GSK Showcases Breakthrough Innovation Bepirovirsen and Strategic Collaboration at CIIE to Advance a 'Future Without Hepatitis B'

According to statistics, there are approximately 75 million hepatitis B virus (HBV) carriers in China.^[1], China remains a "major hepatitis B country" on a global scale. In recent years, due to the widespread use of vaccines and other preventive measures, significant progress has been made in the prevention and control of hepatitis B, with infection rates showing a downward trend. However, given the large population base, the number of new patients remains considerable, and "existing patients" are gradually becoming the focus of prevention and treatment efforts.

As a pioneer in the global hepatitis B prevention and treatment field, GlaxoSmithKline (GSK) is leveraging significant innovations as a starting point, aiming to reshape today's landscape of chronic hepatitis B treatment and lead Chinese patients into a "new chapter of treatment."

On November 7, at the 7th China International Import Expo, GSK presented the latest updates on its highly anticipated investigational innovative drug, Bepirovirsen.

At the same time, during the themed event "For a Future Without Hepatitis B," authoritative experts and representatives from the China Foundation for Hepatitis Prevention and Control gathered at the GSK booth to have in-depth discussions on topics such as the current state and future outlook of hepatitis B treatment, and accelerating the path to a cure for hepatitis B.

"A Future Without Hepatitis B" is Gradually Becoming a Reality.

Memorandum of Strategic Cooperation for the Long-term Management Program of Chronic Hepatitis B Disease Signed

"Functional Cure"May Rewrite the Treatment Landscape for Chronic Hepatitis B

In contrast to the large patient base, the diagnosis rate and treatment rate for chronic hepatitis B in China are only 22% and 15%, respectively. As a progressive disease, if chronic hepatitis B is not effectively controlled, the condition may further progress to liver cirrhosis, liver failure, or liver cancer.^[2]。

"At present, oral antiviral drugs are one of the main treatments for chronic hepatitis B, but this treatment has limitations, and patients generally require long-term or even lifelong antiviral therapy."Professor You Hong from Beijing Friendship Hospital, Capital Medical University introduced"This also means that they often have to bear multiple burdens such as treatment fatigue, economic pressure, and drug side effects."

At the same time, due to social prejudice and misunderstanding about hepatitis B, coupled with the pressure brought by lifelong medication, many patients have long been bearing the "double burden" on their physical and mental health. It is urgent to "reduce their burden."

From traditional interferons to nucleotide drugs, humanity has "made significant progress" in the fight against hepatitis B, and the goals of hepatitis B treatment have "continued to rise."

Now, realize"Functional Cure"Has become a phased goal in hepatitis B treatment, which means that although the virus will not be completely eradicated from the body, the viral load in the blood is so low that it remains undetectable.^[3], achieving long-term immunological control without the need for medication can not only help patients摆脱长期服药的负担, but also significantly reduce the risk of subsequent disease progression, greatly improving quality of life.

GSK, which has been deeply involved in the field of hepatitis B for 30 years, introduced the latest information on its investigational new drug Bepirovirsen at this CIIE, which is undoubtedly a significant breakthrough in the field of hepatitis B.

Bepirovirsen has been granted "Breakthrough Therapy Designation" by the CDE and is currently in global Phase III clinical trials. It is expected to become the first innovative drug approved with functional cure as the clinical endpoint, reshaping the current treatment landscape for chronic hepatitis B and offering options and hope for achieving functional cure.

"Due to factors such as the development process of diagnosis and treatment, social awareness, and more, the overall standardized treatment rate for patients with chronic hepatitis B is currently low, making it difficult to effectively control disease progression."Professor You Hong explained"The research direction of 'functional cure' is expected to become a breakthrough point, enhancing patients' treatment adherence and confidence. As innovative therapies continue to make progress, the vast number of chronic hepatitis B patients are getting closer to 'seeing' a normal life."

"Yu" Road Companions,Promote the Whole-course Management of Hepatitis B

The challenges of hepatitis B prevention and treatment go beyond drugs, as the long-term disease management of patients also urgently needs improvement. In 2016, the World Health Assembly proposed the goal of "eliminating the public health threat of viral hepatitis by 2030." In China, the comprehensive management of hepatitis B still faces many difficulties.

Currently, the main challenges faced by patients include low diagnostic rates and treatment adherence, insufficient standardization in monitoring treatment effectiveness, and inadequate monitoring of early complications. Many patients, even after entering treatment, may struggle to maintain effective management due to adherence issues and resource limitations.

Drug accessibility is a key link in solving the whole-process management challenge. From the launch of the first oral antiviral drug, to the introduction and continuous updates of the *Guidelines for the Prevention and Treatment of Chronic Hepatitis B*, to the successive market entries of various innovative drugs and their inclusion in the National Essential Medicines List, the progress of standardized treatment for hepatitis B has been continuously advancing, and drug accessibility has been steadily improving.

"For many years, China has consistently adhered to the strategy of 'prevention first, combining prevention and treatment' for hepatitis B, emphasizing early detection, early treatment, and personalized medical care, which has played a crucial role in curbing the progression of hepatitis B and reducing the infection rate."Wang Yu, Chairman of the China Foundation for Hepatitis Prevention and Control, said。

Facing "existing patients," how to promote the early diagnosis of hepatitis B, enhance standardized treatment, and thereby prevent disease progression is another crucial challenge in the prevention and control of hepatitis B.

At this year's CIIE, GSK partnered with the China Foundation for Hepatitis Prevention and Control to jointly sign a memorandum of strategic cooperation for the long-term management project of chronic hepatitis B. The initiative is dedicated to enhancing comprehensive disease management, achieving full-chain management from in-hospital to out-of-hospital care, improving diagnostic and treatment outcomes as well as patient compliance, and advancing the level of hepatitis B prevention and control.

Wang Yu said"Compared with many previous ecological cooperations, this project has made a greater breakthrough."This project empowers patient management through 'digital and intelligent means,' covering the entire cycle from improving awareness, enhancing adherence, monitoring disease progression, standardizing follow-up management, to exploring predictions of disease progression."To optimize patient health management with modern technology, promote the integration of scientific research and clinical practice, advance public health policies, and contribute to the goal of 'Eliminating viral hepatitis as a public health threat by 2030.'"

Thick Accumulation, Thin Emission: Towards a "Future Without Hepatitis B"

Whether it is actively promoting the development of innovative drugs such as Bepirovisen, or upgrading cooperation with the China Foundation for Hepatitis Prevention and Control, these initiatives are further evidence of GSK's long-term commitment to the field of hepatitis B.

Yang Haosheng, Head of Medical Affairs for Infectious Diseases at GSK China, introduced"GSK has been deeply engaged in the field of hepatitis B in China for thirty years, always committed to innovation-driven efforts to provide patients with effective prevention and treatment solutions. From the approval and launch of the recombinant hepatitis B vaccine in China in 1994 to the present day where Bepirovisen makes 'functional cure' possible, GSK continues to expand the boundaries of prevention and treatment to meet the needs of Chinese patients."

Currently, there are three treatment milestones for anti-hepatitis B virus therapy in clinical practice: partial cure, functional cure, and complete cure. However, existing technologies cannot yet achieve a complete cure, so the industry has high hopes for the therapeutic prospects of Bepirovirsen.

Yang Haosheng saidThe Phase IIb B-Clear study of Bepirovirsen has yielded promising results, with global synchronized R&D and its implementation in China being the next key focus.

For promoting the local implementation of innovative achievements in China,Zhang Ning, Vice President of GSK and Head of China Specialty Medicines Business, also expressed confidence."GSK always pays high attention to the accessibility of innovation, continuously accelerating the R&D and introduction of innovative products, striving to bring more innovative medicines to the Chinese people more quickly." Zhang Ning further stated, "Of course, addressing the 'shortcomings' in hepatitis B prevention and treatment cannot be achieved without the joint efforts of all sectors of society. In the future, GSK will continue to collaborate with ecosystem partners to explore innovative models and empower full-path disease management, contributing to the realization of a 'future without hepatitis B.'"

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