China Approves COBENFY, First Novel Schizophrenia Therapy in Over 70 Years
核心洞察
China's National Medical Products Administration has approved COBENFY (xanomeline and trospium chloride) for treating schizophrenia in adults, marking the first major therapeutic advance in decades.
The drug represents a breakthrough with its novel mechanism targeting M1 and M4 muscarinic receptors, offering a fundamentally different approach from traditional dopamine-blocking antipsychotics.
COBENFY has already been included in China's national schizophrenia treatment guidelines and addresses the needs of approximately 8 million Chinese adults living with the condition.
China's National Medical Products Administration (NMPA) has approved COBENFY (xanomeline and trospium chloride) for treating schizophrenia in adults, marking the first schizophrenia therapy with a novel mechanism of action approved in over 70 years. The approval represents a groundbreaking milestone for the approximately 8 million adults living with schizophrenia in China, many of whom continue to struggle with persistent symptoms or challenging side effects from existing therapies.
Revolutionary Mechanism of Action
COBENFY offers a fundamentally new approach to treating schizophrenia by selectively activating M1 and M4 receptors in the brain, addressing core disease pathways beyond traditional dopamine-blocking antipsychotics. The drug is a combination of xanomeline, an oral M1/M4-preferring muscarinic acetylcholine receptor agonist, and trospium chloride, a muscarinic acetylcholine receptor antagonist that acts peripherally to mitigate cholinergic side effects.
"COBENFY represents the first truly new therapeutic approach for schizophrenia in decades," said Prof. Gang Wang, M.D., Dean of Beijing Anding Hospital, Capital Medical University and the leading principal investigator for the Phase 3 China study. "COBENFY 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 a problematic movement disorder called extrapyramidal symptoms, offering a meaningful new option for patients."
Addressing Critical Unmet Medical Needs
Schizophrenia is characterized by three core symptom domains: positive symptoms such as hallucinations and delusions, negative symptoms including deficits in motivation and social withdrawal, and cognitive impairment affecting memory, concentration, and decision-making. Despite the availability of antipsychotic therapies in China, many patients experience inadequate improvement across symptom domains and intolerable side effects.
The condition severely impacts functioning, with only 10% of patients gainfully employed and many struggling to meet adult milestones such as living independently. The life expectancy of people living with schizophrenia is reduced by 10-20 years compared to a healthy population. Approximately 75% of patients discontinue medication before 18 months due to limited efficacy and problematic side effects.
Clinical Evidence and Regulatory Support
The NMPA's approval is supported by results from a Phase 1 pharmacokinetics study conducted in China, the Phase 3 China study (ZL-2701-001), and data from three global EMERGENT clinical studies. The approval underscores the urgent need for new therapeutic options, as evidenced by COBENFY's inclusion in the "China Schizophrenia Prevention and Treatment Guidelines (2025 Edition)" released by the Chinese Medical Association in September—marking the first national-level guideline to include the therapy.
"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, Head of Global Research and Development at Zai Lab. "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."
Partnership and Development
Zai Lab holds an exclusive license from Karuna Therapeutics (搜索), Inc., a company acquired by Bristol Myers Squibb (搜索), to develop, manufacture, and commercialize COBENFY in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The approval positions COBENFY as a potential game-changer for schizophrenia treatment in a region where few patients are obtaining adequate symptom improvement with current antipsychotic therapies.