Based on the research and development ability and level of Chinese enterprises, the best choice is to research and development new drugs based on the changes to approved drugs, for example, dosage form, strength, route of administration, formulation, dosing regimen, active ingredient, indication and so on.So 505(o)(2) is the best choice.Luye Pharma focuses on R&D new preparation, for example, long-acting extended-release microspheres, liposomes.3 cases for new drugs which are on the road to submission NDA to FDA by 505(b)(2) pathway from LUYE Pharm will be shared in the report.LY03004, which is formulated as extended release microspheres for intramuscular injection for the treatment of schizophrenia and/or schizoaffective disorders, for example.On the meeting of 10 September 2015, the FDA confirmed that the results of the completed pivotal study involving a total of 108 patients enrolled in the U.S.can be used to support a NDA submission via the 505(b)(2) pathway for LY03004 without additional clinical trials.This will significantly cut down costs and time required for obtaining FDA approval for LY03004.LUYE Pharm is currently preparing the NDA report for LY03004.LY03004 has several advantages over the marketed drug, Risperdal(R) Consta(R), there is no need to administer oral formulation during the three weeks after the first injection of LY03004 compared to Risperdal(R) Consta(R).The stable plasma drug level can be reached much faster with LY03004 as compared to Risperdal(R) Consta(R).