To address the demand in China for high-quality, affordable generic pharmaceuticals, CASI has acquired from Sandoz (a Novartis company) 25 U.S. FDA approved ANDA generic products and 4 pending ANDA submissions, and acquired from Laurus Labs Limited., Tenofovir disoproxil fumarate (TDF) indicated for the treatment of hepatitis B virus (HBV). A list of the acquired ANDA products provided below.
CASI will prioritize a select subset of products from the portfolio and begin work immediately on transferring these products to lower cost manufacturing facilities in China and contemplates submitting CBE-30 supplement or Prior Approval Supplement (PAS) to the approved/pending ANDAs as soon as possible. CASI’s primary commercial focus for these generic products is the China market. Transferring the manufacturing to China will also allow CASI to take advantage of the evolving Chinese FDA (CFDA) 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 US ANDA assets to strategic partners. U.S. ANDAs.
Many of the acquired U.S. ANDA products are approved for indications that represent large potential commercial markets in China such as entecavir for hepatitis B, the anti-hypertension products bisoprolol and hydrochlorothiazide-telmisartan combination, repaglinide for type 2 diabetes, desvenlafaxine for depression and the short-acting muscle relaxant tizanidine.
For the treatment of Hepatitis B Virus (HBV)