A Phase III, Multicenter, Randomized, Double-Masked, Parallel Controlled, Non Inferior Study to Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (wAMD)

The purpose of this study is to compare the efficacy and safety of SCT510A versus Lucentis in the treatment of wet age-related macular degeneration.

Start Date14 Feb 2023

Sponsor / Collaborator

Sinocelltech Group Ltd.

CTR20221725 / RecruitingPhase 3

一项比较重组人源化抗VEGF单克隆抗体眼用注射液（SCT510A）和雷珠单抗注射液治疗湿性年龄相关性黄斑变性患者有效性、安全性的多中心、随机双盲、平行对照、非劣效III期临床研究

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

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]

Main objective: To compare the efficacy 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] Multicenter safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of multiple-dose recombinant humanized anti-VEGF monoclonal antibody ophthalmic injection (SCT510A) in wet age-related macular degeneration , Open Phase I/II clinical study

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 pharmacokinetics, pharmacodynamics and immunogenicity characteristics of SCT510A in wAMD subjects; 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)

100 Translational Medicine associated with Bevacizumab biosimilar(Sinocelltech Group)

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

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

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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Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	CN	Shenzhou Cell Engineering Co Ltd.	27 Jun 2023
Hepatocellular Carcinoma	CN	Shenzhou Cell Engineering Co Ltd.	27 Jun 2023
Metastatic Colorectal Carcinoma	CN	Shenzhou Cell Engineering Co Ltd.	27 Jun 2023
Non-squamous non-small cell lung cancer	CN	Shenzhou Cell Engineering Co Ltd.	27 Jun 2023
Ovarian Epithelial Carcinoma	CN	Shenzhou Cell Engineering Co Ltd.	27 Jun 2023
Primary peritoneal carcinoma	CN	Shenzhou Cell Engineering Co Ltd.	27 Jun 2023
Recurrent Glioblastoma	CN	Shenzhou Cell Engineering Co Ltd.	27 Jun 2023
Uterine Cervical Cancer	CN	Shenzhou Cell Engineering Co 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	CN	Sinocelltech Group Ltd.	14 Feb 2023
Advanced Hepatocellular Carcinoma	Phase 3	CN	Sinocelltech Group Ltd.	11 Nov 2020
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Shenzhou Cell Engineering Co Ltd.	08 Mar 2019
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	Shenzhou Cell Engineering Co Ltd.	08 Mar 2019
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Preclinical	-	Sinocelltech Group Ltd.	01 Feb 2019

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