Zai Lab Announces Approval of COBENFY (xanomeline and trospium chloride) in China, a First-in-Class Therapy for Schizophrenia

Core Insights - Zai Lab Limited has received approval from China's National Medical Products Administration (NMPA) for COBENFY® (xanomeline and trospium chloride), marking the first new schizophrenia therapy with a novel mechanism in over 70 years [1][3] - COBENFY selectively activates M1 and M4 receptors in the brain, providing a new approach to treating schizophrenia beyond traditional dopamine-blocking antipsychotics [1][3] Company Overview - Zai Lab is a biopharmaceutical company focused on developing innovative products for significant unmet medical needs in oncology, immunology, neuroscience, and infectious diseases [9] - The company holds an exclusive license from Karuna Therapeutics, Inc. to develop, manufacture, and commercialize COBENFY in Greater China [6] Industry Context - Schizophrenia affects approximately 8 million adults in mainland China, with many patients experiencing inadequate symptom improvement and intolerable side effects from existing antipsychotic therapies [3][8] - The recent "China Schizophrenia Prevention and Treatment Guidelines (2025 Edition)" includes COBENFY as a novel treatment, indicating its recognition in national-level guidelines [4] Product Details - COBENFY is a combination of an oral M1/M4-preferring muscarinic acetylcholine receptor agonist and a muscarinic acetylcholine receptor antagonist, designed to improve treatment outcomes for psychiatric conditions [5] - The therapy has shown comprehensive improvement across positive, negative, and cognitive symptoms while avoiding common adverse effects associated with traditional antipsychotics [3][5]