{
  "schema_version": "1.0",
  "type": "article",
  "title": "FDA 提前放行，黃馨祥賭贏膀胱癌",
  "url": "https://drugnews.com.tw/articles/2026-10-18-immunitybio-anktiva-papillary-early-approval.html",
  "markdown_url": "https://drugnews.com.tw/articles/2026-10-18-immunitybio-anktiva-papillary-early-approval.md",
  "lang": "zh-Hant",
  "date": "2026-10-18",
  "publish_at": "2026-10-18T08:00:00+08:00",
  "updated_at": "2026-10-18",
  "category": "商業分析系列",
  "topic": "商業分析系列",
  "tags": [
    "ImmunityBio",
    "Anktiva",
    "膀胱癌",
    "FDA",
    "J&J"
  ],
  "summary": "2025 年 5 月，FDA 連 ImmunityBio 的文件都不收，要它重做隨機試驗。黃馨祥沒做，2026 年 10 月 14 日卻提前 84 天拿到乳頭狀膀胱癌標籤。BCG 缺貨十多年，FDA 選擇用速度換證據。",
  "key_points": [
    "FDA 在 2026 年 10 月 14 日核准 ImmunityBio 的 Anktiva 搭配 BCG 擴大用於 BCG 治療失敗、只有高惡性度乳頭狀腫瘤的非肌肉侵犯性膀胱癌，比原訂 2027 年 1 月 6 日的審查期限早 84 天，療效依據是把原位癌世代（77 人、完全緩解率 62%）外推，沒有新的隨機試驗。",
    "FDA 曾在 2025 年 5 月對這項補充申請發出拒絕受理函，要求先做對照化療的隨機試驗；ImmunityBio 2026 年 1 月談出不需新試驗的重新送件路，補交 80 名乳頭狀病人的長期追蹤（12 個月無病存活 58.2%、36 個月免膀胱切除 81.8%）。",
    "Anktiva 2026 年第二季淨產品營收 5,070 萬美元、年增 92%，與 UroGen Zusduri 同季 5,040 萬美元幾乎打平；對手 J&J Inlexzo 原位癌完全緩解率 82% 且不需 BCG，CG Oncology 預計 2026 年第四季完成 cretostimogene 的 BLA。"
  ],
  "facts": [
    {
      "claim": "FDA 核准 Anktiva 擴大至 BCG 失敗乳頭狀膀胱癌",
      "value": "2026-10-14",
      "unit": "日期",
      "as_of": "2026-10-14",
      "source": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "claim": "Anktiva 乳頭狀補充申請原訂 PDUFA 期限",
      "value": "2027-01-06",
      "unit": "日期",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "核准比原訂期限提前天數",
      "value": "84",
      "unit": "天",
      "as_of": "2026-10-14",
      "source": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "claim": "原位癌世代（n=77）完全緩解率",
      "value": 62,
      "unit": "%",
      "as_of": "2026-10-14",
      "source": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "claim": "FDA 對乳頭狀補充申請發出拒絕受理函",
      "value": "2025-05",
      "unit": "年月",
      "as_of": "2025-07-25",
      "source": "https://ir.immunitybio.com/node/10811"
    },
    {
      "claim": "乳頭狀世代病人數",
      "value": 80,
      "unit": "人",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "乳頭狀世代 12 個月無病存活",
      "value": 58.2,
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "乳頭狀世代 36 個月疾病專一存活",
      "value": 96,
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "乳頭狀世代 36 個月免膀胱切除",
      "value": 81.8,
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "2026 年 1 月宣布新路徑當日股價漲幅",
      "value": "超過 17",
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "Anktiva 2026 Q2 淨產品營收",
      "value": 50.7,
      "unit": "百萬美元",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva 2025 Q2 淨產品營收",
      "value": 26.4,
      "unit": "百萬美元",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva 2026 Q2 營收年增",
      "value": 92,
      "unit": "%",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva 2026 上半年淨產品營收",
      "value": 94.8,
      "unit": "百萬美元",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva 2025 全年淨產品營收",
      "value": 113,
      "unit": "百萬美元",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "ImmunityBio 現金與有價證券（2026-06-30）",
      "value": 357.4,
      "unit": "百萬美元",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "ImmunityBio 2026 上半年營運現金流出",
      "value": 141.9,
      "unit": "百萬美元",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "ImmunityBio 股價年初至 10/14 漲幅",
      "value": "超過 400",
      "unit": "%",
      "as_of": "2026-10-14",
      "source": "https://stocktwits.com/news-articles/markets/equity/ibrx-stock-rallies-after-fda-clears-broader-anktiva-use-in-bladder-cancer-months-ahead-of-deadline/cZxfvaYRBq0"
    },
    {
      "claim": "APP Pharmaceuticals 售予 Fresenius 金額",
      "value": 4.6,
      "unit": "十億美元",
      "as_of": "2008-07",
      "source": "https://en.wikipedia.org/wiki/Patrick_Soon-Shiong"
    },
    {
      "claim": "《洛杉磯時報》收購現金",
      "value": "近 500",
      "unit": "百萬美元",
      "as_of": "2018-06-18",
      "source": "https://en.wikipedia.org/wiki/Patrick_Soon-Shiong"
    },
    {
      "claim": "Inlexzo 原位癌完全緩解率（n=83）",
      "value": 82,
      "unit": "%",
      "as_of": "2025-09-09",
      "source": "https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis"
    },
    {
      "claim": "UroGen Zusduri 2026 Q2 淨產品營收",
      "value": 50.4,
      "unit": "百萬美元",
      "as_of": "2026-08-05",
      "source": "https://www.biospace.com/press-releases/urogen-reports-50-4-million-of-zusduri-revenue-and-provides-second-quarter-2026-financial-results-and-highlights"
    },
    {
      "claim": "Zusduri 啟用治療據點／開藥醫師（2026-06-30）",
      "value": "1,444 / 452",
      "unit": "個／人",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/urogen-reports-50-4-million-of-zusduri-revenue-and-provides-second-quarter-2026-financial-results-and-highlights"
    },
    {
      "claim": "CG Oncology BOND-003 24 個月完全緩解率（46/110）",
      "value": 41.8,
      "unit": "%",
      "as_of": "2025-11-14",
      "source": "https://cgoncology.com/?p=234114"
    },
    {
      "claim": "CG Oncology 現金（2026-06-30）",
      "value": 1,
      "unit": "十億美元",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/cg-oncology-reports-second-quarter-2026-financial-results-and-provides-business-updates"
    }
  ],
  "sections": [
    "01｜一封拒收函，17 個月後變成提前核准",
    "02｜Anktiva 不殺癌細胞，它把殺手叫醒",
    "03｜療效最好的不是它：J&J 不用 BCG 就有 82%",
    "04｜FDA 為什麼肯外推：BCG 缺了十多年",
    "05｜84 天值多少：Anktiva 一天賣 56 萬美元",
    "參考資料"
  ],
  "references": [
    {
      "title": "FDA approves expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer",
      "source": "U.S. FDA",
      "date": "2026-10-14",
      "url": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "title": "IBRX Stock Rallies After FDA Clears Broader Anktiva Use In Bladder Cancer Months Ahead Of Deadline",
      "source": "Stocktwits",
      "date": "2026-10-14",
      "url": "https://stocktwits.com/news-articles/markets/equity/ibrx-stock-rallies-after-fda-clears-broader-anktiva-use-in-bladder-cancer-months-ahead-of-deadline/cZxfvaYRBq0"
    },
    {
      "title": "ImmunityBio Reports Record Q2 2026 Net Product Revenue of $50.7 Million",
      "source": "ImmunityBio／BioSpace",
      "date": "2026-08-04",
      "url": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "title": "ImmunityBio Reports 60% Increase in Revenue in Q2 2025（Refuse-to-File 說明",
      "source": "ImmunityBio",
      "date": "2025-07-25",
      "url": "https://ir.immunitybio.com/node/10811"
    },
    {
      "title": "ImmunityBio rises as route opens to broader Anktiva label",
      "source": "pharmaphorum",
      "date": "2026-01-21",
      "url": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "title": "Patrick Soon-Shiong",
      "source": "Wikipedia",
      "date": "2026-10-17",
      "url": "https://en.wikipedia.org/wiki/Patrick_Soon-Shiong"
    },
    {
      "title": "FDA Approves TAR-200 in BCG-Unresponsive NMIBC With CIS",
      "source": "OncLive",
      "date": "2025-09-09",
      "url": "https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis"
    },
    {
      "title": "UroGen Reports $50.4 Million of ZUSDURI Revenue and Provides Second Quarter 2026 Financial Results",
      "source": "UroGen／BioSpace",
      "date": "2026-08-05",
      "url": "https://www.biospace.com/press-releases/urogen-reports-50-4-million-of-zusduri-revenue-and-provides-second-quarter-2026-financial-results-and-highlights"
    },
    {
      "title": "CG Oncology Reports Third Quarter 2025 Financial Results",
      "source": "CG Oncology",
      "date": "2025-11-14",
      "url": "https://cgoncology.com/?p=234114"
    },
    {
      "title": "CG Oncology Reports Second Quarter 2026 Financial Results and Provides Business Updates",
      "source": "CG Oncology／BioSpace",
      "date": "2026-08-06",
      "url": "https://www.biospace.com/press-releases/cg-oncology-reports-second-quarter-2026-financial-results-and-provides-business-updates"
    },
    {
      "title": "BCG Shortage: Key Facts for Bladder Cancer Patients & Families",
      "source": "BCAN",
      "date": "2026-10-17",
      "url": "https://bcan.org/bcg-shortage-bladder-cancer/"
    },
    {
      "title": "ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG",
      "source": "ImmunityBio／BioSpace",
      "date": "2026-05-17",
      "url": "https://www.biospace.com/press-releases/immunitybio-signs-exclusive-u-s-agreement-with-japan-bcg-laboratory-for-the-tokyo-strain-of-bcg-to-enhance-bcg-supply-in-the-united-states"
    }
  ],
  "images": [
    {
      "alt": "圖1｜從拒收到提前核准，中間沒有新的隨機試驗",
      "url": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval/figure-01.png"
    },
    {
      "alt": "圖2｜四種膀胱癌新藥打在四個位置",
      "url": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval/figure-02.png"
    },
    {
      "alt": "圖3｜第二季膀胱癌新藥營收，Anktiva 與 Zusduri 幾乎打平",
      "url": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval/figure-03.png"
    }
  ],
  "cover_image": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval/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（2026-10-18）。FDA 提前放行，黃馨祥賭贏膀胱癌。https://drugnews.com.tw/articles/2026-10-18-immunitybio-anktiva-papillary-early-approval.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": {}
}