Drug intelligence / Profile preview

GenSci098

Development stage
Phase 2
Lead developer
Changchun GeneScience Pharmaceutical
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

GenSci098 is a humanized anti-TSHR (thyroid stimulating hormone receptor) antagonistic monoclonal antibody developed for the treatment of Thyroid Eye Disease (TED), also known as Graves' ophthalmopathy. TED is an autoimmune orbital inflammatory disease associated with thyroid dysfunction, particularly Graves' disease, and can lead to significant morbidity including vision impairment. GenSci098 acts by inhibiting TSHR, thereby blocking the pathological activation of orbital fibroblasts that drive inflammation and tissue remodeling in TED. Preclinical studies have demonstrated that GenSci098 binds strongly to TSHR and effectively blocks its activity, reducing pro-inflammatory cytokine production and thyroid hormone secretion without inducing hypothyroidism in animal models. The drug is currently in Phase 1 clinical trials for TED. It was developed by Changchun GeneScience Pharmaceutical Co., Ltd., which has received regulatory approval to commence clinical trials both from the US FDA and China's NMPA[1][2][3][4][5].

Other names
GenSci098 InjectionGenSci-098 InjectionGenSci 098 Injection
02

Targets

TSHR (Thyroid-stimulating hormone receptor)

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