Delving into the Latest Updates on Chongqing Genrix Biopharmaceutical Co., Ltd. with Synapse

Overview

Tags

Infectious Diseases

Immune System Diseases

Skin and Musculoskeletal Diseases

Monoclonal antibody

Bispecific antibody

Bispecific T-cell Engager (BiTE)

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	9
Immune System Diseases	8
Neoplasms	5
Hemic and Lymphatic Diseases	2

Top 5 Drug Type	Count

Monoclonal antibody	10
Bispecific antibody	4
Bispecific T-cell Engager (BiTE)	3
Antibody	1
Nanobody	1

Top 5 Target	Count

IL-1R(Immunoglobulin-like family of IL-1 receptors)	2
IL-17A(Interleukin 17A)	1
CD3 x MAGEA4	1
Tetanus toxin	1
RSV F protein(Respiratory syncytial virus F protein)	1

主要目的：评价GR2001注射液在疑似破伤风暴露者中的有效性。次要目的：比较GR2001注射液与HTIG在疑似破伤风暴露者中的临床结局；比较GR2001注射液与HTIG的安全性；评价GR2001注射液在疑似破伤风暴露者中的药代动力学（PK）特征；评价GR2001注射液在疑似破伤风暴露者中的免疫原性。

[Translation]

Primary objective: To evaluate the effectiveness of GR2001 injection in patients with suspected tetanus exposure. Secondary objectives: To compare the clinical outcomes of GR2001 injection and HTIG in patients with suspected tetanus exposure; To compare the safety of GR2001 injection and HTIG; To evaluate the pharmacokinetic (PK) characteristics of GR2001 injection in patients with suspected tetanus exposure; To evaluate the immunogenicity of GR2001 injection in patients with suspected tetanus exposure.

Start Date03 Sep 2024

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

NCT06635798 / RecruitingPhase 3

A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin(HTIG) Controlled Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus

The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.

Start Date03 Sep 2024

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

NCT06566547 / RecruitingPhase 2

Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Start Date26 Aug 2024

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

100 Clinical Results associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

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4

Literatures (Medical) associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

10 Sep 2024·Journal of clinical pharmacology

Population Pharmacokinetics of Xeligekimab: An Anti-IL-17A Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis.

Article

Author: Shi, Haiyang ; Meng, Qingheng ; Zhang, Lingxiao ; Liu, Hongxia ; Wang, Wei ; Zheng, Qingshan ; Xu, Ling

Xeligekimab, a recombinant fully human IgG4 monoclonal antibody, has been strategically developed to target IL-17A and is presently in the developmental phase for treating moderate to severe plaque psoriasis. This study aims to investigate the pharmacokinetic profile of Xeligekimab, utilizing data derived from clinical trials specifically conducted in Chinese patients. The study conducted a population pharmacokinetic (PopPK) analysis involving 614 patients with plaque psoriasis. Examined covariates encompassed demographics, baseline laboratory tests, anti-drug antibodies (ADA), injection site, and disease-related baseline characteristics. Model evaluation utilized goodness-of-fit, prediction-corrected visual prediction check, and bootstrap methods. The clinical significance of covariates statistically associated with Xeligekimab was assessed through simulation analysis. The PopPK model of Xeligekimab demonstrated characteristics of a two-compartment model with first-order absorption and linear elimination. Inter-individual variability (IIV) was estimated for clearance and volume of distribution. For a typical plaque psoriasis patient, the estimated values for absorption rate constant (Ka), apparent clearance (CL/F), central compartment volume (V_c/F), peripheral compartment volume (V_p/F), and inter-compartmental clearance (Q/F) was 0.225 per day, 2.223 L/day, 4.02 L, 4.13 L, and 1.11 L/day, respectively. The estimated IIV for CL/F and V_c/F was 25.8% and 49.8%, respectively. The elimination half-life (t_1/2) was approximately 28.5 days. CL/F was significantly influenced by factors such as body weight, age, gender, and baseline total protein. V_c/F was significantly influenced by body weight, age, gender, and baseline albumin. However, the clinical relevance of these covariate effects on exposure parameters was determined to be limited.

01 Aug 2023·Journal of Medical Virology

Development of a novel bispecific antibody GR1801 for rabies

Article

Author: Wang, Lan ; Hao, Xiaobo ; Sun, Sheng ; Liu, Zhigang ; Long, Caifeng ; Bian, Lin ; Yu, Chuanfei ; Feng, Ye ; Wang, Wenbo ; Tu, Changchun

AbstractRabies is a zoonotic viral disease characterized by an almost 100% fatality rate once symptoms appear. However, it can be prevented through timely postexposure prophylaxis (PEP). Currently, there is a growing trend to replace polyclonal rabies immune globulin (RIG) with monoclonal antibodies (mAbs) in rabies PEP. In this study, we developed a human bispecific antibody, GR1801, by combining two mAbs, A2 and B353, which target distinct epitopes. GR1801 is an asymmetric immunoglobulin G1 molecule, with one arm (A2 targeting epitope III) in fragment antigen‐binding (Fab) form and the other arm (B353 targeting epitope I) in single‐chain variable fragment (scFv) form, constructed using Knobs‐into‐Holes technology. GR1801 demonstrated the ability to neutralize 90 naturally occurring rabies virus (RABV) glycoprotein antigenic variants, 21 pseudotyped, and 18 live street RABVs, exhibiting broad‐spectrum neutralizing activity. In vivo, GR1801 provided protection equivalent to that of human RIG in golden hamsters challenged with lethal RABV. In conclusion, these findings demonstrate the neutralization potency and breadth of GR1801, which can be a promising candidate drug for rabies PEP, and a comprehensive testing against a broad spectrum of Chinese prevalent RABVs will be investigated in great detail in the future for the in vitro and in vivo studies.

02 Dec 2021·XenobioticaQ4 · MEDICINE

Evaluation of MTBH, a novel hesperetin derivative, on the activity of hepatic cytochrome P450 isoform in vitro and in vivo using a cocktail method by HPLC-MS/MS

Q4 · MEDICINE

Article

Author: Shen, Chenlin ; Huang, Xiaohui ; Fan, Yuru ; Zhang, Tianci ; Wang, Jie ; Song, Shuai ; Chen, Guanjun ; Zhang, Yilong ; Qin, Yan ; Li, Jun ; Dong, Haijun ; Wang, Sheng ; Sun, Jiayin ; Wang, Wei

1. 8-methylene-tert-butylamine-3',5,7-trihydroxy-4'-methoxyflavanone (MTBH), a novel hesperidin derivative, has potential in the prevention of hepatic disease, however, its effects on cytochrome P450 isoforms (CYP450s) remains unexplored. The purpose was to investigate the effects of MTBH on the mRNA, protein levels, and activities of six CYP450s (1A2, 2C11/9, 2D2/6, 3A1/4, 2C13/19, and 2E1) in vitro and in vivo.2. In vitro study, rat and human liver microsomes were adopted to elucidate the inhibitory effect of MTBH on six CYP450s using probe drugs. In vivo study, Sprague-Dawley male rats were treated with MTBH (25, 50, or 100 mg/kg for 28 consecutive days), phenobarbital (80 mg/kg for 12 consecutive days), or 0.5% CMC-Na solution (control group) by intragastric administration, then, the mRNA, protein levels and activities of liver CYP450s were analysed by real-time PCR, western blotting and probe-drug incubation systems, respectively.3. The in vitro study indicated that MTBH inhibits the activities of CYP3A1/4 and CYP2E1 in rat and human liver microsomes. In vivo data showed that MTBH inhibits mRNA, protein levels, and activities of CYP3A1 and CYP2E1 in medium- and high-dose MTBH groups.4. MTBH has the potential to cause drug-drug interactions when co-administered with drugs that are metabolised by CYP3A1/4 and CYP2E1.

100 Deals associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

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100 Translational Medicine associated with Chongqing Genrix Biopharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 05 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

3

7

Preclinical

Phase 1 Clinical

3

2

Phase 2 Clinical

Phase 3 Clinical

3

1

Approved

Other

4

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Xeligekimab ( IL-17A )	Plaque psoriasis More	Approved
Vecantoxatag ( Tetanus toxin )	Tetanus More	Phase 3
Silevimig ( RABV-G )	Rabies More	Phase 3
Telikibart ( IL-4Rα )	Dermatitis, Atopic More	Phase 3
GR-1603 ( IFNAR-1 )	Systemic Lupus Erythematosus More	Phase 2