[drug gajun] Yichang humanwell is expecting to challenge the status of dizosin, the first anesthetist brother? This week, there are Huahai, Fosun, jiankangyuan

Highlight: after the approval of Yichang humanwell potential generic drug, it is expected to challenge the status of dizosin, the first anesthetist? Zhejiang Huahai depression drug has been approved in China, and Fosun Group has withdrawn its clinical application for herpes zoster live attenuated vaccine after its injection was approved by FDA Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd has obtained the clinical approval for class 1 small molecule targeted anti-tumor innovative drug Jiankangyuan 10 billion MAb (tuozhumab) biological similar drug has obtained the clinical approval for drug review and approval The new status of drug production has been reported This week (Nov 2-nov 9) only generic drugs are reported in the production trend, while new drugs and imported drugs have no trend Data source: intellectual drug registration and acceptance database Yichang humanwell dapenta hydrochloride tablets, fentanyl citrate oral patches November 2, Yichang humanwell dapenta hydrochloride tablets, fentanyl citrate oral patches show "approval completed - to be prepared" He spray more, developed by Janssen company, a subsidiary of Johnson & Johnson, and grunenthal GmbH, a German pharmaceutical company, which was approved by FDA to be listed in the United States on November 21, 2008, and then approved to be listed in more than 80 countries It is mainly used to relieve the moderate and severe acute pain of patients aged 18 or above, and can be used to relieve the severe pain during the operation In 2012, the increase of indications was used for the neuropathic pain caused by diabetic peripheral neuropathy According to the pharmaceutical intelligence sales database, the sales volume of the drug in 2017 was 1.617 billion yuan Data source: at present, the sales database of pharmaceutical and intellectual drugs has not been officially approved for listing in China Janssen, the original research institute of import, is temporarily approved In addition, at the end of 2013, CFDA and the General Administration of Customs jointly released the catalogue of narcotic psychotropic drugs, which included him as a psychotropic drug for management Currently, only Yichang humanwell is applying for listing If it is approved formally this time, it will seize the market The insiders say that some enterprises expect more from him, which is the position of future substitute Zosin Fentanyl citrate oral patch is a commonly used drug in general anesthesia According to the domestic drug database of pharmaceutical intelligence, there are currently three domestic enterprises holding approval documents for fentanyl citrate injection, including Yichang humanwell, Jiangsu Enhua and Langfang Branch of State Pharmaceutical Group Industry Co., Ltd Oral patch is a new dosage form At present, only Yichang humanwell has applied for listing Zhejiang Huahai Duloxetine Hydrochloride Enteric Capsule on November 2nd, the Duloxetine Hydrochloride Enteric Capsule of Zhejiang Huahai Pharmaceutical Co., Ltd showed "approval completed - to be prepared certificate", which was developed by Lilly and approved by the FDA on August 3, 2004 The product name is Cymbalta The drug is used to treat major depression (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuralgia (DPNP), fibromyalgia (FM) and chronic muscle and bone pain According to the pharmaceutical intelligence sales database, in 2017, the sales volume of the drug Lilly reached 5.112 billion yuan, and yanye reached 1.415 billion yuan Data source: at present, there are two enterprises holding approval documents of duloxetine hydrochloride enteric coated tablets in China, including Shanghai Shangyao Sinopharm and Jiangsu Enhua, and only one in Shanghai Shangyao Sinopharm holds approval documents of capsule Because the products of the two enterprises are approved according to the old registration classification, the first is evaluation At present, traditional Chinese and Western medicine is in progress in Shanghai This time, Huahai not only declared according to the new classification, but also included in the priority review on the basis of "production in the same production line, listed in the United States in 2017" If it is approved to directly put quality and original research into the market, it will win a favorable situation for it On November 2, hisico captopril betamethasone ointment showed "approval completed - to be prepared", which was mainly used for local treatment of stable plaque psoriasis At present, there are only imported drugs of this medicine in China, and the enterprises that produce the generic pharmaceutical newspaper include Jiangsu Sao Paulo Pharmaceutical Co., Ltd., Chongqing Huabang Pharmaceutical Co., Ltd and Sichuan hisic In addition to Hisilicon, two other enterprises have been approved for clinical application Nine generic drugs and one imported drug have been registered The details are shown in the following table: data source: drug intellectual drug registration and acceptance Database Enterprise announcement drug dynamic Fosun Group withdraws the clinical experiment application of herpes zoster live attenuated vaccine On November 2, Shanghai Fosun Pharmaceutical Co., Ltd said its holding subsidiary Dalian yalifeng biopharmaceutical Co., Ltd had been approved for the application of "withdrawal of live attenuated vaccine of herpes zoster for clinical application" The vaccine is a prevention biological product independently developed by Fosun Group, which is mainly used to prevent herpes zoster Up to now, Zostavax ® of Merck is the main live attenuated vaccine of shingles on the market in the world According to the 2017 financial report published by Merck, the global sales of Zostavax ® in 2017 is about 668 million US dollars There is no listed live attenuated vaccine for herpes zoster in China (excluding Hong Kong, Macao and Taiwan), but the applications of Shanghai Institute of biological products, Changchun Changsheng biology, Changchun Qijian biology, Beijing Wantai biology and Changchun Baike biology have been approved As of September 2018, Fosun Group has invested about 1.4 million yuan (Unaudited) in research and development of the vaccine Zhejiang huahailong ammonium bromide injection was approved by FDA on November 5, Zhejiang Huahai Pharmaceutical Co., Ltd issued a notice, saying that its new drug brief application (anda, i.e American generic application, which means the applicant can produce and sell the product in the U.S market) for the injection has been approved Glulammonium bromide injection is mainly used for gastric and duodenal ulcer, chronic gastritis, excessive gastric acid secretion and other symptoms Gelong ammonium bromide injection was developed by West ward pharmaceuticals and was listed in the United States in 1982 At present, the main manufacturers of glulammonium bromide injection in the United States are hikma, American regent, etc.; there is no such product on the market in China On November 6, Heilongjiang Treasure Island Pharmaceutical Co., Ltd issued a notice saying that its hzb1006 capsule (specification: 2mg, 10mg) obtained clinical approval (approval No.: 2018l03198, 2018l03199) The product is a class 1 innovative drug jointly researched and developed by HA Zhenbao and Shanghai yaomingkant new drug development Co., Ltd according to the "technical development contract for class 1 new drug project of pan-fgfr inhibitor treatment for liver cancer" signed by both parties Ha Zhenbao owns independent intellectual property rights Pan-fgfr inhibitor hzb1006 capsule is a small molecule targeted anti-tumor drug It is a multi kinase inhibitor mainly composed of FGFR and VEGFR It has the dual effects of cell inhibition and anti angiogenesis It is announced that the drug has better in vivo efficacy than the same commercial control drug in pre clinical liver cancer model evaluation On November 7, jiankangyuan tuozhumab biological similar drug obtained the clinical approval document Jiankangyuan pharmaceutical released the announcement that its holding subsidiary Zhuhai lizzhumab Biotechnology Co., Ltd received the clinical approval document of "recombinant humanized anti-human IL-6R monoclonal antibody injection" (approval document No.: 2018l03177) The accumulated R & D cost of the drug is about 48.1086 million yuan Recombinant humanized anti-human IL-6R monoclonal antibody injection "is a biological analogue of tocilizumab (trade name: actemra ®), which has the same mechanism as the original drug It can specifically combine with IL-6R, inhibit the signal transduction mediated by IL-6 and IL-6R, reduce the inflammatory response, and is suitable for the treatment of insufficient response to anti rheumatic drugs (DMARDs) to improve the condition Of adult patients with moderate to severe active rheumatoid arthritis At present, the anti-il-6r monoclonal antibody product has been put on the market in foreign countries According to pharmaceutical intelligence data, the sales of the drug continued to increase from 2012 to 2017 In 2017, Roche's sales reached 13.215 billion yuan, and the sales of Sino foreign pharmaceutical Co., Ltd reached 1.908 billion yuan There are no domestic products on the market in China Up to now, there are 6 approved clinical monoclonal antibody manufacturers targeting at "IL-6R / IL-6" (including Lizhu monoclonal antibody) Data source: drug intelligence drug sales database information source: announcement data source of relevant enterprises: drug intelligence database