ROCKVILLE, MD and SHENZHEN, CHINA – [March 10, 2026] – HighTide Therapeutics, Inc. (2511.HK), a clinical-stage biopharmaceutical company specializing in the development of multi-functional, multi-targeted therapies for chronic metabolic diseases with significant unmet medical needs, today announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for HTD1801 for the treatment of Type 2 Diabetes Mellitus (T2DM). This marks the first NDA submitted by HighTide Therapeutics and a major milestone on its path towards product commercialization.
HTD1801 has completed three multicenter, randomized, double-blind, controlled Phase III clinical trials for the T2DM indication — all of which met their primary endpoints as well as multiple secondary endpoints. Across these studies, HTD1801 consistently demonstrated improvements in multiple dimensions of the cardiovascular-kidney-metabolic (CKM) spectrum, including glycemic control, lipid metabolism, inflammatory markers, and renal function. These results highlight the potential of HTD1801 to deliver comprehensive, multi-system therapeutic benefits through a single therapy.
“We are very pleased that the NMPA has accepted the New Drug Application for our lead product HTD1801,” said Dr. Liping Liu, Founder, Chairperson, and CEO of HighTide Therapeutics. “This milestone marks an important step forward in HighTide’s journey towards commercialization. We will continue to explore the clinical potential of HTD1801 across CKM diseases, to provide patients worldwide with integrated therapeutic solutions that deliver comprehensive and meaningful clinical benefits.”
About HTD1801
HTD1801 is a first-in-class new molecular entity that targets the residual risks underlying cardiovascular–kidney–metabolic (CKM) diseases. It is an orally delivered, anti-inflammatory metabolic modulator (AIMM) that, as a single molecule, exerts a unique dual mechanism of action through activation of AMP Kinase and inhibition of the NLRP3 inflammasome, two complementary pathways that mitigate metabolic dysfunction. Multiple global clinical studies have demonstrated the comprehensive benefits of HTD1801, including improved insulin sensitivity, glycemic control, lipid lowering, renal protection, weight reduction, hepatic improvement, and anti-inflammatory effects. Collectively, these findings support the potential of HTD1801 to serve as a foundational therapy in CKM disease management.
About HighTide Therapeutics
HighTide Therapeutics, Inc. (2511.HK) is a biopharmaceutical company dedicated to developing multifunctional, multi-targeted therapies for chronic metabolic diseases, with a strategic emphasis to address the residual risks of cardiovascular–kidney–metabolic (CKM) syndrome. The company focuses on delivering breakthrough treatments that generate comprehensive, multi-organ benefits for patients worldwide. HighTide has built an innovative, globally integrated pipeline of proprietary assets and advanced multiple clinical programs across chronic metabolic diseases. The company’s lead asset, HTD1801, has received two Fast Track designations and one Orphan Drug designation from the US Food and Drug Administration (FDA), and has been selected for China’s National Major Science and Technology Project for Significant New Drug Development.
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