On August 21, 2025 BioDlink reported that its Bevacizumab Injection has obtained marketing authorization from Indonesia’s National Agency of Drug and Food Control (BPOM) (Press release, BioDlink, AUG 21, 2025, View Source [SID1234655437]). 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.
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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."