Core Viewpoint - The company has received approval from the National Medical Products Administration of China for the registration of the TaurusTrio™ Transcatheter Aortic Valve (TAV) system, which is designed to treat patients with severe aortic regurgitation (AR) [1][2] Group 1: Product Development and Approval - The TaurusTrio™ TAV system is developed and manufactured based on an exclusive license obtained from JenaValve Technology, Inc. for the Trilogy™ Transcatheter Heart Valve (THV) system [1] - The approval date for the TaurusTrio™ TAV system is set for December 11, 2025 [1] - The system is specifically designed for treating patients with severe aortic regurgitation, which presents unique challenges compared to aortic stenosis patients [1] Group 2: Clinical Significance and Market Potential - The Trilogy™ THV system has received CE mark certification in May 2021 and has been used in over 1,000 commercial surgeries in real-world clinical practice as of the announcement date [2] - The company anticipates that the TaurusTrio™ TAV system will provide a safe and effective treatment option for patients with severe AR in China, addressing a significant unmet clinical need [2]

Core Insights - Ken-Valve, a transcatheter aortic valve replacement (TAVR) product developed by the company, has successfully completed its first commercial implants in key hospitals across China, marking a significant milestone in its commercialization process [1][2] - The product is designed to treat severe aortic regurgitation or combined aortic stenosis, addressing a critical clinical need in the market for TAVR products [1] - The design features of Ken-Valve, including a one-piece clamping positioning key and an active bending delivery system, enhance valve stability and coaxiality during implantation, catering to patients with complex anatomical structures [1] Market Strategy - The successful launch of Ken-Valve signifies the initiation and smooth advancement of its commercial application in China, prompting the company to expand its sales network and pursue global commercialization of its core products, including the Ken-Valve and LuX-Valve series [2] - The company aims to optimize production costs and operational efficiency to achieve its revenue targets as soon as feasible [2]