Zai Lab Receives China Approval For Its New Drug Application For COBENFY To Treat Schizophrenia In Adults

Benzinga · 2d ago

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China's National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for COBENFY® (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. COBENFY is the first schizophrenia therapy with a novel mechanism of action approved in over 70 years [1], offering a fundamentally new approach to treating schizophrenia. By selectively activating M1 and M4 receptors in the brain, COBENFY addresses core disease pathways beyond traditional dopamine-blocking antipsychotics.

Schizophrenia is a chronic and often disabling mental health disorder affecting how a person thinks, feels, and behaves. It is characterized by three core symptom domains including positive symptoms (e.g., hallucinations and delusions), negative symptoms (e.g., deficits in motivation, pleasure and social withdrawal), and cognitive impairment (e.g., deficits in memory, concentration, and decision-making). In China, despite the availability of antipsychotic therapies, many patients experience inadequate improvement across symptom domains and intolerable side effects.