Peijia to maintain exclusive rights in Greater China to commercialize JenaValve's
Trilogy Transcatheter Heart Valve (THV) System
SUZHOU, China, July 25,
2024 /PRNewswire/ -- Peijia Medical Limited (Peijia,
(9996.HK)), a leading Chinese domestic player in the high-growth
transcatheter valve therapeutics and neurovascular interventions
markets, today commented on the expected acquisition of JenaValve
Technology, Inc. ("JenaValve"), an exclusive technology licensing
partner of Peijia, by Edwards Lifesciences ("Edwards").
On July 24, 2024, Edwards
announced that it had entered into an agreement to acquire
JenaValve, a pioneer in the transcatheter treatment of aortic
regurgitation (AR), a deadly disease that impacts a significant and
growing population and is currently untreated today. JenaValve
presented positive results of its U.S. pivotal trial for the
treatment of symptomatic, severe AR in high-risk patients late last
year. Edwards will accelerate development of this novel technology
with the goal to enable earlier patient access. Edwards anticipates
U.S. Food and Drug Administration (FDA) approval of the JenaValve
Trilogy Heart Valve System in late 2025, which will represent the
first approved therapy for patients suffering from AR.
In late 2021, Peijia and JenaValve entered into a collaboration
and license agreement wherein Peijia obtained the exclusive rights
to develop, manufacture and commercialize the Trilogy THV System
for AR and Aortic Stenosis (AS) in Greater China. Peijia also became a minority
shareholder of JenaValve. Subsequently, Peijia elected to re-brand
the technology to be TaurusTrio and carried out a pivotal clinical
trial for severe AR in China. The
patient enrollment of the trial was successfully completed in
January 2024.
"Peijia would like to congratulate the teams at both JenaValve
and Edwards on this announcement," said Dr. Michael Zhang, Chairman and Chief Executive
Officer of Peijia Medical. "We became a proud partner of JenaValve
to develop an improved AR treatment before the groundbreaking TCT
announcement of the ALIGN-AR trial results. The evidence of
ALIGN-AR not only demonstrated to the medical community that an AR
TAVR could be available soon, but also greatly strengthened the
awareness toward AR among doctors. The world-leading TAVR player,
Edwards, acquiring JenaValve endorses the future prospect of the
technology, and we believe this will accelerate the development of
AR TAVR globally."
As a result of the proposed acquisition, Peijia will maintain
the exclusive license for the JenaValve Trilogy THV System in
Greater China. Peijia also
maintains the right to further develop its AR pipeline and products
on the basis of JenaValve's IP independently in Greater China.
Dr Zhang continued, "With continued access to JenaValve's
Trilogy THV System, Peijia is proud to be at the forefront of the
Chinese market, where we are meeting a substantial clinical need
for a complete transcatheter valve therapeutics pipeline. Our
product portfolio covers all major replacement and repair systems
across the spectrum of regurgitation and stenosis conditions. We
will continue to see growth opportunities within TAVR while
providing patients and physicians access to innovative technologies
and superior care throughout China."
About Peijia
Peijia Medical (9996.HK) was established in 2012 and is
headquartered in Suzhou, China.
Peijia Medical focuses on the high-growth interventional procedural
medical device market in China,
and aims to become a world-renowned medical device platform that
provides comprehensive treatment solutions for structural heart and
neurovascular diseases. The Company now has two generations of TAVR
systems and sixteen neurointerventional devices commercialized in
China and various innovative
product candidates at different stages of development. For more
information about Peijia visit peijiamedical.com/about.
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SOURCE Peijia Medical