Lizhu Pharmaceuticals (01513): Notice of approval for clinical trials of new drugs for NS-041 tablets to treat depression

Zhitong Finance App News, Lizhu Pharmaceutical (01513) announced that the company's wholly-owned subsidiary Lizhu Pharmaceutical Factory (Lizhu Pharmaceutical Factory) has received the “Drug Clinical Trial Approval Notice” (Notice No.: 2025LP03436, 2025LP03437) for the treatment of depression with the approval and issuance of the China Drug Administration, and agreed to conduct clinical trials for the new indications of NS-041 tablets. NS-041

NS-041 tablets are a novel highly selective KCNQ2/3 agonist. It is aimed at treating neuropsychiatric diseases such as epilepsy and depression. It is currently the only KCNQ2/3 agonist approved in China to simultaneously conduct clinical research on epilepsy and depression. On December 27, 2023, NS-041 tablets were approved for clinical trials of an indication for epilepsy. Currently, this indication is undergoing phase II clinical research.

The newly approved clinical trial indication for NS-041 tablets is 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 depressive symptoms. In preclinical studies of this indication, NS-041 tablets showed good antidepressant effects in classic models of acute and chronic depression in mice; target selectivity was higher than that of drugs under development with the same target, and no potential risk of eye toxicity was found.

NS-041 tablets were introduced by Lizhu Pharmaceutical Co., Ltd. and New Ocean Pharmaceuticals (Shanghai) Co., Ltd. signed a license agreement in 2024. Livingzhu Pharmaceuticals exclusively enjoys all rights of the drug in Greater China. As of the date of this announcement, the total direct investment in R&D expenses for the NS-041 film is approximately RMB 58.5394 million.