Delving into the Latest Updates on Bevacizumab biosimilar(Shanghai Institute of Biological Products) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Bevacizumab Biosimilar (Shanghai Institute of Biological Products Co., Ltd.), 贝伐珠单抗生物类似药（上海生物制品研究所有限责任公司）

+ [2]

Target

VEGF-A

Action

inhibitors

Mechanism

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

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [4]

Active Indication

Fallopian Tube CarcinomaHepatocellular CarcinomaMetastatic Colorectal Carcinoma+ [6]

Inactive Indication-

Originator Organization

Shanghai Institute of Biological Products Co., Ltd.

Active Organization

Shanghai Institute of Biological Products Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (08 Jan 2025),

Fallopian Tube CarcinomaHepatocellular CarcinomaMetastatic Colorectal Carcinoma+ [5]

Regulation-

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Structure/Sequence

Sequence Code 41637L

The sequence is quoted from: *****

Sequence Code 41632H

The sequence is quoted from: *****

A Randomized, Double-blind, Parallel-controlled Study Comparing the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (SIBP04) and Bevacizumab Injection (Avastin) in Combination With Paclitaxel and Carboplatin Respectively in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Start Date17 Apr 2020

Sponsor / Collaborator

Shanghai Institute of Biological Products Co., Ltd.

[+1]

NCT04135898

/ CompletedPhase 1

A Randomized, Double-blind, Phase I Study Comparing the Pharmacokinetic and Safety of SIBP-04 and Bevacizumab in Healthy Male Subjects

This is a randomised, double-blind, positive drug parallel controlled clinical trial in China. In the trial, it is planned to enroll 88 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.

Start Date23 Oct 2019

Sponsor / Collaborator

Shanghai Institute of Biological Products Co., Ltd.

100 Clinical Results associated with Bevacizumab biosimilar(Shanghai Institute of Biological Products)

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100 Translational Medicine associated with Bevacizumab biosimilar(Shanghai Institute of Biological Products)

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100 Patents (Medical) associated with Bevacizumab biosimilar(Shanghai Institute of Biological Products)

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1

Literatures (Medical) associated with Bevacizumab biosimilar(Shanghai Institute of Biological Products)

01 Nov 2023·Journal of cancer research and clinical oncology

Outcome benefits of bevacizumab biosimilar (SIBP04) combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer patients with EGFR mutation: subgroup analysis of a prospective, randomized phase III clinical trial.

Article

Author: Zhang, Yuntao ; Zhang, Huijun ; Qu, Aidong ; Li, Sixiu ; Yang, Yunkai ; Zhang, Shiying ; Chen, Dandan ; Li, Songsong ; Li, Xiuling ; Yang, Ji ; Zhang, Yaowen ; Zou, Hongxia ; Huang, Yubao

PURPOSESIBP04 is a bevacizumab biosimilar, and bevacizumab combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer (nsqNSCLC) has been recommended as the first-line treatment choice. However, the efforts of bevacizumab combined with carboplatin and paclitaxel for nsqNSCLC patients with EGFR mutation remained unclear. Here we report an EGFR mutation subgroup analysis of a prospective, randomized phase III clinical trial (NCT05318443).METHODSIn this randomized, double-blind, multi-center, parallel controlled, phase III clinical trial, locally advanced, metastatic NSCLC patients were enrolled, and EGFR expression was examined and considered as a stratification factor. All patients received 4 to 6 cycles of paclitaxel and carboplatin plus SIBP04 or bevacizumab 15 mg/kg intravenously followed by SIBP04 15 mg/kg maintenance until intolerable toxicity, disease progression or death. Patients with EGFR mutation and wild-type were assessed for progression-free survival (PFS) and overall survival (OS).RESULTSEGFR expression was examined in 398 NSCLC patients (142 with EGFR mutation, 256 with EGFR wild type). PFS in EGFR mutation patients was significantly longer than EGFR wild-type patients (10.91 vs. 7.82 months; HR = 0.692, 95% CI 0.519-0.921, P = 0.011). The median OS in patients with EGFR mutation was not reached while that of EGFR wild-type group was 17.54 months (HR = 0.398, 95% CI 0.275-0.575, P < 0.001). However, there were no significant differences in objective response rate (61.97% vs. 55.86%, P = 0.237) or disease control rate (90.14% vs. 89.84%, P = 0.925).CONCLUSIONBevacizumab combined with chemotherapy significantly prolonged the PFS and OS of advanced nsqNSCLC patients with EGFR mutation.

100 Deals associated with Bevacizumab biosimilar(Shanghai Institute of Biological Products)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025
Hepatocellular Carcinoma	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025
Metastatic Colorectal Carcinoma	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025
Non-squamous non-small cell lung cancer	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025
Ovarian Epithelial Carcinoma	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025
Primary peritoneal carcinoma	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025
Recurrent Glioblastoma	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025
Uterine Cervical Cancer	China	Shanghai Institute of Biological Products Co., Ltd.	08 Jan 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Shanghai Institute of Biological Products Co., Ltd.	17 Apr 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05318443 (Literature) Manual	Phase 3	Non-squamous non-small cell lung cancer First line	517	SIBP04 + paclitaxel + carboplatin	(alsvtoevys) = nakgsqkwqy qfwjuzjcre (gzmfzgigis, 49.3 - 61.8) Met	Positive	06 Jan 2025
				Avastin® + paclitaxel + carboplatin	(alsvtoevys) = ivhgngwqyb qfwjuzjcre (gzmfzgigis, 53.0 - 65.4) Met
NCT05318443 (Pubmed) Manual	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma First line	398	SIBP04 + carboplatin and paclitaxel (EGFR mutation)	(trdqebiplb) = nsqwxbtsur zzgabdfbeh (rcpcwvpqph ) View more	Positive	15 Jul 2023
				SIBP04 + carboplatin and paclitaxel (EGFR wild type)	(trdqebiplb) = ezvccelsyb zzgabdfbeh (rcpcwvpqph ) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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