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Yichang Renfu Pharmaceutical’s Brilintec tablets have been approved for clinical trials.
Release time:
2024-07-23 10:44
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Recently, Yichang Humanwell Pharmaceutical received the “Notice of Approval for Clinical Trials” for Bricanizumab Tablets issued by the National Medical Products Administration, granting approval to conduct clinical trials for this product. The intended indication is: the treatment of partial-onset seizures in patients aged 1 month and older. Currently, no other companies in China have yet been approved to market this product.
Epilepsy is a chronic, long-term brain disorder characterized by a syndrome of brain dysfunction caused by sudden, abnormal, and excessive electrical discharges from brain cells due to underlying brain lesions. Brivaracetam is a structural analog of levetiracetam that binds to synaptic vesicle protein 2A (SV2A) in the human central nervous system. By modulating synaptic function, it inhibits voltage-gated Na+ channels and the release of excitatory neurotransmitters, thereby reducing both the duration and frequency of epileptic seizures and exerting an antiepileptic effect. Brivaracetam has demonstrated potent preventive and control activity against seizures in various epilepsy models, showing good efficacy for both partial and generalized seizures. Moreover, it may exert dual effects—cognitive enhancement and antiepileptic action—on epilepsy patients with cognitive impairments, thus effectively minimizing the physical harm caused by the disease.
After receiving the approval notice, the company will promptly complete the clinical studies of the drug and submit a marketing authorization application to the National Medical Products Administration, thereby meeting the clinical medication needs of domestic patients at an early date.
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