[drug gajun] China made "Gleevec" competition plus a company, Hengrui heavy weight class 1 new drug will be on the market, and xinlitai will take the lead in imitating Gleevec

1 domestic medicine news: this week (July 28-august 3), CDE has undertaken a total of 10 newly produced drugs, including 9 generic drugs and 1 imported drug, without new drugs In addition, the handling status of four drugs reported for production has changed In addition, we also learned from some enterprise information that there are several heavy-duty drugs that have received approval documents Let's take a look at the specific situation of some of them: 1 Imatinib mesylate was undertaken On July 30, the imatinib mesylate tablet declared by Chongqing Yaoyou Pharmaceutical Co., Ltd was undertaken It was originally developed into Novartis "Gleevec" in the early hot circle of friends At present, there are three domestic enterprises with imatinib mesylate, namely Zhengda Tianqing, Ouyi of petrochemicals and Haosen of Jiangsu Province On June 14, Jiangsu Haosen's imatinib film was the first to pass the consistency evaluation and has a good market competitiveness At present, Qilu Pharmaceutical (Hainan), Nanjing Youke pharmaceutical, Shanghai CHUANNUO pharmaceutical and Shenzhen xinlitai are applying for imatinib mesylate tablets to enter the Anda sequence Qilu is the first to evaluate varieties, the competition is fierce 2 Wuxi Hebang biological exenatide injection was undertaken August 2 Wuxi Hebang biological technology's exenatide injection was undertaken to improve blood glucose control in patients with type 2 diabetes It is suitable for patients who only use metformin, sulfonylureas, and metformin combined with sulfonylureas, but whose blood glucose is still under control At present, only the imported drugs have been approved in China, and the production application of new drug category 3.1 reported by domestic Changchun Baike biology and Qinghai Chenfei pharmaceutical has been withdrawn In the review and approval of six generic applications of Chengdu shengnuo biology, Shenzhen Hanyu Pharmaceutical Co., Ltd and Changchun Baiyi Pharmaceutical Co., Ltd., the competition for the first generic listing is still ongoing 3 On August 1, the application for the listing of the rare disease drug AGA glucoamylase α was accepted, and the import application for the concentrated solution for injection of AGA glucoamylase α was accepted It is reported that the drug is used for the treatment of Fabry's disease, which is a rare inherited disease caused by the deficiency of α - galactosidase 4 Pyrrolidine maleate, a new class 1 drug of Hengrui, will be put on the market in China on July 27 Pyrrolidine maleate, a heavyweight class 1 new drug of Hengrui, has been "under approval" Pyrrolidine maleate, a class 1.1 EGFR / HER2 inhibitor independently developed by Hengrui, was approved in China in may 2012 5 In the evening of August 2, the company was informed by xinlitai that its tegrilol tablets had obtained the "drug registration approval" issued by the State Drug Administration, which is also the first tegrilol to be listed in China, and will change the market pattern of anti blood small board drugs and even cardiovascular drugs in China Tegrilol is a reversible, direct acting, oral P2Y12 receptor antagonist (platelet aggregation inhibitor) developed by AstraZeneca It was initially approved by FDA on July 20, 2011 to reduce acute coronary syndrome, and approved by CFDA on November 22, 2012 to enter the Chinese market Its sales have been on the rise Moreover, because of its excellent efficacy, tegrilol was included in the national health insurance negotiation catalogue in July 2017 Recently, Zhejiang Huahai Pharmaceutical Co., Ltd issued a notice that the company received the notice from the FDA of the United States, and the brief application for new drug of the company has been approved temporarily At present, Huahai Pharmaceutical Co., Ltd has reached a settlement with the original manufacturer on legal proceedings, but the product still needs to be qualified for sale in the U.S market after the expiration of the patent right and the final approval of FDA Rofustist is mainly used to treat bronchitis related cough and myxosis in patients with severe COPD Rofluorostat tablets were developed by AstraZeneca and launched in the United States in 2011 Because the drug is still in the patent protection period, only the original research company sells the drug In 2017, the sales volume of the drug in the U.S market was about $205.5 million (data source: IMS database) The drug has not been marketed in China 7 Clinical approval of MEK inhibitors in cornerstone pharmaceutical On July 30, cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical") announced that the clinical trial application of its self-developed small molecule MEK1 / 2 inhibitor cs3006 has been approved by the State Drug Administration ("SFDA") Since April of this year, SFDA announced that it has only three months to accept the clinical trial application of cs3006 8 Two monoclonal antibodies of Xinda biological Co., Ltd obtained the clinical approval document at the same time Recently, Xinda Biological Pharmaceutical Co., Ltd released the news that the recombinant all human anti OX40 monoclonal antibody for injection (R & D Code: ibi101) and the recombinant all human anti RANKL monoclonal antibody injection (R & D Code: ibi307) developed by the company obtained the clinical test approval document issued by the State Drug Administration at the same time Ibi101 is the first OX40 monoclonal antibody approved for clinical trials in China Ibi307 is a recombinant all human anti RANKL monoclonal antibody injection, which will be used to treat osteoporosis and cancer metastasis related dissolved bone damage The first drug for the treatment of rare adrenal tumors was approved in the United States on July 30 The FDA announced on its website that it approved the launch of the new drug azedra (iobenguane I131) for the treatment of rare adrenal tumors by intravenous injection It is worth mentioning that this is the first FDA approved drug for the treatment of this rare adrenal tumor, which is suitable for adolescents and adults aged 12 and over 2 In the treatment of schizophrenia, the first long-term injection was approved Recently, the individual announced the approval of perseris by the US FDA Gamma Marketed for the treatment of adult patients with schizophrenia This is the first monthly long-term subcutaneous risperidone injection (LAI) First injection of perseris without load dose or any oral risperidone Gamma It can reach the clinical level PERSERIS Gamma Contains risperidone, which is a mature treatment for schizophrenia PERSERIS Gamma A sustained release delivery system was used to form subcutaneous storage and then to provide sustained levels of risperidone for one month The initial peak of risperidone in the blood occurred within 4 to 6 hours after administration, which came from the initial release of the drug during the formation of subcutaneous storage 3 On July 30, Novartis / Amgen migraine drug aimovig was approved by the European Union Novartis announced that the European Commission (EC) approved aimovig ® (erenumab) to prevent adult migraine patients with migraine for 4 or more days per month The approval of the EMA applies to all 28 EU Member States, as well as Iceland, Norway and Liechtenstein Aimovig has been approved by the US FDA for preventive treatment of adult migraine on May 17, 2018, Swissmedic in Switzerland on July 13, 2018 and TGA registration in Australia on July 3, 2018 Aimovig is the first and only treatment specifically designed for migraine prevention Content source: Pharma intelligence data, Pharma intelligence net, Pharma mingkant, Pharma Zongheng, CPHI Pharma online, Sina Pharma