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Rachel V Thomas

Libevitug: China Rolls Out World's First Hepatitis D Monoclonal Antibody Drug

China has become the world’s first country to approve a monoclonal antibody drug called Libevitug to treat <a href="https://www.healthandme.com/health/hepatitis">hepatitis</a> D — a severe, chronic liver disease.

The drug, which was rolled out at a Beijing hospital recently, was granted conditional approval by China's National Medical Products Administration in January 2026 following priority review, Science and Technology Daily reported. 

Libevitug is a monoclonal antibody developed by a team from Tsinghua University and the Beijing-based biopharmaceutical company Huahui Health. 

It works by blocking hepatitis B and D viruses from entering liver cells.

Clinical trials on Libevitug demonstrated significant efficacy in virological response and normalization of liver function, with particularly notable benefits for patients with cirrhosis. 

<h2>What Is Hepatitis D? What Are The Key Symptoms? </h2>

Hepatitis D, or HDV, is different from the others—it can't infect the liver by itself. It only exists in those already infected with hepatitis B, employing the outer shell of the HBV virus to replicate. 

When HBV and HDV infect the liver concurrently (a co-infection) or if HDV is contracted later on superimposition of pre-existing HBV (a superinfection), the immune system is twice assaulted. The liver has to cope with more intense inflammation, resulting in more rapid fibrosis progression and a much increased risk of cirrhosis and hepatocellular carcinoma. 

In individuals with co-infection, liver injury is more severe, and complications arise years sooner than in HBV mono-infection. There are no specific therapies for HDV currently, and its management relies mostly on the control of hepatitis B. 

It is also possible to prevent HBV infection and thereby hepatitis D by vaccination. Antiviral therapy and close follow-up can likewise decrease the chances of serious HDV complications in those already infected with HBV. 

Simultaneous infection with HBV and HDV can lead to mild-to-severe hepatitis, with signs and symptoms typically appearing 3–7 weeks after initial infection and include: 

<ul><li>fever, </li><li>fatigue, </li><li>loss of appetite, </li><li>nausea, </li><li>vomiting, </li><li>dark urine, </li><li>pale-colored stools, </li><li>jaundice (yellow eyes)</li><li>fulminant hepatitis.</li></ul>

Also read: <a href="https://www.healthandme.com/health-wellness/hepatitis-on-rise-in-india-what-is-causing-it-article-151035337" data-type="tilCustomLink">Hepatitis On Rise In India: What Is Causing It?</a>

Of the over 254 million chronic hepatitis B carriers worldwide, approximately 5 percent are co-infected with the hepatitis D virus, and patients with co-infection have long lacked effective targeted therapies. 

Clinical trials for the drug began in 2018, with an international multi-center study launched in 2023 among patients with chronic co-infection. 

The drug previously received "Breakthrough Therapy Designation" from both the Center for Drug Evaluation (CDE) of the China NMPA and the US Food and Drug Administration (FDA). 

Also read: <a href="https://www.healthandme.com/health-wellness/hepatitis-a-to-e-how-each-virus-affects-your-liver-article-152366961" data-type="tilCustomLink">Hepatitis A To E: How Each Virus Affects Your Liver?</a>

"Libevitug demonstrates outstanding clinical efficacy and significantly improves liver stiffness, with particularly remarkable efficacy in patients with HBV/HDV-related cirrhosis," stated Professor Niu Junqi, principal investigator of the Libevitug trial from the First Hospital of Jilin University. 

"This drug aligns with the core objectives of China's Action Plan for the Prevention and Control of Viral Hepatitis (2025–2030), which aims to improve diagnosis and treatment rates for viral hepatitis and reduce the incidence of liver cancer and mortality," Junqi added. 

Junqi noted that Libevitug is expected to effectively lower the risk of disease progression to advanced severe diseases such as liver cancer, drive the diagnosis and treatment of HDV in China, as well as advance the goal of eliminating viral hepatitis as a public health problem by 2030.

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China has become the world’s first country to approve a monoclonal antibody drug called Libevitug to treat hepatitis D — a severe, chronic liver disease. The drug, which was rolled out at a Beijing hospital recently, was granted conditional approval by China's National Medical Products Administration in January 2026 following priority review, Science and Technology Daily reported. Libevitug is a monoclonal antibody developed by a team from Tsinghua University and the Beijing-based biopharmaceutical company Huahui Health. It works by blocking hepatitis B and D viruses from entering liver cells. Clinical trials on Libevitug demonstrated significant efficacy in virological response and normalization of liver function, with particularly notable benefits for patients with cirrhosis. What Is Hepatitis D? What Are The Key Symptoms?  Hepatitis D, or HDV, is different from the others—it can't infect the liver by itself. It only exists in those already infected with hepatitis B, employing the outer shell of the HBV virus to replicate.  When HBV and HDV infect the liver concurrently (a co-infection) or if HDV is contracted later on superimposition of pre-existing HBV (a superinfection), the immune system is twice assaulted. The liver has to cope with more intense inflammation, resulting in more rapid fibrosis progression and a much increased risk of cirrhosis and hepatocellular carcinoma.  In individuals with co-infection, liver injury is more severe, and complications arise years sooner than in HBV mono-infection. There are no specific therapies for HDV currently, and its management relies mostly on the control of hepatitis B.  It is also possible to prevent HBV infection and thereby hepatitis D by vaccination. Antiviral therapy and close follow-up can likewise decrease the chances of serious HDV complications in those already infected with HBV.  Simultaneous infection with HBV and HDV can lead to mild-to-severe hepatitis, with signs and symptoms typically appearing 3–7 weeks after initial infection and include: fever, fatigue, loss of appetite, nausea, vomiting, dark urine, pale-colored stools, jaundice (yellow eyes)fulminant hepatitis.Also read: Hepatitis On Rise In India: What Is Causing It?How Does Libevitug Work?  Of the over 254 million chronic hepatitis B carriers worldwide, approximately 5 percent are co-infected with the hepatitis D virus, and patients with co-infection have long lacked effective targeted therapies. Clinical trials for the drug began in 2018, with an international multi-center study launched in 2023 among patients with chronic co-infection. The drug previously received "Breakthrough Therapy Designation" from both the Center for Drug Evaluation (CDE) of the China NMPA and the US Food and Drug Administration (FDA). Also read: Hepatitis A To E: How Each Virus Affects Your Liver?"Libevitug demonstrates outstanding clinical efficacy and significantly improves liver stiffness, with particularly remarkable efficacy in patients with HBV/HDV-related cirrhosis," stated Professor Niu Junqi, principal investigator of the Libevitug trial from the First Hospital of Jilin University. "This drug aligns with the core objectives of China's Action Plan for the Prevention and Control of Viral Hepatitis (2025–2030), which aims to improve diagnosis and treatment rates for viral hepatitis and reduce the incidence of liver cancer and mortality," Junqi added. Junqi noted that Libevitug is expected to effectively lower the risk of disease progression to advanced severe diseases such as liver cancer, drive the diagnosis and treatment of HDV in China, as well as advance the goal of eliminating viral hepatitis as a public health problem by 2030.

libevitug: china rolls out world's first hepatitis d monoclonal antibody drug

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