Fuhong Hanlius' ``bevacizumab'' biosimilar drug approved in China

ArticleMedicine Guanlan

On December 2, China's National Food and Drug Administration (NMPA) announced that the listing application of the bevacizumab biosimilar HLX04 declared by Fuhong Henlius had been approved

Bevacizumab is a humanized monoclonal antibody IgG1, which is a vascular endothelial growth factor (VEGF) inhibitor

Public information shows that HLX04 is a bevacizumab biosimilar developed by Henlius in accordance with the Technical Guidelines for the Development and Evaluation of Biosimilars (Trial).

According to a press release issued by Fuhong Henlius earlier, HLX04 selected the indication for metastatic colorectal cancer in the design of the phase 3 clinical study

This is a multicenter, randomized, double-blind, parallel-controlled phase 3 clinical trial named HLX04-mCRC03.

It is worth mentioning that the Phase 1 clinical study results of the similarity between HLX04 and the original product, and the Phase 3 clinical study results of combined chemotherapy for the treatment of patients with metastatic colorectal cancer have been published in the internationally renowned journal Cancer Chemotherapy and Pharmacology ( CCP) and BioDrugs

references:

[1] On December 2, 2021, the drug approval document pending information is released.