Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

Core Viewpoint - Amarin Corporation's commercial partner EddingPharm has received regulatory approval from China's National Medical Products Administration (NMPA) for VASCEPA to reduce the risk of cardiovascular events in specific high-risk adult patients [1][2] Group 1: Regulatory Approval and Market Potential - VASCEPA is approved as an adjunct to statin therapy for adult patients with elevated triglyceride levels (≥150 mg/dL) and established cardiovascular disease or diabetes with additional risk factors [1][2] - EddingPharm is working to include VASCEPA in the National Reimbursement Drug Listing (NRDL), which covers 98% of the Chinese population, allowing for public reimbursement [2] Group 2: Cardiovascular Disease Context in China - Cardiovascular disease (CVD) accounts for 44-47% of all deaths in China, with an estimated 330 million patients suffering from CVD [3] - The World Heart Federation projects a 50% increase in cardiovascular events in China from 2010 to 2030 due to population aging and growth [3] Group 3: Financial Implications and Partnerships - Amarin will receive a regulatory milestone payment of $15 million from EddingPharm following the NMPA approval [4] - EddingPharm will pay Amarin tiered double-digit percentage royalties on net sales of VASCEPA in China [4] Group 4: Future Developments - NMPA has requested EddingPharm to conduct a post-approval study to verify VASCEPA's efficacy in reducing cardiovascular events in Chinese patients [3][4]