{"id":63447,"date":"2026-04-17T21:28:32","date_gmt":"2026-04-17T13:28:32","guid":{"rendered":"https:\/\/flcube.com\/?p=63447"},"modified":"2026-04-17T21:28:33","modified_gmt":"2026-04-17T13:28:33","slug":"hengrui-pharmas-nectin-4-adc-shr-a2102-granted-second-nmpa-breakthrough-therapy-designation-for-cervical-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=63447","title":{"rendered":"Hengrui Pharma&#8217;s Nectin-4 ADC SHR-A2102 Granted Second NMPA Breakthrough Therapy Designation for Cervical Cancer"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>; <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG: 1276<\/a>) announced that its <strong>Category 1 therapeutic biologic, SHR-A2102<\/strong>, has received <strong>Breakthrough Therapy Designation (BTD)<\/strong> from China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong>. This is the second BTD for the asset, following a prior designation in December 2024 for urothelial carcinoma.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>National Medical Products Administration (NMPA), China<\/td><\/tr><tr><td><strong>Asset<\/strong><\/td><td>SHR-A2102 (Category 1 Therapeutic Biologic)<\/td><\/tr><tr><td><strong>New Indication (BTD)<\/strong><\/td><td>Recurrent or metastatic cervical cancer post platinum-based chemo and PD-(L)1 inhibitor failure<\/td><\/tr><tr><td><strong>Previous Indication (BTD)<\/strong><\/td><td>Locally advanced or metastatic urothelial carcinoma (Dec 2024)<\/td><\/tr><tr><td><strong>Molecule Type<\/strong><\/td><td>In-house developed Antibody-Drug Conjugate (ADC)<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>Nectin-4<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-portfolio\">Clinical Development Portfolio<\/h2>\n\n\n\n<p>SHR-A2102 is a cornerstone of Hengrui\u2019s oncology pipeline, with an expansive clinical program spanning <strong>Phase I to Phase III<\/strong> trials across multiple solid tumor types, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Advanced urothelial carcinoma \/ bladder cancer<\/li>\n\n\n\n<li>Esophageal cancer<\/li>\n\n\n\n<li>Lung cancer<\/li>\n\n\n\n<li>Head and neck cancer<\/li>\n\n\n\n<li>Cervical cancer<\/li>\n<\/ul>\n\n\n\n<p>The BTD for cervical cancer specifically addresses a critical unmet need for patients who have exhausted standard-of-care options, including chemotherapy and immunotherapy. Nectin-4, a well-validated target in urothelial cancer (e.g., enfortumab vedotin), is also expressed in a significant subset of cervical cancers, providing a strong scientific rationale for this expansion.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-significance\">Strategic Significance<\/h2>\n\n\n\n<p>Securing a second BTD for the same ADC asset underscores the strength of Hengrui\u2019s internal R&amp;D capabilities and the broad therapeutic potential of SHR-A2102. The NMPA\u2019s BTD status facilitates an expedited review process, potentially accelerating the drug\u2019s path to market for both key indications. This dual-indication strategy significantly enhances the asset\u2019s commercial value and positions Hengrui as a leader in the next generation of targeted oncology therapies in China.<\/p>\n\n\n\n<p><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding the development and regulatory pathway of SHR-A2102. The granting of BTD does not guarantee approval, and clinical trial outcomes remain subject to risk.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/600276_20260417_UWR0.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260417_UWR0.\"><\/object><a id=\"wp-block-file--media-09d1e63e-f23e-4015-894c-f3a1659387f5\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/600276_20260417_UWR0.pdf\">600276_20260417_UWR0<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/600276_20260417_UWR0.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-09d1e63e-f23e-4015-894c-f3a1659387f5\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its Category 1 therapeutic&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,34,2586,4228,852],"class_list":["post-63447","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-breakthrough-therapy","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-sha-600276"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui Pharma&#039;s Nectin-4 ADC SHR-A2102 Granted Second NMPA Breakthrough Therapy Designation for Cervical Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its Category 1 therapeutic biologic, SHR-A2102, has received Breakthrough Therapy Designation (BTD) from China\u2019s National Medical Products Administration (NMPA). This is the second BTD for the asset, following a prior designation in December 2024 for urothelial carcinoma.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=63447\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui Pharma&#039;s Nectin-4 ADC SHR-A2102 Granted Second NMPA Breakthrough Therapy Designation for Cervical Cancer\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its Category 1 therapeutic biologic, SHR-A2102, has received Breakthrough Therapy Designation (BTD) from China\u2019s National Medical Products Administration (NMPA). 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