HK-listed Luye shares gain as U.S. FDA NDA submission for LY03004 on track

Hong Kong-listed Luye Pharma's New Drug Application (NDA) to the U.S. FDA for candidate LY03004 (risperidone), aimed at treating schizophrenia and bipolar disorders, is under way without the agency requesting further clinical trials, Barron's reported, sending shares higher on Friday. Barron's said the move means a drug launch could come by the end of 2017, citing Shaojing Tong and Rachel Yang from UBS. They told Barron's that the company next needs to run "a 12-month test to prove the stableness of manufacturing quality, and submit three batches of sample drugs to the FDA. Management expects to submit the NDA application for Risperidone LAR by the end of 2016, and potentially launch the drug by end of 2017 in the U.S. market." In May, the company said it completed three clinical studies of LY03004 in 172 patients in the U.S. and planned to approach the FDA to discuss a possible NDA, possibly making it one of the first Chinese companies to obtain an FDA NDA approval. In June, Luye terminated a $600 million deal to buy a majority stake in Beijing Jialin Pharmaceutical that would have beefed up its pipeline of cardiovascular drugs while expanding its product lineup. Report