#China #Beijing #Hepatitis D #Huahui Health #Libevitug

Libevitug Injection: A New Hope for Hepatitis D Patients

In a significant advancement in the treatment of viral hepatitis, Libevitug, developed by Huahui Health, has been granted conditional approval by the China National Medical Products Administration (NMPA). This marks a pivotal moment for individuals suffering from chronic hepatitis D virus (HDV) infections, particularly those with co-existing conditions such as compensated cirrhosis.

Understanding Hepatitis D and Its Challenges

Hepatitis D is a satellite virus that requires Hepatitis B virus (HBV) for its replication. The co-infection creates a severe health challenge, as it often leads to progressive liver diseases, including cirrhosis and hepatocellular carcinoma. The World Health Organization (WHO) identifies co-infection as the most acute form of chronic viral hepatitis, which makes the need for effective treatments urgent.

According to WHO estimates, nearly 12 million people globally are infected with HDV, impacting nearly 5% of all chronic HBV carriers. In China alone, the prevalence of chronic hepatitis B infections exceeds 75 million, yet treatment options specifically targeting HDV have been scarce. The approval of Libevitug offers renewed hope as it represents the first treatment of its kind available in the country.

The Science Behind Libevitug

Libevitug is a human monoclonal antibody designed to target the PreS1 domain of the large envelope protein of HBV and HDV, effectively blocking the viruses from accessing hepatocytes (liver cells). This innovative mechanism stops viral entry and potentially curbs the progression of liver disease in affected patients.

The drug had previously received Breakthrough Therapy Designation from both the U.S. FDA and China's CDE, highlighting its potential to significantly benefit population health.

Clinical Trial Success

The clinical trials, specifically the pivotal registrational study (HH003-204), demonstrated remarkable efficacy in patients treated with Libevitug. Results showcased a combined response rate of 44.1%, an impressive 60% virological response rate, and a 70% normalization rate of alanine aminotransferase (ALT) levels, indicating liver function improvement. Significantly, the treatment led to reduced liver stiffness over time, an encouraging sign for patients facing cirrhosis.

Professor Niu Junqi from Jilin University, who was the lead investigator, stated, "Libevitug not only demonstrates outstanding clinical outcomes but also aligns with China's initiatives to address viral hepatitis treatment effectively. We are optimistic about its potential to mitigate the risks associated with liver diseases, including cancer, and to facilitate better diagnostic and treatment strategies across the nation."

A Scientific Breakthrough Years in the Making

The journey to developing Libevitug began over a decade ago when Dr. Li Wenhui and his research team at the National Institute of Biological Sciences made a groundbreaking discovery regarding the NTCP receptor's role in HBV and HDV infections. This key finding led to the eventual creation of Libevitug through collaborative efforts aimed at addressing the pressing health crisis posed by viral hepatitis.

Dr. Chen Bin, the CEO of Huahui Health, expressed the company's commitment to ongoing research and development. He emphasized, "Our goal is to build an integrated platform that addresses liver diseases comprehensively. We're proud that Libevitug will help fulfill our promise to deliver innovative therapies to patients and contribute to global health initiatives efficiently."

Future Prospects

As China advances towards its Action Plan for the Prevention and Control of Viral Hepatitis (2025–2030), the approval of Libevitug is a major step towards achieving the goal of reducing viral hepatitis' impact. It highlights the potential for improving diagnosis, treatment access, and ultimately, patient outcomes across the region.

The introduction of Libevitug into the market stands as a beacon of hope for those grappling with chronic hepatitis D, and presents a vital new tool in the fight against viral hepatitis on a global scale. Huahui Health aims to continue its quest to innovate further therapeutic options for HDV and other liver diseases, positioning itself as a leader in addressing one of the world's most challenging health concerns.