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    Home > Medical News > Latest Medical News > [yaocajun] drug review trends: Hengrui's 1 billion level potential class 1 new drugs are on the market at an accelerated pace; hisilic's "Viagra" rival generic drugs and class 1 new drugs are on the market; Kelun adds "Lieting" again, the first generic production report

    [yaocajun] drug review trends: Hengrui's 1 billion level potential class 1 new drugs are on the market at an accelerated pace; hisilic's "Viagra" rival generic drugs and class 1 new drugs are on the market; Kelun adds "Lieting" again, the first generic production report

    • Last Update: 2019-08-12
    • Source: Internet
    • Author: User
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    Highlights: 1.9 drugs are to be included in the priority review, and drugs for three rare diseases are to be used 2 Hengrui's 1 billion level potential class 1 new drug was put on the market at an accelerated pace; 3 It is the second one in China, and Xinda bio came back to meropener '; 7 Kelen added "retin", the first imitated production report in China 1 This week (August 2-9), CDE released a new batch of drugs to be included in the priority review, including 9 drugs, 3 of which are drugs for rare diseases Five of them are new drugs, involving class 1 new drugs of Jiangsu Hengrui [rimazolune mesylate for injection], biological analogues of Cinda biology [rituximab injection], etc in addition, there are four imported drugs, two of which are monoclonal antibodies Hengrui medicine [ramazolam toluenesulfonate for injection] ramazolam is a short acting GABAA receptor agonist, which belongs to benzodiazepine type central nervous system drugs, initially developed by paionag company in Germany In December 2018, Mengdi pharmaceutical was authorized to submit the listing application in Japan, and in April 2019, the new drug application was submitted in the United States In June 2019, the United States FDA has accepted the application Upon inquiry, there is no similar product on the market at home and abroad Yichang humanwell (authorized by paionag company) submitted the listing application to the State Drug Administration on November 15, 2018, which was included in the priority review in December, and the current status is "under review and approval" Ramazolam toluene sulfonate declared by Hengrui pharmaceutical is a salt modified compound of ramazolam, which has higher stability than that of ramazolam According to the public clinical information of Hengrui, the physical and chemical properties of rimazolum toluene sulfonate have many advantages, and the toxicity of toluene sulfonate is lower than that of benzene sulfonate, which improves the clinical safety The industry is generally optimistic about rimazolom toluene sulfonate, and believes that the drug has the potential to become a 1 billion or 2 billion class heavyweight variety Up to now, Hengrui has invested about 65.47 million yuan in the R & D project Cinnabio [rituximab injection] Rituximab was jointly developed by Baijian and Roche (including Genentech in the United States and Chinese and foreign pharmaceuticals in Japan) It was approved by FDA on November 26, 1997, EMA on June 2, 1998, PMDA on June 20, 2001, and China food on April 21, 2008 The drug regulatory agency (CFDA) has approved the listing and is sold by Baijian and Roche in the United States, Europe, Japan and China under the trade names of rituxan and mabthera Rituximab is a monoclonal antibody targeting CD20 Its approved indications are non Hodgkin's lymphoma, chronic lymphoblastic leukemia, rheumatoid arthritis, granulomatous vasculitis and microscopic polyangitis On July 13, 2017, rituximab (rituximab) was included in China's class B medical insurance through negotiation, with the price of 2418 yuan (100mg / 10ml / bottle) and 8289.87 yuan (500mg / 50ml / bottle), Limited recurrence or drug resistance of central follicular lymphoma (B-cell non-Hodgkin's lymphoma of subtypes B, C and D of the international working classification), CD20 positive stage Ⅲ - Ⅳ follicular non-Hodgkin's lymphoma, CD20 positive diffuse large B-cell non-Hodgkin's lymphoma; up to 8 courses of treatment On February 22, 2019, Shanghai Fuhong Hanlin biopharmaceutical Co., Ltd listed its bio similar drugs, becoming the first one approved to produce bio similar drugs in China, filling the gap in the market of bio similar drugs Its approved indications include three subtypes of non-Hodgkin's lymphoma, which are also all the indications approved by the original research institute in China The trade name is "hanlikang" According to the public data, after hanlikang was approved to be listed on the market, the price of 1640 yuan / piece (100mg / 10ml) was successively linked to the Internet in Guangxi, Guizhou and other places, with a decrease of about 32% compared with the medical insurance price of meiluohua However, in the near future, based on the adjustment of the original market strategy of rituximab, Fuhong Hanlin lowered the price of hanlikang once again From July 29, the latest price of 1398 yuan / piece (100mg / 10ml) will be successively implemented in retail pharmacies nationwide, with a decrease of 14.8% The market competition is fierce, and the application of Cinda biology is included in the priority review If the listing is accelerated later, a new round of competition will start Report the update of the processing status of the production drugs and report the 25 acceptance numbers of the production drugs, including 2 new drug acceptance numbers, 4 imported drug acceptance numbers and 19 generic drug acceptance numbers It is worth noting that the approval of Gilead three in one new anti AI drug [bectiravir / enrotabine / propofol tenofovir tablets], Pfizer pharmaceutical and Sichuan Huiyu's [docetaxel injection] has been completed, and the [quetiapine fumarate sustained release tablets] of Foshan derico pharmaceutical has entered the "approval in progress" Gilead [biketiravir / enteltabine / propofol tenofovir tablets] on August 5, the three in one anti AI compound preparation developed by Gilead [biketiravir / enteltabine / propofol tenofovir tablets] showed that "the preparation of the certificate is completed and the approval is pending" Gilead was approved by the US FDA on February 7, 2018, and used to treat HIV-1 infection In 2018, the sales volume has reached US $1184 million Pfizer, Sichuan Huiyu [docetaxel injection] Docetaxel (docetaxel), also known as docetaxel, is the first semi synthetic anti-tumor drug developed by Sanofi Aventis company in France It was first listed in Mexico in April 1995, and then listed in Britain, the United States, France, Italy, Germany, Japan and other places In 1996, docetaxel entered China Since 2002, many domestic enterprises have started to produce imitations Docetaxel is mainly used for the treatment of advanced breast cancer and non-small cell tumor According to the data of pharmaceutical intelligence, at present, there are 21 domestic manufacturers of the product, including Jiangsu Hengrui, Qilu pharmaceutical, Haizheng Pfizer, Yangzijiang pharmaceutical, etc., and 4 enterprises have applied for conformity evaluation The product has been selected into the national class B medical insurance catalog, and the purchase volume of Hengrui docetaxel reached 1.296 billion yuan in 2018 Sichuan Huiyu's application for docetaxel injection has been approved on January 25, 2019, and this time it is another dosage form acceptance number It was included in the priority review on the basis of "production of the same production line, listing in the EU in 2013" Foshan derico pharmaceutical [quetiapine fumarate sustained release tablets] quetiapine fumarate was developed by AstraZeneca (AZ) It was first approved by the U.S Food and Drug Administration (FDA) on September 26, 1997, and then approved by the Japanese pharmaceutical medical device comprehensive agency (PMDA) on December 12, 2000 Sold in the United States by AstraZeneca under the name seroquel Quetiapine fumarate is an antagonist used to treat schizophrenia, bipolar I manic disorder, bipolar disorder and depression At present, domestic enterprises are mainly tablets, 4 domestic enterprises hold production approval documents, 2 enterprises apply for conformity evaluation, and Hunan Dongting Pharmaceutical Co., Ltd is approved At present, there is no approval for the sustained-release tablets Foshan derico Pharmaceutical Co., Ltd is likely to become the first one 2 Review and approve the new acceptance This week, 22 production acceptance numbers were accepted by CDE, including 3 new drugs, 1 imported drug and the rest generic drugs Haisike [hsk3486 emulsion injection] and [avanafit tablets] hsk-3486 are new intravenous anesthetics developed by haisike with independent intellectual property rights, which are intended to be used for anesthesia induction in surgery, sedation / anesthesia and other indications for endoscopic diagnosis and treatment In January 2016, hsk3486 obtained the phase I-III approval for clinical trials of drugs issued by China food and Drug Administration and started clinical trials Based on the consideration of opening up the international market of hsk-3486 in the future, Hisense also plans to carry out clinical trials in the United States In March 2019, Hisense submitted the pre ind meeting application to the U.S FDA and obtained email confirmation Stendra is manufactured by vivus and belongs to the same class of drugs as Viagra and hilly These drugs are all type 5 phosphodiesterase inhibitors (pde5-i) that act by increasing blood flow to the penis Approved by the U.S Food and Drug Administration (FDA) on April 27, 2012 The FDA states that patients should take stendra 30 minutes before sex But in the study, the drug has been shown to work in as little as 15 minutes, faster than the 30-60 minutes reported for other drugs (although they were not directly compared in the study) At present, the drug has not been listed in China, and hispec is the first generic drug manufacturer Hausen pharmaceutical [dextrosoprazole enteric coated capsule] dextrosoprazole was developed by Takeda and approved by the US Food and Drug Administration (FDA) on January 30, 2009 Sold in the United States by Takeda under the trade name dexilant Right lansoprazole, a proton pump inhibitor (PPI), specifically acts on the H + / K + - ATPase of gastric parietal cells to inhibit the secretion of gastric acid, mainly by acting on specific proton pump, thus hindering the last step of gastric acid production The drug can be used to treat all levels of erosive esophagitis (EE), maintain the healing of EE, relieve heartburn, and treat non erosive gastroesophageal reflux disease (GERD) related heartburn symptoms At present, there are no enterprises listed in China, and only three acceptance numbers are produced in the generic drug report, involving Zhengda Tianqing Pharmaceutical Co., Ltd and hausen Pharmaceutical Co., Ltd Kelun Pharmaceutical Co., Ltd [tegletin hydrobromide tablets] tegletin hydrobromide tablets (trade name: tenelia), developed by taganabe Mitsubishi Pharmaceutical Co., Ltd., were first listed in Japan in September 2012 This product is a dipeptidyl peptidase - Ⅳ (DPP - 4) inhibitor, which is used in the treatment of type 2 diabetes By inhibiting the activity of DPP-4, the degradation of glucagon like peptide-1 (GLP-1) is hindered, so as to improve the concentration of GLP-1 in blood and play a role in reducing blood glucose At present, only Kelun pharmaceutical has applied for the listing of generic drugs in China Guizhou shengjitang Pharmaceutical Co., Ltd., Jiangxi Shimei Pharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd and Tianjin hankang Pharmaceutical Biotechnology Co., Ltd have applied for the old class 3.1 new drugs, which have been approved for clinical use For some information, please refer to the announcement of CFA, HISCO, Hengrui and other enterprises, and the statement on the official website of FDA: the viewpoint of this article only represents the author, not the position of drug intelligence network, and you are 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.
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