<p>Zai Lab Ltd. has announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application for COBENFY® (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. This marks COBENFY as the first major advance in schizophrenia therapy in over 70 years, introducing a novel mechanism of action that targets the M1 and M4 receptors in the brain, unlike traditional dopamine-blocking antipsychotics. The approval is supported by a Phase 1 pharmacokinetics study in China, a Phase 3 China study, and data from three global EMERGENT clinical studies. COBENFY has also been included in China’s national-level schizophrenia treatment guidelines. There is no indication that this regulatory approval involved multiple organizations beyond Zai Lab Ltd. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zai Lab Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251223179134) on December 23, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)</p>

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<p>Zai Lab Ltd. has received approval from China's NMPA for COBENFY®, a new schizophrenia treatment, marking a major advance in therapy with a novel mechanism targeting M1 and M4 receptors. Supported by multiple studies, COBENFY is included in national treatment guidelines.</p>

- Zai Lab Ltd. has received approval from China's National Medical Products Administration for COBENFY® (xanomeline and trospium chloride) to treat schizophrenia in adults.  
- This approval represents the first significant advancement in schizophrenia treatment in over 70 years, utilizing a new mechanism targeting M1 and M4 receptors instead of traditional dopamine-blocking methods.  
- The approval is based on several studies, including a Phase 3 study in China and global EMERGENT clinical studies, and COBENFY has been incorporated into national treatment guidelines for schizophrenia.

Zai Lab Wins NMPA Approval for COBENFY Schizophrenia Treatment in China