China-Focused and Nasdaq-listed CASI Pharmaceuticals ($CASI) has won China FDA approval to extend a U.S. Phase II clinical trial into China for its candidate ENMD-2076 aimed at fibrolamellar carcinoma.
The candidate is currently the focus of three Phase II trials in China and the U.S. for other indications for the oral Aurora A/angiogenic kinase inhibitor.
"We are pleased with CFDA's approval of our application to expand the ongoing Phase II trial for FLC into China," Ken K. Ren, CEO, said in a statement.
"This is our fourth approval from CFDA to conduct Phase II trials with our novel and orally-active Aurora A/angiogenic kinase inhibitor, and confirms our core competency to navigate and obtain CFDA approvals to conduct trials in China as part of a global clinical program."
The candidate has already received U.S. FDA orphan drug designations covering ovarian, multiple myeloma, acute myeloid leukemia and hepatocellular carcinoma--as well as a similar EMA designation on hepatocellular carcinoma.
The development of the drug is in addition to ongoing licensing efforts by CASI in oncology in China. In January, CASI won a China FDA nod for oncology therapy Marqbio licensed for China rights from Spectrum Pharmaceuticals ($SPPI) in a 2014 deal covering two oncology therapies.
The company plans a confirmatory trial in China for the spectrum candidate in China, part of a growing clinical profile that was aided by raising $25 million in a secondary offering last year earmarked for clinical trials.
- here's the release from CASI