{"id":10328,"date":"2023-12-28T23:53:00","date_gmt":"2023-12-28T15:53:00","guid":{"rendered":"https:\/\/flcube.com\/?p=10328"},"modified":"2024-10-29T23:56:52","modified_gmt":"2024-10-29T15:56:52","slug":"fosuns-hlx42-receives-fast-track-designation-from-fda-for-nsclc-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10328","title":{"rendered":"Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment"},"content":{"rendered":"\n

Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196<\/a>; SHA: 600196<\/a>) has announced that its antibody-drug conjugate (ADC) HLX42 has received fast-track designation from the U.S. Food and Drug Administration (FDA). The drug is being co-developed with its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696<\/a>) and Suzhou-based Medilink Therapeutics, specifically targeting advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations in patients who have progressed following treatment with third-generation EGFR tyrosine kinase inhibitors (TKIs).<\/p>\n\n\n\n

HLX42 is a novel ADC that targets the epidermal growth factor receptor (EGFR), combining highly specific humanized IgG1 EGFR antibody molecules with cleavable novel ligands and a new DNA topoisomerase I (TOPO I) small molecule payload. Pre-clinical studies, including pharmacological and pharmacokinetic evaluations, have demonstrated HLX42’s efficacy in inhibiting tumor growth while maintaining a favorable safety profile. The drug was approved for Phase I clinical trials in advanced\/metastatic solid tumors in both China and the U.S. in October and November of this year, respectively.- Flcube.com<\/a><\/p>\n\n\n\n

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Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate…<\/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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,16,159,270,893,862,892],"class_list":["post-10328","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-fosun-pharmaceutical","tag-henlius-biotech","tag-hkg-2196","tag-hkg-2696","tag-sha-600196"],"yoast_head":"\nFosun's HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Fosun Pharmaceutical (Group) Co., Ltd. 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(HKG: 2696) and Suzhou-based Medilink Therapeutics, specifically targeting advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations in patients who have progressed following treatment with third-generation EGFR tyrosine kinase inhibitors (TKIs).\" \/>\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=10328\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fosun's HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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