What happened
At an Asian liver conference in Singapore from Aug 31 to Sep 5, researchers unveiled the first global look at Chinese patient data from the Phase III B-Well study of the antisense oligonucleotide drug Bepirovirsen. The results showed that functional cure rates in Chinese patients with chronic hepatitis B could reach as high as 61%, with efficacy and safety patterns matching the global profile.
The response varied by baseline hepatitis B surface antigen levels. Cure rates climbed from 35% for patients with baseline HBsAg between 100 and 1000 IU/mL to 44% for those between 100 and 500 IU/mL, and hit 61% for patients whose baseline fell between 100 and 200 IU/mL. By contrast, the placebo group saw a 0% functional cure rate.
The global first approval of Bepirovirsen as a functional cure for chronic hepatitis B came in Japan just days before the data release. GSK had already filed another application in China in late May, and via a strategic partnership, China Biopharmaceutical's subsidiary Chia Tai Tianqing is set to handle import, distribution, hospital access and promotion in mainland China.
Why it matters
These data suggest that a defined subset of Chinese patients with lower HBsAg levels could potentially end lifelong antiviral therapy after a finite course of treatment. For the roughly 75 million chronic HBV carriers in China, that possibility marks a meaningful advance over conventional nucleos(t)ide analogues, which rarely achieve functional cure.
Yet the high response is limited to an advantaged population, and real-world deployment faces several practical walls. The expected high upfront cost of this novel small nucleic acid therapy, the outcome of medical insurance negotiations, and weak quantitative HBsAg testing capacity at grassroots hospitals are all factors that will determine how many of the estimated 20-30 million treatment-needing chronic hepatitis B patients can actually access the breakthrough.
Key facts
Bepirovirsen is an antisense oligonucleotide drug tested in the global Phase III B-Well study; Chinese subgroup data were presented for the first time at an Asian hepatology meeting in Singapore from Aug 31 to Sep 5.
The functional cure rate in Chinese patients reached up to 61% when baseline HBsAg was between 100 and 200 IU/mL, while the placebo group had a 0% rate.
Bepirovirsen received its world-first approval in Japan on Aug 24 as a functional cure for chronic hepatitis B in patients previously treated with nucleos(t)ide analogues for at least six months.
About 75 million people in China are chronic HBV carriers, with roughly 20-30 million needing treatment, according to a CDC-led 2020 survey cited in the report.
Traditional nucleos(t)ide analogue therapy keeps most patients virally suppressed at low annual cost, but its real-world functional cure rate is less than 1%.
What to watch next
Whether Bepirovirsen's approval in mainland China arrives around the industry's forecast of the first half of 2027, and whether Chinese medical insurance negotiations will make the drug affordable beyond a narrow group of wealthier patients.
Domestic efforts in antisense and siRNA approaches, including AHB-137 and HRS-5635, are advancing into Phase III trials; they may lag Bepirovirsen in timeline but could enter the market later with cost advantages.
How hospitals and public health systems strengthen screening and multidisciplinary management, which experts say is essential for identifying the advantaged patients who would benefit most and for improving the overall diagnosis and treatment of chronic hepatitis B in China.