{"id":22248,"date":"2025-01-20T15:26:19","date_gmt":"2025-01-20T07:26:19","guid":{"rendered":"https:\/\/flcube.com\/?p=22248"},"modified":"2025-01-20T15:26:22","modified_gmt":"2025-01-20T07:26:22","slug":"frontier-biotechnologies-gains-nmpa-approval-for-albuvirtide-phase-ii-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22248","title":{"rendered":"Frontier Biotechnologies Gains NMPA Approval for Albuvirtide Phase II Study"},"content":{"rendered":"\n<p>Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its version of albuvirtide, China\u2019s first domestically developed innovative HIV therapy. The study will assess the drug\u2019s efficacy in addressing immune reconstitution insufficiency in HIV-1 infected patients who are receiving stable antiretroviral therapy and have achieved virological suppression (HIV-1 RNA &lt; 50 copies\/mL).<\/p>\n\n\n\n<p><strong>Albuvirtide: World\u2019s First Long-Acting HIV Drug<\/strong><br>Albuvirtide is described as the world\u2019s first long-acting HIV drug. It is a cell fusion inhibitor that prevents the HIV virus from fusing with healthy cells. The drug is characterized by low medication frequency, fast onset, high resistance barrier, high safety, and minimal side effects. Albuvirtide was included in China\u2019s National Reimbursement Drug List (NRDL) in 2020, with its status renewed in January 2023 at the same price and payment scope.<\/p>\n\n\n\n<p><strong>HIV Infections and Immune Dysfunction<\/strong><br>As of June 30, 2024, over 1.32 million individuals with HIV infections have been reported across 31 provinces in China. Despite long-term antiretroviral therapy achieving virological suppression, about 20% to 30% of HIV-infected patients still experience poor CD4+ T cell count recovery, a condition known as immune dysfunction. Individuals with immune dysfunction face a significantly increased risk of developing opportunistic infections, malignant tumors, other complications, and even death. The Phase II study of albuvirtide aims to address this critical unmet need in HIV treatment.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":22249,"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":[62,320,631],"class_list":["post-22248","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-frontier-biotechnologies","tag-hiv-aids-care"],"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>Frontier Biotechnologies Gains NMPA Approval for Albuvirtide Phase II Study - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its version of albuvirtide, China\u2019s first domestically developed innovative HIV therapy. 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