{"id":39191,"date":"2025-08-21T12:00:00","date_gmt":"2025-08-21T12:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4756408_CN56408_0"},"modified":"2025-08-21T12:00:00","modified_gmt":"2025-08-21T12:00:00","slug":"biodlinks-bevacizumab-approved-for-market-launch-in-indonesia-marking-fourth-consecutive-emerging-market-authorization","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=39191","title":{"rendered":"BioDlink&#8217;s Bevacizumab Approved for Market Launch in Indonesia, Marking Fourth Consecutive Emerging Market Authorization"},"content":{"rendered":"<div id=\"dvContent\" readability=\"113.18691588785\">\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2682341\/BioDlink_EN_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><b>Bevacizumab Injection officially approved by <span class=\"xn-location\">Indonesia&#8217;s<\/span> National Agency of Drug and Food Control (BPOM)<\/b>, following <span class=\"xn-location\">Nigeria<\/span>, <span class=\"xn-location\">Pakistan<\/span>, and <span class=\"xn-location\">Colombia<\/span> \u2013 <b>accelerating global commercialization<\/b><\/li>\n<li>Approval in ASEAN&#8217;s largest pharma market strengthens BioDlink&#8217;s position as a global supplier of antibody\/XDC therapies via <b>international GMP standards and commercial capabilities<\/b><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">SUZHOU, <span class=\"xn-location\">China<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Aug. 21, 2025<\/span><\/span> \/PRNewswire\/<span id=\"spanHghltbbde\">&nbsp;&#8212;&nbsp;<a href=\"http:\/\/www.biodlink.com\/\" target=\"_blank\" rel=\"nofollow noopener\">BioDlink<\/a> <\/span>announced that its Bevacizumab Injection has obtained marketing authorization from <span class=\"xn-location\">Indonesia&#8217;s<\/span> National Agency of Drug and Food Control (BPOM). This marks BioDlink&#8217;s fourth international approval within two months \u2013 following <span class=\"xn-location\">Nigeria<\/span>, <span class=\"xn-location\">Pakistan<\/span>, and <span class=\"xn-location\">Colombia<\/span> \u2013 signaling accelerated BioDlink&#8217;s global expansion into a sustained commercialization phase.<\/p>\n<p><b>Strategic Significance of Indonesian Approval<\/b><br \/><span class=\"xn-location\">Indonesia<\/span>, the world&#8217;s fourth-most populous nation, reports over 400,000 new cancer cases annually (WHO). Yet biologics accessibility remains below 15%. As ASEAN&#8217;s largest pharmaceutical market and regulatory hub, this approval expedites regional market access across <span class=\"xn-location\">Southeast Asia<\/span>. BioDlink&#8217;s cost-effective bevacizumab, manufactured in <span class=\"xn-location\">China<\/span> in compliance with international GMP standards, is helping to address critical treatment gaps for patients in <span class=\"xn-location\">Indonesia<\/span>.<\/p>\n<p><b>Global Standards, Proven Quality &amp; Compliance<\/b><br \/>BPOM&#8217;s rigorous review process, fully aligned with PIC\/S international standards, reinforces the clinical value of bevacizumab while reaffirming BioDlink&#8217;s world-class quality systems. Our manufacturing facility is GMP-certified across multiple regions\u2014including <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Brazil<\/span>, <span class=\"xn-location\">Egypt<\/span>, <span class=\"xn-location\">Indonesia<\/span>, <span class=\"xn-location\">Colombia<\/span>, <span class=\"xn-location\">Argentina<\/span>, and Pakistan\u2014and recognized by <span class=\"xn-location\">Japan&#8217;s<\/span> PMDA. This comprehensive accreditation ensures end-to-end compliance for antibodies, ADCs\/XDCs, and biosimilar products.<\/p>\n<p>This approval has proven BioDlink&#8217;s mature global commercialization capabilities:<\/p>\n<ul type=\"disc\">\n<li><b>Manufacturing Scale<\/b>: Four commercial-scale manufacturing lines at the Suzhou site ensure a reliable global supply of antibodies, ADCs\/XDCs, and biosimilars.<\/li>\n<li><b>Regulatory Excellence: <\/b>BPOM&#8217;s PIC\/S-aligned approval stands as a global benchmark, underscoring the strength of BioDlink&#8217;s quality systems.<\/li>\n<li><b>Strategic Momentum: <\/b>Successive approvals across four markets are driving accelerated expansion in <span class=\"xn-location\">Southeast Asia<\/span> and <span class=\"xn-location\">Latin America<\/span>.<\/li>\n<\/ul>\n<p><b>Dr. <span class=\"xn-person\">Jun Liu<\/span>, Chief Executive Officer and Executive Director of BioDlink<\/b>, stated:<br \/>&#8220;These consecutive approvals demonstrate the strength of our quality systems and commercial execution.<b>&nbsp;With Indonesia as a key ASEAN hub, and in close partnership with Kexing Biopharm, we are shifting from single-market breakthroughs to regional impact&nbsp;<\/b>\u2014expanding access, diversifying growth, and delivering affordable, high-quality therapies worldwide.&#8221;<\/p>\n<p><b>About BioDlink<\/b><\/p>\n<p>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.<\/p>\n<p>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 <span class=\"xn-location\">China<\/span>. With our cutting-edge technology platforms and expert teams, BioDlink facilitates accelerated development timelines, with clients spanning <span class=\"xn-location\">Europe<\/span>, the Americas, <span class=\"xn-location\">Asia<\/span>, and several key emerging markets.<\/p>\n<p>BioDlink operates with a clear service philosophy: &#8220;Quality-Driven, Innovation-Enabled, Growth-Shared,&#8221; 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:<span id=\"spanHghlt2d3d\"> <a href=\"http:\/\/www.biodlink.com\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/biodlink.com\/<\/a>&nbsp;<\/span><\/p>\n<\/p><\/div>\n<p>Source: BioDlink Biopharm Co., Ltd.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bevacizumab Injection officially approved by Indonesia&#8217;s National Agency of Drug and Food Control (BPOM), following Nigeria, Pakistan, and Colombia \u2013 accelerating global commercialization Approval in ASEAN&#8217;s largest pharma market strengthens BioDlink&#8217;s position as a global supplier of antibody\/XDC therapies via international GMP standards and commercial capabilities SUZHOU, China, Aug. 21, 2025 \/PRNewswire\/&nbsp;&#8212;&nbsp;BioDlink announced that its [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-39191","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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