{"id":15463,"date":"2024-11-28T15:16:30","date_gmt":"2024-11-28T07:16:30","guid":{"rendered":"https:\/\/flcube.com\/?p=15463"},"modified":"2024-11-28T15:16:33","modified_gmt":"2024-11-28T07:16:33","slug":"immunochina-pharmaceuticals-im19-car-t-therapy-accepted-for-review-by-nmpa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15463","title":{"rendered":"Immunochina Pharmaceuticals’ IM19 CAR-T Therapy Accepted for Review by NMPA"},"content":{"rendered":"\n

Beijing-based biotech company Immunochina Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its chimeric antigen receptor T cell (CAR-T) product, IM19. The therapy is being sought for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r\/r DLBCL).<\/p>\n\n\n\n

IM19’s Clinical Trial Progress and Indications<\/strong>
IM19 has previously received clinical trial approvals in China for the treatment of r\/r-DLBCL, acute B-cell leukemia (B-ALL), and mantle cell lymphoma (MCL), with all indications currently in late-stage clinical trials. The NDA submission is supported by results from an open-label, single-arm, multi-center, confirmatory clinical study conducted in China, which demonstrated the therapy’s good efficacy and safety profile.<\/p>\n\n\n\n

Commercialization Rights and Licensing Deal<\/strong>
Huadong Medicine Co., Ltd (SHE: 000963<\/a>) secured the commercialization rights to IM19 in mainland China through a significant RMB 1 billion licensing deal in August. This deal underscores the potential market impact and therapeutic value of Immunochina’s CAR-T therapy as it moves through the regulatory review process.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

Beijing-based biotech company Immunochina Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has…<\/p>\n","protected":false},"author":1,"featured_media":15465,"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":[21,77,114,1772,887],"class_list":["post-15463","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-car-t","tag-cell-therapy","tag-huadong-medicine","tag-immunochina-pharmaceuticals","tag-she-000963"],"yoast_head":"\nImmunochina Pharmaceuticals' IM19 CAR-T Therapy Accepted for Review by NMPA - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Beijing-based biotech company Immunochina Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its chimeric antigen receptor (CAR) T cell product, IM19. 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