Prestige BioPharma Limited
Founded in 2015 and listed on KOSPI in 2021, Prestige BioPharma develops antibody biosimilars and novel antibody drugs including Tuznue.
As of 2026-10-10, Prestige BioPharma Limited has 17 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).
Price
Change
Market cap
Products & technology
- TuznueTrastuzumab (Herceptin) biosimilar
- HD204Avastin (bevacizumab) biosimilar
- PBP1502Humira (adalimumab) biosimilar
- PBP1510 (Ulenistamab)Pancreatic cancer antibody therapeutic (Anti-PAUF antibody)
Global clinical trials
ClinicalTrials.gov · sponsor-matchedPhase 1/2 · Active not recruiting · 2023-06 · NCT05141149
Phase 1 · Active not recruiting · 2022-03 · NCT05108259
Phase 3 · Active not recruiting · 2019-11 · NCT03390686
Phase 1 · Completed · 2019-04 · NCT03776240
Phase 1 · Completed · 2018-09 · NCT03390673
Phase 3 · Completed · 2018-02 · NCT03013504
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.
Key disclosures
KRX KIND via OpenDARTShow 4 more events
Publications
PubMed · affiliation-matched- Dual Inhibition of TNF-α and IL-6R mitigates cytokine release syndrome via protection of endothelial integrity and reduction of organ damage in mouse models.
Frontiers in immunology · 2026-01 · Won H, Park E, Roh YG 외 2
- Therapeutic effect of amniotic membrane mesenchymal stem cell-derived exosome-rich conditioned medium in cerebral palsy model.
Stem cells translational medicine · 2026-01 · Yoon EJ, Jeong J, Choi Y 외 5
- Quantitative immunohistochemistry analysis of pancreatic adenocarcinoma upregulated factor expression in pancreatic cancer and its prognostic significance.
World journal of gastrointestinal oncology · 2025-09 · Kim JH, Na HY, Jung K 외 5
- Mesenchymal Stem Cell-Based CO2-Bubble-Generating Liposomes for Targeted and Controlled Chemotherapy.
ACS applied bio materials · 2025-09 · Lee CM, Lee JH, Won JE 외 2
- Genetic and pharmacologic alterations of claudin9 levels suffice to induce functional and mature inner hair cells.
bioRxiv : the preprint server for biology · 2024-11 · Chen Y, Lee JH, Li J 외 10
- Pancreatic Adenocarcinoma Up-Regulated Factor (PAUF) Transforms Human Monocytes into Alternative M2 Macrophages with Immunosuppressive Action.
International journal of molecular sciences · 2024-10 · Kim YJ, Nanda SS, Jiang F 외 4
- Anticancer Effects of BAF312 (Siponimod) in Epithelial Ovarian Cancer.
Anticancer research · 2024-10 · Ha H, Ryu JY, Yoon S 외 6
- Demyelination and Na+ Channel Redistribution Underlie Auditory and Vestibular Dysfunction in PMP22-Null Mice.
eNeuro · 2024-02 · Lee JH, Park S, Perez-Flores MC 외 8
- The Piezo channel is a mechano-sensitive complex component in the mammalian inner ear hair cell.
Nature communications · 2024-01 · Lee JH, Perez-Flores MC, Park S 외 21
- Anti-cancer effect of fenbendazole-incorporated PLGA nanoparticles in ovarian cancer.
Journal of gynecologic oncology · 2023-09 · Chang CS, Ryu JY, Choi JK 외 9
Show 7 more publications
- The Piezo channel is central to the mechano-sensitive channel complex in the mammalian inner ear.
Research square · 2023-07 · Lee JH, Perez-Flores MC, Park S 외 21
- CTHRC1 Induces Pancreatic Stellate Cells (PSCs) into Myofibroblast-like Cancer-Associated Fibroblasts (myCAFs).
Cancers · 2023-06 · Kang MK, Jiang F, Kim YJ 외 5
- Adenylyl cyclase isoform 1 contributes to sinoatrial node automaticity via functional microdomains.
JCI insight · 2022-11 · Ren L, Thai PN, Gopireddy RR 외 16
- PAUF Induces Migration of Human Pancreatic Cancer Cells Exclusively via the TLR4/MyD88/NF-κB Signaling Pathway.
International journal of molecular sciences · 2022-09 · Youn SE, Jiang F, Won HY 외 4
- Enhancement of anticancer immunity by immunomodulation of apoptotic tumor cells using annexin A5 protein-labeled nanocarrier system.
Biomaterials · 2022-09 · Lee SE, Lee CM, Won JE 외 6
- PAUF as a Target for Treatment of High PAUF-Expressing Ovarian Cancer.
Frontiers in pharmacology · 2022-01 · Kim YJ, Jiang F, Park J 외 5
- TROIKA-1: A double-blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU-Herceptin® and US-Herceptin® in healthy male subjects.
Pharmacology research & perspectives · 2021-08 · Demarchi M, Coliat P, Mclendon K 외 10
Patents
KIPRIS · applicant-matchedUS · Published · 2024-07 · Application 18776613
- Subsidiary: 프레스티지바이오파마 아이디씨 주식회사점막점착성-PLGA 나노입자
Registered · 2022-07 · Application 1020220092488
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Sources and updates
Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- Approvals & clinical trials
- Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
- Key disclosures
- KRX KIND via OpenDART exchange filings — updated daily
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- ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
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- Measured 2026-10-01
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