{"id":4578,"date":"2024-10-09T15:56:19","date_gmt":"2024-10-09T07:56:19","guid":{"rendered":"https:\/\/flcube.com\/?p=4578"},"modified":"2024-11-23T21:26:03","modified_gmt":"2024-11-23T13:26:03","slug":"cspc-pharmaceutical-secures-nmpa-approval-for-omalizumab-biosimilar","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=4578","title":{"rendered":"CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar"},"content":{"rendered":"\n<p>China-based CSPC Pharmaceutical Group Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/1093:HKG\">HKG: 1093<\/a>) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis\u2019s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb).<\/p>\n\n\n\n<p>CSPC Pharma\u2019s biosimilar product is described as the first omalizumab biosimilar developed as a Category 3.3 biologic product in China. It is indicated for the treatment of adult and adolescent (12 years and older) patients with chronic spontaneous urticaria who continue to experience symptoms despite treatment with H1 antihistamines. A head-to-head study has demonstrated that the biosimilar is highly similar to Xolair in terms of quality, safety, and efficacy, with no clinically significant differences. <a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval&#8230;<\/p>\n","protected":false},"author":1,"featured_media":4580,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[43,171,855,15],"class_list":["post-4578","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biosimilars","tag-cspc-pharmaceutical","tag-hkg-1093","tag-product-approvals"],"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>CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis\u2019s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb).\" \/>\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=4578\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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