[yaocajun] 11 heavyweight drugs have been approved, as well as generic drugs of Hengrui, Haizheng and Hanyu pharmaceutical industries. This week, Beida global new class 1 drugs have been accepted

Highlights: 1 Three class 1 new drugs have been approved and launched in China, two kinds of PD-1 monoclonal antibodies; 2 The first traditional Chinese medicine variety commissioned by the research and development institution as the holder has been born; 3 Seven heavy drugs have been approved and imported; 4 Hengrui and Haizheng 1 billion level generic drugs have been approved, increasing market competition; 5 Hengrui's first generic drugs have been approved, with sales of 10 million US dollars in 2017; 6 Shenzhen Hanyu Pharmaceutical Co., Ltd has been approved as the first model; 7 Beida Pharmaceutical Co., Ltd has been accepted as a new class 1 innovative drug in the world 2018 is over, so in December, which drugs catch the tail of 2018 and get approval in the last month? Let's take a look at it briefly Drug approval in December, 2018 new drugs in December, 2018, a total of 4 new drugs were approved, all of which are heavyweight drugs On December 17, the PD-1 antibody drug of Suzhou Zhonghe biomedical Co., Ltd under Junshi was approved for marketing The drug is a biological product innovation drug independently developed by Junshi and with full independent intellectual property rights It is also the first PD-1 antibody to be marketed in China, which is used to treat local progress or metastatic melanoma after previous standard treatment failure On December 21, the second anti-PD-1 antibody came into the market shortly after Junshi's listing The dilimab injection of Xinda biological was approved Xindilimab injection is a class 1 innovative drug independently developed by Xinda biology and has full independent intellectual property rights It has been supported by national major new drug development and key R & D plan projects, and has been approved for listing through the priority review and approval process For the treatment of relapsed or refractory classical Hodgkin's lymphoma after second-line chemotherapy On December 18, vasasta capsule (China), a class 1 innovative drug declared by vasasta (trade name: aridro), was launched on the market to treat anemia caused by chronic kidney disease (CKD) in patients undergoing dialysis treatment The drug has not yet been listed in any other country It is a global R & D drug and the first drug in China On December 21, Jinrong Xiaopi granules of Kangyuan Pharmaceutical Co., Ltd was approved as a new traditional Chinese medicine drug of Kangyuan Pharmaceutical Co., Ltd in Guangzhou It is a compound preparation of traditional Chinese medicine The prescription is composed of epimedium, Cistanche deserticola, Yujin, Salvia miltiorrhiza, etc The main functions are tonifying the kidney and promoting blood circulation, resolving phlegm and dispersing the stasis, regulating and taking Chong Ren, which are used for the syndrome of phlegm and blood stasis and Chong Ren maladjustment in hyperplasia of mammary gland The symptoms include breast pain, tenderness, chest and flank pain, depression and irritability, insomnia and dreaminess, mental fatigue and weakness, sore waist and knees, light red or purple tongue or petechiae on the tongue edge, white fur, thin or slippery pulse strings At the same time, Kangyuan pharmaceutical was also approved as the pilot product of drug listing license holder system, which is the first traditional Chinese medicine product commissioned by the R & D institution as the holder In December 2018, 7 of the imported drugs were approved for import, 5 of which were priority varieties for evaluation On December 14, selexipag tablet of aiketelong pharmaceutical was approved for import Celepag tablet, as a clinically urgent variety, was included in the priority review procedure to speed up the review and approval The drug is used for the treatment of pulmonary hypertension Celepax tablet is an effective, highly selective and long-acting non prostaglandin prostaglandin receptor (IP receptor) agonist, which can improve the endothelium-dependent relaxation of injured pulmonary artery, and may inhibit the proliferation of human pulmonary smooth muscle cells and the thickening of pulmonary vascular wall Compared with prostacyclin, which has been marketed for the treatment of pulmonary hypertension, it is the first oral preparation, which can improve the compliance of patients It is convenient to use, avoids the reaction of injection site of intravenous administration, and avoids the throat irritation reaction and cough of inhalation dosage form In December, the two imported drugs of Roche were approved The two kinds of drugs were emicizumab injection and patozumab injection Emicizumab injection is a kind of drug urgently needed in clinic, and it is included in the priority review It is used to treat hemophilia A patients with coagulation factor Ⅷ inhibitor The drug, developed by Roche, is a recombinant humanized, bispecific monoclonal antibody, which can replace the cofactor activity of activated coagulation factor Ⅷ, promote the activation of F Ⅹ by F ⅸ a, and then lead to a significant increase in thrombin production, so as to achieve hemostasis in the bleeding sites of patients with F Ⅷ dysfunction or complete lack of F Ⅷ On December 17, the application for import registration of patuzumab injection was approved, and the combination of trastuzumab and chemotherapy was used for adjuvant treatment of early breast cancer patients with high risk of recurrence Patuzumab injection is a new type of anti HER2 drug developed by Roche company It can produce anti HER2 effect by inhibiting the heterologous and homologous two polymers of HER2 The global key phase III adjuvant therapy research shows that compared with the current standard treatment of trastuzumab combined with chemotherapy, patazomab combined with trastuzumab and chemotherapy are used for the adjuvant treatment of HER2 positive early breast cancer patients with high risk of recurrence, significantly improving the patient's non-invasive disease survival period and controllable adverse reactions On December 3, Janssen tablet of abiolone acetate was approved for import, and the drug was first approved in China in 2015 Abitrone, developed by janssenbiotech, was approved by FDA on April 28, 2011, EMA on September 5, 2011, and PMDA on July 4, 2014 Johnson & Johnson is responsible for its marketing in the United States and Europe AstraZeneca is listed and sold in Japan under the trade name of zytiga Abitron is a CYP17 (17 α - hydroxylase / c17,20-lyase) inhibitor The drug was used in combination with prednisone in the treatment of metastatic castrated refractory prostate cancer In early December, Gilead dipivofosfovir tablets were approved for import Harvoni is the second new oral hepatitis C drug launched by Gilead in the United States in October 2014, which is suitable for chronic hepatitis C infection of gene 1,4,5,6 In more than two months, harvoni has generated a sales revenue of 2.1 billion US dollars, and in 2015, it has achieved a sales revenue of 13.8 billion US dollars At the beginning of December, the mefalen hydrochloride for injection, which was declared by the biomedical science and technology of yingchuangyuanda (Beijing), was approved to be imported for the treatment of multiple myeloma The drug is a rare disease drug in clinical shortage, and was included in the 19th batch of priority review on June 6, 2017 on the basis of "obvious treatment advantages compared with existing treatment methods" In December, a total of 7 generic drugs were approved, notably injection On December 5, the generic drug parecoxib sodium for injection declared by Haizheng and Hengrui was approved for production The drug was jointly developed by Pfizer and famasia company, trade name: dynastat In 2002, parecoxib sodium for injection was first listed in Europe, and has been listed in at least 15 countries such as Germany, France and the United Kingdom The first generic drug in China is Kelun pharmaceutical, and Qilu is the second approved enterprise According to the prediction of the insiders, the generic drug is expected to become a 1 billion level large variety, which is currently included in the national health insurance category B in 2017 Now two generic drugs have been approved, with fierce competition In addition, Zhengda Tianqing's application for the drug also shows "issued" On December 3, temozolomide for injection was approved by Hengrui Temozolomide for injection has been listed in many countries and regions such as the European Union, the United States and Japan, and only temozolomide capsule has been approved for listing in China Except that temozolomide for injection of Hengrui pharmaceutical was approved for listing, no other companies in China have submitted the listing application of temozolomide injection, and Hengrui is the first to imitate According to the public information, temozolomide is an imidazolium tetrazine alkylating agent with antitumor activity The drug can be used to treat the newly diagnosed adult patients with glioblastoma multiforme It is first treated with radiotherapy and then used as maintenance treatment; it can also be used to treat adult patients with refractory anaplastic astrocytoma Through inquiry, temozolomide was first developed by Aston University in the UK, and then obtained the sole development right of the product in most of the global markets from Schering plough pharmaceutical in Germany, and it has been listed in two dosage forms: capsule and injection According to IMS database, the global sales volume of temozolomide for injection in 2017 was about US $11.304 million On December 5, Shenzhen Hanyu Pharmaceutical Co., Ltd applied for listing of cetrix acetate for injection, which was declared by Shenzhen Hanyu Pharmaceutical Co., Ltd to be approved Cetrix acetate, developed by Merck Serono, was approved by the European Drug Administration (EMA) on April 13, 1999, then approved by the U.S Food and Drug Administration (FDA) on August 11, 2000, and then approved by Japan's pharmaceutical and medical device integration Agency (PMDA) on April 20, 2006, and then marketed by Merck Serono Its trade name is cetroti De Cetrix acetate is a GnRH antagonist for injection The drug is suitable for preventing women from ovulating in advance under controlled ovarian stimulation, facilitating subsequent oocyte collection and assisted reproductive technology treatment At present, there are only imported drugs in China, and Shenzhen Hanyu Pharmaceutical Co., Ltd is the first imitation enterprise Reviewing the drug approval in December 2018, we can see that whether it is innovative drugs, imported drugs or generic drugs, a number of blockbuster drugs have been approved intensively, which is a satisfactory end for 2018 After knowing the situation in December, what drugs are reported for production this week (December 29, 2018 - January 4, 2019)? Here's a brief look This week, two class 1 new drugs were accepted as ensatinib hydrochloride and its capsules of Beida Pharmaceutical Co., Ltd., according to drug intelligence data One imported drug was accepted, and five generic drugs were accepted, as shown in the table below: Benda pharmaceutical ensatinib hydrochloride On January 2, 2019, ensatinib hydrochloride (x-396) declared by Beida Pharmaceutical Co., Ltd was accepted for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) positive who had been treated with or were intolerant to clozatinib Ensatinib hydrochloride (x-396) is xcoveryholdings, a subsidiary of Beida pharmaceutical, The new molecular entity compound jointly developed by Inc with completely independent intellectual property rights is a new generation of strong and highly selective ALK inhibitor According to the announcement of the work plan for the reform of chemical drug registration and classification issued by the State Food and drug administration, ensatinib hydrochloride belongs to the "domestic and foreign unlisted innovative drug", and its registration and classification are chemical drugs There are 1 kinds of products On January 2, 2019, the application for import of praqusha injection from Mengdi (China) pharmaceutical was accepted Pratraxar was developed by spectrum pharmaceutical company and approved by the U.S Food and Drug Administration (FDA) on September 24, 2009 Its trade name is folotyn Praqusha is a kind of metabolic inhibitor of folate analogues, which can competitively inhibit dihydrofolate synthetase and polyglutamoyl synthetase This inhibition can block thymine and its