In January, Luye Pharma Group announced that Luye Pharma's innovative drug for the treatment of schizophrenia and bipolar disorder, risperidone sustained-release microspheres for injection (LY03004), has entered the final stage of preparation for NDA filing. Following the pre-NDA communication meetings with the US Food and Drug Administration (FDA) and the subsequent series of procedures, positive results have been achieved in the preparation of the application. Currently, the FDA has approved LY03004 under the brand name Rykindo®. LY03004 is used to treat schizophrenia and bipolar disorder. Luye Pharma has applied to FDA for an NDA number for LY03004 and has been assigned NDA Application number 212849 by FDA. The NDA application materials for LY03004 have been prepared and are being prepared in Electronic Common Technical Document (eCTD) format according to FDA requirements. In February of this year, the FDA had approved the drug to apply for an NDA without submitting any pediatric clinical trial protocols. This good news marks that China's first self-developed microsphere preparation product owned by Luye Pharma will enter the US market in the near future. At the same time, the registration of LY03004 in the European Union, China and Japan is also progressing smoothly, making Luye Pharma a solid step closer to becoming an international pharmaceutical company driven by innovative drug research and development. The management of Luye Pharma Group said, "We have been actively promoting the preparation of various application materials for LY03004, including regulatory, pharmaceutical (CMC), non-clinical and clinical data preparation. We are currently proceeding with the FDA filing and marketing of the drug in an orderly manner and on schedule." Luye Pharma expects LY03004 to be available in the United States and China by the end of 2019. According to the World Health Organization, there are currently about 23 million people suffering from schizophrenia and 60 million people suffering from bipolar disorder, and the number of people suffering from mental illness is unusually large and increasing. LY03004 is a sustained-release microsphere formulation that is administered every two weeks by intramuscular injection. Once on the market, the drug is expected to improve medication compliance that is prevalent in patients with oral antipsychotics and optimize clinical treatment regimens. In addition, compared with another marketed product, LY03004 eliminates the need to take oral formulations three weeks after the first injection and can reach steady-state blood concentration faster, providing patients with a new treatment option. As one of the four core therapeutic areas focused by the Group, Luye Pharma is accelerating its strategic layout in the field of central nervous system therapy, and there will be a number of new drugs under research and development scheduled to be launched globally from 2019 to 2025. In addition to LY03004, Rotigotine sustained release microspheres for injection for Parkinson's disease (LY03003) and Ansufasine hydrochloride sustained release tablets for depression (LY03005) have entered phase III clinical trials in the United States and China respectively. The treatment of Alzheimer's disease, Lismindori Patch (30410) has entered pivotal clinical trials in Europe. Paliperidone sustained-release suspension muscle injection (LY03010) for the treatment of schizophrenia and schizoaffective disorder has entered the clinic in the United States. In addition, the application for import listing registration of Lisi's Single Day Patch has also been accepted by the China National Drug Administration. Luye Pharma hopes to continue to strengthen its rich product line in the field of central nervous therapy and further enhance the company's core competitiveness in this field on a global scale.