{"id":35198,"date":"2025-06-13T16:00:02","date_gmt":"2025-06-13T08:00:02","guid":{"rendered":"https:\/\/flcube.com\/?p=35198"},"modified":"2025-06-13T16:00:03","modified_gmt":"2025-06-13T08:00:03","slug":"zhaoke-ophthalmologys-tab014-receives-bla-review-for-wamd-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35198","title":{"rendered":"Zhaoke Ophthalmology&#8217;s TAB014 Receives BLA Review for wAMD Treatment"},"content":{"rendered":"\n<p>China-based Zhaoke Ophthalmology Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/6622:HKG\">HKG: 6622<\/a>) announced that its Biologic License Application (BLA) for TAB014, a treatment for wet age-related macular degeneration (wAMD), has been accepted by China\u2019s National Medical Products Administration (NMPA). This marks the first bevacizumab-based antibody product filed for wAMD treatment in China.<\/p>\n\n\n\n<p><strong>Clinical Trial Success<\/strong><br>The BLA filing is supported by results from a completed Phase III study in China. This randomized, double-blinded, non-inferiority trial enrolled 488 patients across 57 centers, with Peking Union Medical College Hospital as the lead institution. The study demonstrated that TAB014 is non-inferior to the comparator drug Lucentis (ranibizumab) in improving visual acuity, meeting all primary and key secondary endpoints.<\/p>\n\n\n\n<p><strong>Product Details<\/strong><br>TAB014 is a recombinant anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) administered via intravitreal injection. It works by inhibiting pathological angiogenesis in wAMD. The product has been included in China&#8217;s National Major New Drug Innovation Program and is manufactured in collaboration with Tot Biopharmaceutical International Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/1875:HKG\">HKG: 1875<\/a>).<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2025061200300_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025061200300_c.\"><\/object><a id=\"wp-block-file--media-ff1c8a72-fdd8-4adc-bef6-6881b314a47d\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2025061200300_c.pdf\">2025061200300_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2025061200300_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ff1c8a72-fdd8-4adc-bef6-6881b314a47d\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its Biologic License Application (BLA) for TAB014,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":35201,"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":[1894,942,38,44,2571,166],"class_list":["post-35198","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hkg-1875","tag-hkg-6622","tag-market-approval-filings","tag-ophthalmology","tag-tot-biopharm","tag-zhaoke-ophthalmology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Zhaoke Ophthalmology&#039;s TAB014 Receives BLA Review for wAMD Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its Biologic License Application (BLA) for TAB014, a treatment for wet age-related macular degeneration (wAMD), has been accepted by China\u2019s National Medical Products Administration (NMPA). This marks the first bevacizumab-based antibody product filed for wAMD treatment in China.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=35198\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zhaoke Ophthalmology&#039;s TAB014 Receives BLA Review for wAMD Treatment\" \/>\n<meta property=\"og:description\" content=\"China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its Biologic License Application (BLA) for TAB014, a treatment for wet age-related macular degeneration (wAMD), has been accepted by China\u2019s National Medical Products Administration (NMPA). 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