{"slug":"biosimilars-cdmo","as_of":"2026-10-22","verified_at":"2026-10-22","languages":{"zh":{"title":"台灣生物相似藥與 CDMO 公司總表","summary":[{"text":"截至2026年10月22日，本表收錄10家台灣公司的生物相似藥或生物藥CDMO產品與服務。","source_urls":["https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda","https://glyconex.com.tw/pipeline/","https://www.formosapharma.com/formosa-pharmaceuticals-files-clinical-trial-application-for-tsy-110-an-antibody-drug-conjugate-biosimilar-targeting-her2-positive-breast-cancers/","https://mycenax.com/news-detail.php?id=94","https://tanvexusa.com/news/tanvex-biopharma-usa-inc-achieves-dual-u-s-regulatory-milestones-fda-approves-nypozi-and-fda-accepts-biosimilar-biologics-license-application-for-tx-05/","https://www.medigenvac.com/research_vaccine_view.php?id=7","https://www.tfbsbio.com/zh-TW/new/qdvyhgXrjfa2310Z","https://mopsov.twse.com.tw/nas/STR/689120260825M001.pdf","https://www.formycon.com/en/blog/press-release/formycon-and-zydus-fyb206-becomes-first-publicly-announced-keytruda-biosimilar-accepted-for-review-by-fda/","https://bora-corp.com/our-business/?lang=zh-hant"]},{"text":"表中HERWENDA與NYPOZI已取得所列地區核准，FYB206美國申請已受理；永昕、樂迦、啟弘與保瑞所列項目則明列客戶製造或服務角色。","source_urls":["https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda","https://glyconex.com.tw/pipeline/","https://www.formosapharma.com/formosa-pharmaceuticals-files-clinical-trial-application-for-tsy-110-an-antibody-drug-conjugate-biosimilar-targeting-her2-positive-breast-cancers/","https://mycenax.com/news-detail.php?id=94","https://tanvexusa.com/news/tanvex-biopharma-usa-inc-achieves-dual-u-s-regulatory-milestones-fda-approves-nypozi-and-fda-accepts-biosimilar-biologics-license-application-for-tx-05/","https://www.medigenvac.com/research_vaccine_view.php?id=7","https://www.tfbsbio.com/zh-TW/new/qdvyhgXrjfa2310Z","https://mopsov.twse.com.tw/nas/STR/689120260825M001.pdf","https://www.formycon.com/en/blog/press-release/formycon-and-zydus-fyb206-becomes-first-publicly-announced-keytruda-biosimilar-accepted-for-review-by-fda/","https://bora-corp.com/our-business/?lang=zh-hant"]}],"undisclosed":"本表不是完整產業清冊；客戶專案未公開的代號與適應症標為查無，不以商業生產推定其他地區核准。"},"en":{"title":"Taiwan Biosimilar and CDMO Companies","summary":[{"text":"As of October 22, 2026, this table includes biosimilar or biologics CDMO products and services at 10 Taiwan companies.","source_urls":["https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda","https://glyconex.com.tw/pipeline/","https://www.formosapharma.com/formosa-pharmaceuticals-files-clinical-trial-application-for-tsy-110-an-antibody-drug-conjugate-biosimilar-targeting-her2-positive-breast-cancers/","https://mycenax.com/news-detail.php?id=94","https://tanvexusa.com/news/tanvex-biopharma-usa-inc-achieves-dual-u-s-regulatory-milestones-fda-approves-nypozi-and-fda-accepts-biosimilar-biologics-license-application-for-tx-05/","https://www.medigenvac.com/research_vaccine_view.php?id=7","https://www.tfbsbio.com/zh-TW/new/qdvyhgXrjfa2310Z","https://mopsov.twse.com.tw/nas/STR/689120260825M001.pdf","https://www.formycon.com/en/blog/press-release/formycon-and-zydus-fyb206-becomes-first-publicly-announced-keytruda-biosimilar-accepted-for-review-by-fda/","https://bora-corp.com/our-business/?lang=zh-hant"]},{"text":"HERWENDA and NYPOZI have the stated regional authorizations, and the FYB206 U.S. filing is accepted for review; the selected Mycenax, Locus Cell, TFBS and Bora rows identify customer-manufacturing or service roles.","source_urls":["https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda","https://glyconex.com.tw/pipeline/","https://www.formosapharma.com/formosa-pharmaceuticals-files-clinical-trial-application-for-tsy-110-an-antibody-drug-conjugate-biosimilar-targeting-her2-positive-breast-cancers/","https://mycenax.com/news-detail.php?id=94","https://tanvexusa.com/news/tanvex-biopharma-usa-inc-achieves-dual-u-s-regulatory-milestones-fda-approves-nypozi-and-fda-accepts-biosimilar-biologics-license-application-for-tx-05/","https://www.medigenvac.com/research_vaccine_view.php?id=7","https://www.tfbsbio.com/zh-TW/new/qdvyhgXrjfa2310Z","https://mopsov.twse.com.tw/nas/STR/689120260825M001.pdf","https://www.formycon.com/en/blog/press-release/formycon-and-zydus-fyb206-becomes-first-publicly-announced-keytruda-biosimilar-accepted-for-review-by-fda/","https://bora-corp.com/our-business/?lang=zh-hant"]}],"undisclosed":"Coverage is not exhaustive. Undisclosed customer-project codes and indications remain unfilled; commercial production does not establish approval in other jurisdictions."}},"companies":[{"company":"台康生技","company_en":"EirGenix","ticker":"6589","product":"EG12014／HERWENDA（trastuzumab biosimilar）","product_en":"EG12014 / HERWENDA (trastuzumab biosimilar)","indication":"HER2 陽性乳癌與轉移性胃癌","indication_en":"HER2-positive breast cancer and metastatic gastric cancer","stage":"歐盟上市許可；2023-11-15 核發","stage_en":"EU marketing authorization granted November 15, 2023","as_of":"2026-08-18","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda","quote":"marketing authorisation valid","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"台康生技股份有限公司","catalyst":null,"date_basis":"EMA所示產品資訊最後更新2026-08-18；核准日期另列2023-11-15。","product_source":"https://mopsov.twse.com.tw/nas/STR/658920260429M001.pdf","product_quote":"HERWENDA® - Sandoz","product_as_of":"2026-04","product_source_page":5,"product_date_precision":"month"},{"company":"醣聯","company_en":"GlycoNex","ticker":"4168","product":"SPD8（denosumab biosimilar）","product_en":"SPD8 (denosumab biosimilar)","indication":"骨質疏鬆症；癌症相關骨骼事件","indication_en":"Osteoporosis; cancer-related skeletal events","stage":"日本第 3 期完成；2026-06-11 解盲","stage_en":"Phase 3 complete in Japan; unblinded June 11, 2026","as_of":"2026-10-22","source":"https://glyconex.com.tw/pipeline/","quote":"Phase 3 complete in Japan","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"台灣醣聯生技醫藥股份有限公司","catalyst":{"text":"公司管線頁記載日本三期於2026-06-11解盲，主要指標達標。","text_en":"The company pipeline records Japanese Phase 3 unblinding on June 11, 2026, with the primary endpoint met.","as_of":"2026-06-11","source":"https://glyconex.com.tw/pipeline/","quote":"unblinded on June 11, 2026"},"date_basis":"現行管線頁Last updated August2026；as_of為重新查核日。"},{"company":"台新藥","company_en":"Formosa Pharmaceuticals","ticker":"6838","product":"TSY-110／EG12043（ADC生物相似藥）","product_en":"TSY-110 / EG12043 (biosimilar ADC)","indication":"HER2 陽性轉移性與早期乳癌","indication_en":"HER2-positive metastatic and early-stage breast cancer","stage":"歐洲 CTA 已提交","stage_en":"European CTA submitted","as_of":"2026-08-28","source":"https://www.formosapharma.com/formosa-pharmaceuticals-files-clinical-trial-application-for-tsy-110-an-antibody-drug-conjugate-biosimilar-targeting-her2-positive-breast-cancers/","quote":"Clinical Trial Application (CTA)","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"台新藥股份有限公司","catalyst":null},{"company":"永昕","company_en":"Mycenax","ticker":"4726","product":"SCD 的 Eylea 生物相似藥（CDMO客戶專案；代號查無）","product_en":"SCD Eylea biosimilar (CDMO customer project; code undisclosed)","indication":"查無（此公告未列適應症）","indication_en":"Not disclosed in this announcement","stage":"公司公告已達商業生產階段；永昕為製造夥伴","stage_en":"Commercial production stage per company; Mycenax is manufacturing partner","as_of":"2025-06-30","source":"https://mycenax.com/news-detail.php?id=94","quote":"commercial production stage","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"永昕生物醫藥股份有限公司","catalyst":null},{"company":"泰福-KY","company_en":"Tanvex BioPharma","ticker":"6541","product":"NYPOZI（filgrastim-txid；美國子公司產品）","product_en":"NYPOZI (filgrastim-txid; U.S. subsidiary product)","indication":"癌症病人化療引起之嗜中性白血球減少","indication_en":"Chemotherapy-induced neutropenia in cancer patients","stage":"已獲美國FDA核准","stage_en":"FDA approved in the United States","as_of":"2024-08-19","source":"https://tanvexusa.com/news/tanvex-biopharma-usa-inc-achieves-dual-u-s-regulatory-milestones-fda-approves-nypozi-and-fda-accepts-biosimilar-biologics-license-application-for-tx-05/","quote":"(FDA) approved NYPOZI","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"泰福生技股份有限公司","catalyst":null},{"company":"高端疫苗","company_en":"Medigen Vaccine Biologics","ticker":"6547","product":"Palivizumab／RSV抗體生物相似藥","product_en":"Palivizumab / anti-RSV biosimilar","indication":"預防RSV感染","indication_en":"Prevention of RSV infection","stage":"Pilot CHIM先導人體感染控制模型試驗執行中；未指定一期至三期","stage_en":"Pilot controlled human infection model study ongoing; numbered phase unspecified","as_of":"2026-10-22","source":"https://www.medigenvac.com/research_vaccine_view.php?id=7","quote":"先導人體感染控制模型試驗","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":"現行產品頁無發布日，as_of為本次查閱日；不從圖例推定期別。"},{"company":"啟弘生技","company_en":"TFBS Bioscience","ticker":"6939","product":"OGTP腺相關病毒AAV基因治療CDMO服務","product_en":"AAV gene therapy CDMO services for OGTP","indication":"基因治療開發支援；具體客戶產品適應症未揭露","indication_en":"Gene therapy development support; specific customer-product indication undisclosed","stage":"已與ONODERA GT Pharma簽署CDMO合作協議","stage_en":"CDMO collaboration agreement with ONODERA GT Pharma signed","as_of":"2026-10-14","source":"https://www.tfbsbio.com/zh-TW/new/qdvyhgXrjfa2310Z","quote":"與日本ONODERA GT Pharma（OGTP）簽署合作協議","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_R","company_quote":"啟弘生物科技股份有限公司","catalyst":null},{"company":"樂迦再生","company_en":"Locus Cell","ticker":"6891","product":"Elate Ocular（Cambium Bio客戶專案）","product_en":"Elate Ocular (Cambium Bio customer project)","indication":"中重度乾眼症／免疫相關眼表病變","indication_en":"Moderate-to-severe dry eye / immune-related ocular surface disease","stage":"承接客戶國際三期臨床試驗製造需求","stage_en":"Manufacturing for customer’s international Phase 3 trial","as_of":"2026-08-25","source":"https://mopsov.twse.com.tw/nas/STR/689120260825M001.pdf","quote":"樂迦承接 Cambium 三期臨床試驗的製造需求","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_R","company_quote":"樂迦再生科技股份有限公司","catalyst":null,"source_page":19},{"company":"美時","company_en":"Lotus Pharmaceutical","ticker":"1795","product":"FYB206（pembrolizumab biosimilar；部分亞太商業化夥伴）","product_en":"FYB206 (pembrolizumab biosimilar; commercialization partner in parts of APAC)","indication":"腫瘤；此公告未逐一揭露申請適應症","indication_en":"Oncology; filing indications not individually listed in this release","stage":"美國BLA已受理審查；美時權利在部分亞太，非美國","stage_en":"U.S. BLA accepted for review; Lotus rights are in parts of APAC, not the U.S.","as_of":"2026-10-13","source":"https://www.formycon.com/en/blog/press-release/formycon-and-zydus-fyb206-becomes-first-publicly-announced-keytruda-biosimilar-accepted-for-review-by-fda/","quote":"accepted for review","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"美時化學製藥股份有限公司","catalyst":null},{"company":"保瑞","company_en":"Bora Pharmaceuticals","ticker":"6472","product":"保瑞藥業生物製劑CDMO服務","product_en":"Bora Pharmaceuticals biologics CDMO services","indication":"服務型；客戶個別適應症未公開","indication_en":"Service offering; individual customer indications undisclosed","stage":"服務涵蓋生物製劑與無菌注射劑；從配方、臨床至商業化量產與包裝","stage_en":"Services include biologics and sterile injectables, from formulation through clinical and commercial manufacturing and packaging","as_of":"2026-10-22","source":"https://bora-corp.com/our-business/?lang=zh-hant","quote":"生物製劑與無菌注射劑","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"保瑞藥業股份有限公司","catalyst":null,"date_basis":"無日期現行服務頁；as_of為查閱日，服務能力不是個別藥物臨床期別。"}],"scope":{"not_exhaustive":true,"coverage":"Source-verified selection from existing Taiwan company profiles; one row per company, with one named program or service selected for that company.","stage_basis":"Stage is the statement in the cited source as of its stated date; an undated live page uses the access date. Development, trial authorization, recruitment and marketing authorization remain separate.","count_basis":"Company rows, not an industry-wide census or a count of independent drugs. Licensed products, original development and customer manufacturing are identified in product and stage fields."}}