{"slug":"vaccines","as_of":"2026-10-23","verified_at":"2026-10-23","languages":{"zh":{"title":"台灣疫苗公司與產品總表","summary":[{"text":"截至2026年10月23日，本表收錄3家台灣公司的疫苗產品或臨床項目，並將已註銷產品與治療性細胞疫苗分別註明。","source_urls":["https://data.fda.gov.tw/opendata/exportDataList.do?method=ExportData&InfoId=36&logType=5","https://www.substipharm.com/news/mvcs-envacgen-is-granted-first-enterovirus-a71-vaccine-marketing-authorization-in-vietnam/","https://www.medigenvac.com/files.php?file=09c23d235fbaebdbea5a749b15cc6735","https://www.fda.gov.tw/tc/includes/GetFile.ashx?cid=41397&id=f637956703479504511","https://www.medigenvac.com/research_vaccine_view.php?id=3","https://clinicaltrials.gov/api/v2/studies/NCT04115761"]},{"text":"國光安定伏三價與四價流感疫苗的台灣許可證仍在有效期，AdimFlu-V已註銷；高端列有ENVACGEN越南上市許可與MVC-COV1901歷史EUA，並已於2025年年報揭露暫停變異株研發投入；長聖ADCV01為第2期招募中的治療性疫苗。","source_urls":["https://data.fda.gov.tw/opendata/exportDataList.do?method=ExportData&InfoId=36&logType=5","https://www.substipharm.com/news/mvcs-envacgen-is-granted-first-enterovirus-a71-vaccine-marketing-authorization-in-vietnam/","https://www.medigenvac.com/files.php?file=09c23d235fbaebdbea5a749b15cc6735","https://www.fda.gov.tw/tc/includes/GetFile.ashx?cid=41397&id=f637956703479504511","https://www.medigenvac.com/research_vaccine_view.php?id=3","https://clinicaltrials.gov/api/v2/studies/NCT04115761"]}],"undisclosed":"本表選列疫苗產品並非完整清冊，每家公司一列；藥證有效期、歷史專案製造核准與當季接種供應不同。MVC-COV1901依公司現行頁面及TFDA歷史核准文件描述，不把EUA等同一般藥證或當季公費供應。"},"en":{"title":"Taiwan Vaccine Companies and Products","summary":[{"text":"As of October 23, 2026, this table includes vaccine products or clinical programs at 3 Taiwan companies, with cancelled products and therapeutic cell vaccines explicitly identified.","source_urls":["https://data.fda.gov.tw/opendata/exportDataList.do?method=ExportData&InfoId=36&logType=5","https://www.substipharm.com/news/mvcs-envacgen-is-granted-first-enterovirus-a71-vaccine-marketing-authorization-in-vietnam/","https://www.medigenvac.com/files.php?file=09c23d235fbaebdbea5a749b15cc6735","https://www.fda.gov.tw/tc/includes/GetFile.ashx?cid=41397&id=f637956703479504511","https://www.medigenvac.com/research_vaccine_view.php?id=3","https://clinicaltrials.gov/api/v2/studies/NCT04115761"]},{"text":"Taiwan licenses for Adimmune trivalent and quadrivalent AdimFlu-S remain within their validity periods, while AdimFlu-V is cancelled; Medigen entries include Vietnam authorization for ENVACGEN, historical Taiwan EUA for MVC-COV1901 and a pause in variant-vaccine R&D investment disclosed in the 2025 annual report; ADCV01 is a recruiting Phase 2 therapeutic vaccine.","source_urls":["https://data.fda.gov.tw/opendata/exportDataList.do?method=ExportData&InfoId=36&logType=5","https://www.substipharm.com/news/mvcs-envacgen-is-granted-first-enterovirus-a71-vaccine-marketing-authorization-in-vietnam/","https://www.medigenvac.com/files.php?file=09c23d235fbaebdbea5a749b15cc6735","https://www.fda.gov.tw/tc/includes/GetFile.ashx?cid=41397&id=f637956703479504511","https://www.medigenvac.com/research_vaccine_view.php?id=3","https://clinicaltrials.gov/api/v2/studies/NCT04115761"]}],"undisclosed":"This is a product selection rather than a complete census, with one row per company. License validity, historical special manufacturing authorization and seasonal supply are distinct. The MVC-COV1901 entry follows the current company page and TFDA authorization documents; EUA is not regular approval or a statement of current public-program supply."}},"companies":[{"company":"國光生","company_en":"Adimmune","ticker":"4142","product":"安定伏 AdimFlu-S（三價）；安定伏 AdimFlu-S (QIS)（四價）；AdimFlu-V（仿病毒體，歷史產品）","product_en":"AdimFlu-S (trivalent); AdimFlu-S (QIS) (quadrivalent); AdimFlu-V (virosomal, historical product)","indication":"預防流感；AdimFlu-S與QIS現行產品頁適用3歲以上；AdimFlu-V為歷史流感疫苗","indication_en":"Prevention of influenza; current AdimFlu-S and QIS product pages specify ages 3 years and older; AdimFlu-V is a historical influenza vaccine","stage":"AdimFlu-S：2010年9月發證，有效至2031年10月；QIS：2017年6月發證，有效至2027年6月；AdimFlu-V：2014年7月發證，2022年6月因有效期限已屆註銷","stage_en":"AdimFlu-S: license issued September 2010, valid through October 2031; QIS: issued June 2017, valid through June 2027; AdimFlu-V: issued July 2014, cancelled June 2022 because the validity period had expired","as_of":"2026-10-23","source":"https://data.fda.gov.tw/opendata/exportDataList.do?method=ExportData&InfoId=36&logType=5","quote":"2031/10/30","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"國光生物科技股份有限公司","catalyst":null,"date_basis":"TFDA藥品許可證全資料於2026-10-23下載；三價000113發證2010-09-20、有效2031-10-30；四價000138發證2017-06-23、有效2027-06-23；AdimFlu-V 000136發證2014-07-15、2022-06-23註銷。空白註銷狀態僅與有效期合看，不推定當季供應量。","product_source":"https://www.adimmune.com.tw/tw/product/detail/%E4%B8%89%E5%83%B9%E6%B5%81%E6%84%9F%E7%96%AB%E8%8B%97","product_quote":"本疫苗適用於3歲以上","product_as_of":"2026-10-23","additional_verification_sources":["https://www.adimmune.com.tw/tw/product/detail/_%E5%AE%89%E5%AE%9A%E4%BC%8F_%E8%A3%82%E8%A7%A3%E5%9E%8B%E5%9B%9B%E5%83%B9%E6%B5%81%E6%84%9F%E7%96%AB%E8%8B%97"]},{"company":"高端疫苗","company_en":"Medigen Vaccine Biologics","ticker":"6547","product":"ENVACGEN（恩穩健腸病毒71型疫苗）；MVC-COV1901（高端新冠肺炎疫苗）","product_en":"ENVACGEN (enterovirus A71 vaccine); MVC-COV1901 (MVC COVID-19 Vaccine)","indication":"ENVACGEN：預防腸病毒71型感染所致疾病；MVC-COV1901：20歲以上成人主動免疫接種以預防COVID-19","indication_en":"ENVACGEN: prevention of enterovirus A71 disease; MVC-COV1901: active immunization against COVID-19 in adults aged 20 years and older","stage":"ENVACGEN：2026年3月獲越南上市許可；MVC-COV1901原型株：2021年7月台灣有條件核准專案製造（EUA，非一般藥證）；2025年4月年報揭露已暫停新冠變異株疫苗研發投入","stage_en":"ENVACGEN: Vietnam marketing authorization in March 2026; original-strain MVC-COV1901: Taiwan conditional special manufacturing authorization in July 2021 (EUA, not regular approval); the April 2025 annual report states that COVID-19 variant-vaccine R&D investment has been paused","as_of":"2026-03-17","source":"https://www.substipharm.com/news/mvcs-envacgen-is-granted-first-enterovirus-a71-vaccine-marketing-authorization-in-vietnam/","quote":"has received marketing authorization","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"高端疫苗生物製劑股份有限公司","catalyst":null,"date_basis":"ENVACGEN共同新聞稿日期2026-03-17；MVC-COV1901核准年月以TFDA2022-11-03新聞所載2021-07-30為準，2022-08-09版仿單列成人適應症及非一般核准。113年度年報刊印日2025-04-30，第2頁明載已暫停變異株研發投入；此為研發策略，不等於原型株EUA撤銷或已證實停產。2026-10-23重開各來源，未把歷史EUA推成當季公費供應或新疫株核准。","product_source":"https://www.medigenvac.com/files.php?file=09c23d235fbaebdbea5a749b15cc6735","product_quote":"本公司已暫停對新冠疫苗專案的變異株研發投入","product_as_of":"2025-04-30","additional_verification_sources":["https://www.medigenvac.com/research_vaccine_view.php?id=3","https://www.fda.gov.tw/tc/newsContent.aspx?cid=4&id=t601291","https://www.fda.gov.tw/tc/siteList.aspx?sid=11845","https://www.fda.gov.tw/tc/includes/GetFile.ashx?cid=41397&id=f637956703479504511"]},{"company":"長聖","company_en":"Ever Supreme Bio Technology","ticker":"6712","product":"ADCV01（治療性自體樹突細胞疫苗）","product_en":"ADCV01 (therapeutic autologous dendritic-cell vaccine)","indication":"原發性多形性膠質母細胞瘤的附加治療","indication_en":"Add-on treatment for primary glioblastoma multiforme","stage":"第2期；RECRUITING（登錄招募中；NCT04115761）","stage_en":"Phase 2; RECRUITING (NCT04115761)","as_of":"2026-09-24","source":"https://clinicaltrials.gov/api/v2/studies/NCT04115761","quote":"RECRUITING","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"長聖國際生技股份有限公司","catalyst":null,"date_basis":"ClinicalTrials.gov最後公開更新2026-09-24；於2026-10-23重新讀取。治療性細胞疫苗列於預防性疫苗公司之後。"}],"scope":{"not_exhaustive":true,"coverage":"3 companies and 6 selected vaccine products: three Adimmune influenza vaccines (including one cancelled historical product), two Medigen vaccines, and one Ever Supreme therapeutic cell vaccine placed last.","stage_basis":"Stages reflect the cited source and its stated date. An undated live page uses the access date; source review does not make an old status a newly reported event.","count_basis":"3 distinct companies; multiple named products per company are paired with their own indication and regulatory status in the same row."}}