{"id":41867,"date":"2025-09-19T15:25:51","date_gmt":"2025-09-19T07:25:51","guid":{"rendered":"https:\/\/flcube.com\/?p=41867"},"modified":"2025-09-19T15:25:52","modified_gmt":"2025-09-19T07:25:52","slug":"hengrui-pharma-secures-breakthrough-therapy-designation-for-shr%e2%80%911501-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41867","title":{"rendered":"Hengrui Pharma Secures Breakthrough Therapy Designation for SHR\u20111501 in China"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG: 1276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>) announced that its investigational injectable <strong>SHR\u20111501<\/strong> has been added to the National Medical Products Administration\u2019s (NMPA) list of proposed Breakthrough Therapy Designations (BTDs). The designation targets the combination of SHR\u20111501 with <strong>Bacillus Calmette\u2011Gu\u00e9rin (BCG)<\/strong> for patients who remain unresponsive to BCG therapy in non\u2011muscle\u2011invasive carcinoma in situ (CIS) of the bladder.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-shr-1501\">What Is SHR\u20111501?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism of Action<\/strong>: SHR\u20111501 is a self\u2011developed interleukin\u201115 (IL\u201115) fusion protein that selectively expands T cells, B cells, and natural killer (NK) cells\u2014boosting the immune system\u2019s ability to attack tumor cells.<\/li>\n\n\n\n<li><strong>Synergy with BCG<\/strong>: When paired with BCG, SHR\u20111501 enhances the intravesical immune response, generating a stronger anti\u2011tumor effect while avoiding the regulatory T\u2011cell expansion and apoptosis associated with IL\u20112.<\/li>\n\n\n\n<li><strong>Competitive Landscape<\/strong>: The only approved IL\u201115\u2011based therapy in the United States is <strong>Nogapendekin Alfa Inbakicept<\/strong> (Anktiva) from Altor BioScience. No comparable IL\u201115 agents have been approved in China to date.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-significance\">Strategic Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Accelerated Development<\/strong>: The BTD status expedites clinical trial timelines and streamlines regulatory review, positioning SHR\u20111501 as a potential first\u2011in\u2011class therapy for BCG\u2011unresponsive CIS.<\/li>\n\n\n\n<li><strong>Portfolio Expansion<\/strong>: Adding a BTD\u2011designated product strengthens Hengrui\u2019s oncology pipeline and signals its commitment to innovative immunotherapies.<\/li>\n\n\n\n<li><strong>Market Opportunity<\/strong>: BCG\u2011unresponsive CIS affects roughly <strong>10% of bladder\u2011cancer patients<\/strong> annually in China, representing a significant unmet need that SHR\u20111501 could address.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-next-steps\">Next Steps<\/h2>\n\n\n\n<p>Hengrui is preparing to launch a Phase\u202fII\/III study to evaluate the safety, tolerability, and efficacy of the SHR\u20111501\/BCG combination. The company will also engage with key opinion leaders and patient advocacy groups to refine trial design and ensure robust data collection. If early results are favorable, Hengrui plans to seek full NMPA approval and pursue global regulatory submissions by 2028.<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\/2025\/09\/600276_20250919_KL33.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20250919_KL33.\"><\/object><a id=\"wp-block-file--media-7339146a-8ad1-47c2-a711-a510598bf9df\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600276_20250919_KL33.pdf\">600276_20250919_KL33<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600276_20250919_KL33.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-7339146a-8ad1-47c2-a711-a510598bf9df\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its investigational injectable SHR\u20111501&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41870,"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":[34,4228,852],"class_list":["post-41867","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-breakthrough-therapy","tag-hkg-1276","tag-sha-600276"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui Pharma Secures Breakthrough Therapy Designation for SHR\u20111501 in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its investigational injectable SHR\u20111501 has been added to the National Medical Products Administration\u2019s (NMPA) list of proposed Breakthrough Therapy Designations (BTDs). The designation targets the combination of SHR\u20111501 with Bacillus Calmette\u2011Gu\u00e9rin (BCG) for patients who remain unresponsive to BCG therapy in non\u2011muscle\u2011invasive carcinoma in situ (CIS) of the bladder.\" \/>\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=41867\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui Pharma Secures Breakthrough Therapy Designation for SHR\u20111501 in China\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its investigational injectable SHR\u20111501 has been added to the National Medical Products Administration\u2019s (NMPA) list of proposed Breakthrough Therapy Designations (BTDs). The designation targets the combination of SHR\u20111501 with Bacillus Calmette\u2011Gu\u00e9rin (BCG) for patients who remain unresponsive to BCG therapy in non\u2011muscle\u2011invasive carcinoma in situ (CIS) of the bladder.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=41867\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-19T07:25:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-19T07:25:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/1903.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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