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Zhaoke Ophthalmology's TAB014 receives NMPA acceptance for wAMD

June 12, 2025 at 05:07 PM UTCBy FilingReader AI

Zhaoke Ophthalmology Limited (HKEX: 6622) announced that the National Medical Products Administration (NMPA) of China has accepted its Biologics License Application (BLA) for TAB014, indicated for treating wet age-related macular degeneration (wAMD). This marks the first bevacizumab-based antibody filing for wAMD in China. The BLA is supported by positive Phase III clinical trial results demonstrating non-inferiority compared to Lucentis, with the study involving 488 patients across 57 centers, led by Professor Chen Youxin from Peking Union Medical College Hospital. TAB014, a recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody, aims to inhibit angiogenesis by blocking VEGF binding. The wAMD drug market in China is projected to rise from US$241.5 million in 2019 to US$3.5 billion by 2030, presenting a significant opportunity for Zhaoke.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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