Zai Lab Limited (ZLAB) today announced that China's National Medical Products Administration (NMPA) has approved COBENFY for the treatment of schizophrenia in adults.
Schizophrenia is a chronic and disabling mental health disorder marked by positive symptoms such as hallucinations and delusions, negative symptoms including loss of motivation and social withdrawal, and cognitive impairment affecting memory and decision-making.
Despite available antipsychotics, many patients in China continue to experience inadequate symptom control or intolerable side effects, underscoring the need for new therapeutic options.
COBENFY (xanomeline and trospium chloride) is the first schizophrenia therapy with a novel mechanism of action approved in more than 70 years, offering a fundamentally different approach from traditional dopamine-blocking antipsychotics. By selectively activating M1 and M4 muscarinic receptors in the brain, the therapy targets core disease pathways while avoiding common adverse effects such as weight gain, hyperprolactinemia, and extrapyramidal symptoms.
The approval is supported by data from a Phase 2 PK study in China, a Phase 3 trial (ZL-2701-001), and three global EMERGENT studies, all of which demonstrated broad improvements across positive, negative, and cognitive symptoms.
COBENFY has also been included in China's national schizophrenia treatment guidelines, marking the first time a muscarinic-based therapy has been featured at the national level.
COBENFY was previously approved in the U.S. in September 2024, for the treatment of schizophrenia in adults.
Zai labs holds exclusive rights from Karuna Therapeutics, now part of Bristol Myers Squibb to develop and commercialize COBENFY in China.
ZLAB has traded between $16.82 and $44.34 over the past year. The stock closed Tuesday's trading at $17.48, down 1.30%.
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