{
 "name": "台生材",
 "slug": "tw-6649",
 "aliases": [
  "台灣生醫材料股份有限公司",
  "TWBM",
  "6649"
 ],
 "ticker": "6649",
 "industry": "生技醫療業",
 "website": "www.twbm.com.tw",
 "summary": "台生材（6649）是上櫃的生技醫療類股公司，2012 年成立，2019 年上櫃。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": "台灣生醫材料股份有限公司",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "英文簡稱",
   "value": "TWBM",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "產業類別",
   "value": "生技醫療業",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "掛牌市場",
   "value": "證券櫃檯買賣中心上櫃",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "上櫃日期",
   "value": "2019-06-05",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "成立日期",
   "value": "2012-11-12",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "董事長",
   "value": "宗緒福",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "總經理",
   "value": "馬茂峯",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "實收資本額",
   "value": 420000000,
   "unit": "新台幣元",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "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://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "公司網址",
   "value": "www.twbm.com.tw",
   "unit": "",
   "as_of": "2026-10-21",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O"
  },
  {
   "claim": "月營收（2026-09）",
   "value": 17018,
   "unit": "新台幣千元",
   "as_of": "2026-10-17",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap05_O"
  },
  {
   "claim": "月營收年增率（2026-09）",
   "value": -49.26,
   "unit": "%",
   "as_of": "2026-10-17",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap05_O"
  },
  {
   "claim": "累計營收年增率（2026 年 1 月至 09 月）",
   "value": -38.48,
   "unit": "%",
   "as_of": "2026-10-17",
   "source": "https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap05_O"
  },
  {
   "claim": "產品許可：ZOOM Aspiration Pump",
   "value": "FDA 510(k) K190105｜美國｜2019-02-21",
   "unit": "",
   "as_of": "2019-02-21",
   "source": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190105.pdf",
   "note": "美國510(k)實質等同性許可，非PMA核准；as_of為FDA核准信日期。"
  },
  {
   "claim": "產品許可：TWBM Pump",
   "value": "FDA 510(k) K180115｜美國｜2018-07-24",
   "unit": "",
   "as_of": "2018-07-24",
   "source": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180115.pdf",
   "note": "美國510(k)實質等同性許可，非PMA核准；as_of為FDA核准信日期。"
  },
  {
   "claim": "產品許可進度：台生材愛克斯導管導引線",
   "value": "TFDA第二等級外銷專用許可，衛部醫器外製字第002116號｜台灣｜已接獲核准通知（發證日期查無）",
   "unit": "",
   "as_of": "2025-08-06",
   "source": "https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=2&spoke_time=173917&spoke_date=20250806&co_id=6649&TYPEK=otc&step=2&firstin=1",
   "note": "發言日期：2025-08-06 17:39:17；主旨：公告本公司「台生材愛克斯導管導引線」獲得台灣衛生福利部 (TFDA)核發之外銷專用醫療器材許可證核准通知。。2025-08-06為公告及收到通知日期，未用作發證日。"
  },
  {
   "claim": "產品許可進度：瑞斯托血液回收系統",
   "value": "TFDA第二等級外銷專用許可，衛部醫器外製字第001891號｜台灣｜已接獲核准通知（發證日期查無）",
   "unit": "",
   "as_of": "2024-07-29",
   "source": "https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=4&spoke_time=171428&spoke_date=20240729&co_id=6649&TYPEK=otc&step=2&firstin=1",
   "note": "發言日期：2024-07-29 17:14:28；主旨：公告本公司「瑞斯托血液回收系統」獲得台灣衛生福利部 (TFDA)核發之外銷專用醫療器材許可證核准通知。。2024-07-29為公告及收到通知日期，未用作發證日。"
  },
  {
   "claim": "管線：泡沫式人工腦膜",
   "value": "硬腦膜缺損修補｜美國IDE已通過，放慢臨床試驗準備步調（年報揭露）｜美國",
   "unit": "",
   "as_of": "2026-04-30",
   "source": "https://doc.twse.com.tw/server-java/t57sb01?step=9&kind=F&co_id=6649&filename=2025_6649_20260609F04.pdf",
   "note": "年報第66-67頁（PDF第70-71頁）；source為指定檔名的官方文件查詢頁，點選唯一PDF連結。公司仍在確認臨床前置與準備作業及尋找合作夥伴，非已完成美國臨床試驗。"
  },
  {
   "claim": "管線：早期退化性關節炎組織修復再生產品",
   "value": "早期退化性關節炎｜動物實驗已具效果，暫緩台灣人體臨床試驗許可申請（年報揭露）｜台灣",
   "unit": "",
   "as_of": "2026-04-30",
   "source": "https://doc.twse.com.tw/server-java/t57sb01?step=9&kind=F&co_id=6649&filename=2025_6649_20260609F04.pdf",
   "note": "年報第67頁；source為指定檔名的官方文件查詢頁，點選唯一PDF連結。未將前臨床結果當作人體療效。"
  }
 ],
 "provided_by": "public_sources",
 "verified_at": "2026-10-22",
 "url": "https://drugnews.com.tw/companies/tw-6649.json",
 "generated_at": "2026-10-23T01:06:05.573Z"
}