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LY03010 is a slow-release mixed suspension injection that is given once a month and is used as an intramuscular injection for the treatment of schizophrenia and schizophrenia.
LY03010 can improve the prevalence of oral antipsychotic drugs in patients with schizophrenia.
LY03010 has the potential to make it easier for patients to use and further improve drug compliance by optimizing the initial administration program compared to another commercially available drug of the same type.
in a pre-IND filing meeting, the FDA confirmed that it could support LY03010's 505(b) NDA listing application by demonstrating that multiple administrations achieve stable bioethics.
LY03010 recently submitted a trial plan for this critical clinical trial to the FDA after completing two clinical trials in the United States, and the FDA completed its review and agreed to the program.
schizophrenia is a serious mental disorder with the characteristics of interrupting thinking, affecting language, concepts and self-awareness.
more than 21 million people worldwide suffer from schizophrenia, and one in two people with schizophrenia is un treated, according to the World Health Organization.
addition to LY03010, the Group has a number of central nervous system research projects, simultaneously developed in China and overseas markets, such as LY03004 (schizophrenia and bipolar I-type affective disorder), LY03003 (Pa Items such asInson's disease and moderate to severe leg syndrome), LY03005 (depression), LY30410/LY03013 (moderate mild Alzheimer's disease), and LY03012 (chronic pain).
source: Green leaf pharmaceutical company announcement