HighTide Therapeutics, Inc. (HighTide-B, 02511.HK) announced that China’s National Medical Products Administration has formally accepted the company’s New Drug Application for HTD1801, targeting the treatment of Type 2 Diabetes Mellitus (T2DM). This represents HighTide’s inaugural NDA and a pivotal step toward product commercialization.

HTD1801 has completed three multicenter, randomized, double-blind, controlled Phase III trials for T2DM. Each study achieved its primary endpoint and multiple secondary endpoints, demonstrating consistent improvements across cardiovascular-kidney-metabolic parameters, including glycemic control, lipid metabolism, inflammatory markers and renal function.

In accordance with Rule 18A.05 of the Hong Kong Listing Rules, the company cautions that successful marketing authorization is not guaranteed. Shareholders and potential investors are advised to exercise prudence when dealing in the company’s shares.