LIVZON PHARMA (01513) announced that its wholly-owned subsidiary, Livzon Pharmaceutical Factory, has received the Drug Clinical Trial Approval Notice (Notice No.: 2025LP03436, 2025LP03437) from the National Medical Products Administration (NMPA) for the additional indication of depression treatment for NS-041 tablets. The approval permits clinical trials for this new indication.

NS-041 tablets are a novel, highly selective KCNQ2/3 agonist intended for the treatment of neuropsychiatric disorders such as epilepsy and depression. It is currently the only KCNQ2/3 agonist in China approved for clinical studies targeting both epilepsy and depression.

On December 27, 2023, NS-041 tablets were approved for clinical trials for epilepsy, and this indication is currently undergoing Phase II clinical studies. The newly approved clinical trial indication for NS-041 tablets is for depression treatment. Research indicates that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area of the midbrain, thereby improving related depressive symptoms.

In preclinical studies for this indication, NS-041 tablets demonstrated significant antidepressant effects in both classic acute and chronic depression models in mice. The drug exhibits higher target selectivity compared to other investigational drugs with the same target and shows no potential ocular toxicity risks.

NS-041 tablets were introduced through a licensing agreement signed between Livzon Pharmaceutical Factory and Nuoshen Pharma (Shanghai) Co., Ltd. in 2024. Livzon Pharmaceutical Factory holds exclusive rights to the drug in Greater China.

As of the date of this announcement, the cumulative direct R&D investment for NS-041 tablets amounts to approximately RMB 58.5394 million.