Peijia Medical-B (09996) Enters into Exclusive Licensing Agreement with JenaValve for Transcatheter Aortic Valve Replacement Products Targeting Aortic Regurgitation

Peijia Medical-B(09996) announced that the group has recently entered into a collaboration and licensing agreement, a service agreement, and a share purchase agreement with the U.S. medical device company JenaValve Technology, Inc. (JenaValve). Under these agreements, JenaValve has granted the group an exclusive license for certain proprietary transcatheter aortic valve replacement (TAVR) products used to treat aortic regurgitation and aortic stenosis. The group is entitled to develop, manufacture, and commercialize the relevant products in Greater China, while the licensor agrees to provide services and assist the group in developing the value of the relevant products within this region. The group has also acquired a certain number of preferred shares of JenaValve, representing a minor equity investment in the licensor.

It is reported that aortic regurgitation is one of the most common types of aortic valve disease. According to Frost & Sullivan, in 2020, there were approximately 27 million patients worldwide and about 3.9 million patients in China suffering from aortic regurgitation. Aortic regurgitation is also commonly seen in patients with aortic stenosis. However, many patients with aortic regurgitation do not have annulus or leaflet calcification, making anchoring and grasping of the leaflets challenging. Currently, almost all TAVR products approved in China are only suitable for treating aortic stenosis, rather than aortic regurgitation. There are no transfemoral TAVR products approved in China for treating aortic regurgitation. Therefore, there remains a significant unmet demand for minimally invasive TAVR products capable of treating aortic regurgitation.

The announcement stated that JenaValve is a private company headquartered in Irvine, California, USA, with manufacturing and assembly bases in Irvine, California, USA, and Leeds, UK. The Trilogy™ Heart Valve System developed by JenaValve is the first and only transarterial device in its class to receive CE Mark approval for the treatment of severe symptomatic aortic regurgitation and aortic stenosis. The system utilizes its patented Positioner Technology, a unique system designed to position the native valve leaflets. By anchoring the Positioner onto the patient's natural anatomy, it ensures the stability of the valve. The distinctive design of the valve also allows for alignment with the anatomical valve, facilitating future coronary interventions and promoting favorable long-term hemodynamics, both of which offer significant clinical advantages in treating aortic regurgitation. The system has also received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

By adding a top-tier aortic regurgitation treatment system, the company considers this transaction a crucial step in expanding its TAVR product line. It aims to benefit more patients in China by extending its product indications to include aortic regurgitation and providing clinically proven minimally invasive treatments. The company currently has two TAVR products approved by the National Medical Products Administration: TaurusOne® and TaurusElite®, as well as three investigational products for treating severe aortic stenosis—TaurusWave® (a non-implantable shockwave therapy system), TaurusNXT® (a non-aldehyde cross-linked dry valve TAVR system), and TaurusApex (a next-generation polymer leaflet TAVR system). This transaction will give the company the most comprehensive TAVR product line covering major aortic valve diseases compared to other competitors in China.