22 August 2025 | Friday | News
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:
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."
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