Laekna's New Drug Application Accepted by China's NMPA
China's National Medical Products Administration (NMPA) has accepted Laekna's New Drug Application for LAE002 (afuresertib) for review. The drug is being investigated for cancer treatment.
Laekna Therapeutics (2105.HK) announced that its New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The acceptance pertains to the treatment of patients with cancer.
This acceptance represents a significant milestone in Laekna's drug development pipeline, paving the way for potential market approval in China. LAE002 is designed to target specific signaling pathways that drive cancer cell growth.
The NMPA's decision follows a review of preclinical and clinical data submitted by Laekna. The regulatory body will now conduct a thorough evaluation of the drug's safety and efficacy.
Laekna will continue to engage with the NMPA throughout the review process and will provide updates as they become available.