Skip to content{"success":true,"data":{"id":"twse-mops-1lmq0zb","title":"本公司向歐盟藥品管理局(EMA)提交生物相似藥EG1206A (Pertuzumab Biosimilar)液體注射劑420毫克產品 之上市許可申請","summary":"1.事實發生日:115/10/06 2.研發新藥名稱或代號: 研發代號：EG1206A (Pertuzumab生物相似藥) 3.用途: 治療HER2早期乳癌、轉移性乳癌 4.預計進行之所有研發階段: (1)人體臨床試驗審查(IND)：已申請。 (2)第一期臨床試驗(Phase I)：已完成。 (3)第三期臨床試驗(Phase III)：豁免。 (4)查驗登記審核(BLA/MAA)：向歐盟藥品管理局(EMA)提出產品上市申請。 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用): (1)提出申請/通過核准/不通過核准/各期人體試驗(含期中分析)結果/ 發生其他影響新藥研發之重大事件： 向歐…","canonicalUrl":"https://mops.twse.com.tw/mops/web/t05st01?TYPEK=all&co_id=6589&encodeURIComponent=1&firstin=1&inpuType=co_id&off=1&step=1&year=115&spoke_date=20261007&spoke_time=000658","sourceName":"TWSE Market Observation Post System","sourceUrl":"https://mops.twse.com.tw/mops/web/t05st01","publishedAt":"2026-10-06T16:06:58.000Z","updatedAt":null,"language":"zh-TW","timeZone":"Asia/Taipei","region":"taiwan","country":"TW","market":"Taiwan","topics":["company-announcement","taiwan"],"relatedAssets":["6589"],"importance":"normal","image":null,"imageRights":null,"contentType":"company-announcement","disclosure":"Official company announcement from 台康生技; use the filtered MOPS search page to verify the complete filing.","provenance":{"sourceId":"twse-mops","sourceType":"exchange","official":true,"verification":"PRIMARY_SOURCE_METADATA","fetchedAt":"2026-10-08T21:23:09.690Z","stale":true,"archived":true,"classificationMethod":"RULE_BASED"}},"meta":{"generatedAt":"2026-10-09T01:25:22.702Z","providers":[{"id":"jiguang-news-archive","name":"Jiguang Finance source archive","kind":"news","status":"degraded","itemCount":1,"cache":"STALE","fetchedAt":"2026-10-08T21:23:09.690Z","sourceUrl":"https://jiguang.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}