{"id":33986,"date":"2025-05-23T18:48:28","date_gmt":"2025-05-23T10:48:28","guid":{"rendered":"https:\/\/flcube.com\/?p=33986"},"modified":"2025-05-23T18:48:29","modified_gmt":"2025-05-23T10:48:29","slug":"chongqing-genrix-bios-gr2001-tetanus-monoclonal-antibody-nda-accepted-by-nmpa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=33986","title":{"rendered":"Chongqing Genrix Bio&#8217;s GR2001 Tetanus Monoclonal Antibody NDA Accepted by NMPA"},"content":{"rendered":"\n<p>China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/688443:SHA\">SHA: 688443<\/a>) recently announced that its New Drug Application (NDA) for GR2001, an in-house developed Category 1 biologic product, has been accepted for review by the National Medical Products Administration (NMPA). The application seeks approval for GR2001 as a passive immunization against tetanus.<\/p>\n\n\n\n<p><strong>GR2001 Monoclonal Antibody<\/strong><br>GR2001 is a monoclonal antibody (mAb) targeting tetanus neurotoxin (TeNT). It has demonstrated significant promise in addressing tetanus through passive immunization. The drug has reached the primary efficacy endpoint in a Phase III clinical trial, underscoring its potential as an effective treatment option.<\/p>\n\n\n\n<p><strong>Market Landscape<\/strong><br>Currently, there is only one similar drug approved in China for passive immunization against tetanus. The acceptance of the NDA for GR2001 marks a step forward in expanding treatment options in this space.<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\/05\/688443_20250523_M0NU.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688443_20250523_M0NU.\"><\/object><a id=\"wp-block-file--media-3dab86c3-6d7b-4d01-ab89-02f3aa9451d8\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688443_20250523_M0NU.pdf\">688443_20250523_M0NU<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/688443_20250523_M0NU.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3dab86c3-6d7b-4d01-ab89-02f3aa9451d8\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) recently announced that its New Drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":33988,"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":[3000,38,877,12],"class_list":["post-33986","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-genrix-biopharmaceutical","tag-market-approval-filings","tag-sha-688443","tag-vaccine"],"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>Chongqing Genrix Bio&#039;s GR2001 Tetanus Monoclonal Antibody NDA Accepted by NMPA - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) recently announced that its New Drug Application (NDA) for GR2001, an in-house developed Category 1 biologic product, has been accepted for review by the National Medical Products Administration (NMPA). The application seeks approval for GR2001 as a passive immunization against tetanus.\" \/>\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=33986\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Chongqing Genrix Bio&#039;s GR2001 Tetanus Monoclonal Antibody NDA Accepted by NMPA\" \/>\n<meta property=\"og:description\" content=\"China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) recently announced that its New Drug Application (NDA) for GR2001, an in-house developed Category 1 biologic product, has been accepted for review by the National Medical Products Administration (NMPA). 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