Peijia Medical-B (09996): Application for registration of the TaurRio™ transcatheter aortic valve system was approved by the China Drug Administration

According to the Zhitong Finance App, Peijia Medical-B (09996) issued an announcement. On December 11, 2025, the company received approval from the State Drug Administration of the People's Republic of China for the registration application for the TaurTrio™ transcatheter aortic valve (TAV) system.

I hereby refer to the Company's announcement dated January 14, 2022. The Taurio™ TAV system is developed and manufactured by the company under the exclusive license of the Trilogy™ transcatheter heart valve (THV) system obtained from JenaValve Technology, Inc. (JenaValve). The system is designed for primary severe aortic regurgitation (AR) patients with transfemoral artery access. Unlike patients with aortic stenosis, AR patients' aortic valves usually lack calcified tissue to anchor TAV, leaving AR patients with limited treatment options. The system uses proprietary positioning key technology, which can be firmly anchored by adhering to the primary valve even when calcified tissue is not present, while ensuring that the valve is aligned with the joint junction.

Jenavalve's Trilogy™ THV system was CE certified in May 2021, and as of the date of this announcement, it has been used in more than 1,000 commercial surgeries in real-world clinical practice. The company expects the TauruRIO™ TAV system to be successfully launched in China. It is expected that it will provide safe and effective treatment options for Chinese patients with severe AR to meet a major unmet clinical need.