BioDlink Clinches Brazil GMP Audit to Strengthen Emerging Markets Growth

• International recognition of quality system with GMP-compliance in the key markets of Brazil, Indonesia, Egypt, Colombia and Argentina
• Passed its first-ever on-site PIC/S audit, reinforcing its strong commitment to stringent international regulatory standards
• Demonstrated BioDlink's capability to develop and deliver globally trusted biosimilars, especially antibody drugs, with proven consistency and reliability

SUZHOU, China, May 21, 2025 /PRNewswire/ -- BioDlink has achieved a significant milestone in regulatory compliance after successfully passing an on-site GMP inspection conducted by Brazil's National Health Surveillance Agency (ANVISA), a member of PIC/S (Pharmaceutical Inspection Co-operation Scheme). This is the first time BioDlink's production site and quality systems have passed an official on-site GMP audit by a PIC/S member country which is a milestone certification for the internationalization of BioDlink's quality system.

This inspection focused on the company's commercial production site in Suzhou and specifically reviewed the manufacturing of its Pusintin^® (bevacizumab) injection, a broad-spectrum anti-VEGF monoclonal antibody treating metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC). Kexing BioPharm, the global licensee for Pusintin^® in emerging markets, worked closely with BioDlink to support this ANVISA inspection.

This inspection was conducted according to the rigorous guidelines of PIC/S and Brazil's national GMP regulations, laying a strong foundation for expanding Pusintin^®, an antibody developed and manufactured by BioDlink, worldwide. Over one week, ANVISA inspectors thoroughly examined the BioDlink site's manufacturing, quality testing, storage, utility systems, and overall quality management, providing a top rating with full approval and no observations.

BioDlink's Suzhou facility—now certified by regulatory authorities in five countries, such as Brazil, Indonesia, Egypt, Colombia and Argentina—spans 50,000 square meters and integrates perfusion fed-batch technology, streamlining antibody production and reducing costs. With four complete production lines, and an annual capacity of 300,000 liters of antibody drug substance, this site supports scalable and regulatory-compliant Pusintin^® production for global markets.

As of recent estimates, the Indonesian pharmaceutical market is valued at around USD 10–12 billion, and growing at a CAGR of 10-12% ^【1】, making it the largest in Southeast Asia. With Indonesia already issuing a PIC/S-based GMP certification to BioDlink's Suzhou site, the company is well-positioned to serve Southeast Asian and Indonesian pharmaceutical demand. With lung cancer ^【2】 being a leading cause of death in Indonesia in the past decade, further Pusintin^® rollout aligns with Indonesia's increasing investments in oncology care and biosimilar integration.

"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," said Dr. Jun Liu, CEO and Executive Director of BioDlink. "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."

" 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.  This GMP certification from Brazil, one of the key markets, is a powerful validation of our collaboration's ongoing global expansion strategy," said Dr. Kelvin Shao, Vice President of Kexing BioPharm. "We are truly proud to celebrate this achievement together with our partners, as we continue working side by side to bring global standards, and affordable oncology treatments where they're needed most to make biosimilars more accessible worldwide."

About PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. PIC/S is an international cooperation platform that comprises 56 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia). It leads the international development, implementation, and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of medicinal products.

Learn more：https://picscheme.org/en/about

About BioDlink Biopharm Co., Ltd.

BioDlink was established in 2010, and has a large-scale commercial GMP production base for biological drugs, a total manufacturing capacity exceeding 20,000 liters. Guided by its "Empowering Innovation with Quality to Grow Together" mission, BioDlink is dedicated to advancing global healthcare through excellence in biosimilars.

The company has built integrated platforms for biosimilars and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its scalable manufacturing lines include top-tier OEB-5 facilities for high-potency ADCs, with commercial antibody production already underway.

BioDlink's quality management system complies with regulatory requirements in China, the U.S., the EU, and Japan. In addition, the company has already passed nearly 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.

About Kexing Biopharm Co., Ltd.

Kexing Biopharm is an innovative biopharmaceutical enterprise mainly engaged in the integration of R&D, production and sales of recombinant protein drugs and microecological preparations. It focuses on antiviral, tumor and immune, blood, digestion, degenerative diseases and other therapeutic fields, builds cutting-edge biotechnology platforms such as new protein, new antibody, nucleic acid drugs, and adheres to the platform driven development model of "innovation+internationalization", At the same time, it explores the extensive application of biotechnology in the field of general health, actively cultivates and incubates new industries, the world's leading industrial platforms such as animal vaccines and synthetic organisms have been distributed, and is committed to becoming a leader in high-quality biopharmaceutics and serving global patients.

Contact information

PR name: Fiona Wu
E-mail: [email protected]

SOURCE BioDlink Biopharm Co., Ltd.