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Bepirovirsen accepted for review in China
GSK plc announced that China's National Medical Products Administration has accepted for review bepirovirsen, an investigational treatment for chronic hepatitis B, which affects an estimated 75 million people in China. This submission is supported by positive Phase III B-Well trial results demonstrating statistically significant functional cure rates, a significant improvement over the current 1% cure rate with standard of care. Bepirovirsen, which previously received Breakthrough Therapy designation in China, aims to offer a functional cure for chronic hepatitis B, a leading cause of liver cancer. Disclaimer*
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[{"type":"text","content":"\n\n30th March 2026, London UK\n \nBepirovirsen accepted for regulatory review in China as a potential first-in-class functional cure for chronic hepatitis B\n \n· Submission supported by statistically significant and clinically meaningful functional cure rates in pivotal Phase III B-Well trials\n· An estimated 75 million people in China live with chronic hepatitis B[1], a leading cause of liver cancer[2]\n· Bepirovirsen granted Breakthrough Therapy designation\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration (NMPA) has accepted for review a new drug application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO), for the treatment of adults with chronic hepatitis B (CHB).\n \nChronic hepatitis B is a major public health challenge, affecting more than 250 million people worldwide and an estimated 75 million people in China1. The current standard of care - typically nucleos(t)ide analogues - often requires lifelong therapy and the functional cure rates remain low, typically only 1%.[3] Functional cure occurs when the hepatitis B virus DNA and viral protein - hepatitis B surface antigen (HBsAg) - are undetectable in the blood for at least 24 weeks after stopping all treatment, indicative of the disease being controlled by the immune system without medication. Functional cure is associated with significant reduction in the risk of long-term liver complications, including liver cancer.[4] Each year, in China, approximately 450,000 deaths are caused by CHB1. \n \nThe regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 Phase III trials, where bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone across all ranked endpoints, including in patients with lower baseline HBsAg levels where an even greater effect was observed. Bepirovirsen demonstrated an acceptable safety and tolerability profile consistent with previous studies. These data will be presented at a congress and submitted for scientific peer-reviewed publication in 2026.\n \nBepirovirsen was granted Breakthrough Therapy ...