BEIJING,Nov. 18,2024 -- Huahui Health,a clinical-stage biotechnology company focused on discovering and developing novel therapies in the areas of viral hepatitis,hepatology,and oncology,today announced that its investigational hepatitis D and B drug candidate,Libevitug (HH-003),an anti-PreS1 human monoclonal antibody,received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic hepatitis delta virus (HDV) infection.

The BTD is based on the clinical results from two independent clinical trials in subjects with chronic HDV infection,HH003-201 (NCT05674448) and HH003-204 (NCT05861674). The result of HH003-201 study has been presented at the European Association of Liver Diseases 2023 Annual Meeting. The HH003-204 study remains ongoing,and Huahui Health will publish the final results when it is completed.

The FDA BTD is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening disease or condition. The BTD grant for Libevitug enables it to benefit from all Fast Track designation features,including FDA's guidance on efficient drug development and expedited regulatory review in the U.S.,and ultimately can accelerate its development and enhance accessibility for chronic HDV infected patients worldwide.

"Libevitug received BTD from the China NMPA (National Medical Products Administration) in April 2023 for the treatment of chronic HDV infection. Today's FDA BTD further signifies a remarkable step forward in the clinical development of Libevitug. We are fully committed to bringing this new therapeutic option to HDV patients worldwide the soonest we can." commented Dr. Bin Chen,CEO of Huahui Health.

About chronic HDV infection: HDV is a liver targeting RNA virus dependent on Hepatitis B Virus (HBV) in replication. HDV requires HBV for assembly and infects hepatocytes via the receptor sodium taurocholate co-transporting polypeptide (NTCP). Chronic HDV infection always co-exists with HBV infection,and the co-infection is regarded as the most severe viral hepatitis due to rapid progression into cirrhosis and hepatocellular carcinoma. According to the WHO,it is estimated that 15 to 20 million people worldwide are chronically infected with HDV. The WHO 2024 guidelines for the prevention,diagnosis,care and treatment for people with chronic hepatitis B infection recommend reflecting test for HDV infection in populations that are hepatitis B surface antigen (HBsAg) positive,where it is practical. At present,there are no approved drugs for the treatment of chronic HDV infection in China and in the U. S..

About Libevitug (HH-003): Libevitug is an innovative anti-HBV/HDV neutralizing antibody specifically targeting the pre-S1 domain of the viral large envelope protein. It blocks the binding of HBV and HDV to their receptor NTCP,thereby preventing the virus from entering hepatocytes and neutralizing HBV/HDV infection infection.

About Huahui Health Ltd. (HHHbio)：

Founded in 2015,Huahui Health Ltd. (HHHbio) is committed to developing innovative therapies for liver diseases and oncology,with a focus on chronic hepatitis B and D (HBV and HDV),two of the world's most prevalent and devastating infectious diseases. Leveraging deep expertise in disease biology and protein engineering,we have further expanded our pipeline to include multiple first- and best-in-class candidates in the area.

Guided by our core values—Innovation,Truth-Seeking,and Collaboration—we strive to become a globally respected leader in biopharmaceuticals.

https://www.huahuihealth.com