China's first innovative drug approved NDA in the US

Updated: 2015-11-06 14:22

By Shan Juan(

  Print Mail Large Medium  Small 分享按钮 0

The leading innovative pharmaceutical company with strong R&D capability and global vision in China market—Luye Pharma Group Ltd., announced that the United States Food and Drug Administration has confirmed that no additional clinical trials are needed for the New Drug Application (NDA) submission for Risperidone Extended-release Microspheres for Injection in the US.

This will significantly cut down costs and time required for obtaining FDA approval for the drug. This is the first truly innovative drug manufactured in China that passes the audits of FDA and it is about to enter the NDA progress. This breakthrough marks Luye Pharma and China's first self-developed innovative drug will enter the US market in the near future.

The drug is formulated as extended release microspheres for intramuscular injection for the treatment of schizophrenia and/or schizoaffective disorders. After the drug comes to the market, it is expected to improve medication compliance in patients with schizophrenia which is a common issue with oral antipsychotic drugs and would simplify treatment regimen since it needs to be injected only once every two weeks.

Furthermore, it has advantages over another marketed drug, for example, there is no need to administer oral formulation during the three weeks after the first injection of the drug compared to the marketed drug. The stable plasma drug level can be reached much faster with it as compared to that marketed drug.

On 10 September 2015, the Company had a meeting with the FDA on the drug. The FDA confirmed that the results of the completed pivotal study involving a total of 108 patients enrolled in the US can be used to support a NDA submission via the 505(b)(2) pathway for it without additional clinical trials. The Company is currently preparing the NDA report for the drug.

According to World Health Organization, schizophrenia affects more than 21 million people worldwide, and one in two people living with schizophrenia does not receive treatment for the condition. It developed by Luye Pharma will bring gospel to a large number of patients living with schizophrenia. Luye believe it has good market potential and will enrich the Company's product pipeline. In addition to obtaining regulatory approval in the US, the Company is also targeting to obtain regulatory approval for it in Europe and Japan. Apart from this drug candidate, the Company is currently developing several new pharmaceutical products in the US, Europe and Japan.