Zai Lab Receives NMPA Approval for COBENFY to Treat Schizophrenia
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 23 2025
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Source: Businesswire
- Innovative Therapy Approval: Zai Lab's COBENFY (xanomeline and trospium chloride) has received approval from China's NMPA, becoming the first new mechanism schizophrenia treatment in over 70 years, marking a significant breakthrough in schizophrenia care.
- Addressing Patient Needs: With approximately 8 million adults in China suffering from schizophrenia and existing treatments offering limited efficacy, COBENFY selectively activates M1 and M4 receptors to provide broader symptom improvement, which is expected to significantly enhance patients' quality of life.
- Clinical Research Support: The NMPA approval is backed by results from a Phase 1 pharmacokinetics study and Phase 3 clinical trials in China, demonstrating COBENFY's effectiveness in improving positive, negative, and cognitive symptoms while avoiding the side effects commonly associated with traditional antipsychotics.
- Enhanced Industry Influence: The inclusion of COBENFY in the China Schizophrenia Prevention and Treatment Guidelines (2025 Edition) not only elevates Zai Lab's standing in the mental health sector but also lays a foundation for future market expansion.
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About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
