Daewoong Pharmaceutical Demonstrates Viral Suppression Efficacy of Hepatitis B Treatment 'Vemliver'

Phase 4 Clinical Trial Results Announced

On June 9, Daewoong Pharmaceutical announced that it had demonstrated a 100% efficacy rate in suppressing viral replication with its hepatitis B treatment, Vemliver.

Eunjeong Hwang, head of the Commercial Research Team at Daewoong Pharmaceutical, is explaining the background of the phase 4 clinical trial for the chronic hepatitis B treatment 'Vemliver'. Daewoong Pharmaceutical

On May 30, at 'The LIVER WEEK 2025' held at the Gyeongju HICO Convention Center, Daewoong Pharmaceutical presented the results of a phase 4 clinical trial of Vemliver (TAF), a treatment for chronic hepatitis B.

This clinical study was a non-inferiority trial designed to confirm the efficacy and safety of Vemliver (TAF) in patients with chronic hepatitis B who were already taking Baracros (ETV) and then switched to Vemliver (TAF).

Currently, antiviral agents such as TAF and ETV are used as first-line treatments for chronic hepatitis B. However, for TAF, which is the most recently introduced formulation, there has been insufficient clinical data on switching from ETV. Therefore, this phase 4 trial was designed to verify the efficacy and safety of Vemliver in a real-world clinical setting.

According to the clinical results, at week 48 after switching to Vemliver, hepatitis B virus (HBV DNA) was either undetectable or at a very low level (below 29 IU/mL). The rate of HBV suppression was 100% in the Vemliver group and 99% in the Baracros group, indicating a high antiviral effect for both medications.

Additionally, neither drug resulted in the development of resistance, and contrary to previous concerns about increased lipid levels, no significant changes in lipid profiles were observed. In the group that switched to Vemliver, changes in low-density lipoprotein cholesterol (LDL), total cholesterol (TC), and triglycerides (TG) were not statistically significant, demonstrating the metabolic safety of Vemliver.

Kang Yeoul, professor of gastroenterology at Dong-A University Hospital, who presented the clinical study results, stated, "Through this phase 4 clinical trial, we confirmed that both generic drugs, Vemliver and Baracros, showed excellent antiviral efficacy and safety in a market dominated by original chronic hepatitis B treatments. In particular, when switching from ETV to TAF, suppression of HBV DNA was maintained, demonstrating non-inferior efficacy."

Park Hyungcheol, head of the ETC Marketing Division at Daewoong Pharmaceutical, said, "It is significant that we have objectively demonstrated antiviral efficacy and safety for Vemliver, comparable to Baracros, through this phase 4 clinical trial. Going forward, Daewoong Pharmaceutical will not only focus on developing and producing generic drugs, but will also continue to provide evidence of efficacy and safety through clinical research, offering a wider range of treatment options to patients and healthcare professionals."