CASI Pharmaceuticals acquired 25 U.S FDA-approved ANDAs from Sandoz
CASI Pharmaceuticals, committed to ushering in quality pharmaceutical products to the Chinese and U.S markets proclaimed that it has obtained a portfolio of 25 U.S FDA- approved abbreviated new drug applications from Sandoz. With a view to select and commercialize certain products from the portfolio assuring economically viable manufacturing in China and or U.S, CASI intends to advocate mentioned products.
Ken Ren, Ph.D., CASI’s Chief Executive Officer commented, “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.”
Dr. Ren affirmed “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 , MARQIBO and ZEVALIN all of which are in various stages of CFDA review. We look forward to completing our Company’s transition from research and development to commercial.”