Zai Lab (ZLAB) said Friday that its new drug application for KarXT to treat adult patients with schizophrenia was accepted by China's National Medical Products Administration.
The application is backed by results from a phase 1 China pharmacokinetics study, the phase 3 China study and data from global Emergent clinical programs, according to the company.
KarXT, or xanomeline and trospium chloride, showed a reduction in positive and negative syndrome scale total score from baseline in the China phase 3 study, Zai Lab added.
Shares of Zai Lab were up 2.1% in recent trading.
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