Shanghai Henlius Biotech has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) for the international multicentre Phase III clinical trial of its pertuzumab biosimilar HLX11.

The trial will assess the biosimilar for the neoadjuvant therapy in HER2-positive, HR-negative, early or locally advanced breast cancer patients.

The company has also submitted clinical trial applications for the biosimilar in other EU countries including Hungary, Bulgaria, the Czech Republic, and Poland, with approval expected soon.

HLX11 is a recombinant, anti-human epidermal growth factor receptor 2 (HER2) subdomain II humanised monoclonal antibody injection.

Specifically, the antibody can bind with the subdomain II of HER2 extracellular domain and inhibit the HER2 heterodimerisation, as well as other HER family receptors, including HER3, EGFR, and HER4.

Through antibody-dependent cell cytotoxicity, HLX11 can also improve the immune cells’ tumour-killing activity.

It has been developed in line with relevant regulations and guidelines on biosimilars in the European Union (EU) and China.

This will enable HLX11 to be potentially used along with trastuzumab and chemotherapy as a neoadjuvant or adjuvant treatment for HER2-positive early breast cancer.

The monoclonal antibody can also be used together with trastuzumab and docetaxel to treat HER2-positive metastatic or unresectable, locally recurrent breast cancer patients.

To date, Shanghai Henlius Biotech has independently developed and manufactured trastuzumab biosimilar Hanquyou.

Hanquyou is claimed to be the first mAb biosimilar to enter the EU and Chinese market.

Shanghai Henlius Biotech noted that HLX11 can also be used along with HANQUYOU and HLX22, an anti-human HER2 humanised monoclonal antibody injection, for creating many other beneficial courses of treatment for patients.