[yaocajun] 5-pound bomb detonates the drug circle, Hengrui, hausen, Bayer, Pfizer and Aberdeen; new 4 kinds of generic drugs attract people's attention, Qilu, Zhengda Tianqing

Highlights: 1 For 12 years, the first long-acting GLP-1 receptor agonist independently innovated in China has been approved; 2 The third domestic PD-1 monoclonal antibody, carrizumab for Hengrui injection, has come; 3 The approval of Bayer radiation therapy drug radium chloride [223ra] injection has been completed; 4 Pfizer's first-line lung cancer drug approved by FDA in 18 years will be in China; 5 After Gilead's "Ji San Dai" bingtongsha was launched in China, the new hepatitis C drugs of alberwin came after it; 6 Qilu's 4 kinds of imitated lenalidomide were approved, which was deemed to have passed the consistency evaluation, including overtaking Shuanglu and Zhengda Tianqing; 7 After hausen, the class I recommended drugs of Zhengda Tianqing pulmonary hypertension also came; 8 Qilujifeitini will reduce the price to protect the market and come to the competitors Zhengda Tianqing will join the battle This week (may 3-May 10), a total of 6 acceptance No (4 varieties) new drugs, 6 acceptance No (5 varieties) imported drugs and 40 acceptance No (29 varieties) generic drugs are reported for production Among them, Haosen and Hengrui are class 1 new drugs, and Bayer, Pfizer and Alberta are imported On May 8, Jiangsu Haosen Pharmaceutical Group obtained the approval of the first class innovative drug, pegylated loseptide injection, trade name: freimer, which was used to improve the blood glucose control of adults with type 2 diabetes According to drug intelligence data, hausen applied for clinical application on March 9, 2007, and has been approved for marketing for 12 years Pegylated losenapeptide is the first long-acting GLP-1 receptor agonist independently innovated in China and the first PEGylated long-acting GLP-1 receptor agonist in the world, which can promote Glucose dependent insulin secretion, cooperate with diet control and exercise, single drug or combination with metformin Up to now, the global approved long-acting GLP-1 receptor agonists include dulaglutide, abirotide, somaluptide, and exenatide microspheres for injection Previously, there were only two domestic products on the market The approval of the original research for dulaglutide of Lilly and exenatide microspheres for injection of Sansheng pharmaceutical will open a new chapter in the domestic Diabetes Market On May 5, carrelizumab for Hengrui injection showed that it was "under approval" According to the insider in the industry, it has been approved and will be listed in May Carrizumab for injection, trade name: alitol, for the treatment of relapsed / refractory Hodgkin's lymphoma (R / r-chl) in the third line It is the second domestic PD-1 monoclonal antibody after Cinda bio's cindilimab (trade name: Dabusu) At present, four PD-1 monoclonal antibodies have been listed in China, two of them are domestic, two of them are imported, and Hengrui will become the third domestic It is reported that the production of imported Bayer radium chloride [223ra] injection may 8, and the radiation treatment drug radium chloride [223ra] injection of Bayer healthcare shows "approval completed - to be prepared" Radium chloride [223ra] (trade name xofigo) is a radiotherapeutic drug developed by Bayer It was approved to be used for castration resistance of prostate cancer patients with bone metastasis symptoms It was approved for listing by FDA on May 15, 2013 In recent years, the market sales increased steadily In 2017, the annual sales revenue reached 408 million euros On May 7, the first new drug of Pfizer, dacomitinib, showed "under approval" The drug was declared to be on the market in May, 2018, and then it was included in the priority review on July 17 on the basis of "obvious treatment advantages compared with existing treatment methods", and will be approved soon Dacomitinib tablet (vizimpro) is an oral irreversible human epidermal growth factor receptor (her) tyrosine kinase inhibitor developed by Pfizer On September 27, 2018, it was approved by FDA through priority review As a first-line therapy, it was used to treat patients with metastatic non-small cell lung cancer (NSCLC) carrying EGFR gene exon 19 deletion or exon 21l858r replacement mutation On May 5, abbvie's application for the import of glecaprivir / pibrentasvir showed that it was "under approval" Maviret is a new hepatitis C drug composed of NS3 / 4A and NS5A inhibitors Maviret covers hepatitis C 1-6, which was approved by FDA on August 3, 2017 and EU on July 28, 2017 It is used to treat adult patients with chronic hepatitis C virus (HCV) genotype 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate or severe kidney disease and dialysis patients Mavyret has also been approved for use in HCV genotype 1 patients who have previously been treated with a regimen containing either an NS5A inhibitor or an NS3 / 4A protease inhibitor (but not both) It is the third new all gene hepatitis C drug after Gilead's epclusa and vosevi At present, Gilead's epclusa has been approved for listing in China on May 23, 2018 Maviret may become the second all gene hepatitis C drug to be listed in China On May 8, the production of Qilu lenalidomide capsule was reported, and Qilu lenalidomide capsule was approved Lenalidomide was developed by new group, and was approved by FDA on December 27, 2005 (trade name: Revlimid), and then approved by EMA on June 14, 2007, and then approved by PMDA on June 25, 2010 In recent years, its global sales have maintained double-digit growth, and it is one of the best-selling cancer drugs At present, in addition to the original research, the first generic drugs of Beijing Shuanglu Pharmaceutical Co., Ltd and the generic drugs of Zhengda Tianqing Pharmaceutical Co., Ltd are listed on the domestic market However, Shuanglu and Zhengda Tianqing are approved according to the application of the old 3.1 new drugs and the old 6 generic drugs, which still need to pass the consistency evaluation At present, they have applied for the supplementary application of consistency evaluation Qilu was approved as a new 4 kinds of generic drugs this time, which is deemed to have passed the consistency evaluation, and the market prospect is promising On May 8, Zhengda Tianqing anlishentan tablets and gefitinib tablets, the generic drug anlishentan tablets of Zhengda Tianqing showed "delivered" Alisentan is a selective endothelin receptor antagonist, which is used in the treatment of pulmonary hypertension It is a class I recommended drug for pulmonary hypertension Developed jointly by Gilead and GlaxoSmithKline, it was approved by the US FDA for listing on June 15, 2007 (trade name: Van Rijk) According to the pharmaceutical sales database, in recent years, the sales volume of alisentan tablets has increased year by year, reaching US $887 million in 2017, equivalent to RMB 5.889 billion At present, only GlaxoSmithKline's imported drugs and Howson's first imitation of "pronoam" in the domestic market have entered the catalogue of drugs listed in China This time, Zhengda Tianqing will have the same advantages to enter the market competition after the application for listing and approval of four kinds of drugs is completed On May 7, Zhengda Tianqing gefitinib tablets showed "under approval" Gefitinib was developed by AstraZeneca (AZ) It was approved by PMDA on July 5, 2002, then approved by FDA on May 5, 2003, and approved by EMA on June 24, 2009 Gefitinib is the first EGFR tyrosine kinase selective inhibitor It is suitable for the continuous treatment of platinum and docetaxel chemotherapy failure of local advanced or metastatic non-small cell lung cancer In 2017, its sales reached US $528 million, equivalent to RMB 3.565 billion At present, the domestic market has the original research of AstraZeneca and the first imitation of Qilu pharmaceutical industry, and Qilu has passed the consistency evaluation Under the influence of 4 + 7 volume procurement, Qilu has made price cuts in many places to keep the market At present, if Zhengda Tianqing is approved, it will take some time for Qilu to officially participate in the competition This week, 23 acceptance numbers of the drugs reported for production were accepted by CDE, including 1 new drug acceptance number, 4 imported drug acceptance numbers and 18 generic drug acceptance numbers On May 5, mesadonlatiravir potassium chewable tablets were accepted by CDE Latiravir potassium, developed by MSD, was first approved by FDA on October 12, 2007, approved by EMA on December 20, 2007, and approved by PMDA on June 24, 2008 Latiravir potassium is the first antiviral drug to integrate enzyme inhibitors At present, there are imported tablets and dry suspension in China On May 6, the generic drug of enbitup group was accepted Nedanib ethanesulfonate was developed by bringer Ingelheim pharmaceutical company and approved by FDA on October 15, 2014, with the trade name of ofev It is suitable for the treatment of idiopathic pulmonary fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a kind of lung disease which has become scarred gradually over time It has serious disability and can be fatal At present, there are only imported drugs in China, and only Shiyao group is the applicant of generic drug listing, which is likely to win the first copy Part of information sources: enterprise announcement data sources: Pharmaceutical intelligence data, enterprise announcement statement: this view only represents the author, not the position of pharmaceutical intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.