{
  "as_of": "2026-11-06",
  "title": "多囊腎（ADPKD）新藥賽道",
  "assets": [
    {
      "section": "approved",
      "asset": "JYNARQUE（tolvaptan）",
      "company": "大塚製藥（Otsuka）",
      "country": "日本",
      "mechanism": "血管加壓素 V2 受體拮抗劑",
      "route": "口服",
      "stage": "已核准",
      "indication": "快速惡化的 ADPKD",
      "trials": [],
      "deal": "—",
      "latest": "美國首個學名藥上市（Lupin，180 天專賣期）",
      "date": "2025-05-13",
      "sources": [
        "https://lupin.com/US/media/lupin-launches-tolvaptan-tablets-in-the-u-s-with-180-day-exclusivity"
      ],
      "asia": true,
      "source_records": [
        {
          "url": "https://lupin.com/US/media/lupin-launches-tolvaptan-tablets-in-the-u-s-with-180-day-exclusivity",
          "date": "2025-05-13",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Claude review 2026-11-06; task corrections"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "farabursen（RGLS8429）",
      "company": "諾華（Novartis，收購 Regulus）",
      "country": "瑞士",
      "mechanism": "miR-17 寡核苷酸",
      "route": "皮下注射",
      "stage": "第一b期完成",
      "indication": "ADPKD",
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        "NCT05521191"
      ],
      "deal": "2025 年諾華收購 Regulus：每股現金 7 美元＋核准後 CVR 每股 7 美元，總值最高約 17 億美元",
      "latest": "收購時已完成第一b期多劑量遞增試驗",
      "date": "2025-04-30",
      "sources": [
        "https://www.sec.gov/Archives/edgar/data/1505512/000119312525105845/d873263dex991.htm",
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      ],
      "asia": false,
      "source_records": [
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          "date_kind": "publication",
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          "provenance": "Claude review 2026-11-06; task corrections"
        },
        {
          "url": "https://www.pharmaceutical-technology.com/news/novartis-regulus-renal-disease/",
          "date": "2025-05-01",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Claude review 2026-11-06; task corrections"
        },
        {
          "url": "https://clinicaltrials.gov/study/NCT05521191",
          "date": "2025-06-03",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "VX-407",
      "company": "Vertex",
      "country": "美國",
      "mechanism": "PC1 摺疊校正劑（小分子）",
      "route": "口服",
      "stage": "第二a期",
      "indication": "帶特定 PKD1 變異的 ADPKD",
      "trials": [
        "NCT07161037"
      ],
      "deal": "—",
      "latest": "第二a期收案完成",
      "date": "2026-09-21",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07161037",
        "https://www.vrtx.com/our-science/pipeline/autosomal-dominant-polycystic-kidney-disease"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT07161037",
          "date": "2026-09-21",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        },
        {
          "url": "https://www.vrtx.com/our-science/pipeline/autosomal-dominant-polycystic-kidney-disease",
          "date": "查無",
          "date_kind": "undated",
          "accessed_at": "2026-11-06",
          "provenance": "Publication date not established; accessed date recorded separately"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "ABBV-CLS-628",
      "company": "艾伯維（AbbVie）／Calico",
      "country": "美國",
      "mechanism": "抗 PAPP-A 單株抗體",
      "route": "靜脈注射",
      "stage": "第二期",
      "indication": "ADPKD",
      "trials": [
        "NCT06902558"
      ],
      "deal": "—",
      "latest": "ANCHOR 第二期收案中",
      "date": "2026-10-06",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06902558",
        "https://www.calicolabs.com/clinical-trial-autosomal-dominant-polycystic-kidney-disease/"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06902558",
          "date": "2026-10-06",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        },
        {
          "url": "https://www.calicolabs.com/clinical-trial-autosomal-dominant-polycystic-kidney-disease/",
          "date": "查無",
          "date_kind": "undated",
          "accessed_at": "2026-11-06",
          "provenance": "Publication date not established; accessed date recorded separately"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "AZD1613",
      "company": "阿斯特捷利康（AstraZeneca）",
      "country": "英國",
      "mechanism": "未公開",
      "route": "注射",
      "stage": "第一期",
      "indication": "ADPKD",
      "trials": [
        "NCT07228364"
      ],
      "deal": "—",
      "latest": "ADPKD 病人多劑量遞增第一期（含中國）",
      "date": "2026-10-13",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07228364"
      ],
      "asia": false,
      "source_records": [
        {
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          "date": "2026-10-13",
          "date_kind": "last_update",
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          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "GSK4771261",
      "company": "葛蘭素史克（GSK）",
      "country": "英國",
      "mechanism": "未公開",
      "route": "—",
      "stage": "第一期",
      "indication": "ADPKD",
      "trials": [
        "NCT06734234"
      ],
      "deal": "—",
      "latest": "健康受試者與 ADPKD 病人第一a／b期",
      "date": "2026-07-30",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06734234"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06734234",
          "date": "2026-07-30",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "PYC-003",
      "company": "PYC Therapeutics",
      "country": "澳洲",
      "mechanism": "胜肽偶聯 PMO 反義寡核苷酸",
      "route": "靜脈注射",
      "stage": "第一期",
      "indication": "ADPKD",
      "trials": [
        "NCT06714006"
      ],
      "deal": "—",
      "latest": "第一期（澳洲、香港、紐西蘭）",
      "date": "2026-07-27",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06714006"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06714006",
          "date": "2026-07-27",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "JMKX003142",
      "company": "濟民可信（Jemincare）",
      "country": "中國",
      "mechanism": "血管加壓素 V2 受體拮抗劑",
      "route": "口服",
      "stage": "第二期",
      "indication": "快速惡化的 ADPKD",
      "trials": [
        "NCT06800651"
      ],
      "deal": "—",
      "latest": "中國第二期收案中，並進行多項第一期配套試驗",
      "date": "2025-07-03",
      "sources": [
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        "https://www.dovepress.com/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-intraveno-peer-reviewed-fulltext-article-DDDT"
      ],
      "asia": true,
      "source_records": [
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        },
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          "url": "https://www.dovepress.com/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-intraveno-peer-reviewed-fulltext-article-DDDT",
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          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Publisher citation_publication_date meta; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "tamibarotene",
      "company": "Rege Nephro",
      "country": "日本",
      "mechanism": "維生素 A 酸受體作用劑（既有藥新用途）",
      "route": "口服",
      "stage": "第二a期",
      "indication": "ADPKD",
      "trials": [
        "NCT06289998"
      ],
      "deal": "—",
      "latest": "日本第二a期，52 週",
      "date": "2025-04-04",
      "sources": [
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      ],
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        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "GV-100",
      "company": "太溪生技新藥（Gilva Therapeutics）",
      "country": "台灣",
      "mechanism": "口服選擇性 HDAC6 抑制劑",
      "route": "口服",
      "stage": "第一期",
      "indication": "ADPKD",
      "trials": [
        "NCT07788014"
      ],
      "deal": "—",
      "latest": "澳洲第一期（健康受試者）單次與多次劑量遞增試驗收案中（預計 80 人，2026-06 開始）",
      "date": "2026-08-26",
      "sources": [
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      ],
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        }
      ]
    },
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      "asset": "GBP-213",
      "company": "上海仁濟醫院",
      "country": "中國",
      "mechanism": "未公開",
      "route": "皮下注射",
      "stage": "早期第一期",
      "indication": "ADPKD",
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      ],
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      "latest": "尚未收案",
      "date": "2026-10-23",
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      ],
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        }
      ]
    },
    {
      "section": "stopped",
      "asset": "venglustat",
      "company": "賽諾菲（Sanofi）",
      "country": "法國",
      "mechanism": "葡萄糖神經醯胺合成酶抑制劑",
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      "indication": "ADPKD",
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        "NCT04705051"
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      "latest": "STAGED-PKD 2021 年期中分析無效終止",
      "date": "2021-08-03",
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      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT03523728",
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          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "stopped",
      "asset": "bardoxolone methyl",
      "company": "Reata／渤健（Biogen）",
      "country": "美國",
      "mechanism": "Nrf2 活化劑",
      "route": "口服",
      "stage": "第三期終止",
      "indication": "ADPKD",
      "trials": [
        "NCT03918447"
      ],
      "deal": "—",
      "latest": "FALCON 第三期終止（公司停止所有 CKD 計畫）",
      "date": "2025-06-03",
      "sources": [
        "https://clinicaltrials.gov/study/NCT03918447"
      ],
      "asia": false,
      "source_records": [
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        }
      ]
    },
    {
      "section": "stopped",
      "asset": "lixivaptan",
      "company": "Palladio Biosciences",
      "country": "美國",
      "mechanism": "血管加壓素 V2 受體拮抗劑",
      "route": "口服",
      "stage": "第三期終止",
      "indication": "ADPKD",
      "trials": [
        "NCT04064346"
      ],
      "deal": "—",
      "latest": "ACTION 第三期終止（商業考量，收 12 人）",
      "date": "2023-02-06",
      "sources": [
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      ],
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      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT04064346",
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          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    }
  ],
  "repurposing": [
    {
      "asset": "dapagliflozin",
      "sponsor": "University of Cologne",
      "stage": "第三期",
      "trial": "NCT07280585",
      "name": "STOP-PKD"
    },
    {
      "asset": "metformin XR",
      "sponsor": "University of Queensland",
      "stage": "第三期",
      "trial": "NCT04939935",
      "name": "IMPEDE-PKD"
    },
    {
      "asset": "hydrochlorothiazide",
      "sponsor": "UMC Groningen",
      "stage": "第三期",
      "trial": "NCT05373264",
      "name": "HYDRO-PROTECT"
    }
  ]
}