Huang, Yifei ; Li, Xinying ; Lv, Ming ; Wang, Qun ; Zhou, Tingting ; Shen, Beifen ; Feng, Jiannan ; Li, Yan ; Yang, Jing ; Lin, Zhou

Angiogenesis is crucial for tumor development, growth and metastasis. Vascular endothelial growth factor (VEGF) has been implicated in promoting solid tumor growth and metastasis via stimulating tumor-associated angiogenesis, and blocking the activity of VEGF can starve tumors. Avastin, which is a humanized anti-VEGF antibody, has been successfully applied in clinics since 2004. However, the price of Avastin is extremely high for Chinese people. Here, we report a novel human anti-VEGF neutralizing antibody, MIL60, which shows an affinity comparable to that of Avastin (the KD value of MIL60 was 44.5 pM, while that of Avastin was 42.7 pM). MIL60 displays favorable actions in inhibiting VEGF-triggered endothelial cell proliferation (the IC50 value of MIL60 was 31±6.4 ng/ml and that of Avastin was 47±8.1 ng/ml), migration (8 µg/ml or 0.8 µg/ml MIL60 versus the control: P<0.05) and tube formation (2 µg/ml or 0.2 µg/ml MIL60 versus the control: P<0.05) via the VEGFR2 signaling pathway. Moreover, MIL60 was shown to inhibit tumor growth and angiogenesis in vivo in xenograft models of human colon carcinoma and ovarian cancer using immunotherapy and immunohistochemistry analysis (MIL60 versus N.S.: P=0.0007; Avastin versus N.S.: P=0.00046). These data suggest that MIL60 is a potential therapeutic, anti-angiogenic agent. Our work provides a novel anti-VEGF antibody, which can be considered an anti-tumor antibody candidate and a new option for patients with various cancers.

100 Deals associated with Bevacizumab biosimilar (Betta Pharma)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	CN	Betta Pharmaceuticals Co., Ltd.	04 Mar 2022
Glioblastoma	CN	Betta Pharmaceuticals Co., Ltd.	04 Mar 2022
Ovarian Cancer	CN	Betta Pharmaceuticals Co., Ltd.	04 Mar 2022
Primary peritoneal carcinoma	CN	Betta Pharmaceuticals Co., Ltd.	04 Mar 2022
Uterine Cervical Cancer	CN	Betta Pharmaceuticals Co., Ltd.	04 Mar 2022
Colorectal Cancer	CN	Betta Pharmaceuticals Co., Ltd.	24 Nov 2021
Non-Small Cell Lung Cancer	CN	Betta Pharmaceuticals Co., Ltd.	24 Nov 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	25 Aug 2017
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	CN	Chinese PLA Academy of Military Medical Sciences	25 Aug 2017
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	15 Aug 2017
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	CN	Betta Pharmaceuticals Co., Ltd.	15 Aug 2017
Metastatic Colorectal Carcinoma	Phase 2	CN	Chinese PLA Academy of Military Medical Sciences	08 Nov 2016
Metastatic Colorectal Carcinoma	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	08 Nov 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03196986 (Pubmed)	Phase 3	Recurrent Lung Non-Squamous Non-Small Cell Carcinoma First line	517	MIL60	iooacbhmih(mxlvhgvyjr) = qtuciiible pkrobwigfl (bjfodsskps ) View more	Positive	01 Dec 2021
				Bevacizumab	iooacbhmih(mxlvhgvyjr) = wntyppsrew pkrobwigfl (bjfodsskps ) View more
NCT03196986 (ESMO2021) Manual	Phase 3	Recurrent Lung Non-Squamous Non-Small Cell Carcinoma First line	517	Paclitaxel+Carboplatin+MIL60	(opbfmarufi) = xaxprsdmdk ycvabrojqa (urjjxtkdzk ) View more	Similar	16 Sep 2021
				Paclitaxel+Carboplatin+Bevacizumab+MIL60	(opbfmarufi) = euiaugvlsd ycvabrojqa (urjjxtkdzk ) View more
Pubmed Manual	Phase 1	-	-	MIL60	(sjuclurnpa) = Bevacizumab demonstrated linear PK properties and a concentration-dependent disposition. When comparing the three biosimilars with bevacizumab-EU, the 90% CIs of the ratios for Cmax, AUC0-t, and AUC0-∞ were within 80-125%. The inter-CV ranged from 12.6 to 23.3%. evveyqoupm (yxhdynqzix ) View more	Positive	01 Oct 2018
				BAT1706