#China #Suzhou #Kexing Biopharm #BioDlink #Bevacizumab

BioDlink Accelerates Global Expansion with Bevacizumab Launch in Colombia and Pakistan

BioDlink Biopharm Co., Ltd. has made significant strides in its global expansion efforts with the recent market authorization of its bevacizumab injection in Colombia and Pakistan. This follows a successful launch in Nigeria, representing a pivotal move in addressing critical healthcare needs in emerging markets. The company's undertakings are part of a broader initiative to improve access to vital oncology treatments, especially in regions where such therapies are often out of reach.

Regulatory Milestones in Key Markets

The approval granted by Colombia's National Institute for Surveillance of Medicines and Foods (INVIMA) and Pakistan's Drug Regulatory Authority signifies important regulatory breakthroughs for BioDlink. These approvals are particularly pertinent in Colombia and Pakistan, where the incidence of colorectal cancer is rising, necessitating improved treatment options. The launch aims to reduce treatment costs for both health care systems and individual patients while adhering to stringent global quality standards.

BioDlink’s bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF), critical in the treatment of various cancers, including metastatic colorectal cancer (mCRC) and metastatic non-squamous non-small cell lung cancer (nsNSCLC). The global market for bevacizumab is robust, with industry sales reaching approximately USD 8.5 billion in 2023, illustrating the high demand for this effective treatment.

Partnerships Driving Innovation

The partnership between BioDlink and Kexing BioPharm has been instrumental in facilitating the rapid approval and launch of this biosimilar. Following their international commercialization agreement signed in early 2022, the two companies have cultivated a closed-loop model, enhancing collaboration in research, development, manufacturing, and distribution. This model capitalizes on BioDlink’s strong commitment to international manufacturing excellence and Kexing’s innovative strategies to achieve localized market access in underserved regions.

With GMP certification in Iran and across several countries, including China, Brazil, Colombia, Argentina, Egypt, Indonesia, and Pakistan, Kexing BioPharm is well-positioned to initiate regulatory filings in a total of 35 countries. This comprehensive certification process showcases BioDlink’s commitment to fostering high standards in biopharmaceutical manufacturing, thus meeting the quality assurances required in varying international markets.

Addressing Public Health Needs

The launch of bevacizumab in Colombia and Pakistan is not just a business endeavor; it is a response to a pressing public health need. Both countries exhibit increasing colorectal cancer rates, necessitating enhanced access to effective treatment options. BioDlink aims to alleviate the financial burden on public health systems and individual patients by providing high-quality oncological biosimilars that maintain affordability without compromising safety or efficacy.

Dr. Jun Liu, CEO and Executive Director of BioDlink, expressed concern regarding the rising cancer rates, particularly among younger populations in developing nations.