Zai Lab Limited (NASDAQ: ZLAB) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
“There are more than eight million patients living with schizophrenia in China who face significant unmet needs due to the limited efficacy and undesirable side effects of current treatment options,” said Dr. Rafael Amado, President, Head of Global Research and Development at Zai Lab. “In clinical trials, KarXT demonstrated statistically significant reductions of schizophrenia symptoms along with a tolerable safety profile. If approved, KarXT has the potential to redefine the treatment landscape.”
“KarXT is the first new class of treatment for patients with schizophrenia in several decades,” said Gang Wang, M.D., Dean of Beijing Anding Hospital, Capital Medical University and the leading principal investigator for the Phase 3 China study. “We are excited about this potentially transformative treatment option in clinical settings to benefit these patients as early as possible.”
The NDA submission is supported by the results from a Phase 1 China Pharmacokinetics (PK) study, the Phase 3 China study (ZL-2701-001) and data from the global EMERGENT clinical programs.
Shares in ZLAB hiked 49 cents, or 1.9%, to $25.86 Friday morning.
