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- Bevacizumab Injection officially approved by Indonesia’s National Agency of Drug and Food Control (BPOM), following Nigeria, Pakistan, and Colombia – accelerating global commercialization
- Approval in ASEAN’s largest pharma market strengthens BioDlink’s position as a global supplier of antibody/XDC therapies via international GMP standards and commercial capabilities
SUZHOU, China, Aug. 21, 2025 /PRNewswire/ — BioDlink announced that its Bevacizumab Injection has obtained marketing authorization from Indonesia’s National Agency of Drug and Food Control (BPOM). This marks BioDlink’s fourth international approval within two months – following Nigeria, Pakistan, and Colombia – signaling accelerated BioDlink’s global expansion into a sustained commercialization phase.
Strategic Significance of Indonesian Approval
Indonesia, the world’s fourth-most populous nation, reports over 400,000 new cancer cases annually (WHO). Yet biologics accessibility remains below 15%. As ASEAN’s largest pharmaceutical market and regulatory hub, this approval expedites regional market access across Southeast Asia. BioDlink’s cost-effective bevacizumab, manufactured in China in compliance with international GMP standards, is helping to address critical treatment gaps for patients in Indonesia.
Global Standards, Proven Quality & Compliance
BPOM’s rigorous review process, fully aligned with PIC/S international standards, reinforces the clinical value of bevacizumab while reaffirming BioDlink’s world-class quality systems. Our manufacturing facility is GMP-certified across multiple regions—including China, Brazil, Egypt, Indonesia, Colombia, Argentina, and Pakistan—and recognized by Japan’s PMDA. This comprehensive accreditation ensures end-to-end compliance for antibodies, ADCs/XDCs, and biosimilar products.
This approval has proven BioDlink’s mature global commercialization capabilities:
- Manufacturing Scale: Four commercial-scale manufacturing lines at the Suzhou site ensure a reliable global supply of antibodies, ADCs/XDCs, and biosimilars.
- Regulatory Excellence: BPOM’s PIC/S-aligned approval stands as a global benchmark, underscoring the strength of BioDlink’s quality systems.
- Strategic Momentum: Successive approvals across four markets are driving accelerated expansion in Southeast Asia and Latin America.
Dr. Jun Liu, Chief Executive Officer and Executive Director of BioDlink, stated:
“These consecutive approvals demonstrate the strength of our quality systems and commercial execution. With Indonesia as a key ASEAN hub, and in close partnership with Kexing Biopharm, we are shifting from single-market breakthroughs to regional impact —expanding access, diversifying growth, and delivering affordable, high-quality therapies worldwide.”
About BioDlink
BioDlink, a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biologics, is committed to being the trusted partner of choice for biopharmaceutical innovators worldwide. Leveraging our advanced one-base integrated platform, BioDlink delivers end-to-end CDMO services for protein-based therapeutics (such as mAb, BsAb), biosimilar, and bioconjugated drugs (such as XDCs/ADCs) from early-stage research through to commercial-scale manufacturing.
BioDlink operates large-scale biopharmaceutical manufacturing facilities compliant with GMP standards and adheres to international quality management systems aligned with regulatory requirements in the US, the EU, and China. With our cutting-edge technology platforms and expert teams, BioDlink facilitates accelerated development timelines, with clients spanning Europe, the Americas, Asia, and several key emerging markets.
BioDlink operates with a clear service philosophy: “Quality-Driven, Innovation-Enabled, Growth-Shared,” and has assembled an experienced and forward-thinking team. Committed to rigorous quality and compliance, the company nurtures a collaborative ecosystem that empowers its partners and delivers shared success. For more information, please visit: https://biodlink.com/
