Delving into the Latest Updates on Chengdu Hongji Biotechnologies Co., Ltd. with Synapse

Overview

Tags

Eye Diseases

Congenital Disorders

Immune System Diseases

AAV based gene therapy

Biological products

Monoclonal antibody

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

Endocrinology and Metabolic Disease	1
Immune System Diseases	1

Top 5 Drug Type	Count

AAV based gene therapy	3
Monoclonal antibody	1
Biological products	1

Top 5 Target	Count

VEGF(Vascular endothelial growth factor)	2
GLP-1R(Glucagon-like peptide 1 receptor)	1
TNF-α(Tumor necrosis factor α)	1

VAN-2201 is Phase I clinical trial to assess the safety and tolerability of KH631 in subjects with neovascular AMD. KH631 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-VEGF treaments, which have demonstrated improvement in vision and reduction in fluid. A one time placement of a product which inhibits VEGF has the potential to reduce the patient burden of regular intraocular injections.

Start Date16 Oct 2023

Sponsor / Collaborator

Chengdu Hongji Biotechnologies Co., Ltd.

CTR20223382 / RecruitingPhase 1/2

KH631眼用注射液在新生血管性（湿性）年龄相关性黄斑变性（nAMD）患者中的耐受性、安全性和疗效探索性I/II期临床试验。

[Translation] An exploratory phase I/II clinical trial of the tolerability, safety, and efficacy of KH631 ophthalmic injection in patients with neovascular (wet) age-related macular degeneration (nAMD).

1期主要评估视网膜下注射不同剂量KH631眼用注射液在新生血管性（湿性）年龄相关性黄斑变性（nAMD）患者中的耐受性，初步评估KH631眼用注射液治疗nAMD的疗效，主要在24周评估总体安全性。2期主要根据1期耐受性、安全性和初步疗效评估的结果，选择2期推荐剂量组扩大样本量评估KH631眼用注射液在nAMD患者中的疗效和安全性，主要在52周评估有效性。长期随访期目的为在已接受KH631眼用注射液视网膜下注射的患者中评估KH631眼用注射液的长期安全性和有效性。

[Translation]

Phase 1 mainly evaluates the tolerability of subretinal injection of different doses of KH631 ophthalmic injection in patients with neovascular (wet) age-related macular degeneration (nAMD), preliminarily evaluates the efficacy of KH631 ophthalmic injection in the treatment of nAMD, and mainly evaluates overall safety at 24 weeks. Phase 2 mainly selects the Phase 2 recommended dose group to expand the sample size to evaluate the efficacy and safety of KH631 ophthalmic injection in patients with nAMD based on the results of Phase 1 tolerability, safety and preliminary efficacy evaluation, and mainly evaluates effectiveness at 52 weeks. The purpose of the long-term follow-up period is to evaluate the long-term safety and efficacy of KH631 ophthalmic injection in patients who have received subretinal injection of KH631 ophthalmic injection.

Start Date10 Apr 2023

Sponsor / Collaborator

Chengdu Hongji Biotechnologies Co., Ltd.

NCT05672121 / RecruitingPhase 1/2

A Phase I/II, Open-label, Multiple-cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

KH631 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.

Start Date06 Feb 2023

Sponsor / Collaborator

Chengdu Hongji Biotechnologies Co., Ltd.

100 Clinical Results associated with Chengdu Hongji Biotechnologies Co., Ltd.

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0 Patents (Medical) associated with Chengdu Hongji Biotechnologies Co., Ltd.

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100 Deals associated with Chengdu Hongji Biotechnologies Co., Ltd.

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100 Translational Medicine associated with Chengdu Hongji Biotechnologies Co., Ltd.

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Pipeline

Pipeline Snapshot as of 18 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

2

1

Preclinical

Phase 2 Clinical

2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

KH-631 ( VEGF )	Wet age-related macular degeneration More	Phase 2 Clinical
KH658	Wet age-related macular degeneration More	Phase 2 Clinical
KH-656 ( TNF-α )	Rheumatoid Arthritis More	Preclinical
CN116376921 ( GLP-1R )	Nutritional and Metabolic Diseases More	Discovery
CN117587028 ( VEGF )	Eye Diseases More	Discovery