The first microsphere preparation in China is approved to submit a new drug application in the United States

Source: Phoenix finance and Economics on October 9, 2015, green leaf Pharmaceutical Group recently announced that the U.S Food and Drug Administration (FDA) confirmed that the risperidone microsphere injection (ly03004) developed by the company does not need any more clinical trials, and can submit a new drug application (NDA) in the United States This indicates that LVYE pharmaceutical, the first microsphere preparation product independently developed by China, will enter the US market in the near future After ly03004 goes on the market, it is expected to improve the medication compliance of oral antipsychotics in schizophrenics, and simplify the treatment course of schizophrenia, because it only needs to be injected once every two weeks In addition, compared with another marketed product, ly03004 does not need to take oral preparation three weeks after the first injection, and can reach steady-state blood concentration faster Ly03004 is a sustained-release microsphere preparation, which is used in the treatment of schizophrenia and / or schizoaffective disorder patients by intramuscular injection At the meeting of green leaf pharmaceutical and FDA in September, FDA confirmed that the critical clinical trials completed earlier this year involving 108 patients in the United States were sufficient to support ly03004 to submit NDA in the United States through 505 (b) (2), without any further clinical trials At present, LVYE pharmaceutical has begun to prepare the NDA report of ly03004 Schizophrenia is a serious mental disease, which has the characteristics of interrupting thinking, influencing language, concept and self cognition According to the World Health Organization, more than 21 million people around the world are suffering from schizophrenia, and one in every two schizophrenics has not been treated According to the National Institutes of health, an estimated 2.4 million Americans suffer from schizophrenia LVYE pharmaceutical believes that ly03004 has good market potential and will enrich its product portfolio In addition to the United States and other countries, LVYE pharmaceutical will also work to obtain the listing approval of ly03004 from European and Japanese regulatory authorities In addition to ly03004, green leaf pharmaceutical is currently developing a variety of new drugs in the United States, Europe and Japan.