- 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 22, 2025—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.
Reference: 1.
NADFC (BPOM) Regulation of
Pharmaceuticals in Indonesia https://www.artixio.com/post/nadfc-bpom-regulation-of-pharmaceuticals-in-indonesia 2.
Lung Cancer in Indonesia https://www.sciencedirect.com/science/article/pii/S1556086423006317
Contact information PR name: Fiona Wu, Jaxon Tan E-mail: pr@biodlink.com, jaxon.tan@momentumai.co