[yaocajun] take advantage of the win and pursue, Hengrui and Haosen heavy weight class 1 drugs are included in the priority review! One billion potential new drugs are on the market; the first imitative crisis, the stone medicine Ouyi comes; the first double insulin is approved

The new review and approval trends are to be included in the priority review this week (may 24-may 31), three drugs have been publicized by CDE and are to be included in the priority review, including class 1 new drugs of Hengrui and hausen On May 31, Hengrui Medicine released a notice saying that it had received the approval document for drug registration and the new drug certificate The approved indications of the drug are: it is suitable for the treatment of relapsed or refractory classic Hodgkin's lymphoma patients who have undergone at least second-line systemic chemotherapy As early as May 5, the industry heard the good news that Hengrui was approved So far, the official announcement has taken more than 20 days Although Hengrui was approved later than Xinda and Junshi, on May 16, Hengrui carrizumab submitted a new listing application, becoming the first domestic PD - (L) 1 McAb submitted for the expansion of indications On May 31, CDE announced that it plans to include the drug in the priority review, which will further promote the development of hengruikalizumab According to IMS data, the global sales volume of anti-PD-1 antibody in 2018 is about US $14178.02 million, and the domestic sales volume is about US $6.4375 million Ometinib mesylate, a new class 1 new drug of Jiangsu Haosen Pharmaceutical Co., Ltd., was declared on April 18 in China for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), mainly for egfrt790m resistant mutation At present, the third generation EGFR-TKI targeted drug market in China only has oxitinib mesylate tablets of astrazenecaab, which monopolizes the market in this field In 2018, oshitini's global sales volume was US $1.86 billion In fact, ometinib declared by hausen is the second domestic third generation EGFR-TKI declared for production Before that, avitinib from Eisen, Zhejiang Province, was declared for listing in June 2018, and then included in special approval and priority review It is expected to become the first domestic one to be approved, filling the gap in the field of third generation lung cancer treatment in China The application of hausen is included in the priority review, and will accelerate its listing and enrich its market product line On April 28, CDE accepted the import application of wibutuximab for injection declared by Takeda The commercial name of ibuproximab (adcetris) is Takeda and Seattle genetics, The anti-CD30 antibody drug conjugate developed jointly by Inc can specifically bind the CD30 antigen of tumor cells with the antibody component "butuximab (CD30 monoclonal antibody)", which is similar to the "biological missile" that precisely transports the coupled anti microtubule chemotherapy drug (MMAE, monomethylorestatin) to the tumor to play a precise anti-cancer role The drug was approved in the United States for the treatment of Hodgkin's lymphoma (HL) and systemic anaplastic large cell lymphoma (salcl) Three drugs have been approved within this week, 6 drugs show "issued", 3 drugs show "in approval" Benwemod cream of Zhonghao Pharmaceutical Co., Ltd approved the first class new drug benwemod cream (formerly known as benwemod cream) declared by Guangdong Zhonghao Pharmaceutical Co., Ltd under Guanhao biological Co., Ltd for local treatment of mild to moderate stable psoriasis vulgaris in adults, the State Food and Drug Administration announced Wednesday Benwemod, a non hormonal small molecule chemical drug, is a tyrosine protein kinase inhibitor, which can play a therapeutic role by inhibiting T cell tyrosine protein kinase, interfering / blocking the release of cytokines and inflammatory mediators, T cell migration and skin cell activation Southwest Securities research report pointed out that the domestic psoriasis market is more than 3 billion yuan, and benwemod is expected to replace the existing other varieties and develop into a large variety of more than 1 billion yuan Recently, nmpa approved the marketing of Novo Nordisk's digumendon double insulin injection (novoja) for the treatment of adult type 2 diabetes As the first soluble double insulin preparation, novojia (digumendon double insulin injection) is composed of 70% digumendon insulin and 30% aspart insulin The two components of digumendon double insulin do not interfere with each other in structure, and independently play the advantages of long-term, stable and peak free hypoglycemic effect of digumendon insulin, as well as the rapid hypoglycemic effect of aspart insulin, taking into account basic blood glucose and postprandial blood glucose Control and realize complementary advantages On May 24, the application for tegrilol tablet by Ouyi showed that it was "under examination and approval" Tegrilol tablet is mainly suitable for the treatment of acute coronary syndrome The original research drug was developed by AstraZeneca and approved by FDA in July 2011, and officially entered the Chinese market in November 2012 In addition to the imported AstraZeneca drugs, there are also the first imitations of Shenzhen xinlitai In 2017, the drug was included in the domestic medical insurance drug catalog, and there is a huge market space in the future It is reported that the expiry date of the compound patent of the original research enterprise is October 30, 2024 According to statistics, the global sales of tegrilol tablets in 2017 was about US $1246.9866 million, including US $69.11942 million (data from IMS) A total of 21 acceptance numbers (16 drugs) of newly accepted drugs reported for production this week have been accepted by CDE, among which 5 acceptance numbers and 3 varieties are imported drugs and the rest are generic drugs This week, not only domestic tegrilol tablets, but also enterprises entered the "in the approval" stage In order to maintain the market, the application for listing of tegrilol tablets was also undertaken Tegrarol dispersible tablets are intended for use in patients who need antiplatelet therapy, but can only be treated by intubation or by swallowing film coated tablets This dosage form provides guarantee for patients to take medicine according to the dosage Part of the information sources: State Food and drug administration, enterprise announcement data sources: Pharmaceutical intelligence data statement: this point of view only represents the author, not the position of pharmaceutical intelligence network, 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.