{"id":24644,"date":"2025-05-29T17:25:49","date_gmt":"2025-05-29T10:25:49","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=24644"},"modified":"2025-05-29T17:25:49","modified_gmt":"2025-05-29T10:25:49","slug":"chinas-her2-targeted-adc-trastuzumab-rezetecan-gains-nmpa-approval-for-her2-mutant-nsclc","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=24644","title":{"rendered":"China’s HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC"},"content":{"rendered":"

SHANGHAI<\/span><\/span>, May 29, 2025<\/span><\/span> \/PRNewswire\/ — The National Medical Products Administration has recently granted approval for\u00a0Trastuzumab\u00a0rezetecan, China’s<\/span> first domestically developed antibody-drug conjugate (ADC),\u00a0for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2<\/i> (ERBB2<\/i>) mutations who have previously received at least one systemic therapy.<\/p>\n

The approval of\u00a0Trastuzumab rezetecan was based on the pivotal\u00a0HORIZON-Lung study led by Professor Lu Shun\u00a0at\u00a0Shanghai Chest Hospital<\/b>, which demonstrated groundbreaking efficacy in\u00a0HER2<\/i>-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved a\u00a0median follow-up of 14.2 months, an\u00a0IRC-confirmed objective response rate (ORR) of 74.5%, and a\u00a0median progression-free survival (mPFS) of 11.5 months\u2014thereby doubling the efficacy of conventional treatments. In addition, Trastuzumab rezetecan\u00a0significantly reduced the toxicity risks typically associated with\u00a0conventional ADCs. These results have\u00a0redefined global benchmarks for ADC research\u00a0and garnered significant attention from the international scientific community.<\/p>\n

Trastuzumab rezetecan\u00a0has achieved breakthroughs in\u00a0both efficacy and safety through pioneering molecular design from the ground up, a milestone made possible by\u00a0Hengrui Pharmaceuticals’ decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAP\u00a0enables end-to-end capabilities spanning\u00a0molecular design, preclinical optimization, and clinical translation. To date, Hengrui has advanced over\u00a010 differentiated ADC candidates\u00a0into clinical development, including\u00a0Trastuzumab rezetecan, its flagship HER2<\/i>-targeted ADC therapy.<\/p>\n

Shun Lu<\/span>, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)\uff0cChina, and principal investigator of Horizon-Lung, said, “the HORIZON-Lung study validates Trastuzumab rezetecan as a transformative therapy for HER2<\/i>-mutant NSCLC, addressing a critical unmet need for advanced HER2<\/i>-driven NSCLC patients in China<\/span>. Grounded in epidemiological data that accurately reflect China’s<\/span> NSCLC epidemiological landscape, this therapeutic advance not only provides a novel treatment option for patients, but also heralds China’s<\/span> emergence as a pioneering force in shaping the global ADC landscape for precision oncology.<\/p>\n

Beyond its established efficacy in lung cancer,\u00a0Trastuzumab rezetecan\u00a0has demonstrated\u00a0significant clinical advances across multiple tumor types, with\u00a0eight additional indications\u2014including\u00a0breast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer\u2014receiving\u00a0Breakthrough Therapy Designation (BTD)\u00a0from China’s<\/span> National Medical Products Administration (NMPA).<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

SHANGHAI<\/span><\/span>, May 29, 2025<\/span><\/span> \/PRNewswire\/ — The National Medical Products Administration has recently granted approval for\u00a0Trastuzumab\u00a0rezetecan, China’s<\/span> first domestically developed antibody-drug conjugate (ADC),\u00a0for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2<\/i> (ERBB2<\/i>) mutations who have previously received at least one systemic therapy.<\/p>\n

The approval of\u00a0Trastuzumab rezetecan was based on the pivotal\u00a0HORIZON-Lung study led by Professor Lu Shun\u00a0at\u00a0Shanghai Chest Hospital<\/b>, which demonstrated groundbreaking efficacy in\u00a0HER2<\/i>-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved a\u00a0median follow-up of 14.2 months, an\u00a0IRC-confirmed objective response rate (ORR) of 74.5%, and a\u00a0median progression-free survival (mPFS) of 11.5 months\u2014thereby doubling the efficacy of conventional treatments. In addition, Trastuzumab rezetecan\u00a0significantly reduced the toxicity risks typically associated with\u00a0conventional ADCs. These results have\u00a0redefined global benchmarks for ADC research\u00a0and garnered significant attention from the international scientific community.<\/p>\n

Trastuzumab rezetecan\u00a0has achieved breakthroughs in\u00a0both efficacy and safety through pioneering molecular design from the ground up, a milestone made possible by\u00a0Hengrui Pharmaceuticals’ decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAP\u00a0enables end-to-end capabilities spanning\u00a0molecular design, preclinical optimization, and clinical translation. To date, Hengrui has advanced over\u00a010 differentiated ADC candidates\u00a0into clinical development, including\u00a0Trastuzumab rezetecan, its flagship HER2<\/i>-targeted ADC therapy.<\/p>\n

Shun Lu<\/span>, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)\uff0cChina, and principal investigator of Horizon-Lung, said, “the HORIZON-Lung study validates Trastuzumab rezetecan as a transformative therapy for HER2<\/i>-mutant NSCLC, addressing a critical unmet need for advanced HER2<\/i>-driven NSCLC patients in China<\/span>. Grounded in epidemiological data that accurately reflect China’s<\/span> NSCLC epidemiological landscape, this therapeutic advance not only provides a novel treatment option for patients, but also heralds China’s<\/span> emergence as a pioneering force in shaping the global ADC landscape for precision oncology.<\/p>\n

Beyond its established efficacy in lung cancer,\u00a0Trastuzumab rezetecan\u00a0has demonstrated\u00a0significant clinical advances across multiple tumor types, with\u00a0eight additional indications\u2014including\u00a0breast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer\u2014receiving\u00a0Breakthrough Therapy Designation (BTD)\u00a0from China’s<\/span> National Medical Products Administration (NMPA).<\/p>\n

<\/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-24644","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\/24644","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=24644"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/24644\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24644"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24644"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24644"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}