Delving into the Latest Updates on Grand Theravac Life Science Nanjing Co. Ltd. with Synapse

Overview

Basic Info

Introduction

Founded in 2015 and joining the China Grand Enterprise Group in 2016, Grand Theravac Life Science (Nanjing) Co., Ltd. operates as the vaccine R&D center within the China Grand Pharma Life Science Group. The company is committed to the development of therapeutic vaccines, novel and improved vaccines, and new adjuvant systems, utilizing its core technology platforms in recombinant vaccines based on E. coli and yeast, scale-up fermentation, protein vaccine purification processes, VLP quality assessment, and immunological evaluation.

Tags

Infectious Diseases

Digestive System Disorders

Prophylactic vaccine

Therapeutic vaccine

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	3

Top 5 Drug Type	Count

Prophylactic vaccine	2
Therapeutic vaccine	1

Top 5 Target	Count

HBcrAg x L-HBsAg	1

To evaluate the safety and tolerability of recombinant hepatitis B vaccine with different CpG-QCX1 adjuvant ratios in people aged 18 years and above, administered in three doses at 0, 1, and 6 months. To explore the immunogenicity of recombinant hepatitis B vaccine with different CpG-QCX1 adjuvant ratios in people aged 18 years and above, administered in three doses at 0, 1, and 6 months.

Start Date27 Oct 2023

Sponsor / Collaborator

Grand Theravac Life Science Nanjing Co. Ltd.

CTR20231429 / RecruitingPhase 2

在经治慢性乙型肝炎患者中评估 TVAX-008 注射液治疗有效性和安全性的多中心、随机、双盲、安慰剂平行对照II 期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of TVAX-008 injection in patients with previously treated chronic hepatitis B

主要目的：评价 TVAX-008 注射液治疗核苷（酸）类似物（NAs）经治的慢性乙型肝炎患者的有效性。次要目的：评价 TVAX-008 注射液治疗核苷（酸）类似物（NAs）经治的慢性乙型肝炎患者的安全性。

[Translation]

Primary objective: To evaluate the efficacy of TVAX-008 injection in the treatment of chronic hepatitis B patients who have been treated with nucleoside (acid) analogs (NAs). Secondary objective: To evaluate the safety of TVAX-008 injection in the treatment of chronic hepatitis B patients who have been treated with nucleoside (acid) analogs (NAs).

Start Date30 May 2023

Sponsor / Collaborator

Grand Theravac Life Science Nanjing Co. Ltd.

CTR20230989 / RecruitingPhase 1

单中心、随机、盲法、阳性对照设计评价重组乙型肝炎疫苗（TVAX-009B）以0、1、6月程序接种在16岁及以上人群的安全性和免疫原性的I期临床试验

[Translation] A single-center, randomized, blinded, positive-controlled phase I clinical trial to evaluate the safety and immunogenicity of a recombinant hepatitis B vaccine (TVAX-009B) administered at 0, 1, and 6 months in people aged 16 years and older

与同类疫苗比较评价重组乙型肝炎疫苗（汉逊酵母）在16岁及以上人群接种的安全性，并探索免疫原性。

[Translation]

To evaluate the safety of recombinant hepatitis B vaccine (Hansen yeast) in people aged 16 years and above by comparing with similar vaccines, and to explore the immunogenicity.

Start Date29 May 2023

Sponsor / Collaborator

Grand Theravac Life Science Nanjing Co. Ltd.

100 Clinical Results associated with Grand Theravac Life Science Nanjing Co. Ltd.

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0 Patents (Medical) associated with Grand Theravac Life Science Nanjing Co. Ltd.

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2

Literatures (Medical) associated with Grand Theravac Life Science Nanjing Co. Ltd.

02 Nov 2021·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Epidemiology and evolution of Norovirus in China

Q3 · MEDICINE

Review

Author: Li, Jianqiang ; Bao, Mengru ; Tan, Changyao ; Ge, Jun ; Wang, Shiwei ; Wei, Na ; Song, Yunlong

Norovirus (NoV) has been recognized as a leading cause of gastroenteritis worldwide. This review estimates the prevalence and genotype distribution of NoV in China to provide a sound reference for vaccine development. Studies were searched up to October 2020 from CNKI database and inclusion criteria were study duration of at least one calendar year and population size of >100. The mean overall NoV prevalence in individuals with sporadic diarrhea/gastroenteritis was 16.68% (20796/124649, 95% CI 16.63-16.72), and the detection rate of NoV was the highest among children. Non-GII.4 strains have replaced GII.4 as the predominant caused multiple outbreaks since 2014. Especially the recombinant GII.P16-GII.2 increased sharply, and virologic data show that the polymerase GII.P16 rather than VP1 triggers pandemic. Due to genetic diversity and rapid evolution, predominant genotypes might change unexpectedly, which has become major obstacle for the development of effective NoV vaccines.

Journal of Veterinary Science

Expression of FMD virus-like particles in yeast Hansenula polymorpha and immunogenicity of combine with CpG and aluminum adjuvant

Article

Author: Zhang, Jianhui ; Ge, Jun ; Shi, Yinghui ; Zhang, Yong ; Sun, Jiaojiao ; Li, Juyin ; Wang, Qiongjin ; Li, Jianqiang ; Zhang, Xiaobo ; Zhao, Xingxu

BACKGROUNDInactivated vaccines are limited in preventing foot-and-mouth disease (FMD) due to safety problems. Recombinant virus-like particles (VLPs) are an excellent candidate for a novel vaccine for preventing FMD, given that VLPs have similar immunogenicity as natural viruses and are replication- and infection-incompetent.OBJECTIVESThe 3C protease and P1 polyprotein of type O FMD virus (FDMV) was expressed in yeast Hansenula polymorpha to generate self-resembling VLPs, and the potential of recombinant VLPs as an FMD vaccine was evaluated.METHODSBALB/c mice were immunized with recombinant purified VLPs using CpG oligodeoxynucleotide and aluminum hydroxide gel as an adjuvant. Cytokines and lymphocytes from serum and spleen were analyzed by enzyme-linked immunosorbent assay, enzyme-linked immunospot assay, and flow cytometry.RESULTSThe VLPs of FMD were purified successfully from yeast protein with a diameter of approximately 25 nm. The immunization of mice showed that animals produced high levels of FMDV antibodies and a higher level of antibodies for a longer time. In addition, higher levels of interferon-γ and CD4⁺ T cells were observed in mice immunized with VLPs.CONCLUSIONSThe expression of VLPs of FMD in H. polymorpha provides a novel strategy for the generation of the FMDV vaccine.

100 Deals associated with Grand Theravac Life Science Nanjing Co. Ltd.

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100 Translational Medicine associated with Grand Theravac Life Science Nanjing Co. Ltd.

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Pipeline

Pipeline Snapshot as of 20 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

IND Approval

5

2

Phase 1 Clinical

Phase 2 Clinical

1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

TVAX-008 ( HBcrAg x L-HBsAg )	Hepatitis B, Chronic More	Phase 2
Tetravalent Recombinant Norovirus vaccine(Hansenula Polymorpha)(Grand Theravac Life Science)	Norovirus Infections More	Phase 1
Recombinant Hepatitis B Vaccine(Hansenula polymorpha)(Grand Theravac)	Hepatitis B More	Phase 1
Recombinant Hepatitis B Vaccine (Hansenula polymorpha,CpG and Aluminum Adjuvant)(Grand Theravac Life Science (Nanjing))	Hepatitis B More	IND Approval
Hexavalent Recombinant Norovirus vaccine(Hansenula Polymorpha)(Grand Theravac Life Science)	Norovirus Infections More	IND Approval