Xinda, Hengrui, Haosen and other eight heavyweight products will be launched soon! The turning point of 2018 pharmaceutical companies' stratification is coming

Almost all of the eight innovative drugs are heavy bomb drugs, which are independently researched and developed by Chinese innovative drug enterprises, with the leading target internationally, and can compete with transnational drug enterprises The intensive listing of 8 domestic new drugs in 2018 will greatly enrich the number of innovative drugs in China and change the pattern of innovative drugs in China In the next few years, the number of innovative drugs approved annually in China will show the trend of blowout According to the 2017 new drug review report issued by GBI health, as of the end of January 2018, eight domestic innovative drugs with the fastest progress have submitted their initial listing applications in China, seven of which have been included in the priority review and special review process, and are expected to be listed in 2018 Almost all of the eight innovative drugs are heavy bomb drugs, which are independently researched and developed by Chinese innovative drug enterprises, with leading international targets, and can compete with multinational drug enterprises The indications include anti-tumor, anti hepatitis C, anti AIDS, diabetes, etc The intensive listing of 8 domestic new drugs in 2018 will greatly enrich the number of innovative drugs in China and change the pattern of innovative drugs in China In recent years, a number of R & D and innovation enterprises have emerged in China, among which Geli is one Under the situation of new drug trade and cooperation in China, Geli introduced four drugs for the treatment of hepatitis C, liver cancer and AIDS from YANGSEN, presidio, Alnylam and other companies through cooperation Among them, danorevir is the core project of Geli in the research product line, and also the HCV NS3 / 4A inhibitor introduced by Geli from Roche pharmaceutical, a multinational pharmaceutical company According to the clinical trial data published by Geli, asc08 (danorevir) has a cure rate of 100% for hepatitis C patients with genotype 1b, while nearly 60% of hepatitis C patients in China are genotype 1b, which means that danorevir is more effective for Chinese patients With a series of new therapeutic oral hepatitis C drugs coming into the market, the global hepatitis C market has experienced a process of "rapid outbreak, rapid saturation and sharp shrinkage" in recent years In 2017, the global market size of hepatitis C drugs was US $12.5 billion, about 50% less than the peak period in 2015 When the standard markets in Europe and America are saturated, the focus of pharmaceutical companies will naturally be on China At present, the prevalence of hepatitis C in China is about 1%, with more than 13 million hepatitis C patients The patient pool is more than three times of that in the United States, which is obviously a large visible market Under the green light of priority review and approval, in 2017, a number of products for the treatment of chronic hepatitis C were approved in China Major hepatitis C drug holders such as BMS, Gilead, Aberdeen and Xi'an Janssen have all been approved in China Local enterprises are also fighting in the field of hepatitis C Geli, dongyangguang, Shenghe pharmaceutical, Suzhou ginkgo tree, Zhengda Tianqing, Kain technology and other products are under research In December 27, 2016, the first original hepatitis C innovative medicine, Dan rrwey, was accepted by CFDA, the fastest progress in China As one of the representatives of local R & D enterprises, it seems that there is no suspense in winning the first place in the domestic hepatitis C market In addition, as a new drug that can cure hepatitis C patients with genotype 1b, danorevir directly targets the products of two multinational pharmaceutical giants Gilead's sofibvir, known as the "God drug of hepatitis C", and EBV's new drug for hepatitis C with genotype 1b Danorevir's approval in China is bound to stir the domestic hepatitis C market In order to win the first chance, golly's pre IPO academic promotion of danoreway has already begun According to an exclusive interview with Geli pharmaceutical industry conducted by e pharmaceutical manager, Geli's production base has obtained the production license After the approval of danorevir's new drug certificate, the patients can take the drugs that can cure hepatitis C within 21 days Gilead, which has never set up an office in China, has set up a high-profile business team in China to promote the listing of sofibway in China It can be seen that its ambition for China's hepatitis C market is inevitable This "Three Kingdoms killing" in the field of hepatitis C is about to break out 2 in June 2017, a new targeted small molecule anticancer drug developed jointly by Hutchison Whampoa pharmaceutical and Lilly was put on the market, and then it was included in the priority review procedure The reason for its inclusion was "obviously of clinical value and major special project" Fiquitinib applied for clinical application in September 2009, and finally submitted the application for listing in June 2017 The clinical study lasted for 8 years In the research and development of furquitini, Hutchison Whampoa and Lilly have a clear division of labor The former is responsible for the production, manufacturing and marketing declaration of products, while Lilly is responsible for its business process in China Fqtinib is the first innovative tumor drug developed completely in China's laboratories It is the first 100% domestic drug developed by Chinese local pharmaceutical companies It was selected into the American Society of Clinical Oncology (ASCO) paper collection and presented orally This is undoubtedly a great affirmation of the innovation of furquitinib itself and the R & D strength of Whampoa The indications of fiquitinib include colorectal cancer, lung cancer and advanced gastric cancer According to the report of ASCO, as the third-line treatment of colorectal cancer, fqtinib can prolong OS 9.3 months, with the most significant effect in the history of prolongation, and has absolute therapeutic advantage TiNi drugs play an important role in targeting anticancer drugs According to the data of minenet, in 2016, China's public medical terminal sales reached 6.63 billion yuan, an increase of 15.59% year on year, ranking fourth in the pattern of anti-tumor chemicals, with a market share of 11.57% So far, China has listed 13 Tinian drugs After a new round of drug price negotiations between the Ministry of human resources and social security, a total of 8 Tinian drugs have entered the medical insurance, more than half of them The TiNi market is very competitive With the expiration of foreign product patents, more domestic TiNi products are in the process of R & D, aiming to segment the 10 billion market It can be seen that in order to break through the siege in the future, TiNi drugs must have irreplaceable advantages As a 100% domestic innovative drug, furquitinib has attracted much attention, and it is responsible for commercial promotion by virtue of its absolute advantages in efficacy and etiquette Once it is listed, it will also change the market pattern of domestic tinib 3 Androtinib HCl, which is expected to be listed in the United States, is the anticancer drug with the most investment so far, and the only drug initiated by Zhengda Tianqing and included in the priority review and special review at the same time In the industry, it is expected to compete with the cetinib hydrochloride of Beida pharmaceutical As a new type of small molecule and multi-target TKI, arotinib has a wide range of indications In addition, the way of taking "two stops one" is also unique The way of stopping one week for two weeks can keep the blood concentration stable within the treatment window As a TiNi product, the greatest significance of enrotinib hydrochloride is expected to fill the blank of the third-line treatment of advanced NSCLC And Zhengda Tianqing also takes this indication as the first choice for listing in China, and then applies for listing of other indications It is worth noting that as early as December 2015, androtinib hydrochloride was awarded the orphan drug qualification of ovarian cancer treatment by the US FDA At present, Zhengda Tianqing and its partners are conducting clinical research on the treatment of ovarian cancer and endometrial cancer by androtinib in the US, which also means that androtinib hydrochloride is expected to be listed in the US in the next few years Pyrrolidine, which is expected to surpass Herceptin and independently developed by pyrrolidine Hengrui medicine, is a small molecule drug targeted at EGFR / HER2 Indications include HER2 + breast cancer, non-small cell lung cancer and gastric cancer At present, the similar products on the market in the world include rapatinib of GSK, afatinib and neratinib of bringer ingelham At present, the gold standard drug for HER2 + breast cancer is Herceptin + chemotherapy In 2016, the global sales of Herceptin reached 6.89 billion US dollars, and the sales volume in China was about 2.5-3 billion yuan Pyrrolidine as a second-line treatment drug, lapatinib was selected as the control The clinical trial data showed that pyrrolidine was better than lapatinib of the same type, and it is expected to become the best in class In the future, it may even surpass Herceptin and become the best in class targeted by HER2 Based on the excellent phase II clinical trial data of pyrrolidine, CFDA accepted the conditional listing application of the drug At present, the phase I clinical application of pyrrolidine in breast cancer and non-small cell lung cancer is also carried out in the United States According to the calculation of CICC, the peak domestic sales of pyrrolidine in the future is expected to reach 3 billion yuan AI Bo Wei Tai: in the report of global anti AI new drug product chain, the international famous journal Nature pointed out that the development of long-term new drugs is the latest strategy to solve long-term drug treatment failure cases The report commented on three long-acting anti AIDS drugs in clinical stage, including ibovetai from China It has been 15 years since Abbott started research and development in 2002 when Xie Dong founded frontier biology The results of phase II clinical trial showed that not only the HIV virus in all patients was reduced to 99%, but also the viral load of 56% patients was reduced to below the detection line, both data were more than twice of the standard second-line treatment scheme recommended by the World Health Organization Since then, ibovetai has become the world's first long-term injection of new anti AI drugs into phase III clinical trials In June 2016, the validation phase III clinical trial of Abbott reached all preset clinical end-point indicators in advance, and then entered the CFDA priority listing review process At the same time, the website of the Ministry of science and technology said that the new generation of new anti AI drug, ibovetai, independently developed by China, is expected to be the first in the world In China, the current AIDS drug use is mainly free of charge China has listed more than 20 anti AIDS drugs, but only eight of them are included in the free catalogue AIDS is generally treated as a chronic disease, the treatment period is long, the free catalog of eight drugs can not cover all AIDS patients As of June 30, 2016, more than 620000 people living with HIV / AIDS have been reported nationwide, more than 190000 deaths have been reported, and more than 420000 people are currently receiving antiviral treatment The lack of drug supply and fewer categories, while the number of patients is still increasing, which is a major adjustment in the prevention and treatment of AIDS There is no doubt that the IPO of ibovetai will greatly benefit patients On May 23, 2017, among the 17th batch of drugs listed by CFDA and included in the priority review procedure, the most noteworthy drug was thimphetamine injection (19K) of Hengrui, which is another masterpiece of Hengrui after apatinib It is expected to reach 2 billion yuan in the domestic market Thiopefigeristine is a recombinant granulocyte colony stimulating factor of polyethylene glycol, a long-acting G-CSF, and an important drug for tumor adjuvant therapy From the international point of view, long-acting granulocyte stimulating factor accounts for 70% of the market share, while the domestic long-acting white drug is less than 3% In 2017, the medical insurance catalog was adjusted, and pegylated recombinant granulocyte colony stimulating factor entered the national medical insurance category B catalog, indicating that it will enter a rapid growth period, with broad growth space in the future At present, only jinyuli and xinruibai of Baike (Shandong) biopharmaceutical and Qilu pharmaceutical have been approved for listing in China Hengrui's 19K will make a big market together with these two products The first domestic long-acting GLP-1 inhibitor losenapeptide polyethylene glycol losenapeptide is a long-acting GLP-1 receptor agonist independently developed by hausen, and also the first long-acting GLP-1 receptor agonist applied for listing in China, which is used for the treatment of type 2 diabetes