{"id":10179,"date":"2024-01-04T10:18:00","date_gmt":"2024-01-04T02:18:00","guid":{"rendered":"https:\/\/flcube.com\/?p=10179"},"modified":"2024-10-29T10:22:51","modified_gmt":"2024-10-29T02:22:51","slug":"shanghai-bdgene-technologys-thalassemia-gene-therapy-bd211-clears-nmpa-for-clinical-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10179","title":{"rendered":"Shanghai BDgene Technology’s Thalassemia Gene Therapy BD211 Clears NMPA for Clinical Trials"},"content":{"rendered":"\n

Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapy BD211. This gene-modified autologous hematopoietic stem cell therapy is designed for the treatment of thalassemia.<\/p>\n\n\n\n

In a preliminary study, BD211 demonstrated safety and efficacy in two severe thalassemia \u03b2 0\/\u03b2 patients over a two-year follow-up period. BDgene, in collaboration with Ruijin Hospital, initiated an investigator-led trial for the drug in thalassemia last September under the guidance of the National Health Commission.<\/p>\n\n\n\n

\u03b2 Thalassemia is a type of hereditary blood disorder caused by mutations in the globin gene. Approximately 1.5% of the global population carries the \u03b2 thalassemia gene, and around 60,000 to 70,000 children with severe \u03b2 thalassemia are born each year. In China, there are an estimated 300,000 individuals with moderate-to-severe forms of the disease who require long-term blood transfusions and iron removal treatments. BDGene aims to develop a one-time, lifelong treatment option for this condition.- Flcube.com<\/a><\/p>\n\n\n\n

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Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has received clinical trial approval…<\/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":[1398,62,66,24],"class_list":["post-10179","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-bdgene-technology","tag-clinical-trial-approval-initiation","tag-gene-therapy","tag-rare-orphan-disease-drugs"],"yoast_head":"\nShanghai BDgene Technology's Thalassemia Gene Therapy BD211 Clears NMPA for Clinical Trials - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapy BD211. 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