Hengrui, Shiyao, LVYE, Zhengda Tianqing and other 30 class 1.1 innovative drugs have entered the third phase! How competitive is it?

Since this year, the innovation of local enterprises has continued to gain, and a number of innovative drug varieties that are favored by the outside world have been approved for listing, which makes the outside world directly say that China's pharmaceutical innovation is really coming Compared with the approved new drugs, there are also a number of innovative drug products on the way According to the public data, at present, there are nearly 30 class 1.1 new drug products in the phase III clinical stage, among which "R & D first brother" Hengrui reserve is not uncommon In addition to 19K has been listed, there are pyrrolidine, albumin binding paclitaxel and other varieties with sales volume of more than 1 billion yuan in the phase III stage The R & D driven small companies are also beginning to enter an important stage this year, among which the new drugs of Geli pharmaceutical industry have just been announced on the market However, three phases of clinical trials are underway in China / USA for both Baiji Shenzhou and Xinda biology Obviously, a booming era of innovative drugs is coming to China's pharmaceutical industry For everyone in the pharmaceutical industry, what kind of future the enterprise chooses is the future of the pharmaceutical industry In the long run, an enterprise that focuses on "magic medicine" with marketing as its main competitiveness will have no future However, according to the logic of "women are afraid of marrying the wrong man, men are afraid of entering the wrong line", the key to win the future is to choose a truly powerful enterprise, whether it is a professional manager or an ordinary person So, at the next time, who will win on the innovative track? Whose reserve products have the most strength?
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Im portant;" width = "800" ALT = "wechat picture" height = "599" / > source: Pharmaceutical intelligence network, industrial securities economic and Financial Research Institute, sorting 1 Hengrui pharmaceutical When it comes to pharmaceutical innovation, Hengrui is inextricable As of May 2018, the company has 7 products in phase III clinical stage, including famitinib, shr-1210 and hytrapospar for tumor treatment; praline henggliptin for diabetes treatment; and shr8554 and rimazolen toluene sulfonate for surgical sedation Famitinib is a new chemical anti-tumor drug independently developed by Hengrui pharmaceutical with intellectual property rights It is an oral multi-target receptor tyrosine kinase inhibitor Famitinib has dual antitumor effects of anti proliferation and anti angiogenesis This product was first applied for clinical application in June 2008, and it is a multi-target small molecule targeted drug At present, the preclinical pharmacodynamic study found that famitinib has obvious inhibitory effect on various target tyrosine kinases Eltrombopag (promacta), a non peptide TPO agonist developed by GlaxoSmithKline, was approved by FDA on November 20, 2008 Although the advantages of etrap are obvious, the side effects still exist The most common serious side effect of etrapa was bleeding, and most of the bleeding reactions occurred after drug withdrawal In addition, etrapa is easy to cause liver toxicity, liver damage and bone marrow fibrosis Therefore, in order to find a more efficient and low toxic TPO agonist, a series of structural modifications have been carried out on etrap, and a highly selective tpor agonist with independent intellectual property rights has been researched and developed Henggelijing is a new drug of 1.1 class independently developed by Hengrui, which belongs to sglt-2 (sodium glucose transporter 2) inhibitor SGLT2 inhibitor can inhibit the reabsorption of glucose by the kidney, increase the amount of excretion of glucose in the urine, and regulate the blood glucose balance in the body This mechanism is different from the existing way of reducing blood sugar, so there is no risk of hypoglycemia and weight gain in theory Based on this characteristic, SGLT2 inhibitors have become a hot spot in the research and development of diabetes drugs Hengrui first submitted henggelijing's clinical application to Jiangsu food and Drug Administration on February 9, 2012, which was accepted by CDE on April 20, 2012 and approved on April 11, 2013 Hengrui medicine submitted the supplementary application of hengglifloxacin in October 2016, and was approved to carry out phase II and phase III clinical trials in March 2017 Shr8554 injection is a small molecule drug targeting at μ opioid receptor (MOR), which can activate mor receptor and is suitable for the treatment of pain Developed and developed by Hengrui pharmaceutical, Jiangsu Shengdi, Chengdu Shengdi and Shanghai Hengrui with independent intellectual property rights Currently, the same product under research abroad is oliveridine (trv130) developed by Trevena company, which is currently in phase III clinical research stage in the United States At present, there is no similar drug in clinical research stage or on the market in China It is expected to fill the gap in this field in China after listing On June 9, 2017, Hengrui announced that its innovative drug, rimazolum toluenesulfonate, was approved by CFDA and successfully entered phase III clinical practice If it is successful, it is expected to be on the market in the past two years Rimazolum toluenesulfonate is a new drug of Hengrui, which is used for intravenous anesthesia of patients, and the indications can be extended to analgesia during microscopy, preoperative anesthesia and ICU sedation The efficacy and safety of rimazolum toluene sulfonate are expected to be better than midazolam and propofol According to the data, the domestic midazolam market is about 200 million yuan, and the propofol market is about 2.3 billion yuan If it is approved to be listed on the market, it is expected to seize the market by virtue of its competitive advantage, with a potential of more than 1 billion yuan 2 The RE4 of Shiyao group belongs to GLP-1 analogue, which is a class 1 biological innovative drug It is currently in the third phase of clinical practice and is expected to be approved in 2019 The product is mainly used for diabetes mellitus and blood sugar reduction At present, the similar products on the market can match the standard drug Novo Nordisk Novo hori (lilalutide), which was launched in 2009 In 2015, the global sales volume reached US $2.07 billion At present, the growth rate is still 18% year-on-year It is expected that after the launch of R4, it will have a certain impact on it and seize market share At present, there are two kinds of products of LVYE pharmaceutical, one is rotigotine microspheres for injection (ly03003), the other is vincristine liposome, which is suitable for the field of tumor Among them, the rotigotine sustained-release microspheres for injection (ly03003) is one of the key products in the research of central nervous system developed by LVYE pharmaceutical long-term sustained-release preparation platform Once a week intramuscular injection is used for drug administration, which is the first product in the world that produces sustained dopamine receptor stimulation for a long time The stable release of the drug in human body can reduce the "on-off" effect of drug treatment in patients with Parkinson's disease, significantly improve the motor complications in patients with late Parkinson's disease, and long-term application is expected to delay the occurrence of motor complications At present, the drug has been developed in the United States, China, Europe and Japan markets simultaneously; and vincristine sulfate lipid for the treatment of acute lymphoblastic leukemia and lymphoma is also in the third stage of clinical practice According to the prediction, the potential market size in China is about 60.3 billion at present, and it is expected to occupy a considerable profit after it is officially listed At present, there are five kinds of products of Fosun medicine, including recombinant human mouse chimeric CD20 monoclonal antibody and injection recombinant anti HER2 humanized monoclonal antibody in the field of tumor, recombinant prolactin, recombinant human insulin and recombinant insulin glargine in the field of diabetes Among them, the recombinant human mouse chimeric CD20 monoclonal antibody is mainly suitable for the treatment of non Hodgkin's lymphoma and rheumatoid arthritis Compared with mouse derived monoclonal antibody, chimeric monoclonal antibody and humanized monoclonal antibody, the heavy chain and light chain of all human derived monoclonal antibody are from human, so the side effects are smaller, and the immune affinity is basically unchanged, which is called the mainstream technology in the future At present, there are less than 10 fully humanized monoclonal antibodies that have been approved and produced in the world Among them, Humira of Abbott is the most effective product, with a global sales volume of about 9.5 billion US dollars in 2012 The recombinant human monoclonal antibody against HER2 was approved by the State Food and Drug Administration in January 2016 The product is used for indications of metastatic gastric cancer and breast cancer Currently, the R & D cost of the product is about 229 million yuan
As the third-generation insulin product, recombinant insulin lysine, which is located in the field of diabetes, has a very close molecular sequence with human insulin Compared with ordinary insulin, its onset time is about 25-30 minutes ahead of time, which improves patients' compliance and can effectively control postprandial blood sugar Moreover, the drug has quick effect, fast elimination, can effectively avoid delayed postprandial hypoglycemia and control hypoglycemia 5 Beida Pharmaceutical Co., Ltd at present, the products under research of Beida Pharmaceutical Co., Ltd include x-396 (ensortinib) and x-82 (vorolanib), which are located in the field of tumor treatment, which have entered the third phase of clinical practice Among them, x-396 (ensortinib) was developed by xccovery Holding Company LLC, a subsidiary of Beida Pharmaceutical Co., Ltd As a new generation of ALK inhibitors for lung cancer treatment, x-396 has the activity of anti ALK, which is used to treat lung cancer patients with ALK mutation The inhibition ability of x-39 to ALK positive lung cancer cell line is 10 times of that to be used as the first-line treatment drug for lung cancer at present Moreover, x-396 also shows strong inhibition activity to l1196m and c1156y mutations which lead to the resistance of clozatinib However, x-82 (vorolanib) is an oral inhibitor targeting at vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR), which can be used in the treatment of Ophthalmology, renal cancer, gastric cancer, lung cancer and other cancers 6 Hutchison Whampoa At present, the products under research of Hutchison Whampoa are waritinib in the field of tumor, which has entered the third phase of clinical practice Waritinib is a powerful and highly selective small molecule c-met kinase inhibitor independently developed by Hutchison Whampoa Pharmaceutical (Shanghai) Co., Ltd., which blocks the growth of tumor cells and prevents their metastasis to the body by inhibiting the production of a kinase for human body called c-met Other parts Voritinib has been shown to inhibit the growth of tumor cells in cell and animal experiments At present, it also shows good safety in animal experiments It is expected that the product will provide a new treatment option for patients with advanced lung cancer after being put on the market At present, ib308, which is located in the field of tumor, has entered the third phase of clinical research Ibi308 is an anti-PD-1 monoclonal antibody injection developed by Cinda biology By blocking the binding between PD-1 and PD-L1 in vivo, T cells can play a normal role, and then use autoimmunity to eliminate tumor cells Ibi308 entered the third phase of clinical practice Xinda has become the second PD-1 / PD-L1 drug development enterprise in China to enter phase III clinical practice after Hengrui 8 Baiji Shenzhou at present, bgb-3111, which is located in the field of tumor, has entered the third phase