China's new drugs go to the United States!

The significance of the release of risperidone microsphere injection (ly03004) is that it is expected to become the first Chinese new drug approved and listed in the United States, and will represent Chinese pharmaceutical enterprises and compete positively with multinational pharmaceutical companies in the international mainstream market Risperidone microsphere injection (ly03004), which is used to treat schizophrenia or schizophrenic affective disorder patients, is a new drug in China Recently, green leaf Pharmaceutical Group (02186.hk, green leaf pharmaceutical) announced that the U.S Food and Drug Administration (FDA) confirmed that ly03004 developed by the company does not need any more clinical trials, and can submit new drug applications in the United States If there is no accident, new drugs independently developed by China will be on the market in the United States for the first time within two years For many years, the United States has been the world's largest and most stringent access to the drug market It seems not excessive to call ly03004's success as a landmark victory in the history of Chinese pharmaceutical industry According to the general rules for the international drug market, there are three phases of clinical trials that need to be carried out before the drug market The first and second phases of trials prove the safety of the drug The third phase of clinical trials that prove the efficacy of the drug, because of the large scale and high requirements of the trials, is the most critical link to determine whether the drug can be listed The miracle ly03004 has created is that in addition to the first phase of clinical trials that have been completed, further human clinical research is no longer needed, and it can directly skip the second and third phase of clinical trials and directly apply for listing in the United States "It is expected that the clinical trial link of the reduction will directly save us $40 million and 2-3 years." Li Youxin, head of the State Key Laboratory of long-term and targeted preparations, senior vice president and chief scientist of LVYE pharmaceutical, said in an interview with the first financial daily For the long-term generic based Chinese pharmaceutical industry, the significance of ly03004's release is that it is expected to become the first Chinese new drug approved for listing in the United States, and it will represent Chinese pharmaceutical enterprises and compete with multinational pharmaceutical companies in the international mainstream market FDA has a great influence in the United States and even in the world Its strict testing and evaluation not only provide good protection, but also cause a lot of criticism from drug and food manufacturers Today, FDA has become the gold shield in the hearts of global food and drug consumers "We have proposed not to do phase III clinical, because according to the experimental data, we can clearly see the efficacy of this drug, and the significance of phase III clinical is not significant." Li Youxin told first financial daily But the harsh FDA initially rejected the green leaf request "It's not because you are from China that you simply think your experimental data is not convincing enough They need enough data to talk about it." "FDA will compare the data provided by us, including many closed data held by FDA, until they think that the new drug is perfect to a very low risk, and the efficacy and side effects can be confirmed," Li said In September this year, at the meeting between green leaf pharmaceutical and FDA, FDA confirmed that the key clinical trials completed earlier this year, involving 108 patients in the United States, are enough to support ly03004 to submit new drug applications in the United States, without any further clinical trials Data submitted to FDA for review and clinical trial data show that ly03004 can significantly improve the medication compliance of oral antipsychotic drugs in schizophrenia patients compared with previous drugs in the treatment of schizophrenia or schizoaffective disorder, and simplify the treatment course of schizophrenia According to the data released by who, there are more than 21 million people suffering from schizophrenia in the world, and one of every two schizophrenics has never been treated This disease, which interrupts thinking and affects language, concept and self cognition, is rapidly attacking more and more people The National Institutes of health report estimates that 2.4 million Americans are conservatively estimated to have schizophrenia According to public information, as early as 2011, there were more than 16 million severe mental patients in China, of which only about 120000 were hospitalized In 2014, there were more than 100000 patients with serious mental illness registered in the system in Guangxi alone According to the different situations of each patient, the longest treatment would take 2-3 years, the shortest one would take more than 3 months, and the annual treatment cost would need 340000 yuan Worldwide, risperidone is the most effective schizophrenic drug at this stage Its sales reached a peak of $4.556 billion in 2007, and the global market size in 2013 was $1.318 billion At present, the main dosage form on the market is Risperdal consta, which is produced by Risperdal consta However, the drug can not reach the blood concentration immediately after the first injection, so it must be supplemented by oral medicine for three weeks "It's not easy for people with mental illness to take their medicine on time and according to the quantity Unlike other drugs, ly03004 only needs to be injected once every two weeks, and no oral preparation is needed within three weeks after the first injection, so it can reach the steady-state blood concentration faster." Li Youxin told first financial daily At present, there are three main directions of global drug research and development: first, to find a new molecular structure of drug research and development, which costs a lot of money and time, with the highest risk and return; The second is generic drugs, that is, after the end of the patent period of drugs, drugs that simply clone their molecular structure belong to low threshold and low risk, but the profit space will be squeezed and easily eliminated; the third is dosage form innovation, that is, new drug delivery system, including the research of long-term and targeted drugs Li Youxin, a scientist, stopped a number of scientific research projects after arriving at LVYE pharmaceutical "The failure rate of R & D drugs is high The earlier problems are found, the earlier inappropriate projects are stopped, and the less losses are." Li Youxin told the first financial daily that long-term sustained-release preparations are the key direction he will focus on in the future In his opinion, long-term sustained-release preparations are all heavy-duty products, with high sales volume and profit margin far higher than ordinary dosage forms "At present, the strength of domestic pharmaceutical companies is not enough to develop new drugs, but the relative risk of developing new drugs is small, the cost is low, and the profit is high, which is worth doing." Li Youxin said in an interview that the sales volume of some new drugs on the market in recent years is very large, all of which are "heavy bomb" drugs Li Youxin said that such a research and development path is the most "practical and realistic" for the current situation that China's pharmaceutical enterprises are small, have little research and development funds and need to improve their innovation ability It is understood that in the process of the declaration of new drugs for risperidone microsphere injection, a team of about 100 people are working hard for it, including many people who are familiar with FDA policies and are on the front line of international drug registration At present, LVYE pharmaceutical has established the first National Key Laboratory of long-term and targeted preparations in China, among which risperidone microsphere injection is one of the achievements According to the 2015 interim report issued by LVYE pharmaceutical on September 29, as of June 30, 2015, the R & D team of LVYE group is composed of 285 employees It has obtained 277 patents in China and 55 patents are in the application stage It has obtained 102 patents overseas and 79 patents are in the application stage.