Zai Lab Limited (NASDAQ:ZLAB) received marketing authorization from China’s National Medical Products Administration (NMPA) for Cobenfy, a groundbreaking treatment for schizophrenia in adults.
The decision marks the arrival of the first antipsychotic with a novel mechanism of action in over 70 years, offering a significant alternative to the dopamine-blocking agents that have dominated the psychiatric landscape since the 1950s.
Cobenfy, a combination of xanomeline and trospium chloride, functions by selectively activating M1 and M4 muscarinic receptors in the brain.
This approach targets the underlying circuits of the disease without the metabolic and motor side effects—such as weight gain and tremors—frequently associated with traditional antipsychotics.
The therapy aims to manage the three core domains of schizophrenia: positive symptoms like hallucinations, negative symptoms such as social withdrawal, and cognitive impairments.
The NMPA’s approval was underpinned by a comprehensive data package, including a Phase 1 pharmacokinetics study in China, a local Phase 3 trial, and the successful global EMERGENT clinical program.
The results demonstrated that Cobenfy could provide robust symptom relief while maintaining a differentiated safety profile.
In a move that underscores the expected impact of the drug, the Chinese Medical Association had already included Cobenfy in its 2025 edition of the “China Schizophrenia Prevention and Treatment Guidelines” prior to the formal NDA approval.