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author: zhang yuqi

the world's first new anti-schizophrenia drug has been approved in the united states.

on september 26, bristol-myers squibb (bms)’s fic (first-in-class, world’s first) cobenfy (xanomeline and trospium chloride combination, karxt) was approved by the u.s. food and drug administration (fda) for treatment in adults with schizophrenia, this is the first new drug in the field of schizophrenia in decades and the first muscarinic acetylcholine receptor agonist approved to treat schizophrenia.

dr. chris boerner, chairman and ceo of bristol-myers squibb, said, "the approval of fic-class schizophrenia treatment drugs is a milestone. after more than 30 years of development, a new drug treatment method for schizophrenia has emerged, which may also change treatment models for related diseases.”

as a promoter of the development, production and commercialization of karxt in greater china, zai lab (09688.hk) told times finance, “currently, unite-1, the registered clinical study of karxt for the treatment of schizophrenia in china, has after completing the enrollment of all patients, we plan to obtain the key data of the study from 2024 to the first half of 2025 and submit a new drug marketing application for karxt for schizophrenia in mainland china.”

cobenfy, formerly known as karxt, is a muscarinic antipsychotic indicated for the oral treatment of schizophrenia in adults. through a novel mechanism of action, karxt acts as an m1/m4 muscarinic acetylcholine receptor agonist in the central nervous system and is thought to improve positive, negative and cognitive symptoms of schizophrenia. unlike existing therapies, karxt does not directly block dopamine receptors, providing a new way to treat schizophrenia. karxt is also exploring treatments for psychiatric disorders associated with alzheimer's disease.

at the end of december last year, bristol-myers squibb acquired the biopharmaceutical company karuna for a total price of approximately us$14 billion. the company's main asset is karxt, which was approved for listing in the united states.

zai lab acquired part of the rights to karxt before bristol-myers squibb acquired karuna, and quickly expanded into the field of schizophrenia in china.

in november 2021, zai lab and karuna reached an exclusive license agreement to obtain the development, production and commercialization rights of karxt in greater china (including mainland china, hong kong, macau and taiwan). karuna received an advance payment of us$35 million. development and registration milestone payments of up to $80 million. karuna will also receive sales milestone payments of up to us$72 million based on karxt's annual net sales in greater china, as well as tiered royalties between ten and twenty percent. zai lab will primarily fund all development, registration and commercialization activities in greater china.

schizophrenia is a chronic and often disabling mental illness that affects the way people think, feel and behave, affecting nearly 24 million people worldwide. it is characterized by positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawing from others), and cognitive impairment (deficits in memory, attention, and decision-making). due in part to limitations of current treatments, people with schizophrenia often have difficulty maintaining employment, living independently, and managing relationships. while current treatments can be effective in controlling some symptoms, they are ineffective for approximately 30% of people, and a further 50% experience only partial improvement in symptoms or experience unacceptable side effects.

about 24 million people worldwide have schizophrenia, and about 2.8 million people in the united states have the disease, according to bristol-myers squibb. according to the business research company, the related treatment market is expected to exceed us$7 billion by 2028.

the latest report released by evaluate predicts that karxt will rank ninth among the top ten most valuable pipelines in 2030, with annual sales expected to reach us$3.1 billion. according to wall street analysts, peak annual sales of the drug will exceed $10 billion.

there are more than 8 million people with schizophrenia in china who urgently need more effective and safer treatments, but less than half of the patients currently receiving treatment have achieved adequate symptom improvement from current antipsychotic treatments. less.

according to the nextpharma database, china currently has only 16 new schizophrenia drugs under development in the clinical trial stage, and most of them are still drugs targeting dopamine receptors and 5-ht receptors. in addition to zai lab, companies deploying related drugs in the chinese market include boehringer ingelheim, merck, hansoh pharmaceuticals, jingxin pharmaceuticals, lundbeck pharmaceuticals/nvar pharmaceuticals, zhongze pharmaceuticals, etc. among them, boehringer ingelheim’s lclepertin (bi 425809) has made the fastest progress and is undergoing global phase 3 clinical trials and is also in the phase 3 clinical development stage in china.