26th Feb 2026 09:42
(Alliance News) - GSK PLC on Thursday reported positive regulatory momentum in Japan and China, where two of its drugs have been accepted for review.
China's National Medical Products Administration has accepted the London-based pharmaceutical firm's Linerixibat for priority review. This should speed up the approval process for the medication, which targets autoimmune liver disease.
Linerixibat is an investigational inhibitor of the ileal bile acid transporter which aims to treats cholestatic pruritus, or itching, in patients with primary biliary cholangitis.
Besides China, marketing applications for the drug are under review in the EU, UK, US and Canada. Linerixibat also has orphan drug designation in the EU, US and Japan, though it is yet to be approved anywhere.
The Chinese application was based on positive findings from a third-phase trial, in which the treatment met primary and key secondary endpoints, showing "sustained improvement" when compared with placebo, GSK noted.
Also on Thursday, the drug developer said its hepatitis B therapy Bepirovirsen had been accepted for review by Japan's Ministry of Health, Labour and Welfare. Bepirovirsen is being assessed "as a potential first-in-class treatment" for the chronic condition, which GSK noted as "a leading cause of liver cancer".
The company licensed Bepirovirsen from US peer Ionis Pharmaceuticals Inc. It is a triple action investigational antisense oligonucleotide, which aims to destroy the genetic components of the hepatitis B virus.
The Japanese application marks GSK's first regulatory filing for the drug, after promising third-phase tests, in which it showed "a statistically significant and clinically meaningful functional cure rate" when paired with standard care, versus standard care alone. That data is slated for publication later in 2026.
Bepirovirsen already has SENKU status in Japan, which accelerates the review process for drugs with the potential to cater to unmet needs. It also has "fast track" designation from the US Food & Drug Administration and has been marked a "breakthrough" therapy in China. Like Linerixibat, it is yet to be approved in any region.
GSK shares traded 0.2% lower at 2,210.00 pence on Thursday morning in London.
By Holly Munks, Alliance News reporter
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