Delving into the Latest Updates on Bevacizumab biosimilar(Sinocelltech Group) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Bevacizumab biosimilar(Sino Cell Technologies), Recombinant humanized anti-VEGF monoclonal antibody(Sinocelltech Group), 重组人源化抗VEGF单抗 (神州细胞工程)

+ [4]

Target

VEGF-A

Action

inhibitors

Mechanism

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

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [6]

Active Indication

Fallopian Tube CarcinomaHepatocellular CarcinomaMetastatic Colorectal Carcinoma+ [10]

Inactive Indication

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Originator Organization

Sinocelltech Group Ltd.

Active Organization

Sinocelltech Group Ltd.

Inactive Organization

Shenzhou Cell Engineering Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

China (27 Jun 2023),

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: *****

[Translation] A multicenter, randomized, double-blind, parallel-controlled, non-inferiority phase III clinical study comparing the efficacy and safety of recombinant humanized anti-VEGF monoclonal antibody ophthalmic injection (SCT510A) and ranibizumab injection in the treatment of patients with wet age-related macular degeneration

主要目的：比较SCT510A和雷珠单抗注射液治疗wAMD患者的有效性。次要目的：1、比较SCT510A和雷珠单抗注射液治疗wAMD患者的安全性。2、观察SCT510A在wAMD患者中的免疫原性。

[Translation]

Primary objective: To compare the effectiveness of SCT510A and ranibizumab injection in the treatment of wAMD patients. Secondary objectives: 1. To compare the safety of SCT510A and ranibizumab injection in the treatment of wAMD patients. 2. To observe the immunogenicity of SCT510A in wAMD patients.

Start Date10 Jan 2023

Sponsor / Collaborator

Shenzhou Cell Engineering Co. Ltd.

CTR20202027

/ CompletedPhase 1/2

重组人源化抗VEGF单克隆抗体眼用注射液（SCT510A）多次给药治疗湿性年龄相关性黄斑变性的安全性、耐受性、药代动力学、有效性和药效学特征的多中心、开放Ⅰ/Ⅱ期临床研究

[Translation] A multicenter, open-label, phase I/II clinical study on the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of multiple-dose recombinant humanized anti-VEGF monoclonal antibody ophthalmic injection (SCT510A) in the treatment of wet age-related macular degeneration

评估SCT510A治疗wAMD的安全性和耐受性；观察SCT510A在wAMD受试者中的药代动力学、药效学和免疫原性特征；探索SCT510A在wAMD受试者中的疗效。

[Translation]

To evaluate the safety and tolerability of SCT510A in the treatment of wAMD; to observe the pharmacokinetic, pharmacodynamic, and immunogenicity characteristics of SCT510A in wAMD subjects; and to explore the efficacy of SCT510A in wAMD subjects.

Start Date06 Jan 2021

Sponsor / Collaborator

Shenzhou Cell Engineering Co. Ltd.

100 Clinical Results associated with Bevacizumab biosimilar(Sinocelltech Group)

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100 Translational Medicine associated with Bevacizumab biosimilar(Sinocelltech Group)

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100 Patents (Medical) associated with Bevacizumab biosimilar(Sinocelltech Group)

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2

Literatures (Medical) associated with Bevacizumab biosimilar(Sinocelltech Group)

01 Nov 2024·Advances in Therapy

Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study

Article

Author: Xie, Liangzhi ; Chen, Rixin ; Li, Xingya ; Gai, Wenlin ; Liu, Lianke ; Zang, Kai ; Kong, Li ; Wang, Rui ; Luo, Hui ; Sun, Shenghua ; Ren, Tiejun ; Sun, Hongmei ; Huang, Zhe ; Jiang, Ou ; Chen, Weiqiu ; Li, Gaofeng ; Yu, Yan ; Sun, Meili ; Pan, Zhanyu ; Li, Wei ; Bian, Tao ; Hu, Chunhong ; Lei, Kaijian ; Wei, Zonghui ; Zhu, Bo ; Zhong, Fukuan ; Chen, Shaoshui ; Zhuang, Wu ; Lin, Dang ; Li, Runpu ; Cheng, Ying ; Hang, Xiaosheng ; Shi, Huaqiu ; Gu, Kangsheng ; Wu, Lin ; Sun, Debin ; Liu, Hailong ; Su, Huo ; Zhao, Li ; Lian, Juanwen ; Ren, Wenwen ; He, Miao

INTRODUCTIONSCT510 is a biosimilar to bevacizumab (Avastin) reference product (RP) that is approved for various metastatic cancers. In this study, we aimed to demonstrate the equivalence of SCT510 and bevacizumab in terms of efficacy, safety, immunogenicity and pharmacokinetics (PK) in patients with advanced non-squamous non-small cell lung cancer (NSCLC).METHODSPatients with non-squamous NSCLC were randomized equally to the SCT510 group (comprising SCT510, paclitaxel, and carboplatin) and the bevacizumab group (comprising bevacizumab, paclitaxel, and carboplatin) for 4-6 cycles, followed by maintenance monotherapy with SCT510. The primary endpoint was the objective response rate (ORR) at week 12. Secondary endpoints included 18-week ORR, disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and 1-year survival rate, as well as assessments of safety, immunogenicity, and multi-dose PK analysis.RESULTSBetween March 29, 2019, and April 27, 2021, 989 patients were screened and 567 eligible patients were randomly assigned to the SCT510 group (285 patients) and the bevacizumab group (282 patients). The ORR at week 12 was 52.6% [95% confidence interval (CI) 46.66-58.55%] in the SCT510 group and 52.5% (95% CI 46.47-58.47%) in the bevacizumab group. The ORR at week 18 was 55.4% (95% CI 49.46-61.30%) for SCT510 and 55.7% (95% CI 49.68-61.62%) for bevacizumab. The ORR risk ratio (RR) at weeks 12 and 18 was 0.99 (90% CI 0.873-1.133) and 0.99 (90% CI 0.872-1.114), respectively, both within the pre-specified equivalence margin of 0.75-1.33. There were no differences between the two groups in relation to other secondary endpoints, specifically DCR, DOR, PFS, OS, and 1-year survival rate. The overall safety findings were similar between the two treatment groups, and both SCT510 and bevacizumab RP exhibited low immunogenicity.CONCLUSIONSSCT510 is similar to bevacizumab in clinical efficacy, safety, immunogenicity, and PK in patients with advanced non-squamous NSCLC. The totality of the evidence supports the clinical equivalence of SCT510 and bevacizumab.TRIAL REGISTRATIONNCT03792074.

01 Jun 2023·Drugs in R&D

A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of SCT510 to Bevacizumab (Avastin^®) in Healthy Chinese Males.

Article

Author: Zhou, Huili ; Wu, Jing ; Zhang, Jingjing ; Shentu, Jianzhong ; Wu, Guolan ; Wu, Lihua ; Xie, Liangzhi ; Xu, Chang ; Lv, Duo

BACKGROUNDSCT510 is a recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), which is intended as a candidate biosimilar of bevacizumab that is approved for various metastatic cancers.Please confirm change in wording to match definition for VEGF belowYes.OBJECTIVEThis study aimed to compare the pharmacokinetics profiles, safety, and immunogenicity of SCT510 to bevacizumab (Avastin^®) in healthy Chinese males.METHODSThis was a single-center, double-blind, parallel-group phase I study. A total of 84 participants were randomly assigned (1:1) to receive a single 3 mg/kg infusion of either SCT510 or bevacizumab and followed up for 99 days. Primary endpoints were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC_0-∞), area under the serum concentration-time curve from time 0 to last quantifiable concentration (AUC_0-t), and the maximum observed concentration (C_max). Secondary endpoints included safety and immunogenicity.Kindly check and confirm the edit made in the article title.Yes.RESULTSA total of 82 subjects completed the study. Geometric means ratios (GMR) for AUC_0-∞, AUC_0-t, and C_max were 0.88, 0.89, and 0.97, respectively, for SCT510 versus bevacizumab (USA). The 90% confidence intervals for GMRs of AUC_0-∞, AUC_0-t, and C_max were all within the prespecified criteria (80-125%). No adverse events (AEs) led to study termination, and no serious adverse events (SAEs) were reported. None of the anti-drug antibodies (ADAs) identified were found to be neutralizing antibodies (NAbs), and only one subject from the SCT510 group tested positive for the ADA at the day 99 visit.CONCLUSIONThis study demonstrated that the pharmacokinetics, safety, and immunogenicity of SCT510 were equivalent to bevacizumab (Avastin^®). As a proposed biosimilar drug to bevacizumab, SCT510 was well tolerated in healthy Chinese males.CLINICAL TRIALS REGISTRATIONNCT05113511.

100 Deals associated with Bevacizumab biosimilar(Sinocelltech Group)

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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	Sinocelltech Group Ltd.	27 Jun 2023
Hepatocellular Carcinoma	China	Sinocelltech Group Ltd.	27 Jun 2023
Metastatic Colorectal Carcinoma	China	Sinocelltech Group Ltd.	27 Jun 2023
Non-squamous non-small cell lung cancer	China	Sinocelltech Group Ltd.	27 Jun 2023
Ovarian Epithelial Carcinoma	China	Sinocelltech Group Ltd.	27 Jun 2023
Primary peritoneal carcinoma	China	Sinocelltech Group Ltd.	27 Jun 2023
Recurrent Glioblastoma	China	Sinocelltech Group Ltd.	27 Jun 2023
Uterine Cervical Cancer	China	Sinocelltech Group Ltd.	27 Jun 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	China	Sinocelltech Group Ltd.	14 Feb 2023
Advanced Hepatocellular Carcinoma	Phase 3	China	Sinocelltech Group Ltd.	11 Nov 2020
Glioblastoma	Phase 3	United States	Sinocelltech Group Ltd.	-
Kidney Neoplasms	Phase 3	China	Sinocelltech Group Ltd.	-
Kidney Neoplasms	Phase 3	United States	Sinocelltech Group Ltd.	-
Metastatic Colorectal Carcinoma	Phase 3	United States	Sinocelltech Group Ltd.	-
Ovarian Cancer	Phase 3	United States	Sinocelltech Group Ltd.	-
Uterine Cervical Cancer	Phase 3	United States	Sinocelltech Group Ltd.	-
Non-Small Cell Lung Cancer	Phase 2	China	Shenzhou Cell Engineering Co. Ltd.	08 Mar 2019
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	-	Sinocelltech Group Ltd.	01 Feb 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03792074 (Pubmed \| Adv Ther) Manual	Phase 3	Non-squamous non-small cell lung cancer Maintenance \| First line	567	SCT510,paclitaxellcarboplatinplatin	(qmpaxrhnyb) = sbtjwqnasc iuefscragq (kwyxejteky, 46.66 - 58.55) View more	Similar	04 Sep 2024
				Bevacizumab,paclitaxellcarboplatinplatin	(qmpaxrhnyb) = xcjnucxufv iuefscragq (kwyxejteky, 46.47 - 58.47) View more
NCT04560894 (SCT-I10A-C301, ASCO2024) Manual	Phase 3	Advanced Hepatocellular Carcinoma First line	346	SCT-I10A + SCT510	(mcfgoijxhy) = xgmydrlbuf rsxizltkqf (dqmtcunspg ) View more	Superior	24 May 2024
				Sorafenib	(mcfgoijxhy) = lzfonxrudp rsxizltkqf (dqmtcunspg ) 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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