Shenzhen Hepalink Pharmaceutical Group Co., Ltd (Hepalink, stock code: 002399) announced that, the small molecule innovative drug of its subsidiary Shenzhen Hightide Biopharmaceutical, Ltd. (Hightide) for treatment of non-alcoholic steatohepatitis (NASH, non-alcoholic Steatohepatitis) has recently been approved by the US Food and Drug Administration for clinical phase II trials. Shenzhen Hightide will conduct phase II clinical trials in the United States as soon as possible. According to previous news, the drug was approved by the US FDA for priority review at the end of September this year for the treatment of primary sclerosing cholangitis (PSC).
According to Hightide Biological’s official website, the company was established in 2011 to discover and develop innovative therapies for people with gastrointestinal diseases and metabolic disorders. HTD1801 is the company’s fastest-growing candidate small molecule new drug. In addition, HTD4010 is a peptide analog of the active fragment of RegIII / PAP protein, and the HTD2802 project for inflammatory bowel disease.
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