{"id":17604,"date":"2023-06-21T00:54:00","date_gmt":"2023-06-20T16:54:00","guid":{"rendered":"https:\/\/flcube.com\/?p=17604"},"modified":"2024-12-12T00:57:58","modified_gmt":"2024-12-11T16:57:58","slug":"jiangsu-hengrui-pharmaceutials-shr-1209-for-hypercholesterolemia-accepted-for-nmpa-review","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=17604","title":{"rendered":"Jiangsu Hengrui Pharmaceutials&#8217; SHR-1209 for Hypercholesterolemia Accepted for NMPA Review"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">China-based Jiangsu Hengrui Pharmaceutials (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>) has announced that a market filing for its Category 1 biologic product, SHR-1209, has been accepted for review by the National Medical Products Administration (NMPA). The product is intended to treat hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Phase III Studies and Filing Basis<\/strong><br>The filing is supported by three multi-center, randomized, double-blind, placebo-controlled Phase III studies, all of which have successfully met pre-set superiority criteria and demonstrated clinically meaningful improvement. This robust clinical trial foundation underscores the potential efficacy and safety of SHR-1209 in managing hypercholesterolemia.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SHR-1209: A Monoclonal Antibody Targeting PCSK9<\/strong><br>SHR-1209 is a monoclonal antibody (mAb) that targets PCSK9, a protein that plays a role in regulating cholesterol levels. By inhibiting PCSK9, SHR-1209 has the potential to lower low-density lipoprotein cholesterol (LDL-C) levels, a key factor in the treatment of hypercholesterolemia.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Market Competition and Domestic Developments<\/strong><br>Amgen\u2019s Repatha (evolocumab) and Sanofi\u2019s Praluent (alirocumab), both PCSK9 inhibitors, are already marketed in China. Domestic biotechs are also actively developing similar products, including Innovent Bio\u2019s IBI306, Hengrui Medicine\u2019s SHR-1209, Junshi Bio\u2019s JS-002, and Akeso Bio\u2019s AK102. The acceptance of SHR-1209 for review by the NMPA signifies the continued growth and innovation in the domestic biologics sector, offering more treatment options for patients with hypercholesterolemia.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":false,"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":[87,2586,38,852],"class_list":["post-17604","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-chronic-disease","tag-hengrui-pharmaceuticals","tag-market-approval-filings","tag-sha-600276"],"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>Jiangsu Hengrui Pharmaceutials&#039; SHR-1209 for Hypercholesterolemia Accepted for NMPA Review - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category 1 biologic product, SHR-1209, has been accepted for review by the National Medical Products Administration (NMPA). 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