LVYE pharmaceutical ly03010 is approved to enter the global product portfolio of clinical central nervous system in the United States for further strengthening

September 26, 2018 / Meitong news agency / -- LVYE Pharmaceutical Group announced that the new drug, palipexone sustained-release suspension muscle injection (ly03010), independently developed by itself for the treatment of schizophrenia and schizoaffective disorder, has been approved by the U.S Food and Drug Administration (FDA) and can enter clinical research in the United States FDA has confirmed in the minutes of pre ind meeting that it can support 505 (b) (2) NDA listing application of ly03010 as long as it proves that multiple administration can achieve stable bioequivalence LVYE pharmaceutical is committed to creating a series of globally competitive product combinations in the field of central nervous treatment, including oral tablets, transdermal patches and injection preparations, covering a number of indications in this field, including the heavy-duty products already on the market, such as sracon (quetiapine fumarate) and its sustained-release tablets, lismin (carbalatin) transdermal patches, and the preparation for NDA application in the United States Risperidone sustained-release microspheres (ly03004) and several new drugs in the later stage of clinical research are in progress The continuous enrichment of the company's product line in the field of central nervous system will further strengthen its leading position in the field of treatment, and lay a solid foundation for the continuous expansion of the global market Ly03010 is administered by intramuscular injection once a month to treat schizophrenia and schizoaffective disorder As one of the most important mental diseases, schizophrenic patients have high relapse rate and relapse due to low treatment compliance, which has become a major difficulty in the treatment of the disease In clinical cases, non-compliance or partial compliance with the treatment is one of the main factors for patients' relapse and readmission, and the more relapse times, the higher the degree of disease deterioration, the longer the maintenance treatment period Ly03010 can improve the compliance of oral antipsychotics in patients Not only that, compared with another similar drug on the market, ly03010 may make the patients' medication more convenient and improve their medication compliance by optimizing the initial drug delivery scheme Suffering from schizophrenia not only causes serious injury to the patient himself, but also causes heavy burden to his family and society According to the statistics of the World Health Organization, more than 21 million people in the world are suffering from schizophrenia, and one out of every two patients has not received treatment According to the 2005 American comorbidity survey, it is estimated that 2.4 million or 1.1% of American adults over the age of 18 have schizophrenia Driven by this unsatisfied disease demand, similar drugs on the market also achieved good market performance For example, the global sales of invega sunstenna / xeplion / trinza / trevicta in 2017 was US $2569 million, an increase of 16% year on year; in the first half of 2018, the global sales of the product was US $1.416 billion, an increase of 14.8% year on year "Ly03010 can effectively improve the characteristics of drug compliance, which has great medical needs for patients, their families and society We are looking forward to the future development of ly03010." "Ly03010 has been approved to enter clinical practice in the United States and will continue to promote the layout of the company's follow-up R & D pipeline in the field of central nervous treatment, consolidating our leading position in the field of treatment," said the management of LVYE pharmaceutical Central nervous system (CNS) is one of the four core therapeutic fields of LVYE pharmaceutical The company has several new drugs under research in this field that are being developed simultaneously in China and overseas markets and have entered the late clinical stage, and will soon be listed in major markets around the world Among them: risperidone sustained-release microspheres for injection (ly03004) for the treatment of schizophrenia and bipolar disorder have entered the final stage of NDA application preparation, and will be applied in China and the United States; rotigotine sustained-release microspheres for injection (ly03003) for the treatment of Parkinson's disease and anshufaxin sustained-release tablets (ly03005) for the treatment of depression have entered the third stage of clinical application in China and the United States; and The lidinori patch for Alzheimer's disease is also in the clinical trial stage, and buprenorphine patch, a new analgesic drug, has also been in the preclinical trial in China In addition to the field of central nervous system, LVYE pharmaceutical also has a wealth of research product lines at home and abroad in the fields of tumor, digestion and metabolism, and cardiovascular Driven by the strategy of "global R & D", LVYE pharmaceutical has set up R & D centers in China, the United States and Europe It has initially established a global R & D system, with 30 drugs under research in China and more than 10 drugs under research overseas Now, LVYE pharmaceutical has reached the international advanced level in the fields of microsphere, liposome, transdermal drug delivery technology, and has made active layout and development in the fields of innovative compounds and antibodies, cells, gene therapy and intelligent agents In order to effectively benefit patients with these rich research and development achievements, LVYE pharmaceutical has established 7 production bases and more than 30 production lines in the world, and established GMP quality management and control system in line with international standards The company has more than 30 listed products, with business in more than 80 countries and regions around the world, including China, the United States, Europe, Japan and other major global pharmaceutical markets, as well as emerging markets with rapid growth High standard global quality management system and global market operation capability will help LVYE pharmaceutical better serve global patients with these high-quality and innovative drugs.