Hengrui Medicine: Application for market approval of Haiqupa ethyl amine tablets for new indications has been accepted

Recently, Jiangsu Hengrui Medicine received a "Notice of Acceptance" from the National Medical Products Administration for its Market Approval Application for Hepang Pethanolamine Tablets. The proposed indication is for adult and 6 years old children with persistent and chronic primary immune thrombocytopenia. The product has already been approved for two adult indications. The Phase III clinical trial reached the main study endpoint in March 2025. ITP is a common bleeding disorder in children and adolescents, with a urgent clinical treatment demand. Similar products have been marketed overseas, with global sales of approximately $25.9 billion in 2024. As of now, the cumulative research and development investment for this drug-related project is approximately 445.87 million yuan.