China's First Innovative Drug Led by Luye Pharma Approved NDA in the U.S.

Oct 09, 2015 21:40 JST

Source: Luye Pharma Group Ltd

HONG KONG, Oct 09, 2015 - (ACN Newswire) - The leading innovative pharmaceutical company with strong R&D capability and global vision in China market-Luye Pharma Group Ltd. (the "Company", together with its subsidiaries, "Luye", stock code: 2186.HK), announced that the United States Food and Drug Administration (the "FDA") has confirmed that no additional clinical trials are needed for the New Drug Application ("NDA") submission for Risperidone Extended-release Microspheres for Injection ("LY03004") in the U.S. This will significantly cut down costs and time required for obtaining FDA approval for LY03004. 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 microsphere preparation products will enter the US market in the near future.

Humphries Pharmaceutical Consulting, LLC (HPC) BD Leader Zhao said that this is an essential way for Chinese pharmaceutical companies to accomplish internationalization and it again represents the breakthrough of domestic pharmaceutical enterprises. It is more difficult than simply developing generic drugs. The breakthrough not only implies that China's R & D level, the international registration standards and international patent awareness have all reached a standard level, but also means that domestic pharmaceutical enterprises have become more and more familiar with the international drug trial game.

LY03004 is formulated as extended release microspheres for intramuscular injection for the treatment of schizophrenia and/or schizoaffective disorders. After LY03004 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, LY03004 has significant advantages over another marketed drug, for example, there is no need to administer oral formulation during the three weeks after the first injection of LY03004 compared to the marketed drug. The stable plasma drug level can be reached much faster with LY03004 as compared to that marketed 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. LY03004 developed by Luye Pharma will bring gospel to a large number of patients living with schizophrenia.

On 10 September 2015, the Company had a meeting with the FDA on LY03004. The FDA confirmed that the results of the completed pivotal study involving a total of 108 patients enrolled in the U.S. can be used to support a NDA submission via the 505(b)(2) pathway for LY03004 without additional clinical trials. The Company is currently preparing the NDA report for LY03004.

Mr. LIU Dianbo, Executive Chairman and Chief Executive Officer of Luye Pharma Group Ltd. said, "The FDA's confirmation of no additional clinical trials are needed for the NDA submission for LY03004 in the U.S is a powerful proof of Luye's strong pharmaceutical research and development capabilities and marks Luye Pharma's another major progress in International Registration and a delightful step in accomplishing internationalization. LY03004 has good market potential and will enrich the Company's product pipeline. In addition to obtaining regulatory approval in the U.S., the Company is also targeting to obtain regulatory approval for LY03004 in Europe and Japan. Apart from LY03004, the Company is currently developing several new pharmaceutical products in the U.S., Europe and Japan. We will unswervingly implement the established strategic objectives, continued to invest in R & D to expand innovative product lines, consolidate existing advantages and strive to become the most respected leading pharmaceutical company in the globe."

Contact:

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Fax: +852 3150 6728

Source: Luye Pharma Group Ltd
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