BRIEF—CASI buys Sandoz portfolio, looks to leverage new CFDA rules

US-based CASI Pharmaceuticals has bought a portfolio of 25 US FDA-approved abbreviated new drug applications (ANDAs), one ANDA that FDA tentatively approved, and three that are pending FDA approval.

The group says it intends to select and commercialize certain products from the portfolio in China and the USA.

CASI chief executive Ken Ren 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.”

“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."

Dr 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.”