CASI Pharmaceuticals has acquired a portfolio of 25 U.S. FDA-approved abbreviated new drug applications (ANDAs), one ANDA that FDA tentatively approved, and three ANDAs that are pending FDA approval. The portfolio was acquired from Sandoz.

CASI intends to select and commercialize certain products from the portfolio that have unique market opportunity and cost-effective manufacturing in China and/or in the U.S. 

Ken Ren, Ph.D., CASI’s chief executive officer, said, “The acquisition of the Sandoz ANDAs enhances our strategic focus to build a robust pipeline and commercialize quality drug candidates in China, including entecavir, an antiviral medication used in the treatment of hepatitis B viral infection (“HBV”), which unfortunately in China accounts for more than half of the estimated 700,000 HBV-related deaths worldwide each year.  With FDA-approved ANDA status and the high-quality standards of Sandoz, we anticipate leveraging the Chinese FDA’s (CFDA) more recent regulations to accept western pharmaceutical and clinical data for rapid entry into China’s market while being competitive in the marketplace.” 

CASI is a U.S. based, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of therapeutics addressing cancer and other unmet medical needs for the global market with a focus on commercialization in China.