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HighTide Announces NMPA Approval for HTD1801 Clinical Trial in China

HighTide Therapeutics (“HighTide”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for non-viral chronic liver diseases, gastrointestinal diseases, and metabolic disorders, today announced that its lead candidate HTD1801 has been approved by China’s Center for Drug Evaluation, National Medical Products Administration (CDE/NMPA) to conduct clinical trials in China to improve blood glucose control in patients with Type 2 Diabetes Mellitus (T2DM). This approval will further accelerate global development of HTD1801 and clinical progress in treating T2DM, especially T2DM comorbid with non-alcoholic fatty liver disease (NAFLD) in China.

Dr. Liping Liu, Founder and CEO of HighTide, commented: “With improvement of living standards and longevity trends, the incidence of metabolic diseases is rapidly increasing; complications such as hyperglycemia, hyperlipidemia, fatty liver, and obesity, have seriously affected human health. In our recent Phase II clinical trial in patients with non-alcoholic steatohepatitis (NASH) comorbid with T2DM in the U.S., HTD1801 demonstrated significant reductions in liver fat, liver enzymes, blood glucose, serum lipids and body weight. The approval granted by CDE further accelerates our global development of HTD1801.”

About T2DM in China

Type 2 Diabetes Milletus (T2DM) is one of the most challenging health problems in the 21st century. China has the largest T2DM patient population in the world, and the number of patients is projected to continue increasing rapidly. The prognosis of patients with T2DM comorbid with non-alcoholic fatty liver disease (NAFLD) is generally poor, with challenges in controlling blood glucose and progress of liver disease. According to the latest research data, about 48.39% of Chinese adults with T2DM have NAFLD; there are approximately 62 million patients in China with T2DM/NAFLD.

About HighTide Therapeutics

HighTide Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutics for non-viral chronic liver diseases, gastrointestinal diseases and metabolic disorders, with a focus on areas of high unmet medical need and lack of effective treatment options.

About HTD1801

HighTide’s lead product candidate, HTD1801, an ionic salt of berberine and ursodeoxycholic acid, is a first-in-class drug new molecular entity being developed for the treatment of non-viral chronic liver diseases and metabolic disorders. HTD1801 has received Fast Track designation from the U.S. FDA for both PSC and NASH, as well as Orphan Drug designation for PSC. In addition, it has also been incorporated in China’s Major New Drug Innovation Program under the 13th Five-year Plan for Major Technology Project. HTD1801 has multi-modal actions with positive effects on glucose and lipid metabolism, bile acid metabolism, inflammation and immunity. Phase II trials of HTD1801 in PSC and NASH comorbid with T2DM met the primary endpoint and several important secondary endpoints.

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