CASI Pharmaceuticals Acquires HBV ANDA from Laurus Labs Limited

CASI Pharmaceuticals, Inc. announces that it has acquired a U.S. FDA-approved abbreviated new drug application (ANDA) from Laurus Labs Limited. The drug, tenofovir disoproxil fumarate (TDF), is indicated for the treatment of hepatitis B virus (HBV). As part of the transaction, CASI will make certain upfront and milestone payments in different phases. There are more than 90 million chronic carriers of hepatitis B in China which accounts for roughly one-third of all HBV chronic carriers in the world, with TDF currently as the first line therapy.

Wei-Wu He, Ph.D., CASI’s Executive Chairman commented, “The acquisition of this ANDA from Laurus enhances our robust and emergent pipeline and is consistent with our broader mission to commercialize U.S. FDA approved drugs in China. The regulatory landscape in China is rapidly evolving to provide patients with quicker and more affordable access to high-quality medicines and we believe CASI is well positioned with infrastructure and leadership to launch products from our ANDA portfolio rapidly and efficiently.”

Dr. Satyanarayana Chava, Founder and CEO, Laurus Labs, commented, “The transfer of TDF ANDA for its use in China enhances our strategic focus to leverage our development and manufacturing capabilities in the markets where we have little presence. Partnering with CASI, in particular, would enable Laurus Labs to monetize its asset in China while building a robust pipeline and commercialize quality drugs in other markets. Laurus Labs is looking forward to venture into the new geographies where it has no footprint and would offer its manufacturing capabilities through strategic ventures and partnerships.”