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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
MHRAproducts approved3
PMDAproducts approved0
HCproducts approved1
CDSCOproducts approved0
EDEproducts registered0
Connections
3molecules3products4 of 7markets2candidates in trials7companies on the same molecules

About Shanghai Henlius Biotech

Henlius, based in Shanghai, has three antibody biosimilars approved in the United States and Europe, all sold by partners: trastuzumab through Accord, and denosumab and pertuzumab through Organon. Its pertuzumab, Poherdy, is the first pertuzumab biosimilar approved outside India.

Portfolio by market

MoleculeProductFDAEMAMHRAPMDAHCCDSCOEDEMarkets
DenosumabBildyos / Bilprevda HLX14Aug 2025Sep 2025MHRA·Mar 2026··4/7
PertuzumabPoherdy HLX11Nov 2025Apr 2026MHRA····3/7
TrastuzumabHercessi / Zercepac HLX02Apr 2024Jul 2020MHRA····3/7

Month shown is the first approval or registration of that product in that market.

In development

ClinicalTrials.gov lists four comparative trials sponsored by Shanghai Henlius Biotech for four molecules: adalimumab, pertuzumab, rituximab, trastuzumab. Candidates without an approval yet in the seven markets: HLX01, HLX03.

MoleculeCandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionIn the AtlasRegistry record
AdalimumabHLX03Shanghai Henlius BiotechHumiraPhase 1Comparative PKCompletedJan 2017Sep 2018no approval in the seven marketsNCT03357939
PertuzumabHLX11Shanghai Henlius BiotechPerjetaPhase 3Comparative efficacyActive, not recruitingApr 2022May 2024PoherdyNCT05346224
RituximabHLX01Shanghai Henlius BiotechMabThera (brand not stated)Phase 3Comparative efficacyCompletedOct 2015May 2018no approval in the seven marketsNCT02787239
TrastuzumabHLX02Shanghai Henlius BiotechHerceptinPhase 3Comparative efficacyCompletedNov 2016Nov 2018Hercessi / ZercepacNCT03084237

Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026.

Companies on the same molecules

Developers whose portfolios overlap most with Shanghai Henlius Biotech, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.

Intas PharmaceuticalsThree shared molecules: denosumab, pertuzumab, trastuzumab12 molecules in its portfolioBiocon BiologicsTwo shared molecules: denosumab, trastuzumab9 molecules in its portfolioCelltrionTwo shared molecules: denosumab, trastuzumab10 molecules in its portfolioEnzene BiosciencesTwo shared molecules: denosumab, pertuzumab6 molecules in its portfolioReliance Life SciencesTwo shared molecules: denosumab, trastuzumab14 molecules in its portfolioSamsung BioepisTwo shared molecules: denosumab, trastuzumab10 molecules in its portfolioZydus LifesciencesTwo shared molecules: pertuzumab, trastuzumab11 molecules in its portfolio

Chronology

Compare Shanghai Henlius Biotech with other developers on the comparison page.

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Data current to September 2026.