[Translation] A single-center, randomized, double-blind, parallel controlled pharmacokinetic study comparing GB242 for injection with infliximab in healthy adult male volunteers in China

主要目的为评估单次给药后GB242与英夫利西单抗（类克®）的主要药代动力学参数（包括AUC0-t、AUC0-inf和Cmax），进行PK比对研究。次要目的为评估单次给药后GB242与英夫利西单抗（类克®）的其他药代动力学参数（主要包括Tmax、t1/2、Vd、CL等）、安全性和免疫原性。

[Translation]

The primary objective is to evaluate the main pharmacokinetic parameters (including AUC0-t, AUC0-inf and Cmax) of GB242 and infliximab (Remicade®) after a single dose, and conduct a PK comparison study. The secondary objective is to evaluate other pharmacokinetic parameters (mainly including Tmax, t1/2, Vd, CL, etc.), safety and immunogenicity of GB242 and infliximab (Remicade®) after a single dose.

Start Date19 May 2020

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

CTR20170127 / CompletedPhase 3

注射用重组抗TNF-alpha人鼠嵌合单克隆抗体有效性和安全性比较研究的临床试验方案

[Translation] Clinical trial plan for comparative study of efficacy and safety of recombinant anti-TNF-alpha human-mouse chimeric monoclonal antibody for injection

比较30周时两组达到ACR20的受试者比率的相似性。

[Translation]

The similarity of the proportion of subjects achieving ACR20 between the two groups was compared at week 30.

Start Date16 Nov 2017

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

NCT04178850 / Unknown statusPhase 3

A Randomized, Double-blind, Multi-center Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.

This study compares the similarity of the proportion of subjects who achieved ACR20 at week 30 in the two groups.

Start Date13 Oct 2017

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

100 Clinical Results associated with Infliximab biosimilar(Genor Biopharma)

100 Translational Medicine associated with Infliximab biosimilar(Genor Biopharma)

100 Patents (Medical) associated with Infliximab biosimilar(Genor Biopharma)

Literatures (Medical) associated with Infliximab biosimilar(Genor Biopharma)

01 Feb 2022·Rheumatology and TherapyQ3 · MEDICINE

Fine Comparison of the Efficacy and Safety Between GB242 and Infliximab in Patients with Rheumatoid Arthritis: A Phase III Study

Q3 · MEDICINE

ArticleOA

Author: Liu, Xiumei ; Gong, Xiaowei ; Chen, Linjie ; Liu, Shengyun ; Wu, Lijun ; Zhao, Cheng ; Wang, Ling ; Zhang, Zhenchun ; Wu, Jian ; Tie, Ning ; Shi, Guixiu ; Liu, Lin ; Wei, Hua ; Liu, Yingxue Cathy ; Li, Xiaomei ; Yang, Niansheng ; Lin, Jinying ; Sun, Lingyun ; Dai, Lie ; Luo, Li ; Liu, Yanying ; Jiang, Zhenyu ; Da, Zhanyun ; Li, Zhanguo ; Wang, Youlian ; Song, Hui ; Lu, Fuai ; Liu, Ju ; Guo, Qian ; Sun, Hongsheng ; Chai, Kexia

INTRODUCTIONThis phase III trial (NCT04178850) evaluated the efficacy, safety, and immunogenicity of GB242, an infliximab biosimilar, vs. infliximab (Remicade^®) reference product in patients with moderate-to-severe active rheumatoid arthritis (RA) combination with methotrexate (MTX) therapy.METHODSPatients were randomized in a 1:1 ratio to receive either GB242 or INF (3 mg/kg). Therapeutic equivalence of clinical response according to the American College of Rheumatology 20% (ACR20) response rate at week 30 was declared if the two-sided 95% CI for the treatment difference was within ± 14%. The comparison of GB242 with INF also included the proportion of patients achieving a week 30 ACR 50 response, ACR70 response, change in Disease Activity Score 28 (DAS28), as well as safety and immunogenicity.RESULTSA total of 570 subjects were randomized into GB242 (N = 285) or INF (N = 285) and 283 subjects in each group were analyzed. At week 30, the ACR20 was 62.54% for the GB242 group (95% CI 56.62-68.20%) and 56.89% for the INF group (95% CI 50.90-62.74%). The difference between the two groups was 5.65% with a 95% CI of - 2.48 to 13.74. ACR50 response was 37.12% for GB242 and 32.86% for INF at week 30. ACR70 response was 19.79% for GB242 and 16.96% for INF at week 30, respectively. The incidence of treatment-emergent adverse events was comparable (77.4% in GB242 vs. 80.2% in INF) and detection of antidrug antibodies (ADA) to infliximab up to week 30 (60.8% in GB242 vs. 59.4% in INF) was comparable.CONCLUSIONSGB242 demonstrated equivalent efficacy to INF at week 30. Moreover, GB242 was well tolerated, with a similar immunogenicity and safety profile comparable to INF.

01 Feb 2019·BioDrugsQ3 · MEDICINE

A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects

Q3 · MEDICINE

Article

Author: Song, Haifeng ; Wang, Qi ; Dong, Lihou ; Ren, Shengbin ; Wang, Qian ; Cheng, Huiyang ; Chen, Guihong ; Lv, Jie ; Zhang, Tan ; Fang, Yi ; An, Youzhong ; Wang, Yitong ; Liu, Chang ; Zu, Li'an ; Zheng, Qingshan

OBJECTIVEThe objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with those of reference infliximab in healthy Chinese subjects.METHODSWe conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were divided equally into a GB242 group and reference infliximab group. Both the test and reference drug were administered as a single intravenous dose of 3 mg/kg. Blood samples were collected as per a designated schedule to evaluate PKs and immunogenicity. Safety was assessed throughout the study. PK similarity was concluded if the 90% confidence intervals (CIs) for the geometric mean ratios of the GB242 to reference infliximab for maximum concentration (C_max), area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC_t), and AUC from time zero to infinity (AUC_∞) were within the predefined bioequivalence range of 80-125%.RESULTSThe mean serum concentration-time curves were similar between GB242 and reference infliximab. The 90% CIs for the geometric mean ratios of the GB242 to reference infliximab for C_max, AUC_t, and AUC_∞ were completely within 80-125% for the PK similarity comparison. The proportion of subjects with treatment-emergent adverse events was similar between the GB242 group and the reference infliximab group. Antidrug antibody profiles were comparable between the two treatments groups.CONCLUSIONSThis study demonstrated high PK similarity between GB242 and its marketed reference infliximab in healthy subjects. Both treatments showed comparable safety and immunogenicity.REGISTRATION NUMBERChiCTR-IPR-15007098.

100 Deals associated with Infliximab biosimilar(Genor Biopharma)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	DB00065

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	CN	Genor Biopharma Co., Ltd.	23 Feb 2022
Ankylosing Spondylitis	CN	Yuxi Genor Biotechnology Co., Ltd.	23 Feb 2022
Colitis, Ulcerative	CN	Genor Biopharma Co., Ltd.	23 Feb 2022
Colitis, Ulcerative	CN	Yuxi Genor Biotechnology Co., Ltd.	23 Feb 2022
Crohn Disease	CN	Yuxi Genor Biotechnology Co., Ltd.	23 Feb 2022
Crohn Disease	CN	Genor Biopharma Co., Ltd.	23 Feb 2022
Psoriasis	CN	Yuxi Genor Biotechnology Co., Ltd.	23 Feb 2022
Psoriasis	CN	Genor Biopharma Co., Ltd.	23 Feb 2022
Rheumatoid Arthritis	CN	Yuxi Genor Biotechnology Co., Ltd.	23 Feb 2022
Rheumatoid Arthritis	CN	Genor Biopharma Co., Ltd.	23 Feb 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04178850 (Pubmed \| Rheumatol Ther) Manual	Phase 3	Rheumatoid Arthritis	570	Infliximab-GB242	(wtdmtmetml) = lfqbrpgenv xbuiljqnxl (kiboefyiev, 56.62 ~ 68.20) View more	Superior	01 Feb 2022
				Infliximab	(wtdmtmetml) = binnocvkzf xbuiljqnxl (kiboefyiev, 50.90 ~ 62.74) View more

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