Recently, GSK announced that two of its innovative drug pipelines, Daplusiran/Tomligisiran and Bepirovirsen, have been approved for clinical trials by the Center for Drug Evaluation of the National Medical Products Administration on November 20, 2024, following their successful inclusion in the pilot project for the review and approval of innovative drug clinical trials in Shanghai, China.
In July 2024, the National Medical Products Administration approved the "Pilot Work Plan for Optimizing and Innovating Clinical Trial Review and Approval of Drugs," aiming to explore the establishment of a working system and mechanism to enhance the quality and efficiency of drug clinical trials. In the same month, the Shanghai Municipal Government issued documents such as the "Several Opinions on Supporting the Full-chain Innovative Development of the Biomedical Industry" to facilitate the R&D and market entry of innovative drugs and medical devices. The successful approval of Daplusiran/Tomligisiran and Bepirovirsen not only demonstrates GSK's active response to policy calls and deep involvement in building China’s pharmaceutical innovation ecosystem but also serves as another testament to GSK's efforts in accelerating innovation R&D to benefit more patients with chronic hepatitis B and contribute to the realization of "Healthy China 2030."
Director of the Department of Infectious Diseases at Huashan Hospital, Fudan UniversityProfessor Zhang WenhongSaid: "We are very pleased to see that the B-UNITED study has been successfully included in the pilot project for clinical trial review and approval in Shanghai. Based on previous research data, we are highly anticipating that the sequential treatment regimen of the two drugs will offer patients a new treatment option, bringing us one step closer to achieving the goal of 'functional cure.' We look forward to the rapid initiation of the B-UNITED clinical study under the promotion of relevant policies, allowing more patients to benefit sooner from breakthroughs in medical innovation."
Currently, chronic hepatitis B virus infection remains one of the major public health issues in China. Over the past three decades, China has made significant progress in reducing the incidence of hepatitis B. However, due to the large base of infected individuals, eliminating hepatitis B still poses a major challenge. Data shows that as of 2022, there are nearly 80 million people with chronic HBV infections in China.1Disease progression in chronic hepatitis B infection can lead to life-threatening complications such as liver cirrhosis, decompensated liver disease, end-stage liver disease, and hepatocellular carcinoma (HCC), imposing a significant burden on both patients and society. Data released by the National Cancer Center of China showed that in 2022, the number of new cases and deaths from primary liver cancer in China ranked 4th and 2nd, respectively, among all types of cancers.2
In China, GSK consistently focuses on unmet therapeutic needs, continuously advancing the research, development, and implementation of innovative therapies. As a leader in hepatitis B and antiviral treatments, GSK constantly expands the boundaries of hepatitis B therapy, redefining the treatment paradigm for chronic hepatitis B.
Vice President,Hui-Ming Yu, General Manager of GSK ChinaSaid: "GSK deeply feels the policy support from the Chinese government in drug innovation research in recent years, and China has become a fertile ground for global pharmaceutical innovation. We look forward to the B-UNITED study being launched in China as soon as possible and being completed with high quality and high standards. In the future, in the field of liver disease and antiviral treatment, GSK will continue to accelerate the introduction of innovative therapies into China with practical actions.'A Future Without Hepatitis B'"And continue to strive."
About Functional Cure
The current standard treatment for chronic hepatitis B isNucleos(t)ide AnaloguesPrimarily, many patients require lifelong treatment to control viral replication; therefore, there is an urgent need for therapies that can achieve functional cures. Functional cure of chronic HBV infection is defined as sustained negativity for HBsAg after cessation of treatment, with or without the appearance of anti-HBs, HBV DNA below the lower limit of detection, and normal liver biochemical indices.3
About the B-UNITED Study
B-UNITED is a Phase IIb, multicenter, randomized, partially placebo-controlled, double-blind clinical trial designed to evaluate the safety and efficacy of Daplusiran/Tomligisiran followed by Bepirovirsen in patients with chronic hepatitis B (CHB) receiving nucleos(t)ide analog (NUC) background therapy.
About Bepirovirsen
Bepirovirsen is an innovative antisense oligonucleotide (ASO) drug. Bepirovirsen received Breakthrough Therapy Designation from China's Center for Drug Evaluation in 2021, the "SENKU (Pioneer) Designation" from Japan’s Ministry of Health, Labour and Welfare in 2024, and "Fast Track" designation from the U.S. FDA.4Bepirovirsen is currently in Phase III clinical trials.
About Daplusiran/Tomligisiran
Daplusiran/Tomligisiran (GSK5637608, DAP/TOM) is a small interfering RNA (siRNA) therapy. DAP/TOM received Breakthrough Therapy Designation from the Center for Drug Evaluation in 2021.
About GSK
GSK is a global biopharmaceutical company with the mission of "uniting science, technology, and talent to push boundaries and overcome diseases together." For more information, please visitwww.gsk.com
References:
1.The Polaris Observatory Collaborators. Global prevalence, cascade of care, and prophylaxis coverage of hepatitis B in 2022: a modelling study. Lancet Gastroenterol Hepatol, 2023, 8(10): 879-907
2. Department of Medical Administration, National Health Commission of the People's Republic of China. Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) [J]. Chinese Journal of Practical Surgery, 2024, 44(4): 361-386.
3. Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)
4.GSK press release 2024 August 28: Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B