{"id":57934,"date":"2026-02-25T14:46:35","date_gmt":"2026-02-25T06:46:35","guid":{"rendered":"https:\/\/flcube.com\/?p=57934"},"modified":"2026-02-25T14:46:36","modified_gmt":"2026-02-25T06:46:36","slug":"bio-theras-bat4406f-bla-accepted-by-nmpa-next-gen-anti-cd20-mab-for-rare-disease-nmosd","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=57934","title":{"rendered":"Bio-Thera’s BAT4406F BLA Accepted by NMPA \u2013 Next\u2011Gen Anti\u2011CD20 mAb for Rare Disease NMOSD"},"content":{"rendered":"\n

Bio-Thera Solutions Inc. (SHA:\u202f688177<\/a>)<\/strong> announced that China’s National Medical Products Administration (NMPA)<\/strong> has accepted the Biologics License Application (BLA)<\/strong> for BAT4406F<\/strong>, a next\u2011generation glyco\u2011optimized anti\u2011CD20 monoclonal antibody<\/strong>. The product is indicated for neuromyelitis optica spectrum disorder (NMOSD)<\/strong> in adult patients who are anti\u2011aquaporin\u20114 (AQP4) antibody\u2011positive<\/strong>, addressing a critical unmet need in this rare autoimmune disease.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Bio-Thera Solutions Inc. (SHA:\u202f688177)<\/td><\/tr>
Product<\/strong><\/td>BAT4406F injection<\/td><\/tr>
Drug Class<\/strong><\/td>Next\u2011generation glyco\u2011optimized fully human anti\u2011CD20 mAb<\/td><\/tr>
Regulatory Action<\/strong><\/td>BLA accepted by NMPA<\/td><\/tr>
Indication<\/strong><\/td>NMOSD in AQP4\u2011antibody\u2011positive adult patients<\/td><\/tr>
Rare Disease Status<\/strong><\/td>NMOSD included in China’s “First National List of Rare Diseases” (2018)<\/td><\/tr>
Clinical Status<\/strong><\/td>Phase II\/III completed; trial terminated early per IDMC recommendation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile \u2013 BAT4406F<\/h2>\n\n\n\n
Feature<\/th>Detail<\/th><\/tr><\/thead>
Platform<\/strong><\/td>Antibody Fc\u2011engineering platform<\/td><\/tr>
Optimization<\/strong><\/td>Glyco\u2011engineered for enhanced effector function<\/td><\/tr>
Target<\/strong><\/td>CD20<\/strong> on B cells and precursors<\/td><\/tr>
Mechanism<\/strong><\/td>Enhanced ADCC (Antibody\u2011Dependent Cellular Cytotoxicity)<\/strong><\/td><\/tr>
Differentiation<\/strong><\/td>High affinity for Natural Killer (NK) cells<\/strong> \u2192 potent B\u2011cell depletion<\/td><\/tr>
Generation<\/strong><\/td>Next\u2011gen vs. first\u2011generation anti\u2011CD20 antibodies (rituximab, ocrelizumab)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 Phase II\/III Study<\/h2>\n\n\n\n
Milestone<\/th>Detail<\/th><\/tr><\/thead>
Study Design<\/strong><\/td>Pivotal Phase II\/III for NMOSD<\/td><\/tr>
Interim Analysis<\/strong><\/td>July\u202f2025<\/td><\/tr>
Result<\/strong><\/td>Significant benefits demonstrated in treatment group<\/td><\/tr>
IDMC Recommendation<\/strong><\/td>“Terminate trial early”<\/strong> due to efficacy<\/td><\/tr>
Outcome<\/strong><\/td>Patient recruitment concluded ahead of schedule<\/td><\/tr>
Implication<\/strong><\/td>Compelling efficacy signal supports BLA submission<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n