BioDlink has achieved a significant regulatory milestone after successfully passing an on-site Good Manufacturing Practice (GMP) inspection conducted by Brazil's National Health Surveillance Agency (ANVISA), a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This marks the first time BioDlink's production site and quality systems have passed an official on-site GMP audit by a PIC/S member country, representing a critical step in the internationalization of the company's quality system.
The week-long inspection focused on BioDlink's commercial production facility in Suzhou, China, specifically reviewing the manufacturing processes for Pusintin® (bevacizumab), a broad-spectrum anti-VEGF monoclonal antibody used in treating metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC). ANVISA inspectors thoroughly examined the site's manufacturing operations, quality testing procedures, storage facilities, utility systems, and overall quality management, ultimately providing a top rating with full approval and no observations.
Kexing BioPharm, which serves as the global licensee for Pusintin® in emerging markets, collaborated closely with BioDlink throughout the ANVISA inspection process.
Strategic Importance for Global Expansion
The successful ANVISA inspection strengthens BioDlink's position in key emerging pharmaceutical markets. The company's Suzhou facility is now certified by regulatory authorities in five countries: Brazil, Indonesia, Egypt, Colombia, and Argentina. This extensive regulatory recognition creates a solid foundation for expanding the global availability of Pusintin®, which is developed and manufactured by BioDlink.
Dr. Jun Liu, CEO and Executive Director of BioDlink, emphasized the significance of this achievement: "Clearing our first on-site GMP audit by a PIC/S member signals more than compliance—it demonstrates BioDlink's capability to develop and deliver globally trusted biosimilars, especially antibodies, with quality and consistency."
Dr. Liu further noted that BioDlink, in strategic alliance with Kexing Biopharm, has initiated overseas registration for Pusintin® in over 30 countries and regions, with the goal of making high-quality oncology biologics more affordable and accessible across Latin America, Southeast Asia, and the Middle East.
Advanced Manufacturing Capabilities
BioDlink's Suzhou facility spans 50,000 square meters and integrates advanced perfusion fed-batch technology, which streamlines antibody production while reducing costs. The facility features four complete production lines with an annual capacity of 300,000 liters of antibody drug substance, supporting scalable and regulatory-compliant production of Pusintin® for global markets.
Established in 2010, BioDlink has developed a large-scale commercial GMP production base for biological drugs with a total manufacturing capacity exceeding 20,000 liters. The company has built integrated platforms for biosimilars and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its manufacturing capabilities include top-tier OEB-5 facilities for high-potency antibody-drug conjugates (ADCs).
Market Opportunities in Southeast Asia
The successful GMP certification positions BioDlink to capitalize on significant market opportunities, particularly in Southeast Asia. The Indonesian pharmaceutical market, valued at approximately USD 10–12 billion and growing at a CAGR of 10-12%, is the largest in the region. With Indonesia having already issued a PIC/S-based GMP certification to BioDlink's Suzhou site, the company is well-positioned to serve the growing pharmaceutical demand in Southeast Asia.
The expansion of Pusintin® in Indonesia is particularly relevant given that lung cancer has been a leading cause of death in the country over the past decade. This aligns with Indonesia's increasing investments in oncology care and biosimilar integration.
Partnership with Kexing BioPharm
Dr. Kelvin Shao, Vice President of Kexing BioPharm, highlighted the importance of the partnership with BioDlink: "Since 2022, our partnership with BioDlink has given us the confidence that we are delivering exceptional levels of technical rigor and reliability in manufacturing—crucial for the complex CMC development and manufacturing of biosimilar drugs, which usually are much more challenging."
Dr. Shao added that the GMP certification from Brazil represents "a powerful validation of our collaboration's ongoing global expansion strategy," emphasizing their joint commitment to bringing global standards and affordable oncology treatments to regions where they are most needed.
Regulatory Compliance and Quality Standards
BioDlink's quality management system complies with regulatory requirements in China, the United States, the European Union, and Japan. The company has successfully passed nearly 100 GMP audits, including a zero-defect EU Qualified Person (QP) audit, with its quality systems earning worldwide recognition.
The PIC/S, established in 1995 as an extension to the Pharmaceutical Inspection Convention of 1970, is an international cooperation platform comprising 56 participating regulatory authorities from around the world. It leads the international development, implementation, and maintenance of harmonized GMP standards and quality systems for inspectorates in the field of medicinal products.
This latest regulatory achievement reinforces BioDlink's mission of "Empowering Innovation with Quality to Grow Together" and its dedication to advancing global healthcare through excellence in biosimilars, particularly in emerging markets where access to affordable biologics remains a significant challenge.
