Advanced biological long-term treatment of HIV original new drug ibowetai phase 3 clinical trial is progressing smoothly

Xie Dong, male, chairman and chief technology officer of Chongqing frontier Biotechnology Co., Ltd., Ph.D and postdoctoral of Johns Hopkins University Former executive director of biomass heat center of Johns Hopkins University, consultant of Otsuka (US) biopharmaceutical company, visiting professor of Tsinghua University, assistant scientist, biophysical laboratory scientist and director of biochemical structure project and biomedical Supercomputer Center of Frederick cancer research and development center of National Cancer Research Institute, Canada noble Laboratory Consultant, director of R & D, tibotec, global project leader Presided over and carried out a number of major scientific and technological projects of the Ministry of science and technology and the Ministry of health We have developed three peptide products with independent intellectual property rights, established and improved the long-term platform technology of peptide drugs, and presided over the first phase I clinical study of ibovetai, a long-term HIV fusion inhibitor in the world He has published 15 articles on cancer and AIDS, has 5 biotechnology patents, and has been invited to speak at the International AIDS Academic Conference for many times Natural medicine, a famous international journal published on April 7 this year, pointed out in the report of global new drug product chain against AIDS that the development of long-term new drugs is the latest strategy to effectively solve long-term drug treatment failure cases The report comments on the three long-term anti AIDS drugs currently in clinical trials Ibovetai from China has entered the final stage of clinical trials and is expected to become the first long-term anti AIDS drug to be listed in the world Fight with the virus, find the target, and then shoot at 35.3 million HIV infected people, 2.3 million new infections, 1.6 million people died of AIDS This is a shocking set of figures that remind us all the time that AIDS has become a serious threat to human health Since the United States first reported AIDS cases in 1981, the international community has made great efforts to develop 28 kinds of synthetic drugs for the treatment of AIDS, but up to now, there is still no effective drug for the treatment and prevention of AIDS "The reason why AIDS is difficult to prevent and cure is that HIV is very cunning It not only attacks the human immune system, but also is very changeable The anti AIDS drugs that have been put on the market now, either because of side effects or because of drug resistance, cause many treatment failures." Xie Dong, chairman of Nanjing frontier Biotechnology Co., Ltd., told reporters As one of the first talents of "Thousand Talents Program" introduced in China, Xie Dong is a doctor of Johns Hopkins University He has worked in many famous research institutions abroad, led and participated in the research and development of three new anti AIDS drugs In 2002, he returned to China with his own intellectual property technology to start a business First of all, he targeted AIDS "HIV is a retrovirus that is highly susceptible to gene mutation The past 30 years' experience tells us that no matter what formula is used for long-term drug treatment, some patients will have drug resistance, even some patients will have drug resistance after a few days of discontinuation At this time, the effect of re administration is unsatisfactory." "What should these patients do? Is it really hopeless? " Xie said that 12 million people around the world have been treated with drugs, and about 3 million people have mutations in drug-resistant genes, while tens of thousands of such patients in China, which is a major hidden danger in global AIDS prevention and control In recent years, there are more and more AIDS patients, but the research and development of new anti AIDS drugs seems to be in a bottleneck period, there are few new drugs in the research, and there are only a few new drugs that have been on the market and achieved remarkable results in clinical The global medical market is in urgent need of new anti AIDS drugs as soon as possible Xie Dong and his team members analyzed two proteins on the surface of HIV, gp120 and gp41, and found that they were the accomplices of HIV invading human T cells They realized that by controlling the two proteins and not allowing them to bind to T cells, they could inhibit the replication and transmission of HIV in the human body They call the new anti HIV drug HIV entry inhibitors Xie Dong introduced to reporters that, from the drug target point of view, ibovetai is a new area of gp41 protein of HIV virus, which can effectively inhibit the vast majority of HIV virus, including drug-resistant virus in mechanism; from the drug structure, ibovetai is an original new peptide drug, which will be metabolized into amino acids in the human body, and will not attack human cells Currently, it is shown that Good security From these two points of view, ibovetai is a big step ahead of the anti AIDS drugs currently on the market What's more surprising is that ibovetai is administered once a week, which can improve the compliance of patients and greatly reduce the treatment failure caused by not taking the medicine on time compared with the products that take a handful of medicine every day In the race against time, loneliness is the biggest opponent "I'm the only one, and frontier creatures can't do it today." Looking back on Ganxin, who has been in business for more than ten years, Xie Dong is most grateful to Lu Rongjian, a postdoctoral fellow of Harvard Medical School, who is engaged in the development of antiviral drugs for biotechnology companies Wang Changjin, a doctor of the school of pharmacy of the University of Kentucky, has been struggling in the field of new drug research and development, market and business for many years In order to develop this original new drug for AIDS treatment, three experts of the "thousand talents plan" have persisted for more than ten years, and have invested hundreds of millions of yuan "People tend to be like this When you don't have to worry about life, you start to struggle." Wang Changjin said that in famous enterprises such as Merck and Pfizer, there are thousands of R & D personnel, and individuals are like a drop of water in the sea Do you want to be a little fish in a big pool or a big fish in a small pool? Finally, the three chose to "dig the pool" New drug research and development are burning money every day Along the way, even if frontier biology gets the support of various funds, the test of "money shortage" is still coming to them "I can't remember how many times I didn't pick them up! First, the executives don't get paid, and then, the executives pay their employees " Wang Changjin said that in ten years, he has spent hundreds of millions of yuan If he bought a piece of land, he would have made an early start But, "we want to make our own achievements and make our own original medicine in China, and we will stick to it." Before the advent of ibovetai, there were few new drugs with independent intellectual property rights for major diseases in China The most fundamental reason is that new drug research and development is a hard system engineering, with long time, high cost, more risk, and tolerance of failure Because of the high cost, most of the new drug market with high profit and great influence is occupied by multinational companies At present, there are 28 original anti AIDS drugs in the world, but none of them are from China "Antiviral drug treatment is an effective means to prevent and control the spread of AIDS, and there will be a constant demand for new drugs in the current situation that it is impossible to cure the disease and needs lifelong treatment It is not only related to the national strategic security and social stability, but also can reduce the huge cost of purchasing foreign new drugs, and help China to help the developing countries suffering from AIDS " Xie Dong said From the 11th Five Year Plan period to the 12th Five Year Plan period, frontier biology has been continuously supported by major national new drug creation science and technology projects; it has entered the "green channel" approved by the State Food and drug administration, and each application for clinical trials of Abbott has been accelerated for approval; at each expert meeting, relevant ministries and commissions have summoned experts from all walks of life This is an unprecedented rare scene in the research and development of new drugs in China "Zero breakthrough", the baton that is expected to deliver life, in February this year, in an unknown, narrow and dim conference room in Beijing, frontier biology convened the phase 3 clinical trial kick-off meeting of ibovetai, marking the final "sprint" to the listing of domestic original new drugs However, the results of the two phase clinical trials that have been completed before show that the efficacy of the combination of ibowetai and klitschke is surprisingly good: the drug has a high degree of safety, not only the HIV virus in all patients has been reduced by 99%, but also the viral load in 56% of patients has been reduced below the test line Both data are more than twice the standard second-line treatment recommended by the World Health Organization Professor Wu Hao, the lead researcher of the trial and director of the infection center of Youan Hospital Affiliated to Capital Medical University, said: "ebweitai is one of the few new drugs developed in China with global patents and potential market competitiveness." According to Wu Hao, the new drug has two distinct characteristics: one is a long-term drug once a week, the other is effective against drug-resistant viruses "Ibovetai is the first new anti AIDS drug aiming at effective treatment of Chinese patients, marking the improvement of the overall research level of AIDS treatment in China In the final key research stage of this product, we hope to get the active participation of patients and clinicians to complete this important research scientifically and efficiently, so as to benefit the AIDS patients in China and the world " In the transformation period of building an innovative country, ibovetai has entered the third phase of clinical trials, and is at the forefront of the global research and development of long-term anti AI new drugs It is expected to take the lead in the market to achieve a "zero breakthrough" and take an important step to break the monopoly of foreign pharmaceutical enterprises on the anti AI new drug market From the initial drug screening to the current clinical trials, every step of ibovetai's research and development and production has kept in close line with international standards: the early efficacy trials were conducted in the United States, the patients in the three phase clinical trials were HIV infected patients who failed the standard first-line treatment scheme, 420 patients were divided into two groups for control trials, and each patient's trial will last 48 weeks The reporter learned that the next step of phase 3 clinical trial of ibovetai will be launched in more than ten drug clinical trial institutions across the country "In our eyes, AIDS is not terrible It is a chronic disease controlled by drugs The premise is that our drug research and development is always ahead of the virus It is gratifying that the phase 3 clinical trials of ibovetai are expected to be completed by the end of 2014 In 2015, it obtained the mid-term data of 24 weeks and applied for new drugs in 2016, which is expected to become the life baton of AIDS patients in China and the world " Xie Dong said About frontier Biotechnology Co., Ltd.: Frontier Biotechnology Co., Ltd is an innovative biomedical enterprise Through ten years of accumulation, we have established an excellent team with experience in developing new drugs at home and abroad, a long-term peptide new drug development platform with global independent intellectual property rights, and a number of products under research, including the national first-class anti AIDS drug ibovetai with international market competitiveness Cutting edge biology is committed to the development, production and marketing of new drug products with significant clinical needs for the international and domestic markets The company operates in three cities in China: 1) Nanjing: the headquarters, R & D and pilot plant of the company, with pilot plant of peptide API and lyophilized powder needle meeting cGMP standard; 2) Chongqing: pilot plant of peptide new drug R & D and peptide API; 3) Beijing: clinical research, drug registration and government affairs.