NeuShen Therapeutics Granted NMPA-CDE IND Approval for Highly Selective KCNQ2/3 Activator

Shanghai, China, and Lexington, MA., - March 11, 2024 - 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 Investigational New Drug (IND) application for its pipeline product NS-041 has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

KCNQ2/3 has emerged as a target with potential in treating epilepsy and MDD based on encouraging recent clinical trial data. Its unique mechanism of action is expected to fill the gaps of existing treatments, indicating its significant clinical and commercial value. A proprietary highly selective KCNQ2/3 activator, NS-041 exhibited good efficacy and safety profiles from preclinical studies, indicating its potential as a best-in-class KCNQ2/3 activator to treat multiple CNS disorders. 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 IND approval for NS-041 marks the Company's rapid growth into a clinical-stage biotechnology company two years after its establishment, attesting to the Company’s rich experiences and strong capabilities in CNS field. The Company will continue to incubate projects with significant clinical value and adhere to the strategy of developing globally leading assets with best-in-class potentials, leveraging its R&D platforms in both China and the United States.

“We are excited and encouraged by the IND approval for NS-041. It is a major breakthrough that recognizes our R&D capabilities,” said Dr. Joan Shen, founder and CEO of NeuShen Therapeutics. “We have full confidence in carrying out the global clinical development plan for NS-041. We hope to fulfill our promises to patients and supporters soon.”

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 and best-in-class potentials and plans to enter its programs successively into clinical development in the near future.