HIGHTIDE-B Receives NMPA Acceptance for New Drug Application of HTD1801

Stock News
03/10

HIGHTIDE-B (02511) announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for HTD1801 for the treatment of Type 2 Diabetes (T2DM). This marks the company's first NDA submission and represents a significant milestone in its path toward product commercialization. HTD1801 has completed three multicenter, randomized, double-blind, controlled Phase III clinical studies for the T2DM indication, all of which met primary and multiple secondary endpoints. The drug demonstrated consistent improvement trends across key cardiorenal metabolic dimensions, including blood glucose, blood lipids, inflammation, and renal function, highlighting its clinical value of multi-effect and comprehensive benefits.

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