{"id":18168,"date":"2023-06-01T22:38:00","date_gmt":"2023-06-01T14:38:00","guid":{"rendered":"https:\/\/flcube.com\/?p=18168"},"modified":"2024-12-15T22:42:42","modified_gmt":"2024-12-15T14:42:42","slug":"betta-pharmaceuticals-befotertinib-approved-by-chinas-nmpa-for-egfr-mutated-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18168","title":{"rendered":"Betta Pharmaceuticals’ Befotertinib Approved by China’s NMPA for EGFR-Mutated NSCLC"},"content":{"rendered":"\n

China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558<\/a>) has announced receiving market approval from the National Medical Products Administration (NMPA) for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), befotertinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation that has progressed following EGFR-TKI treatment. <\/p>\n\n\n\n

Partnership and Licensing Deal with InventisBio<\/strong>
Betta Pharma struck a licensing deal with compatriot firm InventisBio (SHA: 688382<\/a>) in December 2018, obtaining exclusive development and commercialization rights to befotertinib (D0316) in mainland China, Hong Kong, and Taiwan. Clinical studies for the drug in locally advanced or metastatic NSCLC with the T790M mutation following resistance to EGFR-TKI demonstrated an objective response rate (ORR) of 67.6%, a disease control rate (DCR) of 94.8%, a median preogression-free survival (PFS) of 16.6 months, and a median duration of response (DOR) of 18.0 months. Research indicates that befotertinib is comparable to similar drugs in terms of key efficacy indicators such as ORR and intracranial efficacy.<\/p>\n\n\n\n

Market Competition with Other Third-Generation EGFR-TKIs<\/strong>
AstraZeneca\u2019s Tagrisso (osimertinib), Hansoh Pharma\u2019s almonertinib, and Allist Pharma\u2019s furmonertinib are all third-generation EGFR-TKIs that are commercially available in China and included in the National Reimbursement Drug List (NRDL). The approval of befotertinib adds to the competitive landscape of targeted therapies for patients with EGFR-mutated NSCLC in China.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National…<\/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":[231,16,682,15,1495,1030,33],"class_list":["post-18168","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-betta-pharmaceuticals","tag-cancer","tag-inventisbio","tag-product-approvals","tag-sha-688382","tag-she-300558","tag-tkis-egfr-vegf-btk-etc"],"yoast_head":"\nBetta Pharmaceuticals' Befotertinib Approved by China's NMPA for EGFR-Mutated NSCLC - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National Medical Products Administration (NMPA) for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), befotertinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation that has progressed following EGFR-TKI treatment.\" \/>\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=18168\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Betta Pharmaceuticals' Befotertinib Approved by China's NMPA for EGFR-Mutated NSCLC\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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