On September 26th local time, the US Food and Drug Administration (FDA) announced the approval of BMS's schizophrenia drug Cobenfy (KarXT, xanomiline and trospium chloride) for the treatment of adult schizophrenia patients.
This is the first approved new mechanism therapy for schizophrenia in decades, targeting cholinergic receptors instead of dopamine receptors, which have long been the standard treatment.
The epidemiological survey of the World Health Organization shows that there are approximately 24 million schizophrenia patients worldwide in 2022. According to Expert Market Research, the global market size for schizophrenia drugs is estimated to grow from $8.18 billion in 2023 to $12.97 billion in 2032, with a compound annual growth rate of 5.26%.
On January 29th of this year, the well-known pharmaceutical website FINECE Pharma released the top 10 most anticipated drugs for 2024, and Cobenfy was listed as the first of the top 10 most anticipated drugs for 2024, with an expected sales revenue of $2.8 billion in 2028.
KarXT is a drug composed of xanomeline (an M1/M4 receptor agonist) and trospium (a non selective muscarinic antagonist), originally developed by Karuna Therapeutics. At the end of 2023, BMS spent $14 billion to acquire Karuna, obtaining this drug and other pipelines. The collaboration between Zaiding Pharmaceutical (09688. HK) and Karuna originated in 2021. At present, Zaiding Pharmaceutical owns the development, production, and commercialization rights of KarXT in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Public data shows that there are over 8 million patients with schizophrenia in China. KarXT has been approved in the United States, bringing hope to Chinese patients.
According to NextPharma, the global new drug database of the Medical Magic Cube, there are currently only 16 new drugs under development for schizophrenia in China that have entered clinical trials, and most of them are still dopamine receptor and 5-HT receptor targeted drugs. KarXT is one of the two drugs that have progressed to Phase III clinical stage and is expected to become the next approved new drug for schizophrenia in China. Another drug entering phase III clinical stage is the Gly-T1 inhibitor Iclepertin, developed by Boehringer Ingelheim.
Zaiding Pharmaceutical stated that in August 2024, KarXT's registered study UNITE-1 for schizophrenia had completed the enrollment of all mainland Chinese patients. It is expected to obtain key research data from 2024 to the first half of 2025 and submit a new drug application for KarXT for schizophrenia in mainland China.
In July of this year, Zaiding Pharmaceutical also joined the global Phase III ADEPT-2 study in Greater China to evaluate the safety and efficacy of KarXT in the treatment of Alzheimer's disease related psychiatric disorders.
Affected by the positive news of KarXT's approval for listing in the United States, Zaiding Pharmaceutical rose 10.96% to close at HKD 18.02 per share on September 27th, with a total market value of HKD 17.9 billion.