Shanghai, China and Boston, USA - December 22, 2025 - NeuShen Therapeutics announced that its Investigational New Drug (IND) application for NS-041, a Class 1 innovative drug for the treatment of depression, has been approved by the National Medical Products Administration (NMPA). A Phase Ⅱ clinical trial will be initiated. NS-041 is the first KCNQ2/3-targeted drug in China to simultaneously enter Phase II clinical trials for both epilepsy and depression indications, marking a significant breakthrough for NeuShen Therapeutics in the field of CNS disease treatment.
About NS-041
NS-041 is a novel, highly selective KCNQ2/3 agonist with independent intellectual property rights and global rights owned by NeuShen Therapeutics, while Livzon Pharmaceutical holds exclusive rights in Greater China. It modulates the excitability of dopamine neurons in the ventral tegmental area (VTA) of the midbrain, thereby alleviating related depressive symptoms. This target has attracted substantial attention in recent years and has emerged as a cutting-edge direction for new drug research and development in neuropsychiatric disorders. Drugs targeting the same receptor have demonstrated notable advantages in clinical trials for depression, including significant efficacy, rapid onset of action and minimal side effects.
Previously, NeuShen Therapeutics entered into an exclusive licensing agreement with Livzon Pharmaceutical for NS-041 in Greater China. Building on this partnership, the two companies have collaborated closely to advance the development of NS-041, leveraging their respective strengths to expedite its market launch. The Phase Ⅱ clinical trial for the depression indication will be conducted directly based on the completed Phase I trial data for the epilepsy indication, aiming to systematically evaluate the efficacy and safety of NS-041 in patients with depression.
Dr. Shen Huaqiong, Founder and Chief Executive Officer of NeuShen Therapeutics, stated: "We are fully confident in the therapeutic potential of NS-041. The approval of this new depression indication has validated the candidate drug's efficacy potential across multiple neuropsychiatric disorders. We will continue to collaborate closely with the Livzon team to steadily advance the clinical development of NS-041, and look forward to bringing this innovative therapy to patients in need as soon as possible."
Depression is currently the fourth most prevalent disease globally, affecting approximately 330 million people. In China, the patient population exceeds 100 million, with a recurrence rate as high as 75%-90%. The consultation rate stands at only around 10%, and the adequate treatment rate with pharmacotherapy is a mere 0.5%. Currently, mainstream antidepressant drugs primarily target monoaminergic neurotransmitter systems such as serotonin and norepinephrine. However, approximately one-third of patients exhibit poor response to existing treatments, creating an urgent clinical need for safer and more effective antidepressants with novel mechanisms of action.
About NeuShen Therapeutics
NeuShen Therapeutics is a clinical-stage global biopharmaceutical company dedicated to the research and development of innovative therapies for neurological and psychiatric disorders. The company operates R&D centers in both Shanghai and Boston, bringing together an international team of new drug research and development professionals, and receives in-depth guidance from senior experts in academia and industry. NeuShen Therapeutics has established a globally competitive CNS drug pipeline, encompassing multiple programs with best-in-class potential, and its core products have advanced to Phase Ⅱ clinical development.
KylinLab
CNSxplore | Pioneering CNS Drug Discovery--In vitro and in vivo, Beyond limits
Kylin Lab is a preclinical CRO company specializing in central nervous system (CNS) diseases, dedicated to offering one stop solutions for CNS drug discovery. With a portfolio of fully-validated cellular and animal disease models, combined with comprehensive research and analytical capabilities, we empower clients to accelerate the development of innovative therapies and reduce clinical trial risks.
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