{"id":55246,"date":"2026-01-23T06:42:00","date_gmt":"2026-01-22T22:42:00","guid":{"rendered":"https:\/\/flcube.com\/?p=55246"},"modified":"2026-04-21T20:47:04","modified_gmt":"2026-04-21T12:47:04","slug":"hengrui-pharmas-shr-7877-gets-nmpa-nod-for-small-cell-lung-cancer-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55246","title":{"rendered":"Hengrui Pharma\u2019s SHR\u20117877 Gets NMPA Nod for Small Cell Lung Cancer Trials"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA:\u202f600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG:\u202f1276<\/a>) announced that <strong>SHR\u20117877<\/strong> has received <strong>National Medical Products Administration (NMPA)<\/strong> approval to enter clinical trials in combination with <strong>HS\u201120093<\/strong> (with or without adebelisib) for the treatment of <strong>extensive\u2011stage small cell lung cancer (SCLC)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone-amp-trial-design\">Regulatory Milestone &amp; Trial Design<\/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<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>SHR\u20117877 (Category\u202f1 therapeutic biological product)<\/td><\/tr><tr><td><strong>Combination Partner<\/strong><\/td><td>HS\u201120093 (\u00b1 adebelisib)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Extensive\u2011stage small cell lung cancer<\/td><\/tr><tr><td><strong>Approval<\/strong><\/td><td>NMPA clinical trial authorization<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>SHR\u20117877 induces\/activates T cells; HS\u201120093 is a B7\u2011H3\u2011targeting ADC<\/td><\/tr><tr><td><strong>Status<\/strong><\/td><td>Ready to initiate clinical studies<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-innovation\">Drug Profile &amp; Innovation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>SHR\u20117877:<\/strong> Novel T\u2011cell engager that induces and activates patient T cells to recognize and eliminate tumor cells<\/li>\n\n\n\n<li><strong>HS\u201120093:<\/strong> Hengrui\u2019s internally developed <strong>antibody\u2011drug conjugate (ADC)<\/strong> targeting <strong>B7\u2011H3<\/strong>, already cleared for trials in lung cancer, sarcoma, head and neck cancer, and other solid tumors<\/li>\n\n\n\n<li><strong>Synergistic Strategy:<\/strong> Dual immunotherapy (T\u2011cell activation) + targeted cytotoxic payload aims to overcome SCLC\u2019s immunosuppressive microenvironment<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> First\u2011in\u2011China combination of a T\u2011cell engager and B7\u2011H3 ADC for extensive\u2011stage SCLC, a setting with extremely high unmet need<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-commercial-outlook\">Market Impact &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China SCLC Burden:<\/strong> Approximately <strong>150,000\u2013180,000 new SCLC cases<\/strong> annually; extensive\u2011stage disease accounts for <strong>70%<\/strong> of diagnoses with <strong>5\u2011year survival &lt;5%<\/strong><\/li>\n\n\n\n<li><strong>Standard of Care:<\/strong> Limited to platinum\u2011based chemotherapy \u00b1 immunotherapy; no approved targeted therapies exist for extensive\u2011stage SCLC<\/li>\n\n\n\n<li><strong>Market Potential:<\/strong> Analysts project <strong>\u00a52\u20133\u202fbillion<\/strong> (US$280\u2013420\u202fmillion) peak sales potential if SHR\u20117877\/HS\u201120093 combo demonstrates survival benefit in Phase\u202fIII<\/li>\n\n\n\n<li><strong>Strategic Significance:<\/strong> Advances Hengrui\u2019s leadership in ADC and immuno\u2011oncology; validates internal synergy between biologics and ADC platforms<\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> Phase\u202fI\/II trial initiation expected Q2\u202f2026; data may support breakthrough therapy designation and expedited NMPA review<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, market potential, and regulatory pathways for SHR\u20117877 and HS\u201120093. Actual results may differ due to clinical trial outcomes, competitive developments, and NMPA review processes.<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\/01\/600276_20260122_B5P7.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260122_B5P7.\"><\/object><a id=\"wp-block-file--media-cf12bdfc-6cdd-4ac8-8cde-f344c80ee8bb\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260122_B5P7.pdf\">600276_20260122_B5P7<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260122_B5P7.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-cf12bdfc-6cdd-4ac8-8cde-f344c80ee8bb\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that SHR\u20117877 has received National Medical Products&#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":[16,62,2586,4228,852],"class_list":["post-55246","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","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 v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui Pharma\u2019s SHR\u20117877 Gets NMPA Nod for Small Cell Lung Cancer Trials - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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