GSK Antisense Oligonucleotide Bepirovirsen Wins FDA Approval; Chronic Hepatitis B Filing Under CDE Priority Review

GSK's antisense oligonucleotide bepirovirsen (brand name Hibsago) has received full FDA approval, in combination with nucleos(t)ide analogue reverse transcriptase inhibitors, for adults with chronic hepatitis B without cirrhosis. The drug's marketing application has been submitted to the CDE and placed on the priority review list. The partnership model in which a multinational company holds the marketing license while a domestic company handles commercialization is extending from off-patent products to first-in-class drugs not yet approved in China.