The US Food and Drug Administration (FDA) accepted Henlius' application for HLX02 (biosimilar trastuzumab for injection). Meanwhile, Henlius' multicentre phase III clinical trial (NCT04740671) of HLX04-O (biosimilar bevacizumab) for wet age-related macular degeneration (wAMD) commenced in the US with the first patient dosed.
Henlius announced in early 2023 that FDA has accepted their Biologics License Application (BLA) for Henlius' biosimilar HLX02 (trastuzumab for injection). In addition, the first patient was dosed in the US as part of the company’s global multicentre phase III clinical trial (NCT04740671) of biosimilar HLX04-O (bevacizumab) for the treatment of wAMD.
HLX02 trastuzumab biosimilar
HLX02 is the first Chinese copy biological/ biosimilar approved in both China and the EU [1, 2], and now potentially also in the US.
Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers.
The originator product, Herceptin, is sold by Roche/Genentech.
Henlius’ HLX02 trastuzumab has the trade name Zercepac in Europe, Hanquyou in China and Tuzucip and Trastucip in Australia. In the US, the BLA was submitted by the company's business partner Accord BioPharma. The BLA seeks approval of HLX02 for the adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
HLX04 bevacizumab biosimilar
Henlius’ global clinical trial of HLX04-O (bevacizumab) (jointly developed with Essex) for the treatment of wAMD has already had patients dosed in the European Union and Australia, and now US patients join the trial. Singapore and other regions of the world are also to be involved in the trial. In addition, the first patient has been dosed in another phase III clinical trial in China for HLX04-O for the treatment of wAMD.
The NCT04740671 trial is a randomized, double-blind, active-controlled, global phase III study and aims to compare the efficacy and safety of HLX04-O with ranibizumab in patients wAMD. Eligible patients will be randomized 1:1 to receive intravitreal injection of HLX04-O (1.25 mg) or ranibizumab (0.5 mg) every 4 weeks for 48 weeks.
Henlius’ Hanbeitai (汉贝泰, HLX04) bevacizumab copy biological has already been approved in China  for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer. These are the same indications as the originator product Roche’s Avastin.
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A) . It works in a way similar to ranibizumab which can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wAMD, macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss .
Hanbeitai is the company's fourth monoclonal antibody approved in China. Henlius has also gained the National Medical Products Administration approval for its rituximab copy biological, Hanlikon (汉利康, HLX01), trastuzumab copy biological Han Quyou (汉曲优, HLX02: Zercepac in Europe) and adalimumab copy biological, Handa Yuan (汉达远, HLX03) .
LATIN AMERICAN FORUM
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Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
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Henlius makes deal with Getz Pharma for adalimumab copy biological
Progress for bevacizumab copy biologicals from Henlius and Innovent
FDA accepts application for bevacizumab biosimilar BAT1706
1. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 20]. Available from: www.gabionline.net/biosimilars/general/copy-biologicals-approved-in-china
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 20]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars-of-trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 20]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. China approves three bevacizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 20]. Available from:
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 20]. Available from:
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 20]. Available from:
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