Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a notice of acceptance from the National Medical Products Administration (NMPA) for the marketing authorization application of Edaravone Tablets, aimed at treating acute ischemic stroke (AIS) [1][2][3] Drug Information - Drug Name: Edaravone Tablets - Application Type: Domestic production drug registration and marketing authorization - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: Improvement of neurological symptoms and functional impairments caused by acute ischemic stroke, enhancing 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 while delaying neuronal death [1][2] - The oral tablet formulation (TTYP01) is a modified new drug that does not require professional medical personnel for administration, allowing for self-administration by patients and better storage conditions [2] - The clinical trial for TTYP01 was completed in June 2024, demonstrating efficacy and safety comparable to the injectable form while improving patient compliance [2][3] Impact on the Company - The approval of Edaravone Tablets is expected to enhance the company's cardiovascular product pipeline and create synergies with existing products [3] - The drug's unique oral formulation and extended treatment duration may address urgent clinical needs in stroke management, potentially positioning it as a significant player in the market [2][3] - The acceptance of the marketing authorization application is a critical milestone in the drug's development, although it will not have a significant immediate impact on the company's current performance [3]