MediBeacon and Huadong
Medicine will collaboratively work to reach regulatory
approval on MediBeacon's entire portfolio of assets in Greater China
ST. LOUIS, July 31, 2019 /PRNewswire/ -- MediBeacon Inc.,
whose largest shareholder is Pansend Life Sciences, LLC, a
subsidiary of HC2 Holdings, Inc. (NYSE MKT: HCHC), announced today
that they have entered into a definitive agreement with
Huadong Medicine, a publicly traded
company on the Shenzhen Stock Exchange. The agreement will provide
exclusive rights to MediBeacon's portfolio of assets in
Greater China. Huadong Medicine will be responsible to fund the
clinical trials, commercial and regulatory activities in 25 Asian
countries including Greater China
(PRC Mainland China, Hong Kong,
Macau, Taiwan), Thailand, Vietnam, Indonesia, Philippines and Singapore.
MediBeacon's Transdermal Glomerular Filtration Rate Measurement
System (TGFR) is poised to begin its Pivotal trial in the U.S. and
Europe. The TGFR is designed to
measure kidney function at the point of care without the need for
blood sampling or urine collection. The U.S. Food and Drug
Administration (FDA) granted Breakthrough Device designation to the
TGFR in 2018.1 MediBeacon's agents and devices are not
approved for human use by any regulatory agency.
It is estimated that 10.8% of the people in China suffer from Chronic Kidney Disease
(CKD).2 Kidney disease is a "hidden epidemic" affecting
more than 850 million people worldwide.3 The ability to
measure GFR is of high clinical interest especially in patients
with, or at risk of, kidney disease.
Under terms of the deal, MediBeacon will receive an initial
$15 million equity payment at a
pre-money valuation of $300 million
and a second $15 million equity
payment upon achieving U.S. FDA approval for the TGFR at a
pre-money valuation of $400 million.
Huadong Medicine will fund all
commercial and regulatory activities in Greater China and select Asian countries. In
addition, MediBeacon will receive royalty payments on net sales in
the specified countries.
"We are extremely excited to partner with Huadong Medicine in Greater China," says Steve Hanley, CEO and Co-Founder of MediBeacon.
"Huadong has over 6,500 representatives covering all key areas of
China including a strong presence
in the nephrology community. As a leading pharmaceutical company in
China, we believe they are the
perfect partner to drive market adoption for our pipeline of
products."
As part of this transaction, Richard B.
Dorshow, PhD, Chief Scientific Officer and Co-Founder of
MediBeacon Inc., will assume the role of Special Scientific Advisor
to Huadong Medicine.
MediBeacon's fluorescent agent platform for use in physiological
function monitoring has important applications beyond the field of
kidney health. The Company's Transdermal Gastrointestinal
Permeability System has been supported by multiple grants from the
Bill & Melinda Gates Foundation. In addition, the company has
just completed initial pre-clinical studies evaluating use of its
agents in imaging the vasculature of the eye.
About MediBeacon Inc.
MediBeacon's mission is to commercialize biocompatible optical
diagnostic agents for physiological monitoring, surgical guidance,
and imaging of pathological disease in the human population.
Several product concepts in these arenas are contained in the
MediBeacon Intellectual Property estate. MediBeacon's portfolio
includes a renal function system that uses an optical skin sensor
combined with a proprietary fluorescent tracer agent that glows in
the presence of light. This system, currently in human trials, is
designed to enable clinically practical point of care measurement
of a patient's kidney function. Learn more about MediBeacon at
www.medibeacon.com
About HC2 Holdings, Inc.
HC2 Holdings, Inc. is a publicly traded (NYSE MKT:HCHC)
diversified holding company, which seeks opportunities to acquire
and grow businesses that can generate long-term sustainable free
cash flow and attractive returns in order to maximize value for all
stakeholders. HC2 has a diverse array of operating subsidiaries
across seven reportable segments, including Manufacturing, Marine
Services, Utilities, Telecommunications, Life Sciences, Insurance
and Other. HC2's largest operating subsidiaries include DBM Global
Inc., a family of companies providing fully integrated structural
and steel construction services, and Global Marine Systems Limited,
a leading provider of engineering and underwater services on
submarine cables. Founded in 1994, HC2 is headquartered in
New York, New York. Learn
more about HC2 and its portfolio companies at www.hc2.com
About Huadong Medicine Co., Ltd.
Established in 1993, Huadong Medicine Co., Ltd. specializes in
the production and sales of antibiotic, Chinese patent medicine,
synthetic drug, genetic engineering drugs, as well as wholesale
business of Chinese and western medicine, Chinese herbal medicines,
medical apparatus and instruments. Through many years of work,
Huadong has built competitive market position with its rich
portfolio of products, strong commercial capabilities, and well
recognized brand names in the fields of kidney disease, organ
transplantation, diabetes, GI, and operating rooms. The company is
a large comprehensive listed pharmaceutical company integrated with
pharmaceutical R&D, pharmaceutical industry, pharmaceutical
distribution, retail, pharmaceutical logistics, and undertakes the
task of special drug storage of the state, provincial and municipal
governments. The company successfully issued 50 million A-shares on
the Shenzhen stock exchange in
December 1999. (Stock abbreviation:
Huadong Medicine; stock code:
000963). At present, the registered capital of the company is
14.58 million yuan. The company and
its main subsidiaries have more than 8,000 employees. In 2017, the
company realized operating revenue of 27.832
billion yuan. Net profit attributable to shareholders of
listed companies was 1.480 billion
yuan. Learn more about Huadong
Medicine at www.eastchinapharm.com
1 Data on file. MediBeacon Inc., St. Louis, MO.
2 "Prevalence of chronic kidney disease in
China: a cross-sectional survey",
Zhang L. et al, Lancet. 2012 Mar
3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
3 Joint Press Release, June
27, 2018 "The hidden epidemic: Worldwide, over 850 million
people suffer from kidney diseases", American Society of Nephrology
– ASN (https://www.asn-online.org), ERA-EDTA
(http://web.era-edta.org) and ISN (https://www.theisn.org).
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