Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) 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 8 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, M.D., 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.
The China Phase 3 study met its primary endpoint, with KarXT demonstrating a statistically significant 9.2-point difference from placebo in the reduction in the Positive and Negative Syndrome Scale (PANSS) total score from baseline at Week 5 (-16.9 KarXT vs. -7.7 placebo, p=0.0014). The study also met all key secondary efficacy endpoints, demonstrating a significant improvement in PANSS positive symptom subscale score, PANSS negative symptom subscale score, PANSS negative Marder factor score, the Clinical Global Impression-Severity (CGI-S) scale at week five and percentage of PANSS responders at week five compared to placebo. There were no safety signals that were new or unexpected in comparison with prior KarXT trials in schizophrenia. Similar to the global program, the common treatment emergent adverse events in the treatment arm include vomiting, tachycardia, nausea, systemic hypertension, dizziness and diarrhea.
In the global Phase 3 EMERGENT-2 and EMERGENT-3 trials, KarXT met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo. The safety and tolerability profile of KarXT has been established across acute and long-term trials.
In September 2024, the U.S. Food and Drug Administration (FDA) approved COBENFY™ (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. COBENFY does not have atypical antipsychotic class warnings and precautions and does not have a boxed warning.
