[yaocajun] the heavyweight medicine breaking the magic spell of 50 years, hausen is the first one to make 4 kinds of imitations for production; new drugs for children and rare diseases have been approved; there are also Zhengda Tianqing, Ouyi first imitations of stone medicine, new hepatitis C killing tools

Highlights: 1 New antiviral drugs for children and rare diseases were approved for marketing; 2 New antithrombotic generic drug "tegrilol tablet" was approved; 3 Zhengda Tianqing was first imitated again, and MR contrast agent with liver specificity was approved for marketing; 4 New acceptance number of Hengrui class 1 new drugs was added; 5 New liver killing device "Jisi generation" was coming; 6 Hausen reappears the good news, breaking the 50 year curse of the blockbuster generics Hausen is the first to report production with 4 types of generics The review and approval of new trends this week (June 7-14) reported to the production of drugs, 19 acceptance number of dynamic update, involving 2 new drugs, 12 generic drugs Anke biological recombinant human growth hormone injection Anhui Anke biological recombinant human growth hormone injection was approved for listing It is suitable for the treatment of growth retardation caused by endogenous growth hormone deficiency, short stature caused by Noonan syndrome, short stature or growth disorder caused by shox gene defect and severe burn On December 18, 2017, the application was included in the priority review on the basis of "drugs for children, rare diseases" Recombinant human growth hormone for injection (dosage form: lyophilized powder injection; trade name: ansumeng) is one of the main biological products of Anke Recombinant human growth hormone injection is a new dosage form developed on the basis of the existing powder injection dosage form of Anke biology The dosage form does not contain preservatives, has the characteristics of convenient use, and has strong market competitiveness Growth hormone is a first-line drug for the treatment of children's growth dwarfism at home and abroad At present, there are Changchun Jinsai Pharmaceutical Co., Ltd and Novo Nordisk A / s drugs approved for marketing in China The Anda application of octreofylline tablets and tegrilol tablets declared by the company last week shows that they are "under examination" and "issued" this week It is proved that the examination and approval have been completed According to the drug intelligence data, no itracophylline tablets have been approved for listing in China 12 enterprises have applied for the clinical application of class 3.1 new drugs of the drug, all of which have been approved for clinical application successively, including Nanjing Huawei Pharmaceutical Co., Ltd., Shijiazhuang No.4 Pharmaceutical Co., Ltd., Chengdu Shengdi Pharmaceutical Co., Ltd The only company that has applied for listing is Sinopharm Europe Italy pharmaceutical Now it has entered the "issued" stage, and will become the first listed company to imitate Itrotofylline was developed by Kyowa Hakko Kirin, Japan It was approved by PMDA on March 25, 2013 Its trade name is nouriast It is used in combination with drugs containing levodopa to improve the end-of-dose phenomenon of Pakinson patients According to the sales database of smart drugs, the sales volume of the drug in 2018 reached 9.4 billion yen, equivalent to 563 million yuan In addition to itrotofylline tablets, this week's stone drug oetegrel tablet was approved Tegrel, a direct acting, reversible binding P2Y12 platelet inhibitor, is a new antithrombotic drug In combination with aspirin, it can reduce the incidence of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome or with a history of myocardial infarction Tegrilol tablet has been recommended by many international treatment guidelines for the treatment of patients with acute coronary syndrome, which has high clinical application value and good market prospects Recently, the magnetic resonance contrast agent "disodium gadolinate injection" developed by Zhengda Tianqing has been approved, which is the first imitation in China China is a country with high incidence rate of liver diseases The diagnosis and differentiation of liver lesions become a hot topic in clinical and imaging research Disodium gadolinate is a kind of MR contrast agent with liver specificity, which can help to show the structure and patency of the biliary system inside and outside the liver, understand the function of liver cells, and identify different types of liver injury It is helpful to detect liver lesions, especially to improve the detection rate of small liver tumors, so as to facilitate the early diagnosis and treatment of liver lesions The injection has been paid attention by the industry because of its advantages such as accurate effect, convenient use and controllable side effects On June 11, Zhengda Tianqing's generic drug application for carpofungin acetate for injection showed "approval completed - to be certified" Caspofungin acetate, developed by Merck sharp Dohme (MDS), was approved by the U.S Food and Drug Administration (FDA) on January 26, 2001 and entered China in 2002 under the trade name of Cancidas Kapofungin acetate is a new systemic antifungal drug It is suitable for the treatment of invasive aspergillosis which is ineffective or intolerant to other treatments Sales in 2018 reached 326 million US dollars China's market growth is still considerable It is a heavyweight product in the domestic antibiotic market, which has been included in the national health insurance category B in 2015, the sales volume of China's market exceeded 70 million US dollars At present, in addition to the original research, only Jiangsu Hengrui has been approved for the first time At present, Hengrui has applied for conformity assessment If Zhengda Tianqing is approved and applied for conformity assessment in the same period, it is still possible to win a large market share New acceptance of review and approval The new acceptance report has 26 acceptance numbers for the production of drugs It is worth noting that Hengrui has submitted an application for remazolam toluene sulfonate for injection, and Gilead's "fourth generation" hepatitis C drugs have also been declared for domestic import In addition, after its Hansen pharmaceutical registered in Hong Kong stock on June 14, hausen pharmaceutical, as an operating entity, has sent another good news, and heavyweight generic drugs have been declared for listing in the new four categories In March 2018, after Hengrui declared the listing of rimazazolam mesylate and its preparations, Hengrui will submit another application Ramtazolam mesylate for injection is a short acting agonist for GABAA receptor, which is suitable for general anesthesia in selective surgery According to the pharmaceutical intelligence data, at present, in addition to Hengrui pharmaceutical, which has submitted the listing application of rimazolom toluene sulfonate and its preparations, another rimazolom benzene sulfonate and its injection developed by Renfu pharmaceutical are also in the listing application On November 11, the application for import of gildesopropv / vepatavir / vosevi was accepted The drug was approved by FDA on July 18, 2017 It is used to treat adult patients with type 1-6 chronic hepatitis C virus (HCV) without cirrhosis (liver disease) or mild cirrhosis It has significant effect and is known as "Jisi generation" and "hepatitis C new killer" in the industry And it is the first approved single therapy plan once a day The components were sofosbuvir (400mg), velpatasvir (100mg) and voxilaprevir (100mg) In 2017, sales reached US $293 million, while in 2018, sales reached US $396 million, an increase of 35.15% Dabigatranetexilatemesylate, developed by boehringeringelheim company in Germany, is a thrombin inhibitor It was first listed in Germany and UK in April 2008, and approved by FDA on October 19, 2010 It is used to prevent deep vein thrombosis and pulmonary embolism after artificial joint replacement Dabigatran is the first brand-new oral anticoagulant in 50 years after warfarin It is the precursor of dabigatran and a non peptide thrombin inhibitor The market situation of the drug is relatively stable, with sales of RMB 11.48 billion in 2018 According to the data of pharmaceutical intelligence, at present, dabigatran mesylate capsules are not on the market in China There are 23 acceptance numbers for listing application, including 3 new APIs of old 3.1, involving Shandong Luoxin Pharmaceutical Group Co., Ltd., Tianjin Hanrui Pharmaceutical Co., Ltd and Lianyungang hongchuang Pharmaceutical Co., Ltd., which have been approved for clinical use 18 old 6 categories of generic drug applications, involving 8 enterprises including Zhengda Tianqing, hisic, Chenxin pharmaceutical and Chengdu Yuandong Pharmaceutical, have been approved for clinical application Howson became the first company to apply for listing of new 4 types of imitations, or to win the first imitations Data source: Pharmaceutical intelligence data part information reference: relevant enterprise announcement, relevant enterprise news statement: this point of view only represents the author, does not represent the pharmaceutical intelligence network position, 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.