GSK wins first hepatitis-B approval in Japan

GSK’s bepirovirsen, branded Hibsago, has received its first global approval in Japan for adults with chronic hepatitis B. Japanese regulators describe it as the country’s first and only approved treatment offering a “functional cure”—sustained control without ongoing antiviral therapy.

The approval was supported by the Phase III B-Well 1 and B-Well 2 trials. Among patients with lower hepatitis B surface-antigen levels, about 19% achieved a functional cure. GSK says the drug could offer a finite, roughly six-month treatment course rather than lifelong daily pills, though its precise use depends on the approved patient criteria.

Bepirovirsen is an antisense oligonucleotide designed to reduce viral replication and hepatitis B surface-antigen levels while enhancing the immune response. GSK has also submitted it for review in Europe, and U.S. review has priority status; it is not yet approved in those regions.

For Trodelvy, the European Commission has granted another expanded authorization following a positive EMA/CHMP opinion. The new EU use covers Trodelvy with pembrolizumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 with a CPS of at least 10.

The EU update also includes Trodelvy monotherapy for first-line metastatic or locally advanced TNBC patients who are not candidates for PD-1 or PD-L1 inhibitors. Trodelvy is already authorized in the EU for certain later-line TNBC and HR-positive, HER2-negative breast-cancer settings.

Together, the developments strengthen GSK’s infectious-disease pipeline and expand Gilead’s Trodelvy franchise into earlier breast-cancer treatment, although the hepatitis-B “functional cure” claim reflects a clinical endpoint and does not necessarily mean eradication of the virus in every patient.