LVYE pharmaceutical 1.1 new chemical drug anshufaxin hydrochloride sustained release tablets (ly03005) approved for clinical use

Recently, LVYE Pharmaceutical Group Co., Ltd has obtained the approval documents of phase II and phase III clinical trials issued by China food and Drug Administration (CFDA) for the new 1.1 chemical drug slow release tablets (ly03005) This product is the first class 1 antidepressant in China, which has obtained the clinical research approval It is expected to promote the development of LVYE pharmaceutical in the field of psychoneurosis and further enrich the group's product line Incidence rate of depression incidence is about 5% to 6% in China, according to a report released by WHO The incidence rate of depression in China has been increasing year by year in recent years According to IMS data, the total market value of antidepressant products in China in 2014 was about 3.4 billion yuan, mainly occupied by imported brands, and no chemicals with independent intellectual property rights have been listed According to reports, LY03005 is an exclusive product of ansufaxine hydrochloride (a 5- hydroxytryptamine noradrenaline dopamine three fold reuptake inhibitor (SNDRI)) prepared in the form of sustained-release tablets Compared with dual uptake inhibitors, it has faster effect and can effectively improve the side effects of lack of pleasure and obesity Ly03005 has completed three phase I clinical studies in China The results of single dose increasing clinical trial showed that the main active metabolites of healthy subjects increased proportionally with the increase of dose in the range of 20-200mg after oral administration of ly03005 The results showed that food had no effect on bioavailability The results of clinical trials showed that the concentration of main active metabolites could reach steady state in the third day after multiple oral administration of ly03005 40-160 mg / day, and the pharmacokinetics under steady state had dose proportion relationship At the same time, the above three studies showed that ly03005 had good safety and tolerance, which provided clear reference and basis for phase II and phase III tests As a leading innovative pharmaceutical enterprise in China, LVYE pharmaceutical currently has many products including ly03005 registered in China and the United States It is reported that the product is undergoing phase I clinical trials in the United States; not long ago, the company completed three key clinical trials of risperidone sustained-release microspheres intramuscular injection (ly 03004) for the treatment of schizophrenia in the United States, and the next step will be to discuss with the FDA the matter of submitting a new drug listing application (NDA).