[Translation] A randomized, double-blind, single-dose, parallel comparison of QX003S injection and tocilizumab injection in healthy Chinese male volunteers

主要研究目的：比较QX003S注射液和托珠单抗注射液在中国健康男性志愿者单次皮下给药的药代动力学（PK）相似性。次要研究目的：评价QX003S注射液和托珠单抗注射液在中国健康男性志愿者单次皮下给药的安全性、耐受性和免疫原性。

[Translation]

The primary study objective is to compare the pharmacokinetic (PK) similarity of QX003S injection and tocilizumab injection in healthy Chinese male volunteers after a single subcutaneous administration. The secondary study objective is to evaluate the safety, tolerability and immunogenicity of QX003S injection and tocilizumab injection in healthy Chinese male volunteers after a single subcutaneous administration.

Start Date14 Mar 2019

Sponsor / Collaborator

Qyuns Therapeutics Co., Ltd.Startup

100 Clinical Results associated with Tocilizumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd)

100 Translational Medicine associated with Tocilizumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd)

100 Patents (Medical) associated with Tocilizumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd)

Literatures (Medical) associated with Tocilizumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd)

01 Jan 2021·Annals of MedicineQ3 · MEDICINE

A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra ^® ) in Chinese healthy subjects

Q3 · MEDICINE

Article

Author: Zhang, Hong ; Ding, Yanhua ; Fang, Min ; Liu, Jingrui ; Wu, Min ; Li, Cuiyun ; Zhu, Xiaoxue ; Li, Xiaojiao ; Sun, Jixuan

PURPOSEQX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects.DESIGNA randomised, double-blind, two-arm, parallel study was performed to examine the bioequivalence of QX003S (8 mg/kg) with that of Actemra® as a reference drug.RESULTSQX003S (N = 40) and Actemra® (N = 40) groups exhibited similar PK properties. The inter-subject variability ranged from 14.95% to 18.78%. The 90% confidence intervals of the ratios for C_max, AUC_0-t andAUC_0-∞ in both groups were within the range of 80-125%. After administration, the number of subjects who tested positive for anti-drug antibodies (ADA) in the QX003S group and Actemra® groups was 6 (14.3%) and 14 (34.1%), respectively. Adverse reactions occurred in 100% and 97.6% subjects in the QX003S and Actemra® groups, respectively. The most common adverse reactions were decrease in fibrinogen level and neutrophil and leukocyte counts.CONCLUSIONThe PK characteristics and immunogenicity exhibited by QX003S were similar to that of the reference product, Actemra®. The safety profile was similar in the two treatment groups with mild-moderate adverse effects.Trial RegistrationThe trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html#CTR20190002)Key pointsThis was the first clinical report of a new proposed tocilizumab biosimilar, QX003S.This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@).The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles.

100 Deals associated with Tocilizumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd)

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	CN	Qyuns Therapeutics Co., Ltd.Startup	-

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