{"id":5247,"date":"2024-10-12T16:21:25","date_gmt":"2024-10-12T08:21:25","guid":{"rendered":"https:\/\/flcube.com\/?p=5247"},"modified":"2024-10-13T16:57:38","modified_gmt":"2024-10-13T08:57:38","slug":"junshi-biosciences-ongericimab-wins-nmpa-nod-for-hypercholesterolemia-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=5247","title":{"rendered":"Junshi Biosciences&#8217; Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment"},"content":{"rendered":"\n<p>Junshi Biosciences (<a href=\"https:\/\/www.google.com\/finance\/quote\/1877:HKG\">HKG: 1877<\/a>; <a href=\"https:\/\/www.google.com\/finance\/quote\/688180:SHA\">SHA: 688180<\/a>), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for adult patients with primary hypercholesterolemia and mixed dyslipidemia, who are unable to achieve their low-density lipoprotein cholesterol (LDL-C) targets despite moderate or higher doses of statin therapy.<\/p>\n\n\n\n<p>The approval comes on the heels of two pivotal Phase III studies, JS002-003 and JS002-006, which were multi-center, randomized, double-blinded, and placebo-controlled. The JS002-003 study demonstrated that ongericimab significantly reduced LDL-C levels by over 60% compared to placebo and maintained this reduction throughout the 52-week treatment period. Furthermore, it showed significant improvements in other blood lipid parameters, including non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), and total cholesterol (TC).<\/p>\n\n\n\n<p>The JS002-006 study further confirmed the drug&#8217;s efficacy by showing a significant reduction in LDL-C levels by over 70% after just 12 weeks of treatment. Ongericimab also exhibited a favorable safety profile in both studies, positioning it as a promising addition to the treatment armamentarium for patients with uncontrolled hypercholesterolemia.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that&#8230;<\/p>\n","protected":false},"author":1,"featured_media":5248,"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":[899,296,15,900],"class_list":["post-5247","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hkg-1877","tag-junshi-biosciences","tag-product-approvals","tag-sha-688180"],"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>Junshi Biosciences&#039; Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for adult patients with primary hypercholesterolemia and mixed dyslipidemia, who are unable to achieve their low-density lipoprotein cholesterol (LDL-C) targets despite moderate or higher doses of statin therapy.\" \/>\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=5247\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Junshi Biosciences&#039; Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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