The world’s first prescription for ribevirtadalab (Huayounuo®) has been officially issued

March 20, 2026  Source: drugdu 28

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[Beijing, China - March 18, 2026] Huahui Anjian announced that its independently developed, world's first-in-class ribevittamab injection (trade name: Huayounuo), targeting PreS1 of hepatitis B and hepatitis D viruses, was successfully prescribed globally on March 16 at Beijing Friendship Hospital affiliated with Capital Medical University. This marks the official entry of my country's first hepatitis D treatment drug into the clinical application stage. As a domestically developed original drug with independent innovation throughout the entire process from "target mechanism" to "drug creation," ribevittamab will provide a more effective and accessible treatment option for patients with chronic hepatitis D virus (HDV) infection in my country and more countries along the "Belt and Road" initiative.
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Ribevirtamaab received conditional approval from the National Medical Products Administration (NMPA) on January 20, 2026, for the treatment of adult patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis. This product is the world's first approved antibody drug for viral hepatitis and China's first hepatitis D treatment. Furthermore, it previously received Breakthrough Therapy designation from the China Center for Drug Evaluation (CDE) and the U.S. Food and Drug Administration (FDA).
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Dr. Jia Jidong, Director of the Liver Disease Center at Beijing Friendship Hospital, Capital Medical University, explained: “Chronic hepatitis D, caused by co-infection with hepatitis B virus and hepatitis D virus, is the most severe form of chronic viral hepatitis, significantly accelerating liver-related death and the progression of hepatocellular carcinoma. In clinical practice, doctors can combine ribevirtadalafil injection with antiviral therapy for hepatitis B to effectively inhibit the replication of both hepatitis D and hepatitis B viruses, improve liver function, reduce liver stiffness, better control the patient's condition, reduce the risk of cirrhosis and liver cancer, and significantly improve patient prognosis.” (Click “Read the original text” below to view the video report)
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Dr. Chen Bin, CEO of Huahui Anjian, stated, “The successful issuance of the world’s first prescription for ribevitamumab is a model of close integration between basic research and clinical practice, and multi-party collaboration, realizing the transformation of chronic hepatitis D from ‘no available drugs’ to ‘treatable drugs.’ Today is also the 26th National Liver Care Day, and we believe that ribevitamumab will make its due contribution to the theme of ‘curbing cirrhosis and staying away from liver cancer.’ We will fully leverage our strong R&D capabilities and robust end-to-end engine to continuously promote more original Chinese drugs to benefit patients worldwide, contributing Chinese solutions to the goal of eliminating the public health hazard of viral hepatitis by 2030 and promoting the development of global hepatitis prevention and control.”
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Regarding chronic HDV infection
Hepatitis D virus (HDV) is a satellite virus of hepatitis B virus (HBV) that relies on HBV envelope proteins to complete its life cycle. HDV infects hepatocytes by binding to the sodium-taurocholic acid cotransporter (NTCP), a host cell receptor shared with HBV. HDV infection only occurs in cases of concurrent HBV infection. Chronic HBV and HDV co-infection is the most severe form of chronic viral hepatitis, significantly accelerating liver-related death and the progression of hepatocellular carcinoma, resulting in approximately one-sixth of cirrhosis cases and one-fifth of liver cancer cases among chronic hepatitis B patients worldwide. Compared to HBV infection alone, patients co-infected with HBV and HDV have a significantly increased risk of cirrhosis, hepatocellular carcinoma, the need for liver transplantation, and liver-related death. According to the World Health Organization (WHO), approximately 12 million people worldwide are infected with HDV, affecting nearly 5% of chronic HBV carriers. The WHO recommends hepatitis D-related testing and screening in all HBV-positive individuals. Previously, apart from Europe, neither China nor the United States had approved any drugs for the treatment of chronic HDV infection.

Regarding ribevirtadalafil (HH-003)
Ribevirtadalafil is the world's first PreS1 monoclonal antibody drug for hepatitis B / hepatitis D virus (HDV) independently developed by Huahui Anjian Company. Its main mechanism of action is to specifically bind to the PreS1 region on the surface of HDV , blocking the binding of HDV to its receptor NTCP , thereby preventing viral infection or reinfection of hepatocytes. Early-stage research and development of ribevirtadalafil received support from the National Major Project for New Drug Development during the 13th Five-Year Plan period. On January 20, 2026, it received conditional approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with chronic hepatitis D virus (HDV) infection with or without compensated cirrhosis. In 2023 and 2024 , it was granted Breakthrough Therapy Designation ( BTD ) by the China Center for Drug Evaluation ( CDE ) and the US FDA .

https://mp.weixin.qq.com/s/gEN1MRpr7Wh1iFQIkWOZ6g

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