Prestige BioPharma Limited
Founded in 2015 and listed on KOSPI in 2021, Prestige BioPharma develops antibody biosimilars and novel antibody drugs including Tuznue.
Price
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Market cap
Products & technology
- TuznueTrastuzumab (Herceptin) biosimilar
- HD204Avastin (bevacizumab) biosimilar
- PBP1502Humira (adalimumab) biosimilar
- PBP1510 (Ulenistamab)Pancreatic cancer antibody therapeutic (Anti-PAUF antibody)
R&D and key agreements
Source: DART corporate disclosureHD201 (Tuznue) · 허셉틴 바이오시밀러 · 품목허가 완료(EU) · Initial MAA filed with EMA in April 2019; CHMP issued a negative opinion in May 2022; resubmitted in July 2023; CHMP positive opinion in July 2024; final EC marketing authorization granted in September 2024.
HD204 · 아바스틴 바이오시밀러 · 임상 3상 · Global Phase 3 trial ongoing across 17 countries.
PBP1502 · 휴미라 바이오시밀러 · 임상 1상 · Phase 1 trial approved in Spain in January 2022.
PBP1510 (Ulenistamab) · 췌장암 (Anti-PAUF 항체신약) · 임상 1/2a상 · Phase 1/2a trial approved in Spain (Feb 2022), by the US FDA (Jun 2022), Australia (Jul 2023), and Singapore (Sep 2023). INN name 'ulenistamab' registered by WHO in April 2022.
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Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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