Shanghai Henlius Biotech
Biosimilar developer, China. 3 development products across 3 molecules: denosumab, pertuzumab, trastuzumab.
First approval in the Atlas: Jul 2020, Zercepac, trastuzumab (EMA)
FDAproducts approved3
EMAproducts approved3
PMDAproducts approved0
HCproducts approved1
CDSCOproducts approved0
EDEproducts registered0
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Denosumab | Bildyos / Bilprevda HLX14 | Aug 2025 | Sep 2025 | · | Mar 2026 | · | · |
| Pertuzumab | Poherdy HLX11 | Nov 2025 | Apr 2026 | · | · | · | · |
| Trastuzumab | Hercessi / Zercepac HLX02 | Apr 2024 | Jul 2020 | · | · | · | · |
Month shown is the first approval or registration of that product in that market.
Chronology
- EMAJul 2020Zercepac, trastuzumab
- FDAApr 2024Hercessi, trastuzumab
- FDAAug 2025Bildyos, denosumab
- FDAAug 2025Bilprevda, denosumab
- EMASep 2025Bildyos, denosumab
- EMASep 2025Bilprevda, denosumab
- FDANov 2025Poherdy, pertuzumab
- HCMar 2026Bildyos, denosumab
- HCMar 2026Tuzemty, denosumab
- EMAApr 2026Poherdy, pertuzumab
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