#China #Suzhou #Brazil #GMP #BioDlink

BioDlink Secures Key GMP Certification in Brazil

BioDlink, a rising player in the biopharmaceutical industry, is celebrating a remarkable achievement by passing its first-ever on-site Good Manufacturing Practice (GMP) inspection conducted by Brazil's National Health Surveillance Agency (ANVISA). This significant milestone not only validates BioDlink's commitment to stringent international regulatory standards but also opens new doors for its product offerings in key emerging markets such as Indonesia, Egypt, Colombia, and Argentina.

A Boost for Emerging Market Growth

The inspection, which took place at BioDlink's manufacturing facility in Suzhou, was focused on the commercial production of Pusintin® (bevacizumab) injection. This innovative drug is a broad-spectrum anti-VEGF monoclonal antibody used to treat metastatic non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC). The company's global partner, Kexing BioPharm, played a pivotal role in supporting BioDlink during this critical inspection.

The audit process involved ANVISA inspectors conducting an extensive review of BioDlink's manufacturing processes, quality control systems, storage facilities, utility systems, and overall quality management protocols. After a thorough evaluation, the inspectors awarded a top rating with full approval and no significant observations, a rare accomplishment that underscores BioDlink's quality initiatives.

Expanding Facilities and Capacity

BioDlink's production facility, now certified by regulatory bodies in five countries, encompasses an impressive 50,000 square meters and utilizes advanced perfusion fed-batch technology to enhance antibody production efficiency while minimizing costs. This state-of-the-art site features four complete production lines, boasting an annual capacity of 300,000 liters of antibody drug substance capable of catering to the increasing global demand for high-quality oncology biologics.

The company's focus on global markets is strategically timed; the Indonesian pharmaceutical market alone is valued between USD 10-12 billion and is experiencing a rapid growth rate between 10-12%. With lung cancer being a major public health challenge in Indonesia, the rollout of Pusintin® aligns perfectly with the country's growing investment in oncology care and the increasing integration of biosimilars into healthcare.

Future Aspirations

Dr. Jun Liu, CEO and Executive Director of BioDlink, emphasized that successfully passing the GMP audit is not just about compliance but showcases BioDlink's ability to deliver globally trusted biosimilars, especially in the field of monoclonal antibodies. He stated, "With Pusintin® and our strong strategic alliance with Kexing Biopharm, we have initiated overseas registration for Pusintin® in over 30 countries and regions, aiming to make high-quality oncology biologics more affordable and accessible across Latin America, Southeast Asia, and the Middle East."

Dr. Kelvin Shao, Vice President of Kexing BioPharm, praised the partnership with BioDlink, remarking that their collaboration has significantly enhanced production reliability and manufacturing rigor, which are critical in the challenging biopharmaceutical landscape.

About BioDlink

Founded in 2010, BioDlink is dedicated to advancing global health care through its innovative approach to biosimilars. With a total manufacturing capacity of over 20,000 liters, the company focuses on empowering innovation with quality at its core. BioDlink has successfully undergone nearly 100 GMP audits and is recognized globally for its quality management systems that comply with the regulatory standards in China, the U.S., the European Union, and Japan.

Conclusion

BioDlink's recent achievements in securing GMP certification in Brazil are a testament to its commitment to quality and innovation in biopharmaceutical manufacturing. With growing demand in emerging markets and a robust product pipeline, the company is well-positioned to become a leader in the delivery of affordable oncology treatments worldwide.