CASI Pharmaceuticals, Inc. (NASDAQ: CASI) shares rose sharply, on entering into a strategic partnering and contract manufacturing agreement with Yiling Wanzhou International Pharmaceuticals for entecavir and cilostazol.
The Rockville, Maryland-based 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,
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 last January.
The FDA approved entecavir in 2005 for the treatment of chronic hepatitis B viral (HBV) infection. 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 U.S., which accounted for approximately 20% of the patients with chronic HBV receiving entecavir treatment.
CASI shares vaulted $1.38, or 24.1%, to $7.08, within a 52-week trading range of 92 cents to $8.42.
