The long-acting muscle injection of aripiprazole of Kelun Pharmaceutical Co., Ltd. has been approved clinically

[China Pharmaceutical Network Enterprise News 】On October 23, Sichuan Kelun Pharmaceutical Co., Ltd (hereinafter referred to as "Kelun pharmaceutical") issued a new announcement that the once-a-month microcrystalline product aripiprazole long-acting muscle injection developed by its holding subsidiary Hunan Kelun Pharmaceutical Co., Ltd was approved and issued by the State Food and Drug Administration (CFDA) Drug name: aripiprazole long-acting muscle injection dosage form: injection specification: 300mg / 5ml (powder injection + diluent), 400mg / 5ml (powder injection + diluent) registration classification: chemical drugs category 3 application stage: clinical applicant: Hunan Kelun Pharmaceutical Co., Ltd Review conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration and is approved for clinical trial It is reported that Hunan Kelun Pharmaceutical Co., Ltd., the holding subsidiary of Kelun pharmaceutical, submitted the clinical trial application of aripiprazole long-acting muscle injection to CFDA in November 2016 and was accepted Aripiprazole is a global market dopamine (DA) - 5-hydroxytryptamine (5-HT) system stabilizer, which is used in the treatment of schizophrenia While significantly improving the symptoms of schizophrenia, there are no other common side effects of antipsychotics such as weight gain and involuntary muscle activity It is a first-line drug recommended by the domestic and foreign guidelines for schizophrenia Aripiprazole has been marketed in the form of oral preparations, short-term injection and long-term muscle injection The approved product is aripiprazole long-acting muscle injection, which is administered once a month The original research was jointly developed by Otsuka of Japan and Lingbei pharmaceutical company of Denmark FDA of the United States approved it for the treatment of schizophrenia in 2013 The product is called abilify maintena ®, with specifications of 300mg / bottle and 400mg / bottle It has been listed in the United States, the European Union and Japan Compared with oral preparation and short-term injection, aripiprazole long-term intramuscular injection can effectively avoid the problems of missing, hiding and refusing to take medicine It can significantly improve the compliance of patients and reduce the recurrence rate of disease by injecting gluteus or deltoid muscle of arm According to the announcement, currently there is no listing of aripiprazole long-acting muscle injection in China The original research institute has submitted an application for import clinical registration in China, and Kelun pharmaceutical is the first company in China to obtain clinical approval Up to now, Kelun pharmaceutical has invested about 7 million yuan in the R & D project of aripiprazole long-acting muscle injection Kelun pharmaceutical said it would organize and implement the clinical trial of aripiprazole long-acting muscle injection in accordance with the requirements of the approval document for clinical trials of drugs issued by the State Food and drug administration (Kerr) original title: Kelun pharmaceutical aripiprazole long-acting muscle injection won CFDA clinical approval and became the first in China