CASI Pharmaceuticals, Inc., a biopharmaceutical company involved in bringing pharmaceutical products to the Chinese and U.S. markets, 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.
CASI intends to select and commercialize certain products from the portfolio that have unique market opportunity and cost-effective manufacturing in Chinaa nd/or in the U.S.
“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,” Ken Ren, Ph.D., CASI’s chief executive officer, commented. “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.”
Ren continued, “This is an exciting and unprecedented time in the CFDA regulatory landscape, against a backdrop of soaring demand in China for high quality import pharmaceuticals. We are confident in our ability to launch certain products that we acquired from the Sandoz portfolio in China, along with our launch of Evomela, Marquibo, and Zevalin, all of which are in various stages of CFDA review.”
(Source: CASI Pharmaceuticals, Inc.)
