GSK enlists local aid for Chinese rollout of hep B drug

 China will be a big market for GSK's chronic hepatitis B (CHB) treatment bepirovirsen, and the company has enlisted the aid of Sino Biopharm to help it roll out the drug there as quickly as possible if it gets approval.

China's National Medical Products Administration (NMPA) started a review in March of bepirovirsen, an investigational antisense oligonucleotide (ASO) that GSK has developed in collaboration with Ionis, for the treatment of adults with CHB. An estimated 75 million people are living with CHB in China, accounting for a sizeable part of the global patient population of around 250 million.

The agreement with Sino Bio, via its subsidiary Chia Tai Tianqing Pharma (CTTQ), allies GSK with a company that is one of China's foremost liver disease companies, with a portfolio of medicines and a broad commercial footprint that covers more than 5,000 medical centres across the country.

For an initial period of five and a half years, CTTQ will be responsible for importation, distribution, hospital access, and promotional and non-promotional activities for bepirovirsen in mainland China, while GSK will hold the drug's license and retain responsibility for regulatory, quality, pharmacovigilance, and global medical strategy.

There's another side to the alliance as well, with GSK taking an option on "early-stage pipeline assets" at Sino Biopharm that might have potential for development outside China. The Chinese firm's pipeline listing includes four clinical-stage hepatitis B drugs, including small-molecule agonists targeting TLR-7 and TLR-8, a capsid assembly modulator, and an siRNA candidate.

"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 the president of GSK's international business, Mike Crichton.

Bepirovirsen is being tipped as a first-in-class new treatment for CHB that is able to achieve a significantly higher functional cure rate than placebo when added to standard care. While not a complete cure that eradicates HBV from the body, achieving a functional cure is associated with a significant reduction in the risk of long-term liver complications, including liver cancer, as well as all-cause mortality.

China's current five-year plan for hepatitis B, which started in 2025, has set out functional cure as the treatment goal. The NMPA has awarded both breakthrough designation and priority review to bepirovirsen.

Analysts at William Blair have previously suggested that the market for an HBV cure could be around the same size as for hepatitis C virus (HCV), which peaked at around $10 billion a year, although that proved to be a short-lived bonanza, with sales falling sharply as the pool of eligible chronic hepatitis C patients reduced.

GSK has high hopes for bepirovirsen, modelling peak sales of around £2 billion ($2.75 billion) a year, which would make it a big contributor to the company's target of driving annual revenues above £40 billion by 2031.

https://pharmaphorum.com/news/gsk-enlists-local-aid-chinese-rollout-hep-b-drug