GSK (LSE:GSK) has reached two significant regulatory milestones across its oncology and hepatology portfolios, with the US Food and Drug Administration granting priority review to Jemperli for certain patients with locally advanced rectal cancer and Japan approving Hibsago as a functional cure for chronic hepatitis B.
FDA Grants Jemperli Priority Review in Rectal Cancer
The FDA has accepted GSK’s supplemental biologics application for Jemperli in previously untreated patients with stage II or III mismatch repair deficient or microsatellite instability-high locally advanced rectal cancer.
The application has been granted priority review and accepted under the FDA’s Project Orbis programme, which is designed to support international collaboration on oncology product reviews. If approved, Jemperli could become the first immunotherapy authorised for this specific treatment setting.
The submission is supported by results from the phase II AZUR-1 study, which demonstrated a clinically meaningful and sustained complete response lasting at least 12 months. The safety profile was consistent with previous experience using Jemperli across solid tumours.
The treatment could potentially allow some eligible patients to avoid or postpone chemotherapy, radiation treatment and surgery. Approval would therefore represent a potentially significant change in the treatment pathway for this particular subset of locally advanced rectal cancer while expanding GSK’s presence in oncology immunotherapy.
Hibsago Secures First Global Approval in Japan
Separately, Japan’s Ministry of Health, Labour and Welfare has approved GSK’s Hibsago, or bepirovirsen, for the treatment of certain adults with chronic hepatitis B. The decision represents the drug’s first approval worldwide and establishes it as the first functional cure approved for chronic hepatitis B in Japan.
Hibsago is an antisense oligonucleotide indicated for adults already receiving nucleos(t)ide analogue therapy who meet specified viral marker criteria. The approval addresses a substantial patient population in Japan, where close to one million people are estimated to be living with chronic hepatitis B.
Japan accelerated the regulatory process through its SENKU designation, which supports therapies intended to address areas of significant unmet medical need.
Phase III Trials Show 19% Functional Cure Rate
Approval was supported by GSK’s phase III B-Well programme, in which Hibsago achieved a functional cure rate of 19%, compared with 1% among patients receiving existing standard care.
For eligible patients, achieving a functional cure could potentially remove the need for lifelong antiviral treatment while reducing the longer-term risks associated with chronic hepatitis B, including liver cancer.
The Japanese approval also provides an important regulatory milestone as GSK pursues decisions for bepirovirsen in other major markets, including the United States, while building a broader hepatology franchise.
Strong Financial Profile Supports Pipeline Investment
GSK’s wider outlook continues to benefit from strong profitability and solid free cash flow generation, alongside a relatively reasonable valuation and an attractive dividend yield.
Balance-sheet leverage remains a consideration, while earnings and cash conversion have shown some variability. Technical indicators are moderately constructive, with the shares trading above major moving averages, although available momentum signals provide a less complete picture.
More About GSK
GSK is a global biopharmaceutical company focused on vaccines and specialty medicines, using science and technology to develop treatments for major diseases.
Alongside its established businesses, the group is developing a hepatology portfolio targeting chronic and fibro-inflammatory liver diseases. Its areas of research include chronic hepatitis B, metabolic dysfunction-associated steatohepatitis and alcohol-associated liver disease.
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