{"id":43171,"date":"2025-10-13T17:15:49","date_gmt":"2025-10-13T09:15:49","guid":{"rendered":"https:\/\/flcube.com\/?p=43171"},"modified":"2025-10-13T17:15:50","modified_gmt":"2025-10-13T09:15:50","slug":"sichuan-kelun%e2%80%91biotech-wins-nmpa-approval-for-sacituzumab%e2%80%91tirumotecan-in-egfr%e2%80%91mutant-lung-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43171","title":{"rendered":"Sichuan Kelun\u2011Biotech Wins NMPA Approval for Sacituzumab\u2011Tirumotecan in EGFR\u2011Mutant Lung Cancer"},"content":{"rendered":"\n

China\u2011listed Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd.<\/strong> (HKG: 6990<\/a>) announced today that the National Medical Products Administration (NMPA) approved the trophoblast cell\u2011surface antigen 2 (TROP2)<\/strong>\u2011directed antibody\u2011drug conjugate (ADC) sacituzumab tirumotecan (sac\u2011TMT, SKB264\/MK\u20112870)<\/strong> for its third indication: treatment of adult patients with EGFR\u2011mutant\u2011positive locally advanced or metastatic non\u2011squamous non\u2011small cell lung cancer (NSCLC)<\/strong> who have progressed after EGFR\u2011tyrosine kinase inhibitor (TKI)<\/strong> therapy.<\/p>\n\n\n\n

Clinical Evidence<\/h3>\n\n\n\n
Study<\/th>Design<\/th>Key Outcomes<\/th><\/tr><\/thead>
OptiTROPLung04<\/strong><\/td>Randomized, open\u2011label, multi\u2011center Phase\u202fIII<\/td>Progression\u2011free survival (PFS)<\/em>: 8.2\u202fmonths (sac\u2011TMT) vs 5.1\u202fmonths (platinum\u2011based doublet).
Overall survival (OS)<\/em>: 20.4\u202fmonths vs 14.6\u202fmonths. Both differences were statistically significant (p\u202f<\u202f0.01).<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The interim analysis demonstrated a clinically meaningful benefit over the current standard of care, providing a new therapeutic option for a heavily pre\u2011treated patient population.<\/p>\n\n\n\n

Current Indication Portfolio<\/h3>\n\n\n\n
    \n
  1. Triple\u2011negative breast cancer (TNBC)<\/strong> \u2013 unresectable locally advanced or metastatic disease after \u2265\u202f2 prior systemic therapies.<\/li>\n\n\n\n
  2. EGFR\u2011mutant NSCLC<\/strong> \u2013 locally advanced or metastatic, progressed after EGFR\u2011TKI and platinum\u2011based chemotherapy.<\/li>\n\n\n\n
  3. EGFR\u2011mutant NSCLC<\/strong> \u2013 locally advanced or metastatic, progressed after EGFR\u2011TKI therapy only.<\/li>\n<\/ol>\n\n\n\n

    With the latest NMPA approval, sac\u2011TMT now covers a fourth indication, further expanding its market footprint in China.<\/p>\n\n\n\n

    Global Development Strategy<\/h3>\n\n\n\n

    In May\u202f2022, Kelun granted Merck Sharp & Dohme (MSD)<\/strong> exclusive rights to develop, manufacture, and commercialize sac\u2011TMT in all territories outside Greater China. The partnership positions Kelun to leverage MSD\u2019s extensive oncology pipeline and global sales network while retaining full control over the product in the Chinese market.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

    China\u2011listed Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the National Medical Products…<\/p>\n","protected":false},"author":1,"featured_media":43173,"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":[35,971,1832,2675,176,15],"class_list":["post-43171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-hkg-6990","tag-kelun-biotech-biopharmaceutical","tag-merck-sharp-dohme","tag-msd","tag-product-approvals"],"yoast_head":"\nSichuan Kelun\u2011Biotech Wins NMPA Approval for Sacituzumab\u2011Tirumotecan in EGFR\u2011Mutant Lung Cancer - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011listed Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the National Medical Products Administration (NMPA) approved the trophoblast cell\u2011surface antigen 2 (TROP2)\u2011directed antibody\u2011drug conjugate (ADC) sacituzumab tirumotecan (sac\u2011TMT, SKB264\/MK\u20112870) for its third indication: treatment of adult patients with EGFR\u2011mutant\u2011positive locally advanced or metastatic non\u2011squamous non\u2011small cell lung cancer (NSCLC) who have progressed after EGFR\u2011tyrosine kinase inhibitor (TKI) therapy.\" \/>\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=43171\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sichuan Kelun\u2011Biotech Wins NMPA Approval for Sacituzumab\u2011Tirumotecan in EGFR\u2011Mutant Lung Cancer\" \/>\n<meta property=\"og:description\" content=\"China\u2011listed Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the National Medical Products Administration (NMPA) approved the trophoblast cell\u2011surface antigen 2 (TROP2)\u2011directed antibody\u2011drug conjugate (ADC) sacituzumab tirumotecan (sac\u2011TMT, SKB264\/MK\u20112870) for its third indication: treatment of adult patients with EGFR\u2011mutant\u2011positive locally advanced or metastatic non\u2011squamous non\u2011small cell lung cancer (NSCLC) who have progressed after EGFR\u2011tyrosine kinase inhibitor (TKI) therapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=43171\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-13T09:15:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-13T09:15:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/1306.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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