{"schema_version":"1.0","type":"article","title":"IgA腎病新藥擋洗腎，月打一針的先贏","url":"https://drugnews.com.tw/articles/2026-10-27-iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept.html","markdown_url":"https://drugnews.com.tw/articles/2026-10-27-iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept.md","lang":"zh-Hant","date":"2026-10-27","publish_at":"2026-10-27T08:00:00+08:00","updated_at":"2026-10-27","category":"商業分析系列","topic":"商業分析系列","tags":["IgA腎病","洗腎","Voyxact","Trutakna","povetacicept"],"summary":"台灣 9 萬人洗腎，IgA 腎病是常見的一條路。10/22 兩年數據開獎：安慰劑組腎功能每年掉 4 到 6 分，新藥組幾乎不掉。四支藥搶同一個病，四週打一針的大塚與 Vertex 會贏過每週一針、最貴的 Vera。","key_points":["大塚的 Voyxact 會比 Vera 的 Trutakna 先拿到 FDA 完整核准，Vertex 的 povetacicept 會在 2026 年 11 月 30 日 FDA 期限前拿到加速核准；四週打一針的兩支藥會領先每週一針的 Trutakna。","2026 年 10 月 22 日公布的兩年數據：Voyxact 組 eGFR 每年 +0.3、安慰劑組 −4.2（VISIONARY，510 人）；telitacicept 組每年 −0.6、安慰劑組 −5.7（TELIGAN，318 人）。","Vera 的 Trutakna 於 2026 年 7 月 7 日獲 FDA 加速核准，每週注射、美國年定價 42.5 萬美元，高於每四週注射的 Voyxact（39 萬美元）。"],"facts":[{"claim":"台灣洗腎人數","value":"超過 9 萬","unit":"人","as_of":"2025-12-05","source":"https://www.ctee.com.tw/news/20251206700062-430101"},{"claim":"台灣洗腎相關費用（2025 年）","value":"近 500","unit":"億新台幣","as_of":"2025-12-05","source":"https://www.ctee.com.tw/news/20251206700062-430101"},{"claim":"台灣原發性腎絲球腎炎切片中 IgA 腎病占比","value":"約 26","unit":"%","as_of":"2024-04-16","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11021013/"},{"claim":"IgA 腎病 10 年內走到末期腎病的比例（回顧引述）","value":"近三分之一","unit":"比例","as_of":"2024-04-16","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11021013/"},{"claim":"VISIONARY 隨機分派人數","value":510,"unit":"人","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Voyxact 組兩年 eGFR 年斜率","value":0.3,"unit":"mL/min/1.73m²/年","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"VISIONARY 安慰劑組兩年 eGFR 年斜率","value":-4.2,"unit":"mL/min/1.73m²/年","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Voyxact 相對安慰劑 eGFR 斜率差","value":4.5,"unit":"mL/min/1.73m²/年","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"VISIONARY 腎臟複合事件：Voyxact 對安慰劑","value":"1/259 對 28/251","unit":"人","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Voyxact FDA 加速核准日","value":"2025-11-25","unit":"日期","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"TELIGAN 人數","value":318,"unit":"人","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"telitacicept 兩年 eGFR 年斜率（安慰劑 −5.7）","value":-0.6,"unit":"mL/min/1.73m²/年","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"telitacicept 相對安慰劑 eGFR 斜率差","value":5.1,"unit":"mL/min/1.73m²/年","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"telitacicept 第 104 週尿蛋白（UPCR）較起始下降","value":60.3,"unit":"%","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"ORIGIN 3 最終分析人數","value":428,"unit":"人","as_of":"2026-09-15","source":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"claim":"Trutakna 兩年 eGFR 年斜率（安慰劑 −5.6）","value":-0.6,"unit":"mL/min/1.73m²/年","as_of":"2026-09-15","source":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"claim":"ORIGIN 3 疾病惡化複合事件風險下降（11 對 38 人）","value":76,"unit":"%","as_of":"2026-09-15","source":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"claim":"KDIGO 接近生理性腎功能流失速度","value":"<1","unit":"mL/min/1.73m²/年","as_of":"2026-09-29","source":"https://www.hcplive.com/view/atacicept-slows-igan-decline-to-physiologic-rate-with-sayna-norouzi-md"},{"claim":"Trutakna FDA 加速核准日","value":"2026-07-07","unit":"日期","as_of":"2026-07-07","source":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"claim":"Trutakna 美國年定價","value":425000,"unit":"美元","as_of":"2026-07-07","source":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"claim":"Voyxact 美國年批發價","value":390000,"unit":"美元","as_of":"2026-07-07","source":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"claim":"RAINIER 收案人數","value":605,"unit":"人","as_of":"2026-06-01","source":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"claim":"povetacicept 第 36 週尿蛋白較起始下降（扣安慰劑 49.8%）","value":52,"unit":"%","as_of":"2026-06-01","source":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"claim":"povetacicept FDA PDUFA 期限","value":"2026-11-30","unit":"日期","as_of":"2026-06-01","source":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"claim":"VISIONARY 台灣試驗點／BEYOND 台灣試驗點","value":"6／8","unit":"個","as_of":"2026-10-23","source":"https://clinicaltrials.gov/study/NCT05248646"}],"sections":["01｜IgA 腎病為什麼會一路走到洗腎","02｜同一把尺：兩年後，腎功能還剩多少","03｜數據打平，比的是一個月打幾針","04｜誰領先、誰被擠出","05｜台灣病人離這些藥有多遠","參考資料"],"references":[{"title":"Otsuka Presents Landmark Final Phase 3 VISIONARY Results at ASN","source":"Otsuka America Pharmaceutical","date":"2026-10-22","url":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"title":"Telitacicept Demonstrates Durable Preservation of Kidney Function Through Two Years in Phase 3 TELIGAN Trial in IgA Nephropathy","source":"Vor Bio（GlobeNewswire","date":"2026-10-22","url":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"title":"Atacicept Cuts IgAN Progression Risk 76% in ORIGIN 3 Final Data","source":"HCPLive","date":"2026-09-15","url":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"title":"Atacicept Slows IgAN Decline to Physiologic Rate","source":"HCPLive","date":"2026-09-29","url":"https://www.hcplive.com/view/atacicept-slows-igan-decline-to-physiologic-rate-with-sayna-norouzi-md"},{"title":"FDA approves Vera's Trutakna for IgA nephropathy","source":"BioPharma Dive","date":"2026-07-07","url":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"title":"Otsuka's Voyxact faces rival as FDA okays Vera IgAN drug","source":"pharmaphorum","date":"2026-07-08","url":"https://pharmaphorum.com/news/otsukas-voyxact-faces-rival-fda-okays-vera-igan-drug"},{"title":"Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy","source":"Vertex Pharmaceuticals","date":"2026-06-01","url":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"title":"Vor Bio Reports Second Quarter 2026 Financial Results and Provides Corporate Update","source":"Vor Bio","date":"2026-08-11","url":"https://ir.vorbio.com/node/11036/pdf"},{"title":"Review on epidemiology, disease burden, and treatment patterns of IgA nephropathy in select APAC countries","source":"BMC Nephrology","date":"2024-04-16","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11021013/"},{"title":"賴總統：盼2035居家透析盛行率達18％","source":"工商時報","date":"2025-12-06","url":"https://www.ctee.com.tw/news/20251206700062-430101"},{"title":"Trial of Sibeprenlimab in the Treatment of IgA Nephropathy（VISIONARY，NCT05248646","source":"ClinicalTrials.gov","date":"2026-10-23","url":"https://clinicaltrials.gov/study/NCT05248646"},{"title":"A Study of Zigakibart in Adults With IgA Nephropathy（BEYOND，NCT05852938","source":"ClinicalTrials.gov","date":"2026-10-23","url":"https://clinicaltrials.gov/study/NCT05852938"},{"title":"Monthly Dosing of Atacicept in IgAN（NCT07020923","source":"ClinicalTrials.gov","date":"2026-10-23","url":"https://clinicaltrials.gov/study/NCT07020923"}],"images":[{"alt":"圖1｜IgA腎病：四支新藥擋同一條訊號","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept/figure-01.png"},{"alt":"圖2｜兩年保住多少腎功能","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept/figure-02.png"},{"alt":"圖3｜美國三強，同一把尺","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept/figure-03.png"},{"alt":"圖4｜十三個月，四張牌翻開","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept/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（2026-10-27）。IgA腎病新藥擋洗腎，月打一針的先贏。https://drugnews.com.tw/articles/2026-10-27-iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept.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/"}