{
 "name": "康霈*",
 "slug": "tw-6919",
 "aliases": [
  "康霈生技股份有限公司",
  "Caliway",
  "6919"
 ],
 "ticker": "6919",
 "industry": "生技醫療業",
 "website": "www.caliwaybiopharma.com",
 "summary": "康霈*（6919）是上市的生技醫療類股公司，2012 年成立，2024 年上市。基本資料取自臺灣證券交易所／證券櫃檯買賣中心公開資料；重大訊息見 https://drugnews.com.tw/filings/ 。",
 "facts": [
  {
   "claim": "公司全名",
   "value": "康霈生技股份有限公司",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "英文簡稱",
   "value": "Caliway",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "產業類別",
   "value": "生技醫療業",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "掛牌市場",
   "value": "臺灣證券交易所上市",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "上市日期",
   "value": "2024-10-02",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "成立日期",
   "value": "2012-10-22",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "董事長",
   "value": "徐坴暉",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "總經理",
   "value": "凌玉芳",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "實收資本額",
   "value": 778600430,
   "unit": "新台幣元",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "簽證會計師事務所",
   "value": "安侯建業聯合會計師事務所",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "公司網址",
   "value": "www.caliwaybiopharma.com",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap03_L"
  },
  {
   "claim": "月營收（2026-09）",
   "value": 0,
   "unit": "新台幣千元",
   "as_of": "2026-10-17",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap05_L",
   "note": "原檔數值、單位與as_of保留；2026-10-22重開官方OpenAPI逐值核對，資料年月11509、出表日期1151017，欄位：營業收入-當月營收；僅更正不符白名單的舊二手來源網址。"
  },
  {
   "claim": "累計營收年增率（2026 年 1 月至 09 月）",
   "value": -86.08,
   "unit": "%",
   "as_of": "2026-10-17",
   "source": "https://openapi.twse.com.tw/v1/opendata/t187ap05_L",
   "note": "原檔數值、單位與as_of保留；2026-10-22重開官方OpenAPI逐值核對，資料年月11509、出表日期1151017，欄位：累計營業收入-前期比較增減(%)；僅更正不符白名單的舊二手來源網址。"
  },
  {
   "claim": "管線：CBL-514（SUPREME-01／CBL-0301）",
   "value": "大範圍腹部皮下脂肪減少｜全球樞紐Phase III已首例給藥、持續收案｜美國、加拿大",
   "unit": "",
   "as_of": "2026-09-23",
   "source": "https://www.caliwaybiopharma.com/en/news-detail/-CBL-514-SUPREME-01-FPI-ObesityWeek-2026-ENG/",
   "note": "NCT07140939；試驗代號CBL-0301不是另一分子。"
  },
  {
   "claim": "管線：CBL-514（竇根氏症配方／CBL-514D）",
   "value": "竇根氏症｜Phase II試驗取得最終統計結果，主要指標達顯著｜美國",
   "unit": "",
   "as_of": "2026-09-21",
   "source": "https://mops.twse.com.tw/mops/#/web/t05st01?companyId=6919",
   "note": "發言日期 2026-09-21 17:54:09；主旨 本公司新藥CBL-514注射劑用於治療竇根氏症之二期臨床試驗 取得最終統計結果，其主要療效指標在統計上達到顯著有效意義。；序號 2；enterDate=1150921。 NCT06303570（CBL-0202DD）；試驗地區美國由登錄交叉核對。CBL-514D稱呼見同月官網 https://www.caliwaybiopharma.com/en/news-detail/-CBL-514-SUPREME-01-FPI-ObesityWeek-2026-ENG/ ，不與減脂三期混為同適應症階段。"
  },
  {
   "claim": "管線：CBL-514合併tirzepatide（CBL-0201WR）",
   "value": "減少過重或肥胖成人腹部皮下脂肪｜Phase II IND已獲FDA核准｜美國",
   "unit": "",
   "as_of": "2026-08-24",
   "source": "https://mops.twse.com.tw/mops/#/web/t05st01?companyId=6919",
   "note": "發言日期 2026-08-24 17:03:32；主旨 本公司新藥CBL-514注射劑合併tirzepatide(Eli Lilly)用於 減少過重或肥胖成人腹部皮下脂肪之多中心二期臨床試驗申請， 今日已取得美國FDA IND核准。；序號 1；enterDate=1150824。 此為合併治療試驗獲准，不代表與Eli Lilly已簽授權合作；公告未揭露Lilly商業合約。"
  },
  {
   "claim": "管線：CBL-514（橘皮組織；CBL-0201EFP Stage 2）",
   "value": "股後外側中度至重度橘皮組織｜Phase II已完成｜美國",
   "unit": "",
   "as_of": "2026-07-09",
   "source": "https://clinicaltrials.gov/study/NCT05836779",
   "note": "NCT05836779；as_of為Last Update Posted。登錄Phase II完成不等於上市核准。"
  },
  {
   "claim": "催化劑：CBL-514（SUPREME-01／CBL-0301）",
   "value": "試驗主要完成日期（登錄預估）｜2027-07｜已公告",
   "unit": "",
   "as_of": "2026-10-19",
   "source": "https://clinicaltrials.gov/study/NCT07140939",
   "note": "NCT07140939；Primary Completion Date type=ESTIMATED，非解盲日或藥證期限；as_of為Last Update Posted。"
  },
  {
   "claim": "催化劑：CBL-514（SUPREME-02／CBL-0302）",
   "value": "試驗主要完成日期（登錄預估）｜2027-08｜已公告",
   "unit": "",
   "as_of": "2026-10-20",
   "source": "https://clinicaltrials.gov/study/NCT07526974",
   "note": "NCT07526974；Primary Completion Date type=ESTIMATED，非解盲日或藥證期限；as_of為Last Update Posted。"
  },
  {
   "claim": "催化劑：CBL-514（CBL-0206 Stage 1）",
   "value": "試驗主要完成日期（登錄預估）｜2027-04｜已公告",
   "unit": "",
   "as_of": "2026-10-20",
   "source": "https://clinicaltrials.gov/study/NCT07608770",
   "note": "NCT07608770；Primary Completion Date type=ESTIMATED，非解盲日或藥證期限；as_of為Last Update Posted。"
  },
  {
   "claim": "催化劑：CBL-514（OI26）",
   "value": "ObesityWeek臨床前合併療法資料發表｜2026-11｜已公告",
   "unit": "",
   "as_of": "2026-09-23",
   "source": "https://www.caliwaybiopharma.com/en/news-detail/-CBL-514-SUPREME-01-FPI-ObesityWeek-2026-ENG/",
   "note": "公司公告摘要獲接受，會議於華盛頓2026年11月舉辦；未把動物資料發表當臨床療效證實。"
  }
 ],
 "responses": [],
 "provided_by": "public_sources",
 "verified_by": "Drugnews｜藥時事",
 "verified_at": "2026-10-22",
 "disclosure": "Drugnews 依公開來源（公司公告、公開資訊觀測站、試驗登錄、主管機關文件）整理，於 verified_at 逐條核對來源；未經公司審閱。",
 "url": "https://drugnews.com.tw/companies/tw-6919.json",
 "generated_at": "2026-10-23T01:06:05.573Z"
}