Skip to content{"success":true,"data":{"id":"twse-mops-kssrb","title":"代子公司FBD Biologics Limited公告， 向中國大陸國家藥品監督管理局(NMPA) 藥品審評中心 （CDE）提出HCB303新藥臨床試驗（IND）申請","summary":"1.事實發生日:115/11/05 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。HCB303之美國IND已獲美國FDA同意進入臨床開發， 相關訊息本公司已於115年10月3日公告。 台灣 IND 亦已於民國 115 年 10 月 27 日獲衛生福利部 食品藥物管理署（TFDA）核准。 本公司現向中國大陸國家藥品監督管理局（NMPA） 藥品審評中心（CDE）提出HCB303新藥臨床試驗（IND）申請。 該申請仍須依中國大陸相關法規完成受理及審查程序。 待符合適用之臨床試驗許可、人體研究倫理審查及其他相關要求後， 本公司將依臨床開發計畫推進 HCB303於中國大陸之臨床試驗。 4.預計進行之所有研發階段:本公司已向中國大陸 國家藥…","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=20261105&spoke_time=065311","sourceName":"TWSE Market Observation Post System","sourceUrl":"https://mops.twse.com.tw/mops/web/t05st01","publishedAt":"2026-11-04T22:53:11.000Z","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":"2026-11-06T02:21:38.090Z","stale":true,"archived":true,"classificationMethod":"RULE_BASED"}},"meta":{"generatedAt":"2026-11-06T02:24:53.811Z","providers":[{"id":"jiguang-news-archive","name":"GOOSUN FINANCE source archive","kind":"news","provider":"goosun_finance","legacy_provider_alias":["jiguang","jiguang_finance"],"status":"degraded","itemCount":1,"cache":"STALE","fetchedAt":"2026-11-06T02:21:38.090Z","sourceUrl":"https://goosun.uk/sources.html","message":"Archived publisher metadata; original publication and fetch times retained. Archive availability is not source freshness."}],"stale":true,"apiVersion":"v2"},"error":null}