On October 18th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China announced that Kanghong Pharmaceutical (SHE: 002773)’s Class 1 new drug, KH629 tablets, has been granted implicit approval for clinical trials for the treatment of adult non-alcoholic steatohepatitis (NASH). Public information indicates that this is a Class 1 innovative drug independently developed by Kanghong Pharmaceutical, a selective agonist of the thyroid hormone β receptor. The product has previously been approved for clinical trials in the United States, and this marks its first approval for IND in China.
NASH, also known as Metabolic Dysfunction-Associated Fatty Liver Disease (MASH), is the advanced form of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) and is a leading cause of liver-related mortality. Patients with NASH are at a higher risk of progressing to advanced liver diseases, including liver function loss and liver cancer, compared to the general population. For decades, drug development for NASH has been challenging, with the first therapy receiving FDA approval in the United States only in March this year.
KH629 is a selective agonist of the THR-β receptor independently developed by Kanghong Pharmaceutical. Thyroid hormones play a central role in liver function by activating the β receptor in hepatocytes, affecting a range of health parameters from serum cholesterol and triglyceride levels to the pathological accumulation of fat in the liver. The THR-β subtype is primarily expressed in the liver, and the activation of this subtype is beneficial for reducing liver fat and improving dyslipidemia.
According to earlier press releases from Kanghong Pharmaceutical, KH629 is an oral solid dosage form of the drug. Preliminary study results have shown that KH629 tablets have good safety and exhibit potential for the treatment of NASH.- Flcube.com
