{"id":28472,"date":"2022-07-05T00:27:00","date_gmt":"2022-07-04T16:27:00","guid":{"rendered":"https:\/\/flcube.com\/?p=28472"},"modified":"2025-03-03T00:29:23","modified_gmt":"2025-03-02T16:29:23","slug":"hrain-biotech-and-novartis-receive-breakthrough-therapy-designations-for-car-t-and-zolgensma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=28472","title":{"rendered":"Hrain Biotech and Novartis Receive Breakthrough Therapy Designations for CAR-T and Zolgensma"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd’s BCMA – targeted chimeric antigen receptor (CAR) T cell therapy and Novartis’ Zolgensma (OAV101) have been awarded breakthrough therapy designations (BTDs). Hrain Bio\u2019s BCMA CAR – T cell is indicated for relapsed \/ refractory multiple myeloma. The drug previously obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) in December 2018. The study for the drug in this indication showed that, in 20 enrolled subjects, the overall objective response rate was 85%.<\/p>\n\n\n\n

Novartis’s Zolgensma<\/strong>
Novartis’s OAV101 is indicated for spinal muscular atrophy (SMA). A global Phase III STEER study in 2 – 18 – year – old patients with type 2 spinal muscular atrophy was initiated in China in April, expected to enroll 20 and 125 subjects in China and the US respectively. The drug, approved in the US in May 2019 to treat type I SMA patients under two years of age, is undergoing clinical study in elderly patients.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd’s BCMA –…<\/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":[30,34,21,2548,140,68,24],"class_list":["post-28472","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biotech","tag-breakthrough-therapy","tag-car-t","tag-hrain-biotechnology","tag-novartis","tag-pediatric-drugs","tag-rare-orphan-disease-drugs"],"yoast_head":"\nHrain Biotech and Novartis Receive Breakthrough Therapy Designations for CAR-T and Zolgensma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd's BCMA - targeted chimeric antigen receptor (CAR) T cell therapy and Novartis\u2019s Zolgensma (OAV101) have been awarded breakthrough therapy designations (BTDs). Hrain Bio\u2019s BCMA CAR - T cell is indicated for relapsed \/ refractory multiple myeloma. The drug previously obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) in December 2018. The study for the drug in this indication showed that, in 20 enrolled subjects, the overall objective response rate was 85%.\" \/>\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=28472\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hrain Biotech and Novartis Receive Breakthrough Therapy Designations for CAR-T and Zolgensma\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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