GSK Showcases Investigational Hepatitis B Drug GSK836 at CIIE, Committed to a 'Hepatitis B-Free Future' in China

Hepatitis B has consistently ranked among the top three notifiable infectious diseases in China, and the situation for hepatitis B prevention and control in China remains severe. The World Health Organization (WHO) has proposed the goal of "Eliminating viral hepatitis by 2030," and achieving a cure for hepatitis B has been a focal point in the global healthcare industry.

At the 4th CIIE, GSK, the global leader in hepatitis B treatment, fully showcased its comprehensive solutions for the prevention and treatment of hepatitis B, contributing to China's goal of achieving "a future free of hepatitis B."

GSK's New Hepatitis B Drug Aimed at Functional Cure Makes Appearance

From the launch of the first oral antiviral drug in China in 1999 to now possessing a leading portfolio of products covering antiviral therapies and vaccines, GSK has been deeply rooted in China for over 20 years in the field of hepatitis B and antiviral treatment. It has consistently committed itself to providing effective treatment options for patients, benefiting more than one million Chinese patients with hepatitis B.

At this CIIE, the GSK booth fully showcased innovative hepatitis B products. Notably, GSK’s investigational new hepatitis B drug, GSK836, was particularly worth mentioning.

According to Pauline Ng, Medical Director of GSK China's Prescription Drugs, GSK836 is an antisense oligonucleotide that binds to the mRNA used for expressing viral antigens (pathogenic proteins) in liver cells infected with HBV. It is then degraded by ribonuclease H, leading to premature transcription termination and suppression of the levels of the viral protein HBsAg, with the aim of achieving a functional cure for hepatitis B.

Chronic hepatitis B is a progressive and serious disease, and current treatment options cannot completely eradicate the virus. Oral antiviral drugs are one of the main treatments for hepatitis B. These drugs can inhibit the replication of the hepatitis B virus, thereby slowing disease progression and reducing the risk of liver cancer.

"With the increasing number of antiviral drugs, what goals can hepatitis B treatment achieve? According to the guidelines, the current goal is to achieve functional cure, also known as clinical cure, which is characterized by gradually normalized liver function, normal hepatic biochemical indicators, improvement in liver tissue lesions; undetectable hepatitis B virus; and seroclearance of hepatitis B surface antigen. However, under the existing conditions, only a relatively small number of patients can achieve a functional cure, and the majority of patients still require long-term oral antiviral therapy," introduced Professor Wang Hui, Chief Physician of the Department of Infectious Diseases at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and the incumbent Vice Chairperson of the Infectious Disease Branch of the Shanghai Medical Association.

It is reported that, in order to help more patients achieve functional cure or clinical cure, many scientists and enterprises at home and abroad are striving to develop new drugs. Currently, there are many drugs under research, including some antisense oligonucleotides, which bind to viral mRNA and prevent the production of viral proteins; siRNAs, which interfere with and destroy viral RNA; and those that inhibit surface antigen synthesis, among others. Many such drugs are currently in Phase I and Phase II clinical development.

The latest research shows that GSK's investigational new drug, GSK836, can significantly reduce hepatitis B surface antigen (HBsAg) levels and hepatitis B virus DNA load after 4 weeks of treatment. In August this year, the drug was included in the list of breakthrough treatment varieties by the Center for Drug Evaluation (CDE) in China, with the potential to achieve "functional cure" for chronic hepatitis B, bringing new hope to a large number of patients with chronic hepatitis B.

Multiple Measures to Help China Achieve "A Future Without Hepatitis B"

In recent years, thanks to the efforts of all parties, significant achievements have been made in the prevention and control of hepatitis B in China. However, due to the large population base, China remains a country with a high burden of hepatitis B. Data shows that there are approximately 70 million people in China who are chronically infected with the hepatitis B virus (HBV), of which about 20 to 30 million are chronic hepatitis B patients. According to the data from the "2020 China Health Statistics Yearbook," the number of new cases of hepatitis B in China exceeded one million in 2019. Moreover, since early symptoms of hepatitis B are not obvious, it is often neglected by patients, leading to delayed treatment. This can gradually progress to liver cirrhosis or even liver cancer, posing a serious threat to the health of patients.

Overall, China's hepatitis B diagnosis and treatment rates are still far from the WHO requirements. The diagnosis rate for chronic hepatitis B in China is only 22% (VS 90%), and the treatment rate is just 17% (VS 80%). There is significant room for improvement in the diagnosis and treatment rates of hepatitis B.

From the launch of the first oral antiviral drug for chronic hepatitis B in China to the 2014 launch of the oral medication "Viread," Huang Jingxuan, Head of GSK China's Core Prescription Business Unit, introduced: "GSK is committed to providing the most innovative drugs for Chinese hepatitis B patients and helping improve the prevention and treatment of hepatitis B in China. To benefit more patients, we also actively participate in medical insurance negotiations so that effective drugs can reach a larger patient population. At the same time, we continuously conduct research and exploration. In 2019, more pregnancy safety data were added to the Viread instructions, offering additional data references for the safe treatment of pregnant patients with hepatitis B. Moreover, we continue to develop new drugs and expand the boundaries of hepatitis B treatment."

It is worth noting that in recent years, GSK has actively participated in grassroots efforts for the prevention and treatment of hepatitis B, committing to extend standardized antiviral therapy for hepatitis B to deeper, broader, and more needed regions and populations, improving the local status of hepatitis prevention and treatment.

Huang Jingxuan stated that due to the imbalance of medical resources between regions, the professional capabilities in grassroots and underdeveloped western areas remain relatively weak, with a persistently high rate of hepatitis B virus carriers and viral hepatitis cases. Therefore, GSK not only strives to improve the accessibility of antiviral treatments but also partners with various forces by funding relevant foundations to promote doctor education, patient and public awareness. GSK is contributing to raising the overall level of standardized prevention and treatment of hepatitis B in China, ultimately helping to achieve "a future free of hepatitis B."