Peijia Medical-B (09996) Receives NMPA Approval for TaurusTrio™ Transcatheter Aortic Valve System

Zhitong Finance APP reported that Peijia Medical-B (09996) announced on December 11, 2025, that the company received approval from the National Medical Products Administration of the People's Republic of China for the registration application of the TaurusTrio™ Transcatheter Aortic Valve (TAV) System.

Reference is made to the announcement of the Company dated January 14, 2022. The TaurusTrio™ TAV system was developed and manufactured by the Company based on the exclusive license obtained from JenaValve Technology, Inc. (JenaValve) for the Trilogy™ Transcatheter Heart Valve (THV) system. This system is specifically designed for the treatment of native severe aortic regurgitation (AR) patients via femoral artery access. Unlike patients with aortic stenosis, AR patients typically lack calcified tissue in their aortic valves for TAV anchoring, limiting treatment options for AR patients. The system employs proprietary locator key technology, which enables stable anchoring by attaching to the native valve leaflets even in the absence of calcified tissue, while ensuring proper commissural alignment.

JenaValve’s Trilogy™ THV System received CE Mark approval in May 2021 and, as of the date of this announcement, has been used in over 1,000 commercial procedures in real-world clinical practice. The company looks forward to the successful launch of the TaurusTrio™ TAV System in China, which is expected to provide a safe and effective treatment option for Chinese patients with severe AR, addressing a significant unmet clinical need.