Biopharmaceutical company GSK plc (LSE/NYSE: GSK) announced on Monday that it has entered an exclusive strategic collaboration with Sino Biopharmaceutical Limited through subsidiary Chia Tai Tianqing Pharmaceutical Group Co, Ltd to support the launch of bepirovirsen, its investigational chronic hepatitis B treatment, in mainland China.
Bepirovirsen, a potential first-in-class antisense oligonucleotide therapy for chronic hepatitis B, is currently under priority regulatory review in China following positive phase III trial results. The treatment has also received Breakthrough Therapy designation in China, alongside Fast Track and Breakthrough designations from the US Food and Drug Administration and SENKU designation in Japan.
Under the agreement, Chia Tai Tianqing Pharmaceutical Group will manage importation, distribution, hospital access and promotional activities for bepirovirsen across mainland China, leveraging its commercial network of more than 5,000 medical centres. GSK will retain marketing authorisation, regulatory, quality and pharmacovigilance responsibilities and will record sales of the product supplied through the collaboration.
The initial agreement runs for 5.5 years and also gives GSK the option to review selected early-stage pipeline assets within SBP Group for potential collaboration opportunities outside China.
GSK said the partnership targets a major unmet medical need, with chronic hepatitis B affecting around 75 million people in China and remaining a national healthcare priority. Functional cure, defined as sustained undetectable hepatitis B virus DNA and surface antigen levels after treatment cessation, has been identified as a key treatment objective under China's National Action Plan for the Prevention and Treatment of Viral Hepatitis 2025-2030.
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