LVYE pharmaceutical precisely distributes the field of central nervous system, and another new drug applies for NDA in the United States

[industry trends of pharmaceutical network] on October 26, green leaf pharmaceutical announced that its self-developed new depression drug ly03005 has officially submitted a new drug listing application (NDA) to the U.S Food and Drug Administration (FDA), which is also the second central new drug for green leaf pharmaceutical to apply for NDA in the United States Green leaf pharmaceutical said that the declaration was based on the consensus reached at two meetings with FDA At present, depression has become the fourth largest disease in the world It is expected that it will become the second largest disease in the world after coronary heart disease by 2020 According to the data released by the World Health Organization in 2017, the total number of depression patients in the world is more than 300 million, and the overall global prevalence rate is 4.4% Due to the widespread phenomenon of "four high and four low" in patients with depression, at present, only less than half of the patients in the world (less than 10% in many countries) receive effective treatment, and the situation of patients is grim In recent years, with the increasing prevalence of depression and the deepening of people's understanding of depression, the medical treatment rate has increased, driving the growth of antidepressant market According to the data, the market size of antidepressants in the United States is about 4.74 billion US dollars in 2018, with a compound annual growth rate of 7.3% from 2016 to 2018 In this context, the market competition of antidepressants is also gradually fierce, among which Pfizer, Lilly and other large enterprises have greater advantages in the development of new products and market share Ly03005 is a central nervous system product independently developed by green leaf pharmaceutical based on the company's new compound (nce / NTE) platform It is expected that ly03005 will be more helpful to protect the sexual function of patients than traditional antidepressants, with faster onset and better efficacy At present, green leaf pharmaceutical is increasing investment to promote the development of new drugs in the field of antidepressant, and increasing investment in research and development According to the annual report data of LVYE pharmaceutical, the company's R & D investment has increased year by year in recent years In the first half of 2017, the R & D cost was 125 million yuan, an increase of 48.8% over the same period of the previous year In terms of the company's new drug research and development, at present, in addition to ly03005, LVYE pharmaceutical has a number of new drugs in the late stage of NDA or clinical, which are expected to be launched to various global pharmaceutical markets in 2020 Among them, ly03004 (treatment of schizophrenia and bipolar disorder) of NDA has been declared in the United States in March 2019 At present, its production base has passed the pre approval inspection of FDA In addition, LVYE pharmaceutical also has research projects such as 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), etc The industry believes that with the current market channels and global supply chain system covered by LVYE, these follow-up products of LVYE form a competitive product portfolio with the existing products in the field of depression, which is conducive to further playing the synergy effect and continuously improving the global core competitiveness of LVYE in this field According to the performance announcement of LVYE pharmaceutical in the first half of 2019, during the reporting period, the company's sales revenue increased by 42.1% year-on-year to RMB 3.131 billion; the EBITDA increased by 44.1% year-on-year to RMB 1.263 billion; the net profit attributable to shareholders increased by 36.2% year-on-year to RMB 767 million In the first half of the year, LVYE pharmaceutical has made a satisfactory performance return by focusing on the four core treatment areas, especially the central nervous system and tumor area, and laid a solid foundation for the global listing and commercial operation of subsequent series of new drugs.