{
  "schema_version": "1.0",
  "type": "article",
  "title": "藥華藥 ET 五地獲准，默沙東還在三期",
  "url": "https://drugnews.com.tw/articles/2026-10-17-pharmaessentia-china-et-approval-race.html",
  "markdown_url": "https://drugnews.com.tw/articles/2026-10-17-pharmaessentia-china-et-approval-race.md",
  "lang": "zh-Hant",
  "date": "2026-10-17",
  "publish_at": "2026-10-17T08:00:00+08:00",
  "updated_at": "2026-10-17",
  "category": "商業分析系列",
  "topic": "商業分析系列",
  "tags": [
    "藥華藥",
    "百斯瑞明",
    "BESREMi",
    "原發性血小板過多症",
    "默沙東",
    "Incyte",
    "中國藥證"
  ],
  "summary": "10 月 15 日，藥華藥公告拿到中國 NMPA 的 ET 藥證，五個月內在台灣、澳門、日本、美國、中國五地獲准。\n默沙東 bomedemstat 預計 2027 年才有三期主要結果，Incyte 的三期 9 月才開始收案。\n中國 40 萬病人最多，但核准只到第二線，粗算可直接觸及最多 8 萬到 10 萬人。",
  "key_points": [
    "藥華藥 2026 年 10 月 15 日公告，長效干擾素百斯瑞明（BESREMi，ropeginterferon alfa-2b）獲中國國家藥監局 10 月 13 日核准，用於既往接受羥基脲治療效果不佳的成人原發性血小板過多症（ET）；公司引用市場研究推估中國約有 40 萬名 ET 病人。",
    "百斯瑞明 2026 年在 ET 先後取得台灣（5 月 12 日核准函，限第二線）、澳門（8 月 2 日公告，進口藥品預先許可）、日本（8 月 24 日公告）、美國（8 月 28 日，所有成人 ET）與中國（10 月 13 日，限第二線）許可；同一疾病，默沙東的 bomedemstat 預計 2027 年取得三期主要結果，Incyte 的 INCA033989 三期 2026 年 9 月 8 日才開始收案。",
    "藥華藥 2026 年 9 月營收 26.35 億元新台幣，年增 99.98%、月增 0.69%；前 9 月累計 197.37 億元，年增 83.5%，公司說明成長主要來自美國子公司。"
  ],
  "facts": [
    {
      "claim": "中國 NMPA 核准百斯瑞明用於既往羥基脲治療效果不佳的成人原發性血小板過多症（ET）",
      "value": "2026-10-13",
      "unit": "核准日",
      "as_of": "2026-10-15",
      "source": "藥華藥重大訊息（MOPS）2026-10-15",
      "note": "2026-10-15 接獲藥品註冊證書"
    },
    {
      "claim": "中國 ET 病人數（市場研究推估）",
      "value": 400000,
      "unit": "人",
      "as_of": "2026-10-15",
      "source": "藥華藥重大訊息（MOPS）2026-10-15",
      "note": "推估值"
    },
    {
      "claim": "美國 ET 病人數（市場研究推估）",
      "value": 170000,
      "unit": "人",
      "as_of": "2026-08-29",
      "source": "藥華藥重大訊息（MOPS）2026-08-29",
      "note": "推估值"
    },
    {
      "claim": "台灣 ET 病人數（健保資料庫研究）",
      "value": 4500,
      "unit": "人",
      "as_of": "2026-08-16",
      "source": "藥華藥重大訊息（MOPS）2026-08-16",
      "note": "約每 10 萬人 20 人"
    },
    {
      "claim": "美國 FDA 核准百斯瑞明用於所有成人 ET",
      "value": "2026-08-28",
      "unit": "核准日（美國時間）",
      "as_of": "2026-08-29",
      "source": "藥華藥重大訊息（MOPS）2026-08-29"
    },
    {
      "claim": "藥華藥 2026 年 9 月營收",
      "value": 26.35,
      "unit": "億元新台幣",
      "as_of": "2026-10-15",
      "source": "臺灣證交所 OpenAPI t187ap05_L",
      "note": "年增 99.98%，月增 0.69%"
    },
    {
      "claim": "藥華藥 2026 年前 9 月累計營收",
      "value": 197.37,
      "unit": "億元新台幣",
      "as_of": "2026-10-15",
      "source": "臺灣證交所 OpenAPI t187ap05_L",
      "note": "年增 83.5%；公司說明主要來自美國子公司"
    },
    {
      "claim": "默沙東收購 Imago BioSciences（取得 bomedemstat）金額",
      "value": 1.35,
      "unit": "十億美元",
      "as_of": "2022-11-21",
      "source": "BioPharma Dive 2022-11-21",
      "note": "每股 36 美元，2023 年 1 月完成"
    },
    {
      "claim": "Shorespan-006（NCT06079879）主要完成日（預估）",
      "value": "2027-07-14",
      "unit": "日期",
      "as_of": "2026-10-16",
      "source": "ClinicalTrials.gov",
      "note": "二線，約 340 人"
    },
    {
      "claim": "Shorespan-007（NCT06456346）主要完成日（預估）",
      "value": "2027-09-28",
      "unit": "日期",
      "as_of": "2026-10-16",
      "source": "ClinicalTrials.gov",
      "note": "一線對羥基脲，約 300 人"
    },
    {
      "claim": "INCA033989 一期 ET 完全血液學緩解率",
      "value": 70,
      "unit": "%",
      "as_of": "2026-06-13",
      "source": "Incyte EHA 2026 新聞稿",
      "note": "80/114 人，無對照組"
    },
    {
      "claim": "EXCALIBUR-ET2（NCT07623200）開始收案日",
      "value": "2026-09-08",
      "unit": "日期",
      "as_of": "2026-10-16",
      "source": "ClinicalTrials.gov",
      "note": "主要完成日預估 2029-06-15"
    },
    {
      "claim": "SURPASS-ET 第 9 與第 12 個月持久反應率（百斯瑞明 vs 安閣靈）",
      "value": "43 vs 6",
      "unit": "%",
      "as_of": "2026-08-31",
      "source": "BioPharm International 2026-08-31",
      "note": "174 名羥基脲無效或不耐受病人"
    },
    {
      "claim": "用過羥基脲的 PV、ET 病人出現抗藥或無法耐受的比例",
      "value": "20-25",
      "unit": "%",
      "as_of": "2014",
      "source": "Sever M, et al. Leukemia & Lymphoma 2014",
      "note": "用於粗算中國二線上限 8–10 萬人"
    }
  ],
  "sections": [
    "01｜中國病人是美國的兩倍多",
    "02｜同一把尺：ET 現在有哪些藥",
    "03｜中國 40 萬人，先打兩次折",
    "04｜台灣投資人該盯的三個數字",
    "結語｜五地獲准買到的是時間",
    "參考資料"
  ],
  "references": [
    {
      "title": "藥華藥",
      "source": "重大訊息：新藥 BESREMi 獲中國國家藥品監督管理局（NMPA）核准使用於治療成人原發性血小板增多症（ET",
      "date": "2026-10-15",
      "url": "https://mops.twse.com.tw/mops/#/web/t05st01"
    },
    {
      "title": "藥華藥",
      "source": "重大訊息：新藥 BESREMi 獲美國 FDA 核准使用於治療成人原發性血小板過多症（ET",
      "date": "2026-08-29",
      "url": "https://mops.twse.com.tw/mops/#/web/t05st01"
    },
    {
      "title": "藥華藥",
      "source": "重大訊息：向衛福部食藥署申請變更 ET 適應症為治療所有 ET 成人病人",
      "date": "2026-08-16",
      "url": "https://mops.twse.com.tw/mops/#/web/t05st01"
    },
    {
      "title": "藥華藥",
      "source": "重大訊息：BESREMi 獲衛福部 ET 核准函（2026-05-12）、新增適應症領證通知（2026-05-28）、澳門進口藥品預先許可新增 ET（2026-08-02）、獲日本厚生勞動省核准 ET（2026-08-24）、新加坡送件（2026-10-12",
      "date": "",
      "url": "https://mops.twse.com.tw/mops/#/web/t05st01"
    },
    {
      "title": "臺灣證券交易所 OpenAPI",
      "source": "上市公司每月營業收入彙總表（藥華藥 6446，2026 年 9 月",
      "date": "2026-10-15",
      "url": "https://openapi.twse.com.tw/v1/opendata/t187ap05_L"
    },
    {
      "title": "Merck",
      "source": "Merck Announces Phase 3 Trial Initiation for Bomedemstat for the Treatment of Certain Patients With Essential Thrombocythemia",
      "date": "2024-08-27",
      "url": "https://www.merck.com/news/merck-announces-phase-3-trial-initiation-for-bomedemstat-an-investigational-candidate-for-the-treatment-of-certain-patients-with-essential-thrombocythemia/"
    },
    {
      "title": "BioPharma Dive",
      "source": "Merck to acquire Imago BioSciences for $1.35B",
      "date": "2022-11-21",
      "url": "https://www.biopharmadive.com/news/merck-imago-acquire-deal-bone-marrow-cancer/637054/"
    },
    {
      "title": "ClinicalTrials.gov",
      "source": "Shorespan-007（NCT06456346）、Shorespan-006（NCT06079879）、EXCALIBUR-ET2（NCT07623200）試驗登錄",
      "date": "",
      "url": "https://clinicaltrials.gov/study/NCT06456346"
    },
    {
      "title": "Incyte",
      "source": "Incyte Announces New Positive Data at EHA 2026 Showed INCA033989 Achieved Rapid Robust and Sustained Clinical and Molecular Responses and Was Well Tolerated in Patients with Myelofibrosis and Essential Thrombocythemia",
      "date": "2026-06-13",
      "url": "https://investor.incyte.com/news-releases/news-release-details/incyte-announces-new-positive-data-eha-2026-showed-inca033989"
    },
    {
      "title": "BioPharm International",
      "source": "FDA Approves Ropeginterferon Alfa-2b-njft (Besremi) for Essential Thrombocythemia（SURPASS-ET 結果",
      "date": "2026-08-31",
      "url": "https://www.biopharminternational.com/view/fda-approves-ropeginterferon-alfa-2b-njft-besremi-essential-thrombocythemia"
    },
    {
      "title": "Sever M, Newberry KJ, Verstovsek S",
      "source": "Therapeutic options for patients with polycythemia vera and essential thrombocythemia refractory/resistant to hydroxyurea",
      "date": "",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4835800"
    },
    {
      "title": "Klampfl T, et al.",
      "source": "Somatic Mutations of Calreticulin in Myeloproliferative Neoplasms",
      "date": "",
      "url": "https://doi.org/10.1056/NEJMoa1311347"
    }
  ],
  "images": [
    {
      "alt": "圖1｜藥華藥百斯瑞明 2026 年在五個市場取得 ET 許可的時間線",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race/figure-01.png"
    },
    {
      "alt": "圖2｜ET 治療選項同一把尺比較：老藥、藥華藥與默沙東、Incyte 的新藥",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race/figure-02.png"
    },
    {
      "alt": "圖3｜台灣、美國、中國的 ET 病人數，以及中國第二線的粗算上限",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race/figure-03.png"
    },
    {
      "alt": "圖4｜藥華藥 2026 年營收：9 月 26.35 億元、前 9 月 197.37 億元",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race/figure-04.png"
    }
  ],
  "cover_image": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race/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（2026-10-17）。藥華藥 ET 五地獲准，默沙東還在三期。https://drugnews.com.tw/articles/2026-10-17-pharmaessentia-china-et-approval-race.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": {}
}