Laurus Labs transfers USFDA approved HBV ANDA to CASI Pharmaceuticals

Laurus Labs announced the transfer of the U.S. FDA-approved Abbreviated New Drug Application (ANDA) of Tenofovir Disoproxil Fumarate (TDF) to CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to China and other markets.

The TDF is prescribed for the treatment of Hepatitis B virus (HBV). 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 the first line therapy.

As part of the transaction, the Company, in exchange of the transfer of ANDA, would receive certain upfront and milestone payments in different phases. Both parties are in discussions to allow Laurus to continue to manufacture and market TDF for the US market and to potentially supply API for the China market.

 

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