GSK expands China footprint through Sino Biopharmaceutical partnership for Hepatitis B therapy bepirovirsen

CHINA—Britain’s GSK has entered into a collaboration with Hong Kong-listed Sino Biopharmaceutical to expand access to its investigational chronic hepatitis B therapy, bepirovirsen, in mainland China, thereby strengthening its presence in one of the fastest-growing pharmaceutical markets.

Under the agreement, Sino’s subsidiary, Chia Tai Tianqing Pharmaceutical (CTTQ), will handle importation, distribution, hospital access, and promotion of bepirovirsen, while GSK will retain the marketing authorisation and oversee regulatory, quality, pharmacovigilance, and global medical strategy functions.

CTTQ will also purchase a supply of bepirovirsen for an initial period of five and a half years, while GSK will record product sales from the arrangement, though the companies are not disclosing the financial value of the deal.

The collaboration allows GSK to evaluate select early-stage assets from Sino Biopharmaceutical’s pipeline for partnerships outside China, widening future opportunities between the two companies.

Leveraging local commercial scale

CTTQ brings commercial reach in China’s liver disease market, with operations spanning more than 5,000 medical centres, and established as a key player in hepatitis B care through its broad portfolio and diagnostic initiatives.

By combining GSK’s research-driven innovation with CTTQ’s established infrastructure, companies accelerate patient access to bepirovirsen once it receives regulatory approval in China.

Bepirovirsen represents a first-in-class therapeutic candidate to achieve a functional cure in chronic hepatitis B by reducing viral DNA replication, lowering hepatitis B surface antigen levels, and enhancing immune response.

The drug remains under priority regulatory review in China following Breakthrough Therapy designation in August 2021 and Priority Review in April 2026.

Regulatory submissions are supported by the phase III B-Well 1 and B-Well 2 clinical trials, which demonstrate significant functional cure rates in patients with chronic hepatitis B.

Addressing chronic hepatitis B burden

Globally, chronic hepatitis B affects 75 million people in China and more than 250 million worldwide, contributing to liver disease, including hepatocellular carcinoma and long-term liver complications.

According to estimates, more than one million deaths occurred in 2022 due to chronic hepatitis B-related complications, underscoring the urgency for improved treatment options and scalable functional cure strategies.

Regulatory progress and clinical strategy

GSK expects to launch bepirovirsen in select markets this year and anticipates peak annual sales exceeding £2 billion (US$2.5 billion), reflecting a strategic shift toward expanding its speciality medicine portfolio.

The company continues partnerships in China, including a $500 million collaboration with Hengrui and oncology-focused agreements with Hansoh Pharma in 2023, strengthening its presence in Asia’s largest pharmaceutical market.

Mike Crichton, President International at GSK, said combining scientific innovation with CTTQ’s local execution capability will deliver broader access to treatments addressing one of China’s most pressing healthcare priorities.

Meanwhile, China’s National Action Plan for Viral Hepatitis (2025–2030) emphasizes functional cure as a treatment goal, aligning with emerging therapies such as bepirovirsen to achieve sustained viral suppression after treatment cessation.