{"schema_version":"1.0","type":"article","title":"B肝藥不用吃一輩子？FDA准Hibsago，獨家一年半","url":"https://drugnews.com.tw/articles/2026-10-25-gsk-hibsago-hepatitis-b-functional-cure-fda.html","markdown_url":"https://drugnews.com.tw/articles/2026-10-25-gsk-hibsago-hepatitis-b-functional-cure-fda.md","lang":"zh-Hant","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":["B肝","B型肝炎 功能性治癒","Hibsago bepirovirsen","GSK","B肝停藥"],"summary":"台灣 189 萬 B 肝帶原者，吃上口服藥常是好幾年。FDA 10/20 核准 GSK 的 Hibsago：打半年針，19% 病人連口服藥都停掉、病毒沒回來。對手全卡在二期，GSK 至少獨家到 2028 年。","key_points":["美國 FDA 於 2026 年 10 月 20 日核准 GSK 的 Hibsago（bepirovirsen），最近的對手都還在二期、數據最快 2027 年才出來，所以 2028 年 4 月前 FDA 不會核准第二個 B 肝功能性治癒新藥。","兩項三期試驗 B-Well 1／2 合併，Hibsago 組 1,220 人中 233 人（19%）在停掉所有藥 24 週後達到功能性治癒，安慰劑組 614 人為 0；表面抗原 ≤1,000 IU/mL 的病人達 26%。","Hibsago 限用於口服藥治療滿 6 個月、無肝硬化、表面抗原 ≤3,000 IU/mL 的成人，仿單有肝炎發作與血小板減少的黑框警語；GSK 預估巔峰年銷售超過 20 億英鎊，Ionis 可收 10%–12% 權利金。"],"facts":[{"claim":"FDA 核准 Hibsago（bepirovirsen）日期","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 合併：Hibsago 組功能性治癒比例（233／1,220）","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 合併：安慰劑組功能性治癒人數（共 614 人）","value":0,"unit":"人","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 子群：Hibsago 組功能性治癒比例（200／768）","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":"只用標準口服藥一年後功能性治癒比例（GSK 引用）","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":"全球確診慢性 B 肝病人中 HBsAg ≤1,000 IU/mL 的比例（GSK 估）","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":"美國慢性 B 肝病人數","value":170,"unit":"萬人","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":"全球慢性 B 肝病人數","value":2.4,"unit":"億人以上","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 劑量：每週皮下注射","value":300,"unit":"毫克，共 24 週","as_of":"2026-10-21","source":"https://www.hcplive.com/view/fda-approves-bepirovirsen-for-chronic-hepatitis-b"},{"claim":"B-Well 合併：三級以上不良事件比例 Hibsago 對安慰劑","value":"16% 對 3%","unit":"","as_of":"2026-10-21","source":"https://www.hcplive.com/view/fda-approves-bepirovirsen-for-chronic-hepatitis-b"},{"claim":"Hibsago 適用者表面抗原上限","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 對 bepirovirsen 淨銷售的分級權利金","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 預估 Hibsago 巔峰年銷售","value":20,"unit":"億英鎊以上","as_of":"2026-08-24","source":"https://www.emjreviews.com/emj-gold/news/gsk-wins-approval-for-new-hepatitis-b-drug-hibsago/"},{"claim":"日本核准 Hibsago 日期","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":"日本慢性 B 肝病人數（GSK）","value":100,"unit":"萬人（將近）","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 二期 B 肝功能性治癒人數（51 人中）","value":2,"unit":"人","as_of":"2025-05-09","source":"https://www.fiercebiotech.com/biotech/virs-functional-cure-candidate-hepatitis-b-misses-mark-ph-2"},{"claim":"Aligos B-SUPREME 二期預計收案人數","value":200,"unit":"人","as_of":"2026-01-21","source":"https://www.nasdaq.com/press-release/aligos-therapeutics-provides-phase-2-b-supreme-study-progress-updates-2026-01-21"},{"claim":"GSK B-United 二期 2b 預計主要完成日","value":"2027-05-31","unit":"","as_of":"2026-07-07","source":"https://clinicaltrials.gov/study/NCT06537414"},{"claim":"台灣 B 肝帶原者人數","value":189,"unit":"萬人","as_of":"2026-07-27","source":"https://udn.com/news/story/7266/9653369"},{"claim":"台灣 B 肝診斷率","value":69,"unit":"%","as_of":"2026-07-27","source":"https://udn.com/news/story/7266/9653369"},{"claim":"台灣 B 肝治療涵蓋率","value":35,"unit":"%","as_of":"2026-07-27","source":"https://udn.com/news/story/7266/9653369"},{"claim":"健保給付 e 抗原陰性 B 肝口服藥療程（2003 年起）","value":3,"unit":"年","as_of":"2026-10-21","source":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"claim":"長庚研究：停藥且病毒持續受控者每年表面抗原消失比例","value":6.3,"unit":"%","as_of":"2026-10-21","source":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"claim":"長庚研究：繼續服藥者每年表面抗原消失比例","value":0.2,"unit":"%","as_of":"2026-10-21","source":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"claim":"健保署研議放寬 B 肝口服藥給付預估受惠人數","value":"1.7萬–3萬","unit":"人","as_of":"2026-06-02","source":"https://health.ltn.com.tw/article/breakingnews/5457686"}],"sections":["01｜藥吃了十年，病毒為什麼還在？","02｜Hibsago 打的是病毒的訂單","03｜五個人有一個做到，病人值得打嗎？","04｜誰追得上？對手都還卡在二期","05｜台灣病人什麼時候用得到？","台股連結","參考資料"],"references":[{"title":"Hibsago (bepirovirsen) approved in the US for the treatment of chronic hepatitis B","source":"GSK（Business Wire，StockTitan 轉載","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（StockTitan 轉載","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（Nasdaq 轉載","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":"全台189萬B肝帶原者 這年次出生「疫苗斷層世代」恐成肝癌防線破口","source":"聯合報","date":"2026-07-27","url":"https://udn.com/news/story/7266/9653369"},{"title":"B肝口服藥停藥研究（簡榮南、廖運範","source":"長庚醫訊","date":"2026-10-21","url":"https://www.cgmh.org.tw/cgmn/cgmn_file/2310001.pdf"},{"title":"健保署研議放寬B肝用藥給付 預估3萬名患者受惠","source":"自由健康網","date":"2026-06-02","url":"https://health.ltn.com.tw/article/breakingnews/5457686"},{"title":"B 肝新藥在日本獲准，新藥組約兩成受試者達「功能性治癒」","source":"藥時事","date":"2026-09-27","url":"https://drugnews.com.tw/articles/2026-09-27-hibsago-finite-hbv-care.html"}],"images":[{"alt":"圖1｜B肝新藥打的是病毒的RNA","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda/figure-01.png"},{"alt":"圖2｜停藥後還能管住病毒的比例","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda/figure-02.png"},{"alt":"圖3｜一個療程怎麼走","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda/figure-03.png"},{"alt":"圖4｜B肝功能性治癒，誰在追","url":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/gsk-hibsago-hepatitis-b-functional-cure-fda/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）。B肝藥不用吃一輩子？FDA准Hibsago，獨家一年半。https://drugnews.com.tw/articles/2026-10-25-gsk-hibsago-hepatitis-b-functional-cure-fda.html","disclaimer":"本文僅供產業研究與知識分享，不構成投資、醫療、募資或個股建議。","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}