HIGHTIDE-B(02511): New drug application for HTD1801 has been accepted by the China National Medical Products Administration.

HIGHTIDE-B (02511) announced that the China National Medical Products Administration (NMPA) has accepted the new drug application (NDA) for HTD1801 for the treatment of type 2 diabetes (T2DM). This is the first NDA submitted by Junshengtai Medicine and an important milestone for the company's move towards product commercialization. HTD1801 has completed three multicenter, randomized, double-blind, placebo-controlled Phase III clinical studies for the treatment of T2DM, achieving primary and multiple secondary endpoints. It has shown consistent improvement trends in key dimensions of glucose, lipids, inflammation, kidney function, and other key aspects of cardiovascular and renal metabolism, demonstrating its clinical value as a drug with multiple effects and comprehensive benefits.