Qilu Pharmaceutical's Bevacizumab Biosimilar Ankevda Approved as China's First Domestic Product

On December 9, the National Medical Products Administration approved the marketing registration application for Bevacizumab Injection (brand name: AnkeDa) developed by Qilu Pharmaceutical Co., Ltd. This drug is the first bevacizumab biosimilar approved in China, primarily indicated for the treatment of patients with advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer.

Bevacizumab is a humanized monoclonal antibody of the IgG1 subclass, produced using recombinant DNA technology. By binding to human vascular endothelial growth factor (VEGF), it inhibits the interaction between VEGF and its receptors, thereby blocking angiogenic signaling pathways and suppressing tumor cell growth. As one of the key agents in anti-angiogenic therapy, bevacizumab is utilized in the treatment of various malignant tumors.

The bevacizumab injection approved this time was submitted by Qilu Pharmaceutical Co., Ltd. It is the first product in China to use the original bevacizumab as a reference drug, developed and submitted for production following the biosimilar pathway. This product has received support from the National Major New Drug Development Special Program, and the National Medical Products Administration (NMPA) has approved its market launch through the priority review and approval process. The approval of this product will improve the accessibility of such drugs and provide new treatment options for patients in China.

Responsible Editor:Xi Ran

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