[Translation] A single-center, randomized, blinded, parallel controlled pharmacokinetic comparison study of GB221 and Herceptin in healthy adult volunteers after single administration

通过药代动力学试验，评价单次给药后注射用重组抗HER2人源化单克隆抗体GB221和赫赛汀的主要药代动力学参数Cmax、AUC(0- t)，AUC（0-∞）的相似性。

[Translation]

Pharmacokinetic studies were performed to evaluate the similarity of the main pharmacokinetic parameters Cmax, AUC(0-t), and AUC(0-∞) between the recombinant anti-HER2 humanized monoclonal antibody GB221 for injection and Herceptin after a single dose.

Start Date13 Nov 2019

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

NCT04905667 / CompletedPhase 1

A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers

This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.

Start Date13 Nov 2019

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

CTR20171510 / Active, not recruitingPhase 3

比较GB221联合多西他赛和曲妥珠单抗联合多西他赛一线治疗HER2阳性的转移性乳腺癌患者的有效性、安全性的III期临床试验

[Translation] A phase III clinical trial comparing the efficacy and safety of GB221 combined with docetaxel and trastuzumab combined with docetaxel as first-line treatment for patients with HER2-positive metastatic breast cancer

比较GB221 联合多西他赛与曲妥珠单抗联合多西他赛两组的18 周客观缓解率（ORR）。

[Translation]

The 18-week objective response rate (ORR) of GB221 combined with docetaxel and trastuzumab combined with docetaxel was compared.

Start Date09 May 2018

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

100 Clinical Results associated with Trastuzumab biosimilar(Genor Biopharma Co., Ltd.)

100 Translational Medicine associated with Trastuzumab biosimilar(Genor Biopharma Co., Ltd.)

100 Patents (Medical) associated with Trastuzumab biosimilar(Genor Biopharma Co., Ltd.)

Literatures (Medical) associated with Trastuzumab biosimilar(Genor Biopharma Co., Ltd.)

01 May 2024·European Journal of Drug Metabolism and Pharmacokinetics

A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin®) in Healthy Chinese Adults

Article

Author: Song, Haifeng ; Wang, Xuan ; Zhu, Yu ; Fang, Yi ; Li, Xianbo ; He, Jin ; Xiao, Shuangshuang ; Liang, Xintong ; Hu, Zhiqin ; Zhan, Yaoxuan ; Wang, Xiaole ; Wang, Tenghua ; Ou, Lun ; Tian, Jingyuan ; Liu, Haiyan ; Li, Chen ; Chen, Liming ; Zheng, Qingshan ; Li, Tong ; Li, Yongmei

BACKGROUND AND OBJECTIVEGB221 is a recombinant humanized anti-HER2 monoclonal antibody. The purpose of this study was to evaluate the pharmacokinetic, safety, and immunogenicity of GB221 in healthy Chinese adults in comparison to trastuzumab (Herceptin^®).METHODSIn this randomized, double-blind, parallel-group phase I clinical trial, 88 subjects were randomized 1:1 to receive a single intravenous infusion (90-100 min) of GB221 or trastuzumab (6 mg/kg). The primary pharmacokinetic parameters-maximum observed serum concentration (C_max), area under the serum concentration-time curve from zero to the last quantifiable concentration at time t (AUC_0-t), and area under the serum concentration-time curve from time zero to infinity (AUC_0-∞)-of GB221 and trastuzumab were compared to establish whether the 90% confidence interval (CI) attained the 80-125% bioequivalence standard. Safety and immunogenicity were also evaluated.RESULTSThe GB221 group (n = 43) and the trastuzumab group (n = 44) showed similar pharmacokinetic characteristics. The geometric mean ratios (90% CI) of C_max, AUC_0-t, and AUC_0-∞ between the two groups were 107.53% (102.25-113.07%), 108.31% (103.57-113.26%), and 108.34% (103.57-113.33%), respectively. The incidence of treatment-emergent adverse events (TEAEs) was 83.7% (36/43) of the subjects in the GB221 group and 95.5% (42/44) of the subjects in the trastuzumab group. No subjects withdrew from the trial due to TEAEs, and there were no occurrences of serious adverse events. All subjects tested negative for antidrug antibodies (ADA).CONCLUSIONGB221 demonstrated similar pharmacokinetics to trastuzumab and comparable safety and immunogenicity in healthy Chinese adults.

100 Deals associated with Trastuzumab biosimilar(Genor Biopharma Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic breast cancer	Phase 3	CN	Genor Biopharma Co., Ltd.	27 Jun 2022
Breast cancer recurrent	Phase 2	CN	Genor Biopharma Co., Ltd.	13 Nov 2019
Advanced HER2-Positive Breast Carcinoma	Phase 2	CN	Genor Biopharma Co., Ltd.	24 Nov 2016

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