BioDlink Strengthens Global Compliance with Argentina GMP Certification

• Global Milestone: GMP certification from Argentina, marking a key step in its global expansion and regulatory recognition.
• Scalable, Trustworthy Solutions: With advanced manufacturing capabilities, BioDlink deliver Pusintin® (bevacizumab) injection that are not only consistent and cost-effective, but a superior choice for markets seeking dependable therapeutic alternatives.
• Client-Centric Expansion: Strengthened partnership with Kexing Biopharm enables improved access to essential oncology treatments in the Latin American market.

SUZHOU, China, June 5, 2025 /PRNewswire/ -- BioDlink has been granted GMP certification by National Administration of Drugs, Food and Medical Technology (ANMAT) of Argentina. This achievement adds to BioDlink's expanding portfolio of international GMP approvals, following recent certifications in Brazil, Indonesia, Egypt, and Colombia.

The GMP inspection, conducted by ANMAT, focused on commercial manufacturing facility in Suzhou, China, where biosimilar products are produced—including  Pusintin® (bevacizumab) injection. It is 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, collaborated closely with BioDlink to support this AVMAT inspection.

This inspection represents BioDlink's facilities and processes were found to be in full compliance with the stringent GMP standards set by ANMAT. BioDlink's Suzhou facility, which spans 50,000 square meters, is now certified by regulatory authorities in multiple countries. Currently, this site operates with a combined bioreactor capacity of 20,000 liters for antibody drug substance, integrating advanced perfusion fed-batch technology, to enable efficient and cost-effective antibody production. With an annual capacity of 300,000 liters of antibody drug substance, BioDlink is well-equipped to support the growing demand for mAb, BsAb, Antibody-drug Conjugate and biosimilar manufacturing in global markets.

According to a report by MarketsandMarkets，the Rest of Latin America (RoLA) accounted for 59.3% of the Latin American market in 2023. Most pharmaceutical and biopharmaceutical companies in the region prefer to conduct clinical trials in Argentina. So, it is another breakthrough for Pusintin® in the South American market, following the GMP certificates obtained in Colombia and Brazil. Argentina's GDP in 2023 was 646.075 billion US dollars, making it the third-largest economy in Latin America. According to global customs data statistics, in 2023, the import value of pharmaceuticals from around the world in the Latin American market increased by 12.68% year-on-year, with China being the second largest source of imports. Argentina is one of the top ten popular destinations for Chinese pharmaceutical enterprises to export to Latin America.

Dr. Jun Liu, CEO, and Executive Director of BioDlink commented "This GMP certification from Argentina is a significant step in our global expansion strategy, underscoring BioDlink's proven capabilities in reliable, scalable and affordable biosimilars, especially antibody drugs, on a global scale. Our partnership with Kexing Biopharm is better positioned to serve the Latin American market and contribute to improving access to essential oncology treatments."

Dr. Kelvin Shao, Vice President of Kexing BioPharm added "As one of the key partners of us, BioDlink's outstanding industrialization capabilities and superior product quality provide guarantee for overseas quality certification of Pusintin®. With the joint efforts of both sides, Pusintin® (bevacizumab) injection has successively received good news of the approval of GMP overseas, and we hope to help improve the accessibility of biosimilars and benefiting more patients furthermore."

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, 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]

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SOURCE BioDlink Biopharm Co., Ltd.