Zai Lab receives China approval for COBENFY, a first-in-class treatment for schizophrenia
Wednesday, December 24, 2025
Zai Lab Limited has received approval from China’s National Medical Products Administration (NMPA) for the New Drug Application of COBENFY® (xanomeline and trospium chloride) to treat adults with schizophrenia.
COBENFY is the first schizophrenia therapy with a new mechanism of action to be approved in more than 70 years. The treatment works by selectively activating the M1 and M4 receptors in the brain, targeting key disease pathways rather than relying on traditional dopamine-blocking antipsychotics.
Schizophrenia is a long-term and often disabling mental health condition that affects thinking, emotions, and behaviour. Symptoms are generally grouped into three areas: positive symptoms such as hallucinations and delusions; negative symptoms including reduced motivation, loss of pleasure, and social withdrawal; and cognitive problems such as difficulties with memory, focus, and decision-making. In China, many patients continue to experience limited symptom control or troublesome side effects with existing antipsychotic medicines.
The approval is supported by results from a Phase 1 pharmacokinetics study conducted in China, a Phase 3 China study (ZL-2701-001), and data from three global EMERGENT clinical studies. These studies showed that COBENFY can provide improvement across positive, negative, and cognitive symptoms, while avoiding several common side effects linked to standard antipsychotics, such as weight gain, raised prolactin levels, and movement-related disorders.
China is estimated to have around eight million adults living with schizophrenia, highlighting a significant need for new treatment options. COBENFY offers a different approach that may help patients who do not respond well to current therapies.
In September, the Chinese Medical Association published the China Schizophrenia Prevention and Treatment Guidelines (2025 Edition), which included COBENFY as a novel treatment option. This marks the first time the therapy has been included in a national-level clinical guideline.
Source: zailaboratory.com
