{"id":51656,"date":"2025-12-20T20:51:26","date_gmt":"2025-12-20T12:51:26","guid":{"rendered":"https:\/\/flcube.com\/?p=51656"},"modified":"2025-12-20T20:51:28","modified_gmt":"2025-12-20T12:51:28","slug":"bio-thera-nda-for-vegf-a165-antibody-targets-2b-wet-amd-market-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=51656","title":{"rendered":"Bio\u2011Thera NDA for VEGF\u2011A165 Antibody Targets $2B Wet AMD Market in China"},"content":{"rendered":"\n

Bio\u2011Thera Solutions<\/strong> (SHA: 688177<\/a>) submitted a New Drug Application (NDA)<\/strong> to China\u2019s National Medical Products Administration (NMPA)<\/strong> for Velasitaximab injection (BAT5906)<\/strong>, a recombinant humanized anti\u2011VEGF\u2011A165 monoclonal antibody, for the treatment of neovascular (wet) age\u2011related macular degeneration (nAMD)<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Submission Date<\/strong><\/td>19\u202fDec\u202f2025<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>Velasitaximab injection (BAT5906)<\/td><\/tr>
Indication<\/strong><\/td>Neovascular (wet) AMD<\/td><\/tr>
Innovation<\/strong><\/td>Independently developed IgG1\u2011type full\u2011length antibody (149\u202fkDa)<\/td><\/tr>
Mechanism<\/strong><\/td>Binds VEGF\u2011A165, blocking angiogenesis and endothelial cell proliferation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Preclinical Data<\/h2>\n\n\n\n
Attribute<\/th>BAT5906<\/th>Competitive Landscape<\/th><\/tr><\/thead>
Antibody Type<\/strong><\/td>Recombinant humanized IgG1, 149\u202fkDa<\/td>Similar to aflibercept (Eylea) and ranibizumab (Lucentis)<\/td><\/tr>
Target<\/strong><\/td>VEGF\u2011A165 isoform<\/td>Precision targeting vs. pan\u2011VEGF\u2011A agents<\/td><\/tr>
Mechanism<\/strong><\/td>Blocks VEGF\u2011receptor binding \u2192 inhibits angiogenesis<\/td>Standard of care for nAMD<\/td><\/tr>
Administration<\/strong><\/td>Intravitreal injection<\/td>Aligns with existing anti\u2011VEGF regimen<\/td><\/tr>
Preclinical Efficacy<\/strong><\/td>In\u2011vitro models show potent inhibition of endothelial cell proliferation and neovascularization<\/td>Validated mechanism<\/td><\/tr>
Differentiation<\/strong><\/td>First domestic\u2011developed VEGF\u2011A165\u2011selective antibody<\/strong><\/td>Potential for cost advantage vs. imported biologics<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Opportunity<\/h2>\n\n\n\n
Metric<\/th>Value<\/th>Context<\/th><\/tr><\/thead>
China nAMD Prevalence<\/strong><\/td>~3\u20115\u202fmillion patients (2025)<\/td>Growing at 5\u20117% CAGR due to aging population<\/td><\/tr>
China Anti\u2011VEGF Market<\/strong><\/td>\u00a515\u201120\u202fbillion<\/strong> (\u2248\u202fUS$2.1\u20112.8\u202fB)<\/td>Dominated by Eylea<\/strong>, Lucentis<\/strong>, and off\u2011label Avastin<\/strong><\/td><\/tr>
BAT5906 Peak Sales<\/strong><\/td>\u00a52\u20113\u202fbillion<\/strong> (\u2248\u202fUS$280\u2011420\u202fM) by 2030<\/td>10\u201115% share if priced 30\u201140% below imports<\/td><\/tr>
Competitive Advantage<\/strong><\/td>Domestic manufacturing<\/strong> cost advantage; NRDL eligibility<\/td>Faster market access and reimbursement<\/td><\/tr>
Launch Timeline<\/strong><\/td>Potential 2027\u20112028<\/strong> approval<\/td>Filing under standard NDA pathway<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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