Shanghai, China, and Lexington, MA., - December 27, 2023 - NeuShen Therapeutics (the “Company”), a global biotechnology company dedicated to developing innovative treatments for neurological and psychiatric disorders with a dual-platform strategy consisting of small molecule discovery and AAV-based gene therapy, announced today that the first Investigational New Drug (IND) application for its pipeline product NS-041 has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). NS-041, a proprietary highly selective KCNQ2/3 activator, will be developed for the treatment of epilepsy, major depressive disorder (MDD), etc.

NS-041 selectively activates the KCNQ2/3 potassium ion channels, regulating M currents to hyperpolarize neurons, suppress neuronal excitability and repetitive action potential firing, and adjust neurons to enable normal firing. Preclinical studies demonstrate that NS-041 exhibits significant antiepileptic and antidepressant effects in multiple animal models. Furthermore, the differentiated profile of NS-041 in efficacy and safety from preclinical studies indicates its potential as a best-in-class KCNQ2/3 activator to treat multiple CNS disorders.

Recently, Xenon Pharmaceuticals revealed encouraging Phase II data from its KCNQ2/3-targeted small molecule for the treatment of MDD.1 With its good preclinical profile, it is believed that NS-041 has the potential in treating multiple CNS disorders such as seizure disorders, MDD, etc. Its unique mechanism of action is expected to fill the gaps of existing treatments, indicating its significant clinical and commercial value.

The Company has established detailed clinical development strategies for NS-041, including plans to collect preliminary safety and pharmacokinetic data from both Caucasian and Asian populations during Phase I clinical trial to support global development in the future.

The acceptance of NS-041's IND application is a major milestone that marks the Company's swift progression into the clinical stage within just two years since its inception. It is a validation of the Company’s ability in CNS innovative drug development. As NS-041 enters clinical development, the Company is continuing its efforts to advance other programs in the pipeline from its R&D platforms in both China and the US, including an M4 positive allosteric modulator about to enter clinical stage, a target that has attracted much attention in the industry recently.

"I am extremely proud of the rapid progress in our pipeline. Our team's great efforts over the past year to advance the NS-041 project have reflected our rich experiences in CNS innovative drug development and excellent executions under challenging circumstances," said Dr. Joan Shen, founder and CEO of NeuShen Therapeutics. "Given the therapeutic potential of NS-041 in multiple CNS disorders and our strength in CNS clinical development, we anticipate the initiation of global development in the near future. We look forward to bringing a novel treatment to our patients and offering returns to our supporters."

About NeuShen Therapeutics

NeuShen Therapeutics is a global biotechnology company focused on innovative drug research and development to address neurological and psychiatric disorders, using a dual-platform strategy consisting of small molecule discovery and AAV-based gene therapy. With operations in Shanghai, China and Lexington, MA., NeuShen boasts a world-class R&D team in CNS field and is honored to be advised by an outstanding board of directors and scientific advisory board. The company has established a rich CNS pipeline with industry-leading or best-in-class potentials and plans to enter its programs successively into clinical development in the near future.

1. https://investor.xenon-pharma.com/news-releases/news-release-details/xenon-pharmaceuticals-announces-topline-results-phase-2-proof