CASI Pharmaceuticals, Inc., has entered a strategic and long-term manufacturing agreement with Yiling Wanzhou International Pharmaceutical Co., Ltd. for the manufacture of entecavir and cilostazol.

The contracted manufacturing facilities have been inspected by both the U.S. FDA and China FDA (CFDA) and operate to strict International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) 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 said, “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.”