China's first innovative drug is expected to be listed in the United States2016-09-30
Asiapharm group recently announced that the U.S. Food and Drug Administration (FDA) confirmed that risperidone microsphere R & D (LY03004) without any clinical trials, new drugs in the United States can submit a listing application (NDA). This marks the green leaf pharmaceutical, but also China's first independent research and development of microspheres preparation products will enter the U.S. market in the near future.
The news came out, the industry have hot, the core reason is: This is the innovation of drug manufacturing China first true sense of the approved by the FDA in the United States, is about to enter the NDA program, may also be the first approved in the United States listed "Chinese drug" (note that is not "God medicine"). And risperidone microsphere injection (LY03004) at the present stage of new drug application for registration of the smooth, has exceeded the market expected.
Facebook Jun combed the three important concerns among them, for your reference:
First of all, as the first to enter the U.S. new drug application (NDA) program of Chinese new drug, there are many cattle? United States new drug application is simple, can be divided into two stages: the new drug clinical trial application (IND), after the new drug application (NDA). IND popular is the one or two, phase three clinical trials in the United States to complete this phase, for the Chinese pharmaceutical companies, but also costly, time-consuming, the highest threshold of a barrier.
Many are interested in the internationalization of China pharmaceutical companies, to cross the stage, this is the first case of green leaves. For example, recently sold to the United States Incyte Henry with the highest $800 million PD-1 if the varieties of monoclonal antibody to enter the U.S. market must be completed in this stage, the completion time is at least five years; in the United States is the fastest of the clinical progress of imatinib in pyrrole I clinical stage.
NDA generally consists of pharmacology, chemistry, medicine, statistics, pharmacokinetics and bacteriology of different professional personnel to establish a audit team review, a key step is the FDA Advisory Committee convened open the detailed discussion of the experimental results and the pros and cons. How long will it take? Insiders told Jun NEISHI on Facebook, the pharmaceutical industry's fastest NDA audit record is 4 working days! That is, in theory, the green leaf LY03004 submitted NDA application at any time may be listed for approval.
However, due to the fact that most of the new drugs listed on the licensing of information is too much, often can not be completed in a regular time to review. Therefore, the new drug market time, the wording of caution in terms of green. According to the provisions of the United States act, the whole process of the NDA audit is also required to complete the slowest in 10 months.
Secondly, why does the "risperidone microsphere injection (LY03004) do not need any clinical trials"? This has to start from the green leaf for the new drug development project started. It is understood that in September asiapharm meeting with FDA, FDA to confirm the key clinical trials completed earlier this year by the United States, 108 patient enough to support LY03004 by 505 (b) (2) the way to submit NDA in the United States, does not need to carry out any clinical trials. At present, the pharmaceutical industry has begun to prepare NDA LY03004 report.
505 (b) (2) is the meaning of the path of innovation is to change the dosage form, the way to the drug, the new indications, etc.. LY03004 is a kind of slow-release microspheres, by intramuscular injection for treatment of patients with schizophrenia and / or schizoaffective disorder. In other words, the new innovation technology of gold is now the largest drug market of risperidone microspheres is obvious advantages, it is a long time release in a long time, in the stable release of drugs, medication interval is short, so have the advantage of relatively old forms.
Asiapharm group senior vice president Li Youxin said: "after the listing of LY03004, is expected to improve oral antipsychotics in schizophrenia medication compliance are common in patients with schizophrenia, and simplify the course of treatment, because only injected once every two weeks. In addition, compared with another kind of products already on the market, LY03004 for the first time in three weeks after injection without taking oral preparation, and can quickly reach the steady blood concentration." In 2013 the global market size of the drug is about $1 billion 300 million.
Figure: Senior Vice President and chief scientist of asiapharm group, long-term and Target State Key Laboratory of preparation for Li Youxin
Third, the green leaves on the fast track will have the probability of failure? Different from other countries of the new drug application channels in FDA through clinical trials of the new drug application will still have the possibility of bidiao, but industry insiders predict: "the possibility of a green LY03004 bidiao is very low." The reason also lies in 505 (b) (2) of the way.
And 505 (b) (1) the different drugs are completely new way of innovation, which needs a large number of experimental data to clinical evidence and convince the effectiveness and safety of FDA on new drugs, and 505 (b) (2) is standing on the shoulder, the need to prove it is self as compared to the defect of the market for a drug now, and the clinical data of rigid PK.
In addition, the green leaf pharmaceutical said: I believe LY03004 has a good market potential, and will enrich the company's product portfolio. In addition to the United States and abroad, the green leaf pharmaceutical companies will also be committed to the European and Japanese regulators to obtain the approval of the listing of the LY03004. In addition to LY03004, the green leaf pharmaceutical is currently in the United States, Europe and Japan to develop a variety of new drugs.