SBP to Speed Up Commercialization of GSK's New Hepatitis B Drug in China(Yicai) May 12 -- Sino Biopharmaceutical Group has entered into a strategic partnership with UK pharmaceutical giant GlaxoSmithKline to accelerate the commercialization of bepirovirsen, a new drug for the treatment of chronic hepatitis B, in the Chinese market.
SBP's subsidiary Chia Tai Tianqing Pharmaceutical Group will be responsible for importation, distribution, hospital access, and promotional and non-promotional activities for bepirovirsen in the Chinese mainland, GSK and SBP announced in separate statements yesterday.
CTTQ will purchase bepirovirsen from GSK under agreed supply terms for an initial term of 5.5 years, with the possibility of an extension by mutual agreement. GSK will book sales of bepirovirsen supplied to CTTQ through the collaboration.
GSK will remain the marketing authorization holder and retain responsibility for regulatory, quality, pharmacovigilance, and global medical strategy, and gain the ability to review certain early-stage pipeline assets of SBP to evaluate the potential for collaboration opportunities outside China.
"By combining GSK's innovation with CTTQ's extensive local scale and execution, we want to reach more patients, deliver greater impact, and directly address one of China's most pressing healthcare priorities," said Mike Crichton, international president at GSK.
CTTQ is a Chinese market leader in hepatitis B, with one of the country's most comprehensive liver disease portfolios and a broad commercial footprint covering more than 5,000 medical centers. It has played a significant role in advancing the diagnosis and treatment of hepatitis B in China.
Chronic hepatitis B is a viral infection that can cause both acute and chronic liver disease. It affects more than 250 million people worldwide, causing about 1.1 million deaths each year, based on the World Health Organization Global Hepatitis Report 2024.
Chronic hepatitis B remains a significant public health challenge in China, affecting an estimated 75 million people and causing approximately 450,000 deaths annually, the WHO Global Hepatitis Report 2024 also showed. More than 84 percent of patients with liver cancer in China are associated with chronic hepatitis B infection.
For a long time, patients with chronic hepatitis B have needed to take medicine for life to inhibit viral replication, as existing drugs are difficult to completely remove the virus and achieve a complete cure.
Bepirovirsen is considered the world's first drug that promises a complete cure for chronic hepatitis B. It is a triple-action investigational antisense oligonucleotide, designed to inhibit the replication of viral DNA in the body, suppress the level of hepatitis B surface antigen in the blood, and stimulate the immune system to increase the chances of a durable and sustained response.
In January, two key Phase III clinical trials of bepirovirsen met the primary endpoint, showing clinically meaningful functional cure rates.
GSK has submitted marketing applications for bepirovirsen to regulators in the United States, China, and Japan. The drug has been recognized as a Priority Review and Breakthrough Therapy by China's National Medical Products Administration for priority review.
Editors: Dou Shicong, Futura Costaglione