BioDlink, a China-based pharmaceutical company, announced on Wednesday that its self-developed bevacizumab injection biosimilar has received marketing approval from Colombia's National Institute for Surveillance of Medicines and Foods (INVIMA) and Pakistan's Drug Regulatory Authority of Pakistan (DRAP).
Following GMP certification in China, Colombia, Brazil, Argentina, Egypt, Indonesia and Pakistan, Kexing BioPharm, the global licensee for bevacizumab injection in emerging markets, has initiated regulatory filings in 35 countries in close collaboration with BioDlink.
Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), is widely used in the treatment of various cancers, including metastatic colorectal cancer (mCRC) and metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC). According to industry estimates, bevacizumab injection achieved global sales of USD8.5 billion in 2023.
"Cancer incidence is rising sharply, especially colorectal cancer, which has seen a global increase in early-onset cases in middle- and low-income countries," said Dr. Jun Liu, BioDlink CEO and executive director. "With our partnership with Kexing Biopharm, we are committed to serving South American and other emerging markets and combat colorectal and lung cancers, the top two leading causes of cancer-related deaths worldwide."
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
InSysBio agrees new collaborative project with BeOne Medicines
Physiomics secures new modelling contract with Numab Therapeutics
Mabwell reports first patient dosed with 7MW4911 in US trial
Atossa Therapeutics' founder and CEO named one of The Top 50 Healthcare Technology CEOs of 2025
Avacta secures FDA clearance for second pre|CISION oncology programme
Guardant Health and Merck enter multi-year oncology diagnostics collaboration
Akeso secures NMPA review acceptance for gumokimab in ankylosing spondylitis