Skip to content{"success":true,"data":{"id":"twse-mops-q0dos5","title":"代子公司FBD Biologics Limited公告，HCB303美國新藥 臨床試驗申請（IND）獲准進行臨床試驗","summary":"1.事實發生日:115/10/03 2.研發新藥名稱或代號:HCB303 3.用途:HCB303為本公司自主研發之三特異性融合蛋白生物藥，擬開發用於 實體腫瘤治療。目前尚未開始人體臨床試驗，亦尚未經任何主管機關核准上市， 其安全性及療效尚未獲證實。 4.預計進行之所有研發階段:本公司已向美國FDA提出HCB303 新藥臨床試驗申請（IND），並已獲准進行人體臨床試驗。 後續將依開發計畫及各階段臨床試驗結果，進行一期、二期及三期人體臨床試驗， 並視臨床開發結果及相關法規要求，向主管機關提出 生物製品許可申請（BLA）或其他適用之上市許可申請。 5.目前進行中之研發階段(請說明目前之研發階段係屬提出申請/通過核准/ 不通過核准，若未通過者，請說明公司所面臨之風險及因應措施； 另請說明未來經營方向及已投入累積研發費…","canonicalUrl":"https://mops.twse.com.tw/mops/web/t05st01?TYPEK=all&co_id=7827&encodeURIComponent=1&firstin=1&inpuType=co_id&off=1&step=1&year=115&spoke_date=20261003&spoke_time=170054","sourceName":"TWSE Market Observation Post System","sourceUrl":"https://mops.twse.com.tw/mops/web/t05st01","publishedAt":"2026-10-03T09:00:54.000Z","updatedAt":null,"language":"zh-TW","timeZone":"Asia/Taipei","region":"taiwan","country":"TW","market":"Taiwan","topics":["company-announcement","taiwan"],"relatedAssets":["7827"],"importance":"normal","image":null,"imageRights":null,"contentType":"company-announcement","disclosure":"Official company announcement from 漢康-KY創; use the filtered MOPS search page to verify the complete filing.","provenance":{"sourceId":"twse-mops","sourceType":"exchange","official":true,"verification":"PRIMARY_SOURCE_METADATA","fetchedAt":"2026-10-04T01:43:27.652Z","stale":false,"archived":true,"classificationMethod":"RULE_BASED"}},"meta":{"generatedAt":"2026-10-04T01:46:16.157Z","providers":[{"id":"jiguang-news-archive","name":"Jiguang Finance source archive","kind":"news","status":"available","itemCount":1,"cache":"HIT","fetchedAt":"2026-10-04T01:43:27.652Z","sourceUrl":"https://jiguang.uk/sources.html","message":"Archived publisher metadata; original publication and fetch times retained. Archive availability is not source freshness."}],"stale":false,"apiVersion":"v2"},"error":null}