{"id":24599,"date":"2022-11-07T01:24:00","date_gmt":"2022-11-06T17:24:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24599"},"modified":"2025-02-01T01:31:41","modified_gmt":"2025-01-31T17:31:41","slug":"ji-xing-pharmaceuticals-omecamtiv-mecarbil-accepted-for-review-by-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24599","title":{"rendered":"Ji Xing Pharmaceuticals&#8217; Omecamtiv Mecarbil Accepted for Review by CDE"},"content":{"rendered":"\n<p>Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that a market filing for its investigational omecamtiv mecarbil has been accepted for review by the Center for Drug Evaluation (CDE). The small molecule is a potential first-in-class cardiac myosin activator being developed as a treatment for heart failure with reduced ejection fraction (HFrEF).<\/p>\n\n\n\n<p><strong>Partnership and Development Rights<\/strong><br>In December last year, Ji Xing Pharma struck a USD 400 million deal with US-based Cytokinetics Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/CYTK:NASDAQ\">NASDAQ: CYTK<\/a>), securing development and commercialization rights to the drug targeting HFrEF in Greater China. This strategic partnership aims to accelerate the development and availability of omecamtiv mecarbil in the region.<\/p>\n\n\n\n<p><strong>Drug Profile and Clinical Trials<\/strong><br>Omecamtiv mecarbil directly targets the heart&#8217;s contraction mechanism, increasing the number of cardiac myosin head regions interacting with actin during contraction. The Phase III GALACTIC-HF study demonstrated that, compared to a placebo, omecamtiv mecarbil effectively reduces the risk of cardiovascular death or heart failure events (heart failure hospitalization and other emergency treatments for heart failure) in patients receiving standard treatment, with a good safety profile.<\/p>\n\n\n\n<p><strong>Regulatory Progress<\/strong><br>The drug is currently awaiting regulatory decisions in the US, with a market filing made in February this year. The acceptance of the market filing by the CDE marks a significant step forward in making omecamtiv mecarbil available to patients in China, potentially improving treatment options for those with HFrEF.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that a market filing for its&#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_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":[69,1283,141,38,1282],"class_list":["post-24599","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cvd","tag-cytokinetics","tag-ji-xing-pharmaceuticals","tag-market-approval-filings","tag-nasdaq-cytk"],"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>Ji Xing Pharmaceuticals&#039; Omecamtiv Mecarbil Accepted for Review by CDE - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that a market filing for its investigational omecamtiv mecarbil has been accepted for review by the Center for Drug Evaluation (CDE). 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