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NS101 is a first-in-class investigational monoclonal antibody developed by Neuracle Science and Reyon Pharmaceutical for the treatment of neurological diseases characterized by synaptic dysfunction. Its primary mechanism involves binding to and neutralizing FAM19A5 (also known as TAFA5), a brain-specific chemokine that inhibits neurite outgrowth and synaptic connections. By targeting FAM19A5, NS101 acts as a synapse organizer, promoting nerve regeneration and reversing synapse dysfunction. The drug is administered via intravenous infusion and has shown neuroprotective effects in preclinical studies by preventing degeneration and promoting regeneration of neural tissue. Clinical development is focused on sensorineural hearing loss (including sudden sensorineural hearing loss), with additional potential indications in other central nervous system disorders such as Alzheimer's disease, amyotrophic lateral sclerosis (ALS), traumatic spinal cord injury, and optic nerve disease[1][2][5][6][8].
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