{"schema_version":"1.0","type":"article","title":"Hepatitis B Pills Need Not Be for Life: FDA Clears GSK's Hibsago","url":"https://drugnews.com.tw/articles/2026-10-25-gsk-hibsago-hepatitis-b-functional-cure-fda-en.html","markdown_url":"https://drugnews.com.tw/articles/2026-10-25-gsk-hibsago-hepatitis-b-functional-cure-fda-en.md","lang":"en","date":"2026-10-25","publish_at":"2026-10-25T20:00:00+08:00","updated_at":"2026-10-25","category":"製藥巨頭系列","topic":"製藥巨頭系列","tags":["hepatitis B","functional cure","Hibsago bepirovirsen","GSK","Taiwan"],"summary":"1.89 million Taiwanese carry hepatitis B, most on a pill a day for years. On Oct 20 the FDA approved GSK's Hibsago: after six months of shots, 19% stopped all drugs and stayed in control. Every rival is in phase 2.","key_points":["The US FDA approved GSK's Hibsago (bepirovirsen) on October 20, 2026; with every rival still in phase 2 and no data before 2027, the FDA will not approve a second hepatitis B functional-cure drug before April 2028.","In the pooled B-Well 1 and 2 phase 3 trials, 233 of 1,220 Hibsago patients (19%) reached functional cure 24 weeks after stopping all treatment, versus 0 of 614 on placebo; the rate was 26% in patients with HBsAg at or below 1,000 IU/mL.","Hibsago is limited to adults without cirrhosis on oral antivirals for at least six months with HBsAg at or below 3,000 IU/mL and carries a boxed warning for liver flares and low platelets; GSK expects peak sales above £2 billion, with Ionis earning 10–12% royalties."],"facts":[{"claim":"FDA approval date of Hibsago (bepirovirsen)","value":"2026-10-20","unit":"","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"B-Well 1/2 pooled: functional cure rate on Hibsago (233 of 1,220)","value":19,"unit":"%","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"B-Well 1/2 pooled: placebo patients reaching functional cure (of 614)","value":0,"unit":"patients","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"HBsAg ≤1,000 IU/mL subgroup: functional cure on Hibsago (200 of 768)","value":26,"unit":"%","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"Functional cure after one year on standard oral therapy alone (GSK figure)","value":"<1","unit":"%","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"Share of diagnosed CHB patients worldwide with HBsAg ≤1,000 IU/mL (GSK estimate)","value":45,"unit":"%","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"People with chronic hepatitis B in the US","value":1.7,"unit":"million","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"People with chronic hepatitis B worldwide","value":240,"unit":"million (more than)","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"Hibsago dose, weekly subcutaneous injection","value":300,"unit":"mg, 24 weeks","as_of":"2026-10-21","source":"https://www.hcplive.com/view/fda-approves-bepirovirsen-for-chronic-hepatitis-b"},{"claim":"B-Well pooled: grade ≥3 adverse events, Hibsago vs placebo","value":"16% vs 3%","unit":"","as_of":"2026-10-21","source":"https://www.hcplive.com/view/fda-approves-bepirovirsen-for-chronic-hepatitis-b"},{"claim":"HBsAg ceiling for Hibsago eligibility","value":3000,"unit":"IU/mL","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"Ionis tiered royalty on bepirovirsen net sales","value":"10–12","unit":"%","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/IONS/ionis-partner-gsk-announces-hibsago-bepirovirsen-approved-in-the-u-s-6ev464j8ex4t.html"},{"claim":"GSK expected peak annual sales of Hibsago","value":2,"unit":"billion GBP (above)","as_of":"2026-08-24","source":"https://www.emjreviews.com/emj-gold/news/gsk-wins-approval-for-new-hepatitis-b-drug-hibsago/"},{"claim":"Japan approval date of Hibsago","value":"2026-08-24","unit":"","as_of":"2026-08-24","source":"https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-japan-as-first-and-only-functional-cure-for-chronic-hepatitis-b/"},{"claim":"Vir MARCH phase 2: patients reaching functional cure (of 51)","value":2,"unit":"patients","as_of":"2025-05-09","source":"https://www.fiercebiotech.com/biotech/virs-functional-cure-candidate-hepatitis-b-misses-mark-ph-2"},{"claim":"GSK B-United phase 2b estimated primary completion","value":"2027-05-31","unit":"","as_of":"2026-07-07","source":"https://clinicaltrials.gov/study/NCT06537414"},{"claim":"Hepatitis B carriers in Taiwan","value":1.89,"unit":"million","as_of":"2026-07-27","source":"https://udn.com/news/story/7266/9653369"},{"claim":"Taiwan hepatitis B diagnosis rate","value":69,"unit":"%","as_of":"2026-07-27","source":"https://udn.com/news/story/7266/9653369"},{"claim":"Taiwan hepatitis B treatment coverage","value":35,"unit":"%","as_of":"2026-07-27","source":"https://udn.com/news/story/7266/9653369"},{"claim":"NHI-covered oral antiviral course for HBeAg-negative patients (since 2003)","value":3,"unit":"years","as_of":"2026-10-21","source":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"claim":"Chang Gung study: annual HBsAg loss in patients who stopped and stayed controlled","value":6.3,"unit":"%","as_of":"2026-10-21","source":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"claim":"Chang Gung study: annual HBsAg loss in patients who kept taking pills","value":0.2,"unit":"%","as_of":"2026-10-21","source":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"claim":"Patients expected to benefit from proposed wider NHI coverage of oral antivirals","value":"17,000–30,000","unit":"patients","as_of":"2026-06-02","source":"https://health.ltn.com.tw/article/breakingnews/5457686"},{"claim":"Hibsago patients with HBsAg ≤100 IU/mL at week 72 (598 of 1,220, exploratory)","value":49,"unit":"%","as_of":"2026-10-20","source":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"claim":"Hibsago patients meeting criteria to stop existing antiviral","value":24,"unit":"%","as_of":"2026-10-21","source":"https://www.hcplive.com/view/fda-approves-bepirovirsen-for-chronic-hepatitis-b"}],"sections":["01 | Ten years on pills, and the virus is still there","02 | Hibsago goes after the work orders","03 | One in five succeeds. Is it worth the shots?","04 | Who can catch up? Every rival is stuck in phase 2","05 | When can patients in Taiwan get it?","Taiwan stock link","References"],"references":[{"title":"Hibsago (bepirovirsen) approved in the US for the treatment of chronic hepatitis B","source":"GSK (Business Wire via StockTitan","date":"2026-10-20","url":"https://www.stocktitan.net/news/GSK/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-w34ityxphay0.html"},{"title":"FDA Approves Bepirovirsen for Chronic Hepatitis B","source":"HCPLive","date":"2026-10-21","url":"https://www.hcplive.com/view/fda-approves-bepirovirsen-for-chronic-hepatitis-b"},{"title":"Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S.","source":"Ionis (via StockTitan","date":"2026-10-20","url":"https://www.stocktitan.net/news/IONS/ionis-partner-gsk-announces-hibsago-bepirovirsen-approved-in-the-u-s-6ev464j8ex4t.html"},{"title":"Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B","source":"GSK","date":"2026-08-24","url":"https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-japan-as-first-and-only-functional-cure-for-chronic-hepatitis-b/"},{"title":"GSK Wins Approval for New Hepatitis B Drug","source":"EMJ Reviews","date":"2026-08-24","url":"https://www.emjreviews.com/emj-gold/news/gsk-wins-approval-for-new-hepatitis-b-drug-hibsago/"},{"title":"Vir's 'functional cure' candidate for hepatitis B misses mark in phase 2","source":"Fierce Biotech","date":"2025-05-09","url":"https://www.fiercebiotech.com/biotech/virs-functional-cure-candidate-hepatitis-b-misses-mark-ph-2"},{"title":"Aligos Therapeutics Provides Phase 2 B-SUPREME Study Progress Updates","source":"Aligos (via Nasdaq","date":"2026-01-21","url":"https://www.nasdaq.com/press-release/aligos-therapeutics-provides-phase-2-b-supreme-study-progress-updates-2026-01-21"},{"title":"B-UNITED: Sequential Therapy With Daplusiran/Tomligisiran Followed by Bepirovirsen (NCT06537414","source":"ClinicalTrials.gov","date":"2026-07-07","url":"https://clinicaltrials.gov/study/NCT06537414"},{"title":"New Developments in the Treatment of Hepatitis B Virus Infection","source":"Gastroenterology & Hepatology","date":"2026-07-01","url":"https://www.gastroenterologyandhepatology.net/archives/july-2026/new-developments-in-the-treatment-of-hepatitis-b-virus-infection/"},{"title":"1.89 million hepatitis B carriers in Taiwan (in Chinese","source":"United Daily News","date":"2026-07-27","url":"https://udn.com/news/story/7266/9653369"},{"title":"Stopping oral antivirals in hepatitis B: Chang Gung study (in Chinese","source":"Chang Gung Medical Journal newsletter","date":"2026-10-21","url":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"title":"NHIA studies wider hepatitis B drug coverage (in Chinese","source":"Liberty Times Health","date":"2026-06-02","url":"https://health.ltn.com.tw/article/breakingnews/5457686"},{"title":"Hepatitis B drug approved in Japan (in Chinese","source":"Drugnews","date":"2026-09-27","url":"https://drugnews.com.tw/articles/2026-09-27-hibsago-finite-hbv-care.html"}],"images":[{"alt":"Figure 1 | The new hepatitis B drug targets viral RNA","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda-en/figure-01.png"},{"alt":"Figure 2 | Share still in control after stopping drugs","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda-en/figure-02.png"},{"alt":"Figure 3 | How one course of treatment runs","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda-en/figure-03.png"},{"alt":"Figure 4 | Who is chasing a hepatitis B functional cure","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda-en/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda-en/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-10-25）。Hepatitis B Pills Need Not Be for Life: FDA Clears GSK's Hibsago。https://drugnews.com.tw/articles/2026-10-25-gsk-hibsago-hepatitis-b-functional-cure-fda-en.html","disclaimer":"This article is intended for industry research and knowledge sharing only. It does not constitute investment, medical, fundraising, or individual stock advice.","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}