GSK wins US approval for hepatitis B drug as Hutchmed deal closes
GSK PLC on Wednesday announced US regulatory approval for its chronic hepatitis B treatment Hibsago, while Hutchmed China Ltd confirmed the completion of a separate licensing agreement with GSK worth up to USD1.30 billion.
GSK said the US Food & Drug Administration approved Hibsago, also known as bepirovirsen, for eligible adults with chronic hepatitis B who are receiving existing antiviral therapy.
The approval follows phase III clinical trials showing a 19% functional cure rate after a six-month treatment course, compared with no functional cures in the placebo group. Functional cure means the virus remains controlled without medication for at least 24 weeks after treatment ends.
"For the first time, with Hibsago, US patients have the potential to achieve functional cure after a six-month treatment course, with the added convenience of the option of self-administration after the first dose," said GSK Chief Scientific Officer Tony Wood.
GSK said chronic hepatitis B affects approximately 1.7 million people in the US. The company is pursuing further regulatory approvals in other markets.
Separately, Hutchmed said its licensing agreement with GSK for experimental cancer treatment HMPL-A830 had closed following regulatory approvals.
Under the agreement, announced in September, GSK receives exclusive development and commercialisation rights outside mainland China, Hong Kong, Macau and Taiwan.
Hutchmed expects to receive an upfront payment of USD110 million shortly, with potential additional milestone payments of up to USD1.19 billion, alongside royalties on future sales.
The treatment, which targets KRAS-altered tumours, entered phase I clinical trials in September.
Hutchmed will oversee the global phase I programme, while GSK will be responsible for subsequent clinical development and commercialisation in its licensed territories.
GSK shares opened 0.4% lower at 1,861.50 pence in London on Tuesday, while Hutchmed shares were 0.5% lower at 220.80p.
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