OpGen Wins Chinese NMPA Approval for the Curetis Unyvero System
March 01 2021 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, announced today that it has
recently received regulatory approval of the Curetis Unyvero System
as an in vitro diagnostics (IVD) instrument system in China from
the Chinese authorities (National Medical Products Administration,
NMPA). The Medical Device Registration Certificate has been issued
under the Registration number 20213220019.
Since filing the submission dossier for the
complete Unyvero System, consisting of the Unyvero A50 Analyzer,
the Unyvero L4 Lysator and the Unyvero C8 Cockpit in February 2019,
NMPA has been actively engaged in an interactive review process
with OpGen’s subsidiary Curetis and its Chinese partner Beijing
Clear Biotech (BCB) prior to this approval decision. The parties
continue to interact closely with the NMPA during the interactive
review of the submission and filing for the Unyvero A50 pneumonia
cartridge as their first Unyvero-based diagnostic application for
the Chinese market. A dossier for the review and potential future
approval of the pneumonia cartridge was submitted in February 2019,
which includes comprehensive data from various clinical trials and
regulatory submissions of the Unyvero LRT and LRT BAL products
(which are FDA cleared in the USA) and the Unyvero HPN cartridge
for hospitalized pneumonia patients (which is CE-IVD marked in
Europe). Timelines for NMPA response submissions and review had
been extended by several months in 2020 due to the COVID-19
pandemic. The start of commercialization of the Unyvero platform in
China remains subject to also getting approval of the pneumonia
cartridge.
Oliver Schacht, CEO of OpGen commented, “We are
truly excited to see the Chinese regulators approve our Unyvero
System based on the A50 Analyzer as a diagnostic instrument for the
Chinese market. We have been working very closely with the NMPA and
our partner BCB for several years towards this key milestone. Once
we also receive NMPA approval for the Unyvero pneumonia cartridge
for the Chinese market we expect a swift commercial launch in China
by our partners BCB with tremendous growth potential for many years
to come.”Zeeman Zhang, CEO of Beijing Clear Biotech (BCB) added,
“Pneumonia remains one of the leading causes of death in
hospitalized patients with severe infections and is the number two
cause of death in children in China. We believe there is a large
unmet medical need for faster and better diagnostics of the
pathogens as well as their antimicrobial resistance marker profile.
With Unyvero, we have a first-in-class platform that has been
developed and is made in Germany and it has been sold in Europe and
the U.S. for many years. We are delighted to bring this exciting
new platform to China, to the benefit of doctors and patients alike
in our hospitals, improving clinical outcomes and antibiotic
stewardship.”
OpGen’s subsidiary Curetis and BCB are parties
to an exclusive multi-year distribution agreement for the Unyvero
platform and cartridges in China. Once NMPA approves the products,
BCB has agreed to contractual minimum purchases of 360 Unyvero
systems and more than 1.5 million cartridges cumulative over an
8-year exclusivity period which at current transfer prices between
the parties is expected to amount to approximately $180 million in
revenue to OpGen at current exchange rates.
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we
are developing and commercializing molecular microbiology solutions
helping to guide clinicians with more rapid and actionable
information about life threatening infections to improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas®
Lighthouse, and the ARES Technology Platform including ARESdb,
using NGS technology and AI-powered bioinformatics solutions for
antibiotic response prediction.
For more information, please visit
www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
Chinese regulatory approval of OpGen’s subsidiary Curetis’ Unyvero
System and pending review and potential future approval of its
Unyvero pneumonia cartridge and the potential future commercial
launch of the Unyvero platform in China. These statements and other
statements regarding OpGen’s Unyvero products, their
commercialization and launch, future plans and goals constitute
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934 and are intended to qualify for the safe
harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Such statements are subject to risks
and uncertainties that are often difficult to predict, are beyond
our control, and which may cause results to differ materially from
expectations. Factors that could cause our results to differ
materially from those described include, but are not limited to,
our ability to successfully, timely and cost-effectively develop,
seek and obtain regulatory clearance for and commercialize our
product and services offerings, the rate of adoption of our
products and services by hospitals and other healthcare providers,
the fact that we may not effectively use proceeds from recent
financings, including our February 2021 and November 2020
financings, the realization of expected benefits of our business
combination transaction with Curetis GmbH, the success of our
commercialization efforts, the impact of COVID-19 on the company’s
operations, financial results, and commercialization efforts as
well as on capital markets and general economic conditions, the
effect on our business of existing and new regulatory requirements,
and other economic and competitive factors. For a discussion of the
most significant risks and uncertainties associated with OpGen's
business, please review our filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which are based on our
expectations as of the date of this press release and speak only as
of the date of this press release. We undertake no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise.
OpGen:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR matt@fischtankpr.com
OpGen Investor Contact:Megan PaulEdison
Groupmpaul@edisongroup.com
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