Delving into the Latest Updates on Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd) with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

+ [1]

Target

p75NTR

Action

agonists, stimulants

Mechanism

p75NTR agonists(Low affinity neurotrophin receptor p75NTR agonists), Neurons stimulants

Therapeutic Areas

Nervous System DiseasesEye DiseasesOther Diseases

Active Indication

Neurotrophic keratitisGlaucoma, Open-AngleOptic Nerve Injuries

Inactive Indication-

Originator Organization

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

Active Organization

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

Inactive Organization

Dompé Pharmaceutici Spa

License Organization

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

Jiangsu Kanion Pharmaceutical Co., Ltd.

Drug Highest PhasePhase 2

First Approval Date-

RegulationSpecial Review Project (China)

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主要目的：评价在健康受试者中单次、多次局部给予ZX1305滴眼液后的全身系统安全性、耐受性。次要目的：1.评价在健康受试者中单次、多次局部给予ZX1305滴眼液后全身系统的药代动力学特征；2.评价在健康受试者中单次、多次局部给予ZX1305滴眼液后全身系统免疫原性。

[Translation]

Primary objective: To evaluate the systemic safety and tolerability of single and multiple topical administration of ZX1305 eye drops in healthy subjects. Secondary objectives: 1. To evaluate the pharmacokinetic characteristics of the systemic system after single and multiple topical administration of ZX1305 eye drops in healthy subjects; 2. To evaluate the systemic immunogenicity of ZX1305 eye drops in healthy subjects after single and multiple topical administration.

Start Date27 Aug 2024

Sponsor / Collaborator

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

CTR20230387

/ RecruitingPhase 2

重组人神经生长因子（ZX1305）注射液治疗视神经损伤有效性、安全性和免疫原性的Ⅱ 期临床研究

[Translation] Phase II clinical study on the efficacy, safety and immunogenicity of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage

主要研究目的：探索肌肉注射不同剂量的重组人神经生长因子（ZX1305）注射液治疗视神经损伤的有效性，为Ⅲ期临床试验设计提供依据。次要研究目的：探索肌肉注射不同剂量的重组人神经生长因子（ZX1305）注射液治疗视神经损伤的安全性和免疫原性。

[Translation]

The main purpose of the study is to explore the effectiveness of intramuscular injection of different doses of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage, and to provide a basis for the design of Phase III clinical trials. Secondary purpose of the study is to explore the safety and immunogenicity of intramuscular injection of different doses of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage.

Start Date26 Jun 2023

Sponsor / Collaborator

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

CTR20230957

/ RecruitingPhase 2

重组人神经生长因子（ZX1305）注射液治疗开角型青光眼导致的视神经损伤有效性、安全性和免疫原性的II期临床研究

[Translation] Phase II clinical study on the efficacy, safety and immunogenicity of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage caused by open-angle glaucoma

主要研究目的：探索肌肉注射重组人神经生长因子（ZX1305）注射液治疗开角型青光眼导致的视神经损伤的有效性，为后期临床试验设计提供依据。次要研究目的：探索肌肉注射重组人神经生长因子（ZX1305）注射液治疗开角型青光眼导致的视神经损伤的安全性和免疫原性。

[Translation]

The main purpose of the study is to explore the effectiveness of intramuscular injection of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage caused by open-angle glaucoma, and to provide a basis for the design of later clinical trials. Secondary purpose of the study is to explore the safety and immunogenicity of intramuscular injection of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage caused by open-angle glaucoma.

Start Date10 May 2023

Sponsor / Collaborator

Jiangsu Zhongxin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

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100 Translational Medicine associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

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100 Patents (Medical) associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

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5

Literatures (Medical) associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

01 Aug 2021·CorneaQ3 · MEDICINE

Treatment of Dry Eye from Laser-Assisted In Situ Keratomileusis With Recombinant Human Nerve Growth Factor (Cenegermin)

Q3 · MEDICINE

Article

Author: Habibi, Roya N ; Lee, Michele D

Purpose:To describe 2 patients with neurotrophic keratitis after laser-assisted in situ keratomileusis surgery who were treated with recombinant human nerve growth factor (cenegermin) and the treatment course.Methods:Case series.Results:After an 8 week course of cenegermin, there was an improvement in visual acuity, corneal sensitivity, and ocular surface staining. However, these effects were short lived, and the disease regressed at subsequent follow-up visits.Conclusions:Although recombinant human nerve growth factor seems to be effective in short term for neurotrophic keratitis secondary to laser-assisted in situ keratomileusis surgery, alternative dosing for patients with this patient population should be considered to achieve long-lasting resolution.

01 Jun 2021·American Journal of Ophthalmology Case Reports

Neurotrophic keratitis after penetrating keratoplasty for lattice dystrophy

Author: Penatti, Raphael ; Gouvea, Larissa ; Rocha, Karolinne Maia

PURPOSETo report clinical outcomes of a patient with unilateral neurotrophic keratitis following penetrating keratoplasty for lattice dystrophy treated with topical recombinant human nerve growth factor.OBSERVATIONSA 75-year-old male with lattice dystrophy and history of herpes simplex keratitis, presented with recurrent neurotrophic ulceration in the right eye two years following penetrating keratoplasty. The patient was successfully treated with topical recombinant human nerve growth factor.CONCLUSIONNeurotrophic keratitis is a rare chronic disorder that affects quality of life due to the risk of vision loss. Topical recombinant human nerve growth factor is a novel and effective treatment option that may help improve optical quality and patient's satisfaction as shown in this case of recurrent neurotrophic keratitis.

01 Feb 2019·Ophthalmology

Re: Bonini et al.: Phase 2 randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis (Ophthalmology. 2018;125:1332-1343)

Letter

Author: Ting, Darren Shu Jeng

100 Deals associated with Recombinant human nerve growth factor(Jiangsu Zhongxin Medicine Co Ltd)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neurotrophic keratitis	Phase 2	China	Jiangsu Zhongxin Pharmaceutical Co., Ltd.	23 Apr 2025
Glaucoma, Open-Angle	Phase 2	China	Jiangsu Zhongxin Pharmaceutical Co., Ltd.	10 May 2023
Optic Nerve Injuries	Phase 2	China	Jiangsu Zhongxin Pharmaceutical Co., Ltd.	10 May 2023
Glaucoma	Preclinical	United States	Dompé Pharmaceutici Spa	01 Dec 2016

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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