LIVZON PHARMA (01513): NS-041 tablet has obtained drug clinical trial approval notice for the new indication of treating depression.

Livzon Pharma (01513) announced that its wholly-owned subsidiary Livzon Pharmaceutical Group Inc. has received the Drug Clinical Trial Approval Notice approved and issued by the National Medical Products Administration regarding NS-041 tablets for the new indication of treating depression (Notice No.: 2025LP03436, 2025LP03437), allowing the clinical trial for the new indication of NS-041 tablets. NS-041 tablet is a novel high-selective KCNQ2/3 agonist, targeted for the treatment of neurological and psychiatric disorders such as epilepsy and depression. It is currently the only approved KCNQ2/3 agonist in China for conducting clinical studies on both epilepsy and depression. On December 27, 2023, NS-041 tablets were approved for conducting clinical trials for the indication of epilepsy, and the indication is currently undergoing Phase II clinical studies. The newly approved clinical trial indication for NS-041 tablets is for the treatment of depression. Studies have shown that KCNQ2/3 channel activators can regulate the excitability of dopamine neurons in the ventral tegmental area of the midbrain, thereby improving related symptoms of depression. In preclinical studies for this indication, NS-041 tablets demonstrated good antidepressant effects in classical acute and chronic depression models in mice; the target selectivity is higher than other investigational drugs targeting the same site, and no potential ocular toxicity risks have been identified. NS-041 tablets were introduced through a licensing agreement signed in 2024 between Livzon Pharmaceutical Group and NewSchizophreniamedicine (Shanghai) Co., Ltd., with Livzon Pharmaceutical Group having exclusive rights for the drug in the Greater China region. As of the date of this announcement, the cumulative R&D investment in NS-041 tablets is approximately RMB 58,539.4 million.