{"slug":"improved-new-drugs","as_of":"2026-10-23","verified_at":"2026-10-23","languages":{"zh":{"title":"台灣改良型新藥 505(b)(2) 公司總表","summary":[{"text":"截至2026年10月23日，本表收錄5家台灣公司的505(b)(2)產品或規劃管線，包括已下市櫃的台微體與健亞。","source_urls":["https://clinicaltrials.gov/api/v2/studies/NCT04123561","https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma","https://mopsov.twse.com.tw/nas/STR/657620260519M001.pdf","https://clinicaltrials.gov/api/v2/studies/NCT06167265","https://www.formosapharma.com/app13002/","https://www.tlcbio.com/en/about/us","https://www.tpex.org.tw/storage/eb_data/11507/11502017631.html"]},{"text":"智擎ONIVYDE與逸達CAMCEVI三個月劑型已有美國核准；TLC599列第3期開發，PMR有已終止的第3期及已完成的第1期生體相等性試驗，APP13002處於IND-enabling。","source_urls":["https://clinicaltrials.gov/api/v2/studies/NCT04123561","https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma","https://mopsov.twse.com.tw/nas/STR/657620260519M001.pdf","https://clinicaltrials.gov/api/v2/studies/NCT06167265","https://www.formosapharma.com/app13002/","https://www.tlcbio.com/en/pipeline/Orthopedics/TLC599","https://clinicaltrials.gov/api/v2/studies/NCT06886620"]}],"undisclosed":"本表是核對來源後的公司與所選管線名單，並非完整產業清冊。階段依逐列來源日期描述，未公開的品名、適應症與事件日期不填補。"},"en":{"title":"Taiwan Improved New Drug and 505(b)(2) Companies","summary":[{"text":"As of October 23, 2026, this table includes 505(b)(2) products or planned programs at 5 Taiwan companies, including formerly listed Taiwan Liposome and Genovate.","source_urls":["https://clinicaltrials.gov/api/v2/studies/NCT04123561","https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma","https://mopsov.twse.com.tw/nas/STR/657620260519M001.pdf","https://clinicaltrials.gov/api/v2/studies/NCT06167265","https://www.formosapharma.com/app13002/","https://www.tlcbio.com/en/about/us","https://www.tpex.org.tw/storage/eb_data/11507/11502017631.html"]},{"text":"ONIVYDE and three-month CAMCEVI have U.S. approvals; TLC599 is in Phase 3 development, PMR has a terminated Phase 3 trial and a completed Phase 1 bioequivalence trial, and APP13002 is IND-enabling.","source_urls":["https://clinicaltrials.gov/api/v2/studies/NCT04123561","https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma","https://mopsov.twse.com.tw/nas/STR/657620260519M001.pdf","https://clinicaltrials.gov/api/v2/studies/NCT06167265","https://www.formosapharma.com/app13002/","https://www.tlcbio.com/en/pipeline/Orthopedics/TLC599","https://clinicaltrials.gov/api/v2/studies/NCT06886620"]}],"undisclosed":"This is a source-verified selection rather than an industry census. Stages retain their individual source dates; undisclosed names, indications and event dates are not filled in."}},"companies":[{"company":"台微體（2021年下市）","company_en":"Taiwan Liposome (delisted in 2021)","ticker":"4152","product":"TLC599（dexamethasone sodium phosphate緩釋微脂體注射劑；規劃505(b)(2)）","product_en":"TLC599 (extended-release liposomal dexamethasone sodium phosphate; planned 505(b)(2))","indication":"膝骨關節炎疼痛","indication_en":"Pain associated with osteoarthritis of the knee","stage":"第3期開發；EXCELLENCE（NCT04123561）登錄 Completed（已完成）","stage_en":"Phase 3 development; EXCELLENCE (NCT04123561) registered as Completed","as_of":"2024-10-08","source":"https://clinicaltrials.gov/api/v2/studies/NCT04123561","quote":"COMPLETED","company_source":"https://www.tlcbio.com/en/about/us","company_quote":"ticker: 4152","product_source":"https://www.sec.gov/Archives/edgar/data/1722890/000156459021016361/tlc-20f_20201231.htm","product_quote":"505(b)(2) regulatory pathway","product_as_of":"2020-12-31","catalyst":null,"additional_verification_sources":["https://www.tlcbio.com/en/pipeline/Orthopedics/TLC599","https://www.tlcbio.com/en/about/us","https://www.sec.gov/Archives/edgar/data/1722890/000156459021016361/tlc-20f_20201231.htm"],"date_basis":"現行產品頁無日期，2026-10-23查閱列Phase 3；EXCELLENCE登錄最後更新2024-10-08、已完成；505(b)(2)規劃見2020年度20-F。4152為原股票代號，公司2021年自願下市。"},{"company":"智擎","company_en":"PharmaEngine","ticker":"4162","product":"ONIVYDE／安能得（PEP02；irinotecan微脂體；505(b)(2)）","product_en":"ONIVYDE (PEP02; irinotecan liposome; 505(b)(2))","indication":"轉移性胰臟腺癌第一線合併療法（與oxaliplatin、fluorouracil及leucovorin併用）","indication_en":"First-line metastatic pancreatic adenocarcinoma in combination with oxaliplatin, fluorouracil and leucovorin","stage":"美國2015年10月首次核准；2024年2月核准第一線合併療法","stage_en":"Initial U.S. approval in October 2015; first-line combination regimen approved in February 2024","as_of":"2024-02-13","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma","quote":"On February 13, 2024","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"智擎生技製藥股份有限公司","product_source":"https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207793Orig1s000OtherR.pdf","product_quote":"505(b)(2) ASSESSMENT","product_as_of":"2015-10-21","catalyst":null,"additional_verification_sources":["https://www.pharmaengine.com/en/product/index/8"],"date_basis":"FDA公告明列2024-02-13第一線適應症核准；公司產品歷程載2015年10月首次美國核准。FDA原始NDA 207793審查檔含505(b)(2)評估。"},{"company":"逸達","company_en":"Foresee Pharmaceuticals","ticker":"6576","product":"CAMCEVI ETM 21 mg（leuprolide，三個月劑型）","product_en":"CAMCEVI ETM 21 mg (leuprolide, three-month formulation)","indication":"晚期前列腺癌","indication_en":"Advanced prostate cancer","stage":"2025年8月獲美國505(b)(2)藥證核准","stage_en":"U.S. 505(b)(2) approval in August 2025","as_of":"2026-05-19","source":"https://mopsov.twse.com.tw/nas/STR/657620260519M001.pdf","quote":"獲美國FDA授予505(b)(2)新藥藥證","company_source":"https://www.tpex.org.tw/openapi/v1/mopsfin_t187ap03_O","company_quote":"逸達生物科技股份有限公司","catalyst":null,"source_page":8,"date_basis":"簡報封面2026年5月19日，第8頁載2025年8月核准；所引資料的2026Q4上市仍屬計畫。"},{"company":"健亞（2026年7月下櫃）","company_en":"Genovate Biotechnology (delisted in July 2026)","ticker":"4130","product":"PMR（cilostazol每日一次緩釋錠；規劃505(b)(2)）","product_en":"PMR (once-daily extended-release cilostazol; planned 505(b)(2))","indication":"間歇性跛行","indication_en":"Intermittent claudication","stage":"第3期GBL14-001（NCT06886620）登錄 Terminated（2017年2月結束）；第1期生體相等性GBL23-001（NCT06167265）登錄 Completed","stage_en":"Phase 3 GBL14-001 (NCT06886620): Terminated (ended February 2017); Phase 1 bioequivalence GBL23-001 (NCT06167265): Completed","as_of":"2025-03-20","source":"https://clinicaltrials.gov/api/v2/studies/NCT06886620","quote":"TERMINATED","company_source":"https://www.tpex.org.tw/storage/eb_data/11507/11502017631.html","company_quote":"健亞生物科技股份有限公司","product_source":"https://www.prnewswire.com/news-releases/genovate-announces-plans-to-submit-a-new-drug-application-for-pmr-to-the-us-food--drug-administration-in-the-second-half-of-2025-302156484.html","product_quote":"505(b)(2) regulatory pathway","product_as_of":"2024-05-28","catalyst":null,"additional_verification_sources":["https://www.tpex.org.tw/storage/eb_data/11507/11502017631.html","https://www.prnewswire.com/news-releases/genovate-announces-plans-to-submit-a-new-drug-application-for-pmr-to-the-us-food--drug-administration-in-the-second-half-of-2025-302156484.html","https://clinicaltrials.gov/api/v2/studies/NCT06167265"],"date_basis":"第3期GBL14-001在2025-03-20首次公布登錄，狀態Terminated、實際2017-02-08結束；第1期生體相等性試驗GBL23-001最後更新2024-02-23，列Completed。2024-05-28公司原始新聞稿確認505(b)(2)規劃，未將送件計畫當成已送件。櫃買公告自2026-07-28終止上櫃。"},{"company":"台新藥","company_en":"Formosa Pharmaceuticals","ticker":"6838","product":"APP13002（眼用抗生素新劑型；規劃505(b)(2)途徑）","product_en":"APP13002 (ophthalmic antibiotic reformulation; planned 505(b)(2) pathway)","indication":"潛在研發用途：眼前節感染及疾患，包括結膜炎、角膜炎、瞼緣炎與瞼板腺功能障礙","indication_en":"Potential development uses: anterior ocular infections and disorders, including conjunctivitis, keratitis, blepharitis and meibomian gland dysfunction","stage":"臨床前；IND-enabling","stage_en":"Preclinical; IND-enabling","as_of":"2026-10-23","source":"https://www.formosapharma.com/app13002/","quote":"in IND-enablement stages","company_source":"https://openapi.twse.com.tw/v1/opendata/t187ap03_L","company_quote":"台新藥股份有限公司","catalyst":null,"date_basis":"無日期現行產品頁，2026-10-23重新查閱；505(b)(2)為規劃途徑，不等於IND或NDA已提交。"}],"scope":{"not_exhaustive":true,"coverage":"Verified selection from the same read-only company-profile and pipeline inputs used in 0b04, because deploy/engine/src/data does not contain the original company profiles. One program selected per company.","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":"Company rows, not independent assets or an industry-wide census. Parent-group, therapeutic-vaccine and planned regulatory-pathway roles are identified in each row."}}