CAMBRIDGE, Mass. — Zai Lab Limited said China’s National Medical Products Administration has approved the New Drug Application for COBENFY (xanomeline and trospium chloride) for the treatment of schizophrenia in adults, marking the first approval of a schizophrenia therapy with a novel mechanism of action in decades.
The company said COBENFY represents a fundamentally different approach to treating schizophrenia by selectively activating M1 and M4 receptors in the brain, targeting core disease pathways beyond traditional dopamine-blocking antipsychotics. Zai Lab described the approval as a major advance for patients who continue to experience persistent symptoms or intolerable side effects with existing therapies.
Schizophrenia is a chronic and often disabling mental health disorder that affects thinking, emotion, and behavior. Symptoms typically fall into three categories: positive symptoms such as hallucinations and delusions; negative symptoms including reduced motivation, pleasure, and social engagement; and cognitive impairment involving memory, concentration, and decision-making. Zai Lab said that in China, many patients do not achieve adequate symptom control despite available treatments.
“We are pleased to receive NMPA approval for COBENFY, marking a groundbreaking milestone for schizophrenia care in China,” said Rafael G. Amado, M.D., president and head of global research and development at Zai Lab. “Approximately 8 million adults in China are living with schizophrenia, many of whom continue to struggle with persistent symptoms or challenging side effects from existing therapies. With its broad symptom improvement and unique safety profile, COBENFY has the potential to redefine how schizophrenia can be managed, and we look forward to bringing this transformative therapy to patients as soon as possible.”
Gang Wang, M.D., dean of Beijing Anding Hospital at Capital Medical University and the leading principal investigator for the Phase 3 China study, said the therapy offers a meaningful new option for patients.
“COBENFY represents the first truly new therapeutic approach for schizophrenia in decades,” Wang said. “It has demonstrated comprehensive improvement across positive, negative, and cognitive symptoms, while avoiding many of the adverse effects commonly associated with traditional antipsychotics, including weight gain, hyperprolactinemia, and extrapyramidal symptoms.”
Zai Lab said the approval was supported by data from a Phase 1 pharmacokinetics study conducted in China, the Phase 3 China study known as ZL-2701-001, and results from three global EMERGENT clinical studies.
The company also noted that COBENFY has already been included in the China Schizophrenia Prevention and Treatment Guidelines (2025 Edition) released by the Chinese Medical Association, making it the first national-level schizophrenia treatment guideline to recognize the therapy.
