Shanghai, China and Boston, MA., – November 19, 2025 – NeuShen Therapeutics (“NeuShen” or the “Company”), a clinical-stage global biotechnology company focused on developing innovative therapies for neurological and psychiatric disorders, today announced that the first patient has been dosed in a Phase 2 clinical trial of NS-136, a selective M4 muscarinic acetylcholine receptor positive allosteric modulator (M4 PAM) for the treatment of schizophrenia. This milestone represents significant progress for a lead company asset, and marks the beginning of efficacy validation of NS-136, an investigational drug with the potential to become a novel treatment for schizophrenia patients.

Positive allosteric modulation targeting the M4 receptor represents a novel approach for the treatment of a broad range of psychiatric disorders, including schizophrenia and psychosis or agitation associated with Alzheimer’s disease. In a Phase 1 clinical trial completed earlier in China and Australia, NS-136 demonstrated a favorable safety and pharmacokinetic profile in both adult and elderly healthy volunteers. Based on the positive data from preclinical and Phase 1 studies, the Company initiated a Phase 2 clinical trial to further assess the efficacy and safety of NS-136 in patients with schizophrenia.

The Phase 2 clinical trial of NS-136 is led by Dr. Gang Wang, MD, PhD, President of Beijing Anding Hospital, Capital Medical University, and a leading expert in psychiatric disorders in China. Adopting a randomized, double-blind, placebo-controlled, multi-center design, the study will not only support the advancement of NS-136 into pivotal Phase 3 trials but also form the basis for evaluating NS-136 in psychosis or agitation associated with Alzheimer’s disease, as well as additional expanded indications.

“We have advanced NS-136 from concept to Phase 2 stage in less than three years, a testament to NeuShen’s strengths across target discovery, compound optimization, preclinical validation, and clinical execution,” Dr. Joan Huaqiong Shen, founder and CEO of the Company, commented. “I am highly confident in NS-136’s potential to address multiple psychiatric disorders, including schizophrenia, psychosis or agitation associated with Alzheimer’s disease, and other related indications. We remain focused on accelerating its clinical development, and strive to bring this novel therapeutic option to schizophrenia patients as quickly as possible.”

“NeuShen’s NS-136 is the first domestically developed M4 PAM with global competitiveness. Its preclinical and Phase 1 data demonstrated a strong safety profile and promising therapeutic potential,” Dr. Gang Wang, MD, PhD, the study’s principal investigator, commented. “We are pleased to begin this Phase 2 study in close collaboration with NeuShen. We hope to validate NS-136’s clinical efficacy in this trial and ultimately offer a new treatment option to patients suffering from schizophrenia.”

About NS-136

NS-136 is a novel selective muscarinic acetylcholine M4 receptor positive allosteric modulator (M4 PAM) developed through NeuShen Therapeutics’ proprietary small-molecule drug development platform. It is intended for the treatment of schizophrenia and psychosis or agitation associated with Alzheimer’s disease, among other psychiatric disorders. 

Positive allosteric modulation targeting the M4 receptor is a novel mechanism of action that can effectively treat positive symptoms of schizophrenia while avoiding side effects associated with traditional antipsychotics, such as extrapyramidal symptoms. It has also shown potential in improving negative symptoms and cognitive impairment, which is considered a major breakthrough in psychiatric therapeutics in recent years. This novel approach may also be applied to addressing psychiatric symptoms associated with Alzheimer’s disease and Parkinson’s disease. 

NS-136 has demonstrated a favorable safety and pharmacokinetic profile in preclinical and Phase 1 studies, as well as therapeutic efficacy in various behavioral models for both positive and negative symptoms. It is positioned to become a first-in-class and best-in-class drug candidate for treating schizophrenia. NS-136 is currently in Phase 2 clinical development, with multiple global studies planned.

About Schizophrenia

Schizophrenia is a severe and complex psychiatric disorder affecting more than 20 million people worldwide. Symptoms include delusions, hallucinations, social withdrawal, blunted affect, cognitive impairment, etc. As the disease progresses, cognitive decline becomes more pronounced. Current antipsychotic drugs mainly target positive symptoms but offer limited benefits for negative symptoms and cognitive function. Their clinical use is further limited by significant side effects, resulting in substantial unmet medical needs.

About NeuShen Therapeutics

NeuShen Therapeutics is a clinical-stage global biotechnology company focused on developing innovative therapies for neurological and psychiatric disorders. With R&D centers in Shanghai and Boston, the Company brings together an international team of R&D experts and is advised by a group seasoned leaders in academia and industry. NeuShen Therapeutics has established a globally competitive CNS drug pipeline including multiple programs with first- or best-in-class potentials, and its lead assets have advanced into Phase 2 clinical development.