{"id":37705,"date":"2025-07-22T10:19:45","date_gmt":"2025-07-22T02:19:45","guid":{"rendered":"https:\/\/flcube.com\/?p=37705"},"modified":"2025-07-22T10:19:47","modified_gmt":"2025-07-22T02:19:47","slug":"bio-theras-bat4406f-gets-nmpa-nod-for-mcd-and-fsgs-clinical-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=37705","title":{"rendered":"Bio-Thera’s BAT4406F Gets NMPA Nod for MCD and FSGS Clinical Trials"},"content":{"rendered":"\n

Guangzhou-based Bio-Thera Solutions (SHA: 688177<\/a>) announced that its investigational drug, BAT4406F injection, has received approval from the National Medical Products Administration (NMPA) for a clinical trial for the additional indication of minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS). This marks a significant step forward in the development of this promising therapy.<\/p>\n\n\n\n

Drug Mechanism<\/strong>
BAT4406F is a next-generation glyco-optimized fully human anti-CD20 antibody developed by Bio-Thera. It specifically binds to the CD20 molecule on the surface of B cells and precursor cells. By leveraging the Fc region of the antibody, it induces biological effects such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). These mechanisms, in the presence of complement, NK cells, and phagocytic cells, help eliminate B cells.<\/p>\n\n\n\n

Previous Approval<\/strong>
Previously, BAT4406F had already received approval for clinical trials for neuromyelitis optica spectrum disorder. This new approval expands the potential therapeutic applications of the drug, highlighting its versatility and promise in treating various conditions.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that its investigational drug, BAT4406F injection, has received approval…<\/p>\n","protected":false},"author":1,"featured_media":37710,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[289,62,1055],"class_list":["post-37705","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-bio-thera-solutions","tag-clinical-trial-approval-initiation","tag-sha-688177"],"yoast_head":"\nBio-Thera's BAT4406F Gets NMPA Nod for MCD and FSGS Clinical Trials - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that its investigational drug, BAT4406F injection, has received approval from the National Medical Products Administration (NMPA) for a clinical trial for the additional indication of minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS). 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