{"slug":"cell-therapy","as_of":"2026-10-22","verified_at":"2026-10-22","languages":{"zh":{"title":"台灣細胞治療公司與管線總表（含細胞衍生外泌體）","summary":[{"text":"截至2026年10月22日，本表核實9家台灣公司的細胞治療或細胞衍生外泌體管線，每家公司選列一項具公開階段的產品或計畫。","source_urls":["https://www.medigen.com.tw/news_view?id=172","https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte","https://mopsov.twse.com.tw/nas/STR/644620260825E001.pdf","https://www.lumosa.com.tw/file/earning_result_conference/1778900090479.pdf","https://www.ever-supreme.com.tw/news_detail/39","https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=2&spoke_time=181317&spoke_date=20261001&co_id=6794&TYPEK=sii&firstin=true&step=2&year=115&month=","https://clinicaltrials.gov/api/v2/studies/NCT05326243","https://clinicaltrials.gov/api/v2/studies/NCT07137104","https://www.bionettx.com/development-pipeline/"]},{"text":"REGENECYTE已取得美國FDA核准，其核准用途是非親屬捐贈者造血前驅細胞移植；表中其他項目依各自文件列臨床或IND準備階段，LT6001另標為外泌體而非活細胞製劑。","source_urls":["https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte","https://www.lumosa.com.tw/file/earning_result_conference/1778900090479.pdf","https://www.medigen.com.tw/news_view?id=172","https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte","https://mopsov.twse.com.tw/nas/STR/644620260825E001.pdf","https://www.lumosa.com.tw/file/earning_result_conference/1778900090479.pdf","https://www.ever-supreme.com.tw/news_detail/39","https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=2&spoke_time=181317&spoke_date=20261001&co_id=6794&TYPEK=sii&firstin=true&step=2&year=115&month=","https://clinicaltrials.gov/api/v2/studies/NCT05326243","https://clinicaltrials.gov/api/v2/studies/NCT07137104","https://www.bionettx.com/development-pipeline/"]}],"undisclosed":"這是具一手來源的選列，並非全台完整名單；外泌體另明確標示。試驗登錄的預估日期、IND規劃、台灣NDA申請與外銷專用許可，各自保留其範圍，不當成未證實的試驗結果或台灣適應症上市核准。"},"en":{"title":"Taiwan Cell Therapy Companies and Pipelines, Including Cell-Derived Exosomes","summary":[{"text":"As of October 22, 2026, this table verifies cell therapy or cell-derived exosome programs at nine Taiwan companies, selecting one publicly staged product or program per company.","source_urls":["https://www.medigen.com.tw/news_view?id=172","https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte","https://mopsov.twse.com.tw/nas/STR/644620260825E001.pdf","https://www.lumosa.com.tw/file/earning_result_conference/1778900090479.pdf","https://www.ever-supreme.com.tw/news_detail/39","https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=2&spoke_time=181317&spoke_date=20261001&co_id=6794&TYPEK=sii&firstin=true&step=2&year=115&month=","https://clinicaltrials.gov/api/v2/studies/NCT05326243","https://clinicaltrials.gov/api/v2/studies/NCT07137104","https://www.bionettx.com/development-pipeline/"]},{"text":"REGENECYTE is FDA-approved for unrelated-donor hematopoietic progenitor cell transplantation; the other selected programs retain their disclosed clinical or IND-preparation status, with LT6001 identified as an exosome program rather than a living-cell product.","source_urls":["https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte","https://www.lumosa.com.tw/file/earning_result_conference/1778900090479.pdf","https://www.medigen.com.tw/news_view?id=172","https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte","https://mopsov.twse.com.tw/nas/STR/644620260825E001.pdf","https://www.lumosa.com.tw/file/earning_result_conference/1778900090479.pdf","https://www.ever-supreme.com.tw/news_detail/39","https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=2&spoke_time=181317&spoke_date=20261001&co_id=6794&TYPEK=sii&firstin=true&step=2&year=115&month=","https://clinicaltrials.gov/api/v2/studies/NCT05326243","https://clinicaltrials.gov/api/v2/studies/NCT07137104","https://www.bionettx.com/development-pipeline/"]}],"undisclosed":"This is a verified selection, not an exhaustive Taiwan census; exosomes are identified separately. Estimated registry dates, planned INDs, a Taiwan NDA filing and an export-only permit retain their own scope and are not converted into completed trial results or Taiwan indication-specific marketing approvals."}},"companies":[{"company":"基亞","company_en":"MEDIGEN","ticker":"3176","product":"Allogeneic Magicell-NK（異體自然殺手細胞）","product_en":"Allogeneic Magicell-NK","indication":"胰管腺癌或膽管癌術後輔助治療，合併化學治療","indication_en":"Adjuvant treatment after surgery for pancreatic ductal adenocarcinoma or cholangiocarcinoma, with chemotherapy","stage":"第I/II期；2026-06-29完成首位受試者收案","stage_en":"Phase I/II; first patient enrolled June 29, 2026","as_of":"2026-06-30","source":"https://www.medigen.com.tw/news_view?id=172","quote":"完成首位受試者收案","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"基亞生物科技股份有限公司","catalyst":{"text":"2026-06-30公司公告異體Magicell-NK試驗已於前一日完成首位受試者收案。","text_en":"On June 30, 2026, the company announced first patient enrollment in the allogeneic Magicell-NK trial on the preceding day.","as_of":"2026-06-30","source":"https://www.medigen.com.tw/news_view?id=172","quote":"已於2026年6月29日正式啟動人體臨床試驗"}},{"company":"永笙-KY","company_en":"StemCyte","ticker":"4178","product":"REGENECYTE（HPC, Cord Blood）","product_en":"REGENECYTE (HPC, Cord Blood)","indication":"遺傳性、後天性或清髓治療相關造血系統疾病；非親屬捐贈者移植之造血與免疫重建","indication_en":"Hematopoietic and immune reconstitution in unrelated-donor transplantation for inherited, acquired or myeloablative-treatment-related hematopoietic disorders","stage":"美國FDA已核准（2024-11-20）","stage_en":"U.S. FDA approval granted November 20, 2024","as_of":"2024-11-20","source":"https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte","quote":"November 20, 2024 Approval Letter","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"永笙生技股份有限公司","catalyst":{"text":"2026-09-30公告台灣永生經美國永生授權，已提出台灣REGENECYTE再生醫療製劑NDA；尚待藥證審查。","text_en":"On September 30, 2026, the company announced a Taiwan REGENECYTE NDA filed by its Taiwan operation under authorization from StemCyte, Inc.; review remains pending.","as_of":"2026-09-30","source":"https://mopsov.twse.com.tw/mops/web/ajax_t05st01?firstin=1&TYPEK=sii&step=2&co_id=4178&year=115&month=09&b_date=30&e_date=30&off=1&seq_no=1&spoke_time=185257&spoke_date=20260930","quote":"再生醫療製劑查驗登記"}},{"company":"藥華藥","company_en":"PharmaEssentia","ticker":"6446","product":"KRAS TCR-T","product_en":"KRAS TCR-T","indication":"實體腫瘤","indication_en":"Solid tumors","stage":"IND-enabling；公司規劃2027年提出IND","stage_en":"IND-enabling; company plans an IND in 2027","as_of":"2026-08-25","source":"https://mopsov.twse.com.tw/nas/STR/644620260825E001.pdf","source_page":28,"quote":"Planned IND in 2027","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"藥華醫藥股份有限公司","catalyst":{"text":"公司簡報將KRAS TCR-T的IND規劃列於2027年，尚非已提出或核准IND。","text_en":"The presentation schedules the KRAS TCR-T IND for 2027; submission or authorization is not established.","as_of":"2026-08-25","source":"https://mopsov.twse.com.tw/nas/STR/644620260825E001.pdf","quote":"Planned IND in 2027"}},{"company":"順藥","company_en":"Lumosa Therapeutics","ticker":"6535","product":"LT6001／CS026（細胞衍生外泌體，非活細胞製劑）","product_en":"LT6001 / CS026 (cell-derived exosomes, not a living-cell product)","indication":"神經學疾病","indication_en":"Neurological diseases","stage":"IND/IIT規劃階段；未確認正式一期已啟動","stage_en":"IND/IIT planning; a formal Phase 1 start is not established","as_of":"2026-05-15","source":"https://www.lumosa.com.tw/file/earning_result_conference/1778900090479.pdf","source_page":18,"quote":"LT-6001 神經學疾病 外泌體","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"順天醫藥生技股份有限公司","catalyst":null},{"company":"長聖","company_en":"Ever Supreme","ticker":"6712","product":"CAR001","indication":"惡性腫瘤／實體腫瘤","indication_en":"Malignant / solid tumors","stage":"第 IIa 期臨床試驗已啟動","stage_en":"Phase IIa trial initiated","as_of":"2026-07-01","source":"https://www.ever-supreme.com.tw/news_detail/39","quote":"正式啟動Phase IIa臨床試驗","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},{"company":"向榮生技","company_en":"UnicoCell","ticker":"6794","product":"ELIXCYTE-OA（異體脂肪間質幹細胞）","product_en":"ELIXCYTE-OA (allogeneic adipose-derived mesenchymal stem cells)","indication":"膝骨關節炎","indication_en":"Knee osteoarthritis","stage":"第 III 期，已完成最後一位病人收案","stage_en":"Phase III; last patient enrolled","as_of":"2026-10-01","source":"https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=2&spoke_time=181317&spoke_date=20261001&co_id=6794&TYPEK=sii&firstin=true&step=2&year=115&month=","quote":"已分別完成第三期臨床試驗收案","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"向榮生醫科技股份有限公司","catalyst":{"text":"2026-10-01公告UC-hADSC取得外銷專用藥品許可；該許可不等同台灣膝骨關節炎適應症上市許可。","text_en":"On October 1, 2026, the company announced an export-only drug permit for UC-hADSC; this does not establish Taiwan marketing approval for knee osteoarthritis.","as_of":"2026-10-01","source":"https://mopsov.twse.com.tw/mops/web/ajax_t05st01?seq_no=2&spoke_time=181317&spoke_date=20261001&co_id=6794&TYPEK=sii&firstin=true&step=2&year=115&month=","quote":"UC-hADSC取得外銷專用藥品許可證"}},{"company":"沛爾生醫*-創","company_en":"Pell Bio-Med Technology","ticker":"6949","product":"PL001（CD19 CAR-T）","product_en":"PL001 (CD19 CAR-T)","indication":"復發或難治性B細胞淋巴瘤","indication_en":"Relapsed or refractory B-cell lymphoma","stage":"第1/2期（試驗登錄）；持續進行、不再收案","stage_en":"Phase 1/2 (registered study); active, not recruiting","as_of":"2026-10-09","source":"https://clinicaltrials.gov/api/v2/studies/NCT05326243","quote":"ACTIVE_NOT_RECRUITING","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"沛爾生技醫藥股份有限公司","catalyst":{"text":"登錄預估主要完成日為2026-12-31；尚未視為臨床結果完成。","text_en":"The registered estimated primary completion date is December 31, 2026; no completed result is inferred.","as_of":"2026-10-09","source":"https://clinicaltrials.gov/api/v2/studies/NCT05326243","quote":"2026-12-31"}},{"company":"和迅","company_en":"Hexun Biosciences","ticker":"6986","product":"HeXell-2020（間質幹細胞）","product_en":"HeXell-2020 (mesenchymal stem cells)","indication":"穩定型冠狀動脈疾病","indication_en":"Stable coronary artery disease","stage":"第I/IIa期；招募中","stage_en":"Phase I/IIa; recruiting","as_of":"2026-09-29","source":"https://clinicaltrials.gov/api/v2/studies/NCT07137104","quote":"A Phase I/IIa Study","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"和迅生命科學股份有限公司","catalyst":{"text":"登錄預估主要完成日為2028-12-31；這是試驗計畫日期，非已完成結果。","text_en":"The registered estimated primary completion date is December 31, 2028; this is a planned date, not a completed result.","as_of":"2026-09-29","source":"https://clinicaltrials.gov/api/v2/studies/NCT07137104","quote":"2028-12-31"}},{"company":"訊聯智藥","company_en":"BIONET TX Corp.","ticker":"7808","product":"BU01（臍帶間質幹細胞）","product_en":"BU01 (umbilical cord mesenchymal stem cells)","indication":"肺纖維化","indication_en":"Pulmonary fibrosis","stage":"第 II 期臨床試驗","stage_en":"Phase II","as_of":"2026-10-22","source":"https://www.bionettx.com/development-pipeline/","quote":"臍帶間質幹細胞新藥BU-01治療肺部纖維化跨入人體臨床二期","source_date":"2026-09-20","date_basis":"動態管線頁於2026-10-22查閱；頁面顯示2026-09-20更新。","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_R","company_quote":"訊聯細胞智藥股份有限公司","catalyst":null}],"scope":{"coverage":"One selected product or program per company; living-cell therapies plus an explicitly labeled cell-derived exosome development program.","not_exhaustive":true,"stage_basis":"Primary documents reopened on 2026-10-22. Dated releases and registry updates retain their own dates; undated live pages use access dates. Trial phases, filing plans and export-only permits do not establish indication-specific marketing authorization.","additional_verification_sources":["https://stemcytebio.com/fda-approved-cord-blood-product/","https://www.lumosa.com.tw/file/social_care/1756173065440.pdf","https://www.ever-supreme.com.tw/products2/all/1","https://clinicaltrials.gov/api/v2/studies/NCT05526001"],"selection_basis":"Existing company profiles and 16 prior pipeline files, followed by fresh primary-source review; cosmetic products, assay platforms, unidentified or unstaged programs, investor-only exposure and device-only collaborators are excluded."}}