Independent research and development of antidepressants! Ly03005, a new antidepressant drug of LVYE pharmaceutical, has submitted a new drug listing application (NDA) in the United States!

December 27, 2019 / BIOON / -- green leaf Pharmaceutical Group announced that its independently developed new compound ly03005 has officially submitted a new drug listing application (NDA) to the U.S Food and Drug Administration (FDA) The drug is used to treat depression, and it is the second new central nervous drug that LVYE has declared NDA in the United States The declaration is based on the consensus reached by LVYE pharmaceutical and FDA at the end of phase 2-cmc meeting and pnda meeting Ly03005 is an exclusive central nervous system product independently developed based on the company's new compound (nce / NTE) platform It is a serotonin noradrenaline dopamine triple reuptake inhibitor (sndri), one of the active metabolites is a serotonin noradrenaline dual reuptake inhibitor (SNRI) Depression is one of the most common diseases in the field of central nervous system The disease is the primary cause of disability around the world, and also a major factor in the global burden of disease Currently, only less than half of patients (less than 10% in many countries) receive effective treatment, and the situation of patients is grim In general, traditional antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs), are deficient in pleasure, sexual dysfunction, and inability to improve cognitive impairment The serotonin norepinephrine dopamine triple reuptake inhibitor (sndris) is expected to be more helpful than traditional drugs in protecting patients' sexual function, faster onset and better efficacy LVYE pharmaceutical has patents covering ly03005 chemical composition, crystal form and preparation Patents on chemical composition and crystal form have been obtained in China, the United States, Europe, Japan, South Korea and other countries and regions "The global population of patients in the field of central nervous treatment is huge and growing, and this kind of disease has caused serious problems for both patients and their families," said the management of green leaf Pharmaceutical Group We hope to provide more high-quality and innovative original research drugs to help more patients in need in the world and solve the unmet clinical needs " At present, green leaf pharmaceutical is increasing investment to promote the development of new drugs in the field of the disease A number of new drugs are in the late stage of NDA or clinical practice, and are expected to be launched to major global pharmaceutical markets in 2020 In addition to ly03005, ly03004 (treatment of schizophrenia and bipolar disorder), which has been declared NDA in the United States in March this year, has passed the FDA In addition, ly03003 (treatment of Parkinson's disease), ly03010 (treatment of schizophrenia and schizoaffective disorder), ly30410 (treatment of moderate and mild Alzheimer's disease), ly03012 (treatment of chronic pain) and other research projects are in progress These follow-up products will form a competitive product mix with the existing products in the field of the disease through the market channels of more than 80 countries and regions currently covered by LVYE pharmaceutical and the global supply chain system, and further play a synergistic effect to continuously improve the global core competitiveness of LVYE pharmaceutical in this field Original source: green leaf pharmaceutical