{"id":26875,"date":"2022-08-15T20:08:00","date_gmt":"2022-08-15T12:08:00","guid":{"rendered":"https:\/\/flcube.com\/?p=26875"},"modified":"2025-02-15T20:11:06","modified_gmt":"2025-02-15T12:11:06","slug":"zelgen-biopharmaceuticals-donafenib-receives-nmpa-approval-for-thyroid-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26875","title":{"rendered":"Zelgen Biopharmaceuticals&#8217; Donafenib Receives NMPA Approval for Thyroid Cancer"},"content":{"rendered":"\n<p>China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/688266:SHA\">SHA: 688266<\/a>) announced that the supplementary New Drug Application (sNDA) for its Category 1 anti-cancer drug donafenib in locally advanced \/ metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) has been approved by the National Medical Products Administration (NMPA). This is the second indication approval for the drug, following its approval for unresectable hepatocellular carcinoma (HCC) without prior systemic therapy in June last year.<\/p>\n\n\n\n<p><strong>Drug Details<\/strong><br>Donafenib is an orally available multikinase inhibitor that targets Raf kinase and various receptor tyrosine kinases (RTKs). The approval is based on the results of a multi-center, randomized, double-blind, placebo-controlled Phase II study. The study showed that compared with the placebo, donafenib significantly reduced the risk of disease progression, significantly prolonged disease progression-free survival, and produced a better objective response rate.<\/p>\n\n\n\n<p><strong>Market Recognition<\/strong><br>The drug was included in the National Reimbursement Drug List (NRDL) in 2021 and is recommended in the 2022 edition of Chinese guidelines for the diagnosis and treatment of primary liver cancer.<\/p>\n\n\n\n<p><strong>Clinical Trials<\/strong><br>Fineline Info &amp; Tech database shows that donafenib is the subject of 83 clinical studies in China, including 8 Phase III studies. These studies cover advanced HCC, DTC, advanced colorectal cancer (CRC), and more. Although the trial in CRC was prematurely terminated, the drug is also being assessed in pancreatic cancer, bile duct cancer, nasopharyngeal cancer, esophageal cancer, cervical cancer, acute myeloid leukemia, and others.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application&#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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[30,16,109,15,905,246],"class_list":["post-26875","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biotech","tag-cancer","tag-precision-medicine","tag-product-approvals","tag-sha-688266","tag-zelgen-biopharmaceuticals"],"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>Zelgen Biopharmaceuticals&#039; Donafenib Receives NMPA Approval for Thyroid Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application (sNDA) for its Category 1 anti-cancer drug donafenib in locally advanced \/ metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) has been approved by the National Medical Products Administration (NMPA). This is the second indication approval for the drug, following its approval for unresectable hepatocellular carcinoma (HCC) without prior systemic therapy in June last year.\" \/>\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=26875\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zelgen Biopharmaceuticals&#039; Donafenib Receives NMPA Approval for Thyroid Cancer\" \/>\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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