Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773) 4 announced on the evening of April 24 that the company recently received the notice of approval for clinical trial of obecholate tablets issued by the State Drug Administration and agreed to carry out clinical trial. The product is suitable for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or compensatory cirrhosis without evidence of portal hypertension. The product can be combined with ursodeoxycholic acid (UDCA) to treat adult PBC patients with insufficient response to UDCA or intolerance to UDCA as a single drug.
The announcement said that the company’s obecholate tablets were approved to carry out clinical trials according to the registered classification of three categories. At present, no enterprises in China have been approved to be listed. Obeticolic acid (trade name ocaliva) is a farneside X receptor (FXR) agonist developed by intercept company. It was first approved by the U.S. Food and Drug Administration in June 2016 for the treatment of primary biliary cirrhosis.
