[drug gajun] hausen has come to apply for the listing of class 1 "TiNi" new drug! Hengrui, Zhengda Tianqing imitated and attacked, pressing the cardiovascular market

Highlight 1.2 collinear drugs are proposed to be included in the priority review; another member of desenol biological anti HIV drug is added, which weighs heavily on the compound preparation; 2 Xinlitai star product meets the fierce enemy, Hengrui joins in the war; 3 Zhengda Tianqing rare disease drug is "in the approval", which forces hausen to make the first imitation; 4 Hausen also applies for the listing of class 1 "TiNi" new drug; 5 Aosaikang, a super antibiotic in urgent need of severe patients in China, joined in the competition with Zhengda Tianqing for the first time New developments of review and approval are to be included in the priority review this week (April 12-19) There are 4 acceptance No 2 drugs to be included in the priority review, all of which are collinear products On April 18, zidolamibivudine of deseno bio Pharmaceutical Co., Ltd was publicized by CDE and will be included in the priority review The drug was launched in the U.S in 2018 Now it is being applied in China and will be approved faster if it is included in the priority review Zidolamivudine is suitable for HIV infected adults and children over 12 years old These patients have progressive immunodeficiency The drug can reduce the amount of HIV-1 virus and increase the number of CD4 + cells Zidovudine was first synthesized in 1964, developed and marketed by welcom company in the UK, and approved by the US FDA in March 1987 It is the first oral capsule used in the prevention and treatment of HIV / AIDS, and its trade name is "rituximab" Lamivudine, developed by GlaxoSmithKline, was approved by FDA on November 17, 1995, under the trade names of "hepudine" and "yipingwei" It is a kind of cytosine nucleoside derivative oral preparation, which is a single preparation and an important component in the main program of anti HIV "cocktail combination therapy" Later, in 1998, the FDA approved lamivudine as a new indication for anti chronic hepatitis B virus (CHB) infection, further expanding the market share In 1998, GlaxoSmithKline introduced lamivudine into China and obtained administrative protection At present, there are import approval documents of vivhealthcare uklimited, domestic approval documents of GlaxoSmithKline (Tianjin) Co., Ltd and Anhui Baker biopharmaceutical Co., Ltd in China It is worth mentioning that Shanghai desino bio has a layout for a number of anti AIDS drugs, including the popular and clinically used eferent tablets, lamivudine tablets, nevirapine tablets, stavudine capsules and nevirapine zidolamivudine tablets (trade name: jiweijiu) Jiweijiu is the first domestic three in one compound drug 。 At present, dicrano's yifeiwelun tablets and lamivudine tablets have applied for conformity evaluation, while yifeiwelun tablets (0.6g) have passed the conformity evaluation in May, 2018 On April 17, the application of three specifications of felodipine sustained-release tablets of Yiling Wanzhou International was publicized by CDE and will be included in the priority review Felodipine is a calcium channel blocker of dihydropyridine, which acts like nifedipine It is mainly used to treat hypertension and angina At present, 7 domestic enterprises hold the approval documents of felodipine tablets, 1 enterprise holds the approval documents of sustained-release capsules, 5 enterprise holds the approval documents of sustained-release tablets, and the enterprise holds the production approval documents of sustained-release tablets (II) For the time being, no enterprise has applied for consistency evaluation, and 2 enterprises have applied for reference This time, lingwanzhou international took the lead in the market on the basis of the common line, according to the declaration of the new 4 categories, or the consistency evaluation of overtaking This week, there are 16 acceptance numbers to update the processing status of the reported production drugs, including 2 acceptance numbers for imported drugs and 14 acceptance numbers for generic drugs On April 17, Chongqing yuentecavir tablet showed "approval completed - to be certified" Developed by Bristol Myers Squibb (BMS), it was approved by the U.S Food and Drug Administration (FDA) on March 29, 2005 and marketed under the name of Baraclude The drug is suitable for the treatment of chronic hepatitis B virus infection in adults and children over 2 years old with active virus replication, continuous elevation of serum transaminase ALT (ALT or AST) or liver histology showing active lesions The drug is also one of the first-line antiviral drugs recommended by the World Health Organization and guidelines of various countries Its sales volume in 2017 was 7.103 billion yuan At present, there are only three domestic enterprises that hold the approval documents for the production of entecavir tablets Shanghai Shiguibao Pharmaceutical Co., Ltd of China and the United States was approved in 2015, and now it has been put on the reference record Beijing Baiao Pharmaceutical Co., Ltd was approved on March 28, 2019 Entecavir maleate tablets of Zhengda Tianqing Pharmaceutical Group Co., Ltd were approved on May 4, 2017 On April 17, clopidogrel bisulfate tablets of Hengrui pharmaceutical showed "approval completed - to be certified" At present, domestic clopidogrel bisulfate tablets have Shenzhen xinlitai, Lepu pharmaceutical and Sanofi as the main competitors And xinlitai and Lepu pharmaceutical have passed the consistency evaluation, and xinlitai products have also been selected by 4 + 7 volume purchase If Hengrui is approved to join the war, will the situation change as a powerful domestic pharmaceutical enterprise? Wait for market performance On April 17, Zhengda Tianqing anlishengtan tablet showed "under approval" Alisentan tablet was jointly developed by Gilead and GlaxoSmithKline, and was approved by FDA in 2007 It is a selective endothelin receptor antagonist for the treatment of pulmonary hypertension Since its listing, its sales have been increasing year by year In 2017, its global sales have reached US $887 million and RMB 5.989 billion At present, China's first imitation of Howson pharmaceutical's "pronoan" was approved on July 31, 2018, and has entered the catalogue of Chinese listed drugs On April 12, olaratumab injection of Lilly was updated to "issued" from "approved - to be issued" of last week (for details, please refer to the previous drug gajun) Olaratumab has been awarded the breakthrough drug qualification, fast track status, orphan drug status and priority review qualification in the US FDA for the treatment of advanced soft tissue sarcoma It was approved by the FDA on October 19, 2016, and can not be treated with radiotherapy or surgery when combined with doxorubicin, However, it is suitable for adult patients with soft tissue sarcoma (STS) with anthracycline drug therapy, trade name: lartruvo In addition, in February 2015, olamab was granted orphan status by EMA in the treatment of soft tissue sarcoma And obtained conditional listing license from EMA on November 9, 2016 It is reported that since lartruvo went public, its sales increased from US $9.4 million in 2016 to US $180 million in 2017, a nearly 18 fold increase If we open the Chinese market, we will have more considerable income Among the drugs reviewed and approved for new acceptance and reported for production, 27 acceptance numbers were accepted this week, including 4 new drug acceptance numbers, 4 imported drugs and 19 generic drugs On April 17, ometinib mesylate, a new class 1 new drug of Jiangsu Haosen Pharmaceutical Co., Ltd., was put on the market TiNi anti-tumor drug is a new kind of biological targeted treatment of tumor drug At present, the common TiNi anti-tumor drugs in China market include gefitinib, imatinib, etc It is worth noting that this is another class 1 tinib new drug declared for listing by hausen Pharmaceutical Co., Ltd in addition, at present, there is another class 1 new drug, polyethylene glycol loseptide injection, which is also under review and approval On April 16, the sodium e-methanesulphonate for injection of aosaikang was declared to be on the market Polymyxin e-methanesulphonate, which was first developed by parstrile products, belongs to polypeptide antibiotics It is currently the first choice drug for the treatment of infections caused by multidrug-resistant Pseudomonas aeruginosa and other gram-negative bacteria The drug resistance rate is low (below 5%), and it does not produce cross resistance with other antibiotics or antibiotics It is a super antibiotic urgently needed by severe patients in China, but it exists Certain nephrotoxicity At present, no imported drugs have been listed in China, and Zhengda Tianqing Pharmaceutical Co., Ltd has applied for the listing of generic drugs, and Zhengda Tianqing's application was included in the priority review on January 30, 2018 on the basis of "major special projects" At present, the review has been completed, and it is to enter the approval process, and the listing is imminent Some information reference: relevant enterprise announcement and network public information data source: yaozhi.com statement: this point of view only represents the author, not the position of yaozhi.com, 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.