{"id":43393,"date":"2025-10-15T12:49:03","date_gmt":"2025-10-15T04:49:03","guid":{"rendered":"https:\/\/flcube.com\/?p=43393"},"modified":"2025-10-15T12:49:04","modified_gmt":"2025-10-15T04:49:04","slug":"maxvax-biotech-secures-nmpa-acceptance-for-its-recombinant-herpes-zoster-vaccine","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43393","title":{"rendered":"Maxvax Biotech Secures NMPA Acceptance for Its Recombinant Herpes Zoster Vaccine"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Maxvax Biotech<\/strong> announced today that the China National Medical Products Administration (NMPA) has accepted the registration application for its independently developed recombinant herpes zoster vaccine produced in CHO cells. The vaccine, classified as a Category\u202f1.3 drug, integrates the company\u2019s proprietary MA105 adjuvant system and is the first Chinese vaccine to hold independent intellectual\u2011property rights for a composite adjuvant platform.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-overview\">Product Overview<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Technology<\/strong> \u2013 Recombinant protein vaccine manufactured in Chinese hamster ovary (CHO) cells.<\/li>\n\n\n\n<li><strong>Adjuvant<\/strong> \u2013 Self\u2011developed MA105, the first innovative composite adjuvant system in China.<\/li>\n\n\n\n<li><strong>Indication<\/strong> \u2013 Prevention of herpes zoster (shingles) caused by varicella\u2011zoster virus in adults aged 40\u202fyears and older.<\/li>\n\n\n\n<li><strong>Regulatory Status<\/strong> \u2013 Category\u202f1.3 drug; NMPA registration application accepted.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence\">Clinical Evidence<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Study<\/th><th>Participants<\/th><th>Primary Endpoint<\/th><th>Key Findings<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase\u202f3<\/strong><\/td><td>25,000 adults \u2265\u202f40\u202fyears<\/td><td>Protective efficacy \u2265\u202fpre\u2011specified threshold<\/td><td>Demonstrated robust efficacy across all age strata; favorable safety profile with no serious vaccine\u2011related adverse events.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011Mover Advantage<\/strong> \u2013 The MA105 adjuvant gives Maxvax a unique competitive edge in the Chinese vaccine market.<\/li>\n\n\n\n<li><strong>Market Opportunity<\/strong> \u2013 With an aging population, demand for a safe and effective shingles vaccine is projected to grow steadily.<\/li>\n\n\n\n<li><strong>Expansion Potential<\/strong> \u2013 The regulatory approval paves the way for future licensing and global market entry.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-about-maxvax-biotech\">About Maxvax Biotech<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Maxvax Biotech is a Shanghai\u2011based biotechnology company focused on the discovery, development and commercialization of innovative recombinant vaccines. The company\u2019s pipeline spans viral, bacterial and parasitic diseases, supported by a strong research, regulatory and manufacturing platform.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This release contains forward\u2011looking statements regarding regulatory approvals, market potential and future product development. These statements are subject to risks, uncertainties and changes in market conditions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Maxvax Biotech announced today that the China National Medical Products Administration (NMPA) has accepted the&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43394,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[38,580,12],"class_list":["post-43393","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-market-approval-filings","tag-maxvax-biotechnology","tag-vaccine"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Maxvax Biotech Secures NMPA Acceptance for Its Recombinant Herpes Zoster Vaccine - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Maxvax Biotech announced today that the China National Medical Products Administration (NMPA) has accepted the registration application for its independently developed recombinant herpes zoster vaccine produced in CHO cells. 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