医疗器械审批
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沛嘉医疗-B午前涨超7% TaurusTrio经导管主动脉瓣系统中国正式获批
Xin Lang Cai Jing· 2025-12-12 03:55
Core Viewpoint - Peijia Medical-B (09996) has received approval from the National Medical Products Administration of China for its TaurusTrio™ Transcatheter Aortic Valve (TAV) system, which is expected to address a significant unmet clinical need for patients with severe aortic regurgitation (AR) in China [1][5]. Group 1 - Peijia Medical's stock price increased by 7.06%, currently trading at HKD 6.22, with a transaction volume of HKD 7.6868 million [1][5]. - The TaurusTrio™ TAV system is developed and manufactured under an exclusive license from JenaValve Technology, Inc., based on the Trilogy™ Transcatheter Heart Valve (THV) system [1][5]. - The Trilogy™ THV system received CE mark certification in May 2021 and has been used in over 1,000 commercial procedures in real-world clinical practice as of the announcement date [1][5]. Group 2 - The company anticipates that the successful launch of the TaurusTrio™ TAV system in China will provide a safe and effective treatment option for patients suffering from severe AR [1][5].