{"id":23058,"date":"2025-05-08T19:55:38","date_gmt":"2025-05-08T19:55:38","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/biodlink-congratulates-junshi-biosciences-on-ind-approval-of-js212-a-bispecific-adc-therapeutic-candidate\/"},"modified":"2025-05-08T19:55:38","modified_gmt":"2025-05-08T19:55:38","slug":"biodlink-congratulates-junshi-biosciences-on-ind-approval-of-js212-a-bispecific-adc-therapeutic-candidate","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=23058","title":{"rendered":"BioDlink Congratulates Junshi Biosciences on IND Approval of JS212, a Bispecific ADC Therapeutic Candidate"},"content":{"rendered":"<table 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>BioDlink<\/b> congratulates <b>Junshi Biosciences<\/b> on receiving <b>IND approval<\/b> from <span class=\"xn-location\">China&#8217;s<\/span> <b>NMPA<\/b> for <b>JS212<\/b>, the company&#8217;s <b>first bispecific ADC<\/b>.<\/li>\n<li>JS212 combines <b>dual-targeting antibody<\/b> technology with a cytotoxic payload, representing a <b>next-generation therapeutic<\/b>.<\/li>\n<li>BioDlink provided <b>end-to-end development and manufacturing support<\/b>, showcasing its <b>industry-leading ADC capabilities<\/b>.<\/li>\n<li><span>Approval marks a key milestone in the development of next-generation antibody-drug conjugates.<\/span><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">SUZHOU, <span class=\"xn-location\">China<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">May 8, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0<a href=\"https:\/\/www.biodlink.com\/\" target=\"_blank\" rel=\"nofollow\">BioDlink<\/a>, a leading global CDMO,\u00a0proudly congratulates its partner Junshi Biosciences (HKEX-1877; SSE-688180), on receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of <span class=\"xn-location\">China<\/span> to initiate clinical trials for the JS212 injection \u2014\u00a0Junshi Biosciences&#8217; first bispecific antibody-drug conjugate (ADC).<\/p>\n<p>JS212 represents a new class of bispecific ADCs that combine the humanized epidermal growth factor receptor and human epidermal growth factor receptor 3 bispecific antibody-drug conjugate to target both EGFR and HER3 \u2014 two proteins highly expressed in a variety of tumor cells, such as lung cancer, breast cancer, and head and neck cancer. As a bispecific ADC, JS212 has a key advantage over traditional ADCs that only target one protein: it can attack tumors via either EGFR or HER3, potentially increasing its effectiveness against a wider range of cancers and helping to overcome drug resistance.<\/p>\n<p><b>Dr. <span class=\"xn-person\">Jun Liu<\/span>, CEO and Executive Director of BioDlink<\/b>, stated: &#8220;As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics. Our collaboration with Junshi Biosciences is built on mutual trust and deep experience in\u00a0ADC research, development and manufacturing. The\u00a0IND approval of JS212 \u2014 a technically demanding\u00a0bispecific ADC \u2014\u00ad highlights our strong capabilities and strategic value we bring to partners pursuing next-generation biologics. We&#8217;re honored to support the advancement of this important program.&#8221;<\/p>\n<p><b>Dr. <span class=\"xn-person\">Jing Tong<\/span>, Deputy Director of Junshi Biosciences&#8217; Innovation Research Institute<\/b>, shared: &#8220;We are very pleased with the ongoing and highly productive partnership with BioDlink. Their exceptional expertise and proven capabilities in ADC development and manufacturing have played a pivotal role in advancing JS212 to this important milestone. Throughout the collaboration, BioDlink has consistently demonstrated technical excellence, operational efficiency, and a deep understanding of complex bispecific ADCs. This approval marks a key collaboration milestone, and we look forward to deepening our cooperation as we work toward bringing innovative therapies to patients in the future.&#8221;<\/p>\n<p>BioDlink is committed to becoming a trusted CDMO biologics partner. The company operates a large-scale commercial biologics production site that meets international GMP standards and includes multiple integrated production lines for antibodies and ADCs.<\/p>\n<p>With a comprehensive ADC platform supported by key R&amp;D technologies, BioDlink enables efficient, centralized production of antibody intermediates, drug substances, and finished products. This setup accelerates timelines and reduces tech transfer costs. At the same time, BioDlink&#8217;s quality system is built according to international standards and has passed GMP audits in multiple countries, which can empower global customers.<\/p>\n<p><b>About BioDlink Biopharm Co., Ltd.<\/b><\/p>\n<p>With over 10 years of experience in antibody and ADC drug development, BioDlink offers full-service CDMO solutions for biologic drugs \u2014 from early-stage R&amp;D through to commercial production.<\/p>\n<p>The company has built integrated platforms for biologics 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.<\/p>\n<p>BioDlink&#8217;s quality management system complies with regulatory requirements in <span class=\"xn-location\">China<\/span>, the U.S., the EU, and <span class=\"xn-location\">Japan<\/span>. The company has successfully supported over 100 projects with development, clinical filings, and manufacturing services. In addition, the company has already passed near 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.<\/p>\n<p>Guided by its &#8220;Empowering Innovation with Quality to Grow Together&#8221; mission, BioDlink is dedicated to enabling partners and advancing global healthcare through excellence in biologics.<\/p>\n<p><b>About <\/b><b>Shanghai Junshi Biosciences Co., Ltd.<\/b><\/p>\n<p>Founded in <span class=\"xn-chron\">December 2012<\/span>, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&amp;D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company&#8217;s products have received approvals in <span class=\"xn-location\">China<\/span> and international markets, one of which is toripalimab, <span class=\"xn-location\">China&#8217;s<\/span> first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including <span class=\"xn-location\">China<\/span>, the US, and <span class=\"xn-location\">Europe<\/span>. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI\u00ae, and other novel therapies for the prevention and treatment of COVID-19.<\/p>\n<p>With a mission of &#8220;providing patients with world-class, trustworthy, affordable, and innovative drugs,&#8221; Junshi Biosciences is &#8220;In China, For Global.&#8221; At present, the company boasts approximately 2,500 employees in <span class=\"xn-location\">the United States<\/span> (<span class=\"xn-location\">Maryland<\/span>) and <span class=\"xn-location\">China<\/span> (<span class=\"xn-location\">Shanghai<\/span>, Suzhou, <span class=\"xn-location\">Beijing<\/span>, <span class=\"xn-location\">Guangzhou<\/span>, etc.).<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table 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>BioDlink<\/b> congratulates <b>Junshi Biosciences<\/b> on receiving <b>IND approval<\/b> from <span class=\"xn-location\">China&#8217;s<\/span> <b>NMPA<\/b> for <b>JS212<\/b>, the company&#8217;s <b>first bispecific ADC<\/b>.<\/li>\n<li>JS212 combines <b>dual-targeting antibody<\/b> technology with a cytotoxic payload, representing a <b>next-generation therapeutic<\/b>.<\/li>\n<li>BioDlink provided <b>end-to-end development and manufacturing support<\/b>, showcasing its <b>industry-leading ADC capabilities<\/b>.<\/li>\n<li><span>Approval marks a key milestone in the development of next-generation antibody-drug conjugates.<\/span><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">SUZHOU, <span class=\"xn-location\">China<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">May 8, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0<a href=\"https:\/\/www.biodlink.com\/\" target=\"_blank\" rel=\"nofollow\">BioDlink<\/a>, a leading global CDMO,\u00a0proudly congratulates its partner Junshi Biosciences (HKEX-1877; SSE-688180), on receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of <span class=\"xn-location\">China<\/span> to initiate clinical trials for the JS212 injection \u2014\u00a0Junshi Biosciences&#8217; first bispecific antibody-drug conjugate (ADC).<\/p>\n<p>JS212 represents a new class of bispecific ADCs that combine the humanized epidermal growth factor receptor and human epidermal growth factor receptor 3 bispecific antibody-drug conjugate to target both EGFR and HER3 \u2014 two proteins highly expressed in a variety of tumor cells, such as lung cancer, breast cancer, and head and neck cancer. As a bispecific ADC, JS212 has a key advantage over traditional ADCs that only target one protein: it can attack tumors via either EGFR or HER3, potentially increasing its effectiveness against a wider range of cancers and helping to overcome drug resistance.<\/p>\n<p><b>Dr. <span class=\"xn-person\">Jun Liu<\/span>, CEO and Executive Director of BioDlink<\/b>, stated: &#8220;As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics. Our collaboration with Junshi Biosciences is built on mutual trust and deep experience in\u00a0ADC research, development and manufacturing. The\u00a0IND approval of JS212 \u2014 a technically demanding\u00a0bispecific ADC \u2014\u00ad highlights our strong capabilities and strategic value we bring to partners pursuing next-generation biologics. We&#8217;re honored to support the advancement of this important program.&#8221;<\/p>\n<p><b>Dr. <span class=\"xn-person\">Jing Tong<\/span>, Deputy Director of Junshi Biosciences&#8217; Innovation Research Institute<\/b>, shared: &#8220;We are very pleased with the ongoing and highly productive partnership with BioDlink. Their exceptional expertise and proven capabilities in ADC development and manufacturing have played a pivotal role in advancing JS212 to this important milestone. Throughout the collaboration, BioDlink has consistently demonstrated technical excellence, operational efficiency, and a deep understanding of complex bispecific ADCs. This approval marks a key collaboration milestone, and we look forward to deepening our cooperation as we work toward bringing innovative therapies to patients in the future.&#8221;<\/p>\n<p>BioDlink is committed to becoming a trusted CDMO biologics partner. The company operates a large-scale commercial biologics production site that meets international GMP standards and includes multiple integrated production lines for antibodies and ADCs.<\/p>\n<p>With a comprehensive ADC platform supported by key R&amp;D technologies, BioDlink enables efficient, centralized production of antibody intermediates, drug substances, and finished products. This setup accelerates timelines and reduces tech transfer costs. At the same time, BioDlink&#8217;s quality system is built according to international standards and has passed GMP audits in multiple countries, which can empower global customers.<\/p>\n<p><b>About BioDlink Biopharm Co., Ltd.<\/b><\/p>\n<p>With over 10 years of experience in antibody and ADC drug development, BioDlink offers full-service CDMO solutions for biologic drugs \u2014 from early-stage R&amp;D through to commercial production.<\/p>\n<p>The company has built integrated platforms for biologics 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.<\/p>\n<p>BioDlink&#8217;s quality management system complies with regulatory requirements in <span class=\"xn-location\">China<\/span>, the U.S., the EU, and <span class=\"xn-location\">Japan<\/span>. The company has successfully supported over 100 projects with development, clinical filings, and manufacturing services. In addition, the company has already passed near 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.<\/p>\n<p>Guided by its &#8220;Empowering Innovation with Quality to Grow Together&#8221; mission, BioDlink is dedicated to enabling partners and advancing global healthcare through excellence in biologics.<\/p>\n<p><b>About <\/b><b>Shanghai Junshi Biosciences Co., Ltd.<\/b><\/p>\n<p>Founded in <span class=\"xn-chron\">December 2012<\/span>, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&amp;D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company&#8217;s products have received approvals in <span class=\"xn-location\">China<\/span> and international markets, one of which is toripalimab, <span class=\"xn-location\">China&#8217;s<\/span> first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including <span class=\"xn-location\">China<\/span>, the US, and <span class=\"xn-location\">Europe<\/span>. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI\u00ae, and other novel therapies for the prevention and treatment of COVID-19.<\/p>\n<p>With a mission of &#8220;providing patients with world-class, trustworthy, affordable, and innovative drugs,&#8221; Junshi Biosciences is &#8220;In China, For Global.&#8221; At present, the company boasts approximately 2,500 employees in <span class=\"xn-location\">the United States<\/span> (<span class=\"xn-location\">Maryland<\/span>) and <span class=\"xn-location\">China<\/span> (<span class=\"xn-location\">Shanghai<\/span>, Suzhou, <span class=\"xn-location\">Beijing<\/span>, <span class=\"xn-location\">Guangzhou<\/span>, etc.).<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-23058","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/23058","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=23058"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/23058\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=23058"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=23058"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=23058"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}