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.
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 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.