CASI Pharmaceuticals To Build GMP Manufacturing Site in China

By Akia Thorpe -

November 30, 2018

CASI Pharmaceuticals, a Rockville, Maryland-headquartered biopharmaceutical company, has entered into framework agreements to build a manufacturing site located in Jiangsu Province, China. The company has a wholly owned subsidiary and research and development operations in Beijing, China.

The facility will be designed and constructed based on global cGMP requirements and is expected to have capacity for large-scale production. CASI says the facility will be a key asset supporting CASI’s growth and commercialization plans with further agreements to be finalized and the site construction to begin in mid-2019.

CASI’s products include three US Food and Drug Administration (FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals, a Henderson, Nevada-based biotechnology company, for China regional rights. These are currently in various stages in the regulatory process for market approval in China. The company also acquired a portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs) and four pipeline ANDAs that are pending FDA approval from Sandoz, Novartis’ generics arm. CASI also recently acquired a hepatitis B virus ANDA from Laurus Labs, a Visakhapatnam, India-based developer and manufacturer of active pharmaceutical ingredients.

Source: CASI Pharmaceuticals