GC Wellbeing said on the 16th that intravenous injection of the chronic liver disease treatment Lienek had efficacy in phase 3 clinical trials. The company plans to apply for item approval to the Ministery of Food and Drug Safety by the end of this year.
The clinical trial has been conducted in Korea since Apr. 2024 on 226 patients with chronic liver disease. The company said patients who received a high dose of Lienek by intravenous injection showed improved liver function compared with those who received it by subcutaneous injection. Safety was also observed.
Lienek was released in 2005 in a subcutaneous injection form. Subcutaneous injections can administer up to 2.5 ml of a drug, creating the inconvenience of being pricked by a needle multiple times for high doses. Intravenous injections can deliver up to 10 ml of a drug, making them more convenient.
The company expects an additional 20 billion won in annual sales from the intravenous regimen. Jeong Si-young, head of research and development at GC Wellbeing, said it would "provide patients with more effective and safer treatment."