To address the demand by patients in China for high-quality, affordable pharmaceuticals, CASI has acquired a portfolio of FDA-approved and FDA-pending ANDAs for generic products.
From this portfolio, CASI will prioritize a select subset of products to transfer to lower-cost manufacturing facilities in China and intend to submit CBE-30 supplement or Prior Approval Supplement (PAS) for these applicable ANDAs. CASI’s primary focus for these generic products is to accelerate their availability to patients in the greater China region.
Transferring the manufacturing to China will also allow CASI to avail itself to the evolving Chinese FDA (NMPA) rules expected to streamline and accelerate the approval process for these high-quality generic products. CASI intends to develop and market on its own priority products from the portfolio and may partner the remaining U.S. ANDA assets to strategic partners.
A list of the acquired ANDA products is provided below:
For the treatment of chronic hepatitis B virus infections