Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a drug registration acceptance notice from the National Medical Products Administration (NMPA) for edaravone tablets, aimed at treating acute ischemic stroke [1][3]. Drug Information - Drug Name: Edaravone Tablets - Application: Domestic production drug registration and marketing license - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: To improve neurological symptoms and functional impairments caused by acute ischemic stroke (AIS) and enhance daily living capabilities [1]. R&D and Registration Status - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improving brain edema and tissue damage [3]. - The injectable form of edaravone has been approved in Japan and China for AIS treatment, but it requires intravenous administration, limiting patient compliance [3]. - The oral formulation, TTYP01, developed by Shanghai Aozong Biotechnology, is a modified new drug that allows for self-administration and room temperature storage, enhancing convenience and compliance [3][4]. - The clinical trial for TTYP01 was completed in June 2024, showing efficacy and safety comparable to the injectable form while improving patient adherence [3]. Impact on the Company - The approval of edaravone tablets is expected to enrich the company's cardiovascular product pipeline and create synergies with existing products [6]. - The drug is anticipated to meet the urgent clinical needs of stroke patients, potentially becoming a significant product in the treatment field [5][6]. - The company has invested approximately 100.81 million yuan in the development of edaravone tablets [5]. Future Considerations - Following the acceptance notice, the drug will undergo review by the NMPA's drug evaluation center, with the approval timeline and market competition remaining uncertain [6].