About to become 7 kinds of domestic heavy new drugs

Among the 16 companies (R & D pharmaceutical companies) with R & D investment of more than 5%, which new or upcoming varieties are the most innovative and have great potential? Not long ago, pharmaceutical exec published its latest "top 50 global pharmaceutical companies in 2015" The total R & D investment of the top 50 reached 109.8 billion US dollars, with an average R & D investment of 17.6% The three enterprises with the largest R & D investment are Novartis, Roche and Pfizer In 2014, the R & D investment exceeded 7 billion US dollars If ranked according to the proportion of R & D investment, the three enterprises that are most willing to invest are UCB (33.2%), BMS (32.7%) and Servier (27.1%) It should be emphasized that for the vast majority of foreign excellent enterprises, more than 15% of annual R & D investment has become their habit In China, high-intensity R & D investment has not become the mainstream According to the report of CFDA Southern pharmaceutical Economic Research Institute, the average R & D investment of the pharmaceutical industry in 2012 accounted for only 1.62% of the marketing revenue Although there is a huge gap between China and the West in terms of R & D investment, the country has paid more and more attention to pharmaceutical innovation With the introduction of national new drug development policies, the R & D investment of domestic pharmaceutical enterprises has increased Compared with the industry average, the R & D investment of the industry leading enterprises is higher This also forms a virtuous circle: the leading enterprises in the industry can increase their R & D investment to develop more excellent products because of their high income, and the successive successful listing of excellent products can bring higher sales revenue At the 2015 top 100 conference, Nanfang Institute listed the latest top 100 domestic enterprises Although the number of top 100 enterprises only accounts for a small part of the national pharmaceutical enterprises, their influence is very huge, and the concentration of top 100 enterprises has reached 45.8% In 2014, when the growth rate of the industry fell and the average profit growth of the pharmaceutical industry dropped to 7%, the profit growth of top 100 enterprises still exceeded 11% Among them, the importance of R & D and follow-up product lines is an important support for the better performance of top 100 enterprises Then, compared with 1.62% of the industry's R & D investment, what is the proportion of R & D investment of top 100 leading enterprises? Therefore, we sort out 59 domestic listed pharmaceutical enterprises (excluding circulation enterprises) among top 100 enterprises We are pleased to see that the total revenue of the 59 top 100 enterprises in 2014 reached 176.4 billion yuan, including 6.945 billion yuan of R & D investment, accounting for 3.95%, slightly higher than 3.89% in 2013 Although there is still a huge gap between this data and transnational enterprises, some of them have attached great importance to R & D investment, and spent more money on R & D as much as possible, among which 16 companies invested more than 5% in R & D We define these companies as "R & D pharmaceutical enterprises", and the highest proportion of R & D investment is Haizheng pharmaceutical, hisic, Kangyuan pharmaceutical, Huahai pharmaceutical and Hengrui pharmaceutical, among which, the R & D investment of Haizheng pharmaceutical reaches 16.39%, which is close to the level of multinational enterprises; Hengrui pharmaceutical is the company with the largest absolute R & D investment, with R & D investment of 652 million yuan These 16 innovative pharmaceutical enterprises generally have rich product lines, many of which have good market opportunities To this end, we further combed 16 innovative pharmaceutical companies to see which new or upcoming varieties of these companies are expected to explode the market in the future Among these varieties, the author believes that there are 7 varieties with better innovation, including 4 newly approved varieties and 3 varieties that are expected to be approved in the near future Three of them are Hengrui's varieties, which shows that Hengrui pharmaceutical has a strong reserve of products under research; the other four are Haizheng pharmaceutical, hisic, xinlitai and Changchun hi tech 1 Furoglitazone's Pan listed enterprises: Hengrui medical treatment field: innovative hypoglycemic drugs: ★★★ Hengrui, as the pharmaceutical enterprise with the strongest R & D strength in the field of anti-tumor in China, in addition to the field of anti-cancer drugs, another important product line is the field of diabetes Hengrui has many varieties of antidiabetic drugs under research, including some generic drugs and three independently developed new antidiabetic drugs In addition to the original drugs, repagliptin and henggliptin, it is worth paying more attention to furoglitazone Furoglitazone belongs to GPR40 (free fatty acid receptor 1) agonist hypoglycemic drugs This kind of drugs belong to the category of selective stimulation of insulin secretion, which is different from the traditional insulin promoters such as sulfonylurea and gliclazide, and does not produce hypoglycemia At the same time, the hypoglycemic effect of DPP-4 may be stronger than that of DPP-4 because of its direct effect on islet β cells Fasiglifam of Takeda is the fastest-growing drug in the research In phase II clinical trials, it can reduce glycosylated hemoglobin by 1.12%, which is better than glimepiride However, the probability of hypoglycemia is no different from that of placebo Unfortunately, fasiglifam had hepatotoxicity in phase III clinical practice, which led to the termination of the study After that, only Japan's jtt-851 and Hengrui's furoglitazone are in the clinical research stage, and the progress of the two drugs is close Market potential in the context of the failure of fasiglifam, both drugs may become first in class Of course, the biggest concern is how different the varieties of furoglitazone and Takeda are, whether they can achieve superior hypoglycemic effect, without serious side effects such as hepatotoxicity 2 Listed companies of apatinib: Hengrui medical treatment field: Innovation of anticancer drugs: ★★★★★ Hengrui has a very rich product line reserve of anti-tumor drugs There are 6 new drugs of class 1 in clinical research stage, including tyrosine kinase inhibitor apatinib, famitinib and pyrrolidine, as well as new mechanism drugs umideji, cimetidine and hao472 Apatinib is a small molecule tyrosine kinase inhibitor initiated by Jiangsu Hengrui in 2005 At that time, such drugs had become a research and development hotspot in the west, but they were still at the forefront in China Apatinib is a small molecule inhibitor of vascular endothelial growth factor (VEGF) tyrosine kinase Its anticancer mechanism is similar to that of Avastin and other VEGF drugs It can inhibit tumor neovascularization by high selective inhibition of VEGFR-2 At the same time, because of its simple structure and single target, apatinib only acts on VEGFR2 Pharmacological experiments show that it is less toxic Apatinib has been included in 1230 patients with advanced gastric cancer in the pre marketing clinical study The results show that apatinib can prolong the median overall survival period and progression free survival period of patients with advanced gastric cancer for 2 months It is the first small molecule anti angiogenic targeted drug confirmed to be safe and effective in advanced gastric cancer in the world At the same time, the clinical research of apatinib for lung cancer and liver cell cancer has entered phase III, and the clinical research for breast cancer and colorectal cancer has entered phase II Apatinib's internationalization is also in progress Hengrui and its partners are conducting clinical research in South Korea and the United States, which have entered phase III and phase I respectively Market potential because apatinib is the only small molecule targeted drug for gastric cancer, and it has a wider application range, so it has a market potential no less than the first approved small molecule targeted anti-tumor drug exetinib in China 3 Henggelijing listed company: Hengrui medical treatment field: innovative hypoglycemic drugs: ★★★ At present, Hengrui has three original diabetes drugs: first, furoglitazone, which is expected to become the first in class; second, regolitine, which has entered the phase III clinical stage, but there are many DPP-4 inhibitors on the market and under research at home and abroad, and it is difficult for regolitine to show significant advantages in this kind of drugs; third, we will focus on henggliptine The SGLT2 inhibitor, hengglizine, has entered the phase II clinical stage SGLT2 inhibitor has a novel mechanism, which can inhibit the renal proximal tubule sodium glucose transporter 2, prevent the reabsorption of glucose in the original urine, so as to eliminate excessive glucose in the blood From the mechanism of action, the hypoglycemic effect of these drugs is certain, and because they do not affect insulin, hypoglycemia will not occur It is necessary to pay attention to whether there is renal damage and increase the risk of urinary tract infection Because of its novel mechanism and its combination with various existing insulin-related drugs and metformin, this kind of drugs are still of great concern At present, six new molecular entities of SGLT2 inhibitors have been approved in the world, and Hengrui's henggelijing has also entered the phase II clinical stage As the progress is not far from that of approved drugs, if the product can have some unique selling points after being put on the market, then the drug will have a good opportunity in the Chinese market 4 Listed enterprises of Haize Mabu: Haizheng pharmaceutical industry treatment field: Cardiovascular Medicine Innovation: ★★★★★ Haizheng pharmaceutical used to be a very excellent pharmaceutical enterprise exporting APIs However, in recent years, the company has invested heavily in new product development, with R & D investment accounting for the first place in the top 100 enterprises for two consecutive years In 2014, the R & D investment totaled 558 million, accounting for 16.39% of industrial revenue At present, there are 8 new drugs under development, among which the most promising product is hazel mAb As an inhibitor of cholesterol absorption, hazelbut belongs to the isozyme analogue in mechanism At present, phase II a clinical trials of the drug have been completed in the United States, and phase II clinical trials have been successfully promoted in China Ezemeb is a non statins drug developed by methadone At present, the combination of ezemeb and statins is widely used to reduce blood lipid in Europe and America, which can reduce the side effects of statins and the incidence of cardiovascular events Market potential: there are not many achievements in the research and development of similar drugs of ezymab At present, in addition to the fact that ezymab has been put on the market, kt6-971 and heyzemab from Japan are the fastest-growing drugs Two drugs are currently in phase II clinical trials Considering that the annual sales volume of Ezer mAb is more than 2 billion US dollars, if it goes on the market smoothly, it will have an excellent market prospect 5 polyethylene glycol recombinant human growth hormone injection listed enterprise: Changchun hi tech treatment field: hormone Innovation: ★★★ Changchun hi tech is a pharmaceutical listed group controlled by Changchun municipal government Jinsai pharmaceutical, a core enterprise, is the first pharmaceutical subsidiary invested and established Based on genetic engineering drugs, the company has a relatively rich product line of listed and under development genetic engineering drugs The core of Jinsai pharmaceutical industry is the recombinant human growth hormone saizeng Saizeng powder injection is the first approved recombinant human growth hormone in China, which was approved in 1998; in 2005, Jinsai was approved, which became the first listed recombinant human growth hormone injection in China Because water injection is superior to powder injection in terms of starting time, biological activity and antibody production, it accounts for most of the shares Recombinant human growth hormone has a wide range of applications, the primary use of which is children's growth hormone deficiency Due to the short half-life, it needs to be administered once a day Frequent injection is undoubtedly very inconvenient for children, and frequent administration leads to a higher incidence of discomfort in the injection site of children, so the clinical hope is to develop a lower frequency of administration of growth hormone The long-term effect of growth hormone is not only a hot spot in China, but also in the world At present, there are no long-term injections on the market in foreign countries, and what is more hopeful is that opko health has long-term advantages