Securities code: Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773) securities abbreviation: Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773) Announcement No.: 2022019 Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773)
Announcement on the company's receipt of the notice of approval for drug clinical trial
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773) (hereinafter referred to as "the company") recently received the notice of approval for clinical trials of obecholate tablets (Notice No.: 2022lp00707, 2022lp00708) issued by the State Drug Administration and agreed to carry out clinical trials. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Drug name: obecholate tablets
Dosage form: tablet
Indications: This product is suitable for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or compensatory cirrhosis without evidence of portal hypertension. This 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.
Acceptance No.: cyhl2200013, cyhl2200014
Notice No.: 2022lp00707, 2022lp00708
1. Approval conclusion: agree to carry out clinical trial
2、 Product introduction
The company's obecholate tablets were recently approved to carry out clinical trials. Obeticolic acid (trade name ocaliva) is a farneside X receptor (FXR) agonist developed by intercept. It was first approved by the U.S. Food and Drug Administration in June 2016 for the treatment of primary biliary cirrhosis.
3、 Impact on the company
The company has been approved to carry out clinical trials according to the registered classification of 3 categories. At present, no enterprise in China has been approved to be listed.
As the results and time of clinical trial, review and approval are uncertain, please make careful decisions and pay attention to investment risks.
It is hereby announced.
Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773) board of directors April 24, 2022
