Shanghai, China, Oct, 28th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the international multicentre phase 3 clinical trial for the company’s pertuzumab biosimilar HLX11, a recombinant anti-human epidermal growth factor receptor 2 (HER2) subdomain II humanized monoclonal antibody injection, for the neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). At present, the phase 3 clinical trial is currently underway for HLX11 in China. Additionally, Henlius has submitted clinical trial applications for HLX11 in other EU countries including Poland, Bulgaria, Hungary, and the Czech Republic, and such applications are expected to be approved soon.
HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China and the European Union (EU), which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2-positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or unresectable locally recurrent breast cancer patients. HLX11 can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, HLX11 can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity.
With the accumulated results and experience from extensive anti-HER2 research, Henlius has a well-established product pipeline in anti-HER2 treatment and built a solid foundation for discovering and developing anti-HER2 bispecific/multi-target antibodies and antibody-drug conjugates (ADC). Up to now, the company’s independently developed and manufactured trastuzumab biosimilar HANQUYOU (Zercepac®, trade names in Australia: Tuzucip® and Trastucip®), the first Chinese mAb biosimilar entering both the EU and China market, has been successfully launched in more than 30 countries and regions, providing a new standard treatment option for global HER2 positive breast and gastric cancer patients. Besides, HLX22, an anti-human epidermal growth factor receptor-2 (HER2) humanized monoclonal antibody injection in phase 2 clinical trial, has the potential to further improve treatment outcomes for HER2 positive breast cancer and gastric cancer patients. And HLX11 also has the potential to be used in combination with HANQUYOU and HLX22 to help Henlius to create more beneficial course of treatment for patients.
In the future, Henlius will continue to speed the launch of this clinical trial in more countries and regions, as well as innovate and seek breakthroughs to bring more affordable and quality biologics to patients around the globe.