{"id":3409,"date":"2024-05-28T09:43:25","date_gmt":"2024-05-28T01:43:25","guid":{"rendered":"https:\/\/flcube.com\/?p=3409"},"modified":"2024-10-12T11:27:03","modified_gmt":"2024-10-12T03:27:03","slug":"luye-pharmas-subsidiary-gets-nmpa-green-light-for-biosimilar-xgeva","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=3409","title":{"rendered":"Luye Pharma&#8217;s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva"},"content":{"rendered":"\n<p>Shandong Boan Biotechnology Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/6955:HKG\">HKG: 6955<\/a>), a controlling subsidiary of China-based Luye Pharma Group (<a href=\"https:\/\/www.google.com\/finance\/quote\/2186:HKG\">HKG: 2186<\/a>), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen&#8217;s Xgeva (denosumab). BA1102 is now approved for use in treating giant cell tumors of bone that are not removable through surgery or that may result in severe functional impairment, including adult and adolescent patients with mature bone development (defined as at least one mature long bone and a weight of \u2265 45 kg).<\/p>\n\n\n\n<p>Denosumab, a novel RANKL inhibitor originally developed by Amgen, is currently marketed in China by BeiGene. The 120mg dosage form of the drug, sold under the brand name Xgeva, received approval in China in May 2019. Another dosage form, 60mg under the brand name Prolia for treating bone loss (osteoporosis) in at-risk patients, was approved in June 2020. Phase I and Phase III head-to-head clinical studies comparing BA1102 with denosumab have confirmed their similarity in pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.- <a href=\"https:\/\/flcube.com\">Fineline.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group&#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":[43,220,1023,1024,219,15],"class_list":["post-3409","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-boan-biotechnology","tag-hkg-2186","tag-hkg-6955","tag-luye-pharma","tag-product-approvals"],"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>Luye Pharma&#039;s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group (HKG: 2186), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen&#039;s Xgeva (denosumab). BA1102 is now approved for use in treating giant cell tumors of bone that are not removable through surgery or that may result in severe functional impairment, including adult and adolescent patients with mature bone development (defined as at least one mature long bone and a weight of \u2265 45 kg).\" \/>\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=3409\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Luye Pharma&#039;s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva\" \/>\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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