{"id":14082,"date":"2023-09-08T10:54:00","date_gmt":"2023-09-08T02:54:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14082"},"modified":"2024-11-22T10:59:34","modified_gmt":"2024-11-22T02:59:34","slug":"shanghai-haihe-pharmaceuticals-glumetinib-filed-for-marketing-in-japan-for-nsclc-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14082","title":{"rendered":"Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment"},"content":{"rendered":"\n

Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation.<\/p>\n\n\n\n

Glumetinib’s Development and Efficacy<\/strong>
Co-developed by Haihe Pharma and the Chinese Academy of Sciences\u2019 Shanghai Institute of Materia Medica (SIMM), glumetinib has demonstrated preliminary efficacy in MET-positive advanced NSCLC. The drug has shown a good pharmacokinetics safety and tolerability profile in clinical studies. Glumetinib received approval for use in locally advanced or metastatic NSCLC with MET14 exon skipping in China in March this year.<\/p>\n\n\n\n

Japan Filing Supported by Pivotal Phase II Study Data<\/strong>
The filing in Japan is supported by the efficacy and safety data from the pivotal SCC244-108 Phase II study, which underpinned China\u2019s marketing filing. Glumetinib has been shown to be highly efficacious with controllable safety in both na\u00efve and treated patients with locally advanced or metastatic non-small cell lung cancer harboring the METex14 mutation.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for…<\/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":[16,528,38,33],"class_list":["post-14082","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-haihe-pharmaceutical","tag-market-approval-filings","tag-tkis-egfr-vegf-btk-etc"],"yoast_head":"\nShanghai Haihe Pharmaceutical's Glumetinib Filed for Marketing in Japan for NSCLC Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation.\" \/>\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=14082\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shanghai Haihe Pharmaceutical's Glumetinib Filed for Marketing in Japan for NSCLC Treatment\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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