ROCKVILLE, Md., June 21, 2018 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality,
cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces a strategic and long-term manufacturing agreement with Yiling
Wanzhou International Pharmaceutical Co., Ltd. for the manufacturing of entecavir and cilostazol. Yiling Wanzhou International
Pharmaceutical Co., Ltd. is a subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd. The contracted manufacturing facilities
have been inspected by both the U.S. Food and Drug Administration (FDA) and China FDA (CFDA) and operate to strict International
Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Manufacturing Practice (GMP)
standards, which will enable CASI to eventually sell both entecavir and cilostazol in the U.S., China and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications
(ANDAs) that CASI acquired from Sandoz in January 2018.
![CASI Pharmaceuticals logo (PRNewsFoto/CASI Pharmaceuticals, Inc.) CASI Pharmaceuticals logo (PRNewsFoto/CASI Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/321070/casi_pharmaceuticals_logo.jpg)
Ken K. Ren, Ph.D., CASI's Chief Executive Officer stated, "We are very pleased to partner with
Yiling Wanzhou International as our manufacturing site for entecavir and cilostazol. Through this partnership, we will
leverage Yiling's manufacturing knowledge and capabilities in order to provide high quality, cost-effective medicines that are
critically needed for patients both in China and the U.S."
Dr. Ren continued, "This partnership further supports the overarching vision of CASI to bring much needed medicines from the
U.S. into China as well as cost-effective drugs from China to
the U.S. This would also be the first step for CASI to execute on our overall development plan for the acquired ANDAs with
additional development activities and partnering discussions underway."
The FDA approved entecavir in 2005 for the treatment of chronic hepatitis B viral (HBV) infection.1 Entecavir is an
HBV nucleoside analog reverse transcription inhibitor that interferes with HBV replication. There are over 100 million HBV
carriers in China with approximately 20 million people with chronic HBV infection. The 2016
estimated sales in China for entecavir were approximately $1.5 billion
USD, which accounted for approximately 20-percent of the patients with chronic HBV receiving entecavir treatment.
The FDA approved cilostazol in 2006 for the reduction of symptoms of intermittent claudication.2 Cilostazol is a
PDE-III inhibitor. Cilostazol inhibits platelet aggregation, improves endothelial cell function, and acts as a vasodilator
enabling blood to move more easily through peripheral blood vessels. The 2016 estimated sales in China for cilostazol were approximately $65 million USD.
About CASI Pharmaceuticals, Inc.
CASI Pharmaceuticals (NASDAQ: CASI) is a biopharmaceutical company dedicated to the development and delivery of high quality,
cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world. CASI's product pipeline features three U.S. Food and Drug Administration
(FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights.
These are currently in various stages in the regulatory process for market approval in China.
The Company also acquired a portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), and four pipeline ANDAs that
are pending FDA approval. CASI is headquartered in Rockville, Maryland and has a wholly owned
subsidiary and R&D operations in Beijing, China. More information on CASI is available at
www.casipharmaceuticals.com.
Forward Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with
respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals.
Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking
statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual
results could differ materially from those currently anticipated due to a number of factors, including: the risk that we may be
unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the
possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common
stock; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial
dilution of existing stockholders in future stock issuances, the difficulty of executing our business strategy in China; the risk that we will not be able to effectively select, register and commercialize products from our
recently acquired portfolio of ANDAs; our inability to predict when or if our product candidates will be approved for marketing
by CFDA authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and
distribution of our proposed product candidates or future candidates; risks relating to the need for additional capital and the
uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated
with any early-stage products under development; the risk that results in preclinical and early clinical models are not
necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to
the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third
parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory,
patent, product liability, supply, competition and other risks). Such factors, among others, could have a material adverse
effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on
any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that
could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities
and Exchange Commission, which are available at www.sec.gov.
EVOMELA ® , MARQIBO ® , and ZEVALIN ® are proprietary to Spectrum
Pharmaceuticals, Inc. and its affiliates.
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SOURCE CASI Pharmaceuticals, Inc.