Overview
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Research Report
STSP-0902: A Comprehensive Analysis of a Novel Fc-Fusion rhNGF Therapy in Ophthalmology and Male Infertility
Executive Summary
STSP-0902 is a novel, investigational biologic drug developed by Staidson (Beijing) Biopharmaceuticals Co., Ltd. It is engineered as a recombinant human nerve growth factor (rhNGF) Fc fusion protein, a molecular architecture designed to confer significant pharmacokinetic and tolerability advantages over first-generation neurotrophic therapies. The drug is being advanced through a unique dual-indication development strategy, targeting two distinct therapeutic areas with high unmet medical needs: neurotrophic keratitis (NK) in ophthalmology and asthenozoospermia/oligoasthenozoospermia in male infertility.
The mechanism of action for STSP-0902 is centered on its function as a potent agonist of the Tropomyosin receptor kinase A (TrkA). By activating this pathway, STSP-0902 mimics the action of endogenous nerve growth factor (NGF), promoting neuronal survival, differentiation, and regeneration. In neurotrophic keratitis, a degenerative corneal disease caused by impaired nerve function, STSP-0902 aims to restore corneal innervation, promote the healing of epithelial defects, and maintain ocular surface integrity. For male infertility, preclinical evidence indicates that TrkA activation by STSP-0902 stimulates the proliferation of germline and testicular support cells, suggesting a potential to directly improve spermatogenesis, sperm count, and motility.
Clinical Trials
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FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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