[yaocajun] focus: Novartis and Beida class 1 new drugs; the first imitation of Zhengda Tianqing and the consistency evaluation of dongyangguang; tadalafei and Laimei, 2 billion markets

Highlights: 1 Novartis global is applying for domestic listing of class 1 new drugs under research; 2 Zhengda Tianqing applies for listing of heavyweight heart failure generic drugs, competing with Shanghai xuantai Haimen Pharmaceutical Co., Ltd and Sinopharm europeani for the first copy; 3 Posaconazole enteric coated tablet generic drugs apply for listing, the first copy competition starts; 4 Beida class 1 cancer drugs are included in the priority review, listing is imminent; 5 The first PCSK9 inhibitor import application approved by FDA was included in the priority review; in 620 million market, tadalafil was approved for the first time, and Laimei won the exclusive sales agency right; 7.5 drugs passed the consistency evaluation, and the first one of the first-line drugs of dongyangguang influenza was passed; 8 Thymus injection method and cefathiamidine injection were added to the production enterprises, resulting in intensified competition New trends of CDE review and approval 1 In this week (Feb 15-feb 22), there are 4 changes in the handling status of drugs reported for production, all of which are generic drugs On February 19, 3 pharmaceutical companies applied for the generic application of invert sugar electrolyte injection and 3 pharmaceutical companies applied for the generic application of invert sugar electrolyte injection, showing "approval completed - to be certified" Invert sugar injection is suitable for rehydration treatment of patients who need water or energy supplement by non oral way At present, there are 2 domestic enterprises holding the production approval documents of invert sugar electrolyte injection, and 3 domestic enterprises holding the production approval documents of invert sugar electrolyte injection On February 19, rosuvastatin tablets declared by Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd showed "approval completed - to be certified" Rosuvastatin is a selective and competitive HMG-CoA reductase inhibitor, which is one of the latest statins It can be used for primary hypercholesterolemia (type IIA, including heterozygous familial hypercholesterolemia) or mixed type dyslipidemia (type IIB) which can not be properly controlled by diet control and other non drug treatment At present, there are 5 domestic manufacturers and 6 enterprises applying for conformity assessment, of which 5 have been assessed On February 19, esomeprazole sodium for injection (also known as esomeprazole sodium for injection) declared by Hubei Hepu Pharmaceutical Co., Ltd showed "approved - to be certified" Esomeprazole sodium was developed by AstraZeneca (AZ) It was first approved by the Swedish Drug Administration (MPA) on January 1, 2003, and then approved by the U.S Food and Drug Administration (FDA) on March 31, 2005 AstraZeneca is responsible for its marketing The product name is Nexium IV Esomeprazole sodium is a proton pump inhibitor, which can reduce gastric acid secretion by inhibiting H + / K + ATPase of gastric cells, and is used to treat gastroesophageal reflux disease (GERD) At present, there are 13 domestic enterprises holding production approval documents for esmeralazole sodium for injection, and only 2 enterprises applying for conformity evaluation 2 There are 34 new drugs accepted this week, including 4 new drugs, 7 imported drugs and 23 generic drugs The details are as follows: on February 18, the marketing application of sinimod tablet of Novartis was accepted by CDE Siponimod tablet, a sphingosine-1-phosphate receptor modulator developed by Novartis, is currently in the clinical phase III experiment of multiple sclerosis treatment On February 19, the generic drug listing application of sakubaquvalsartan sodium tablet of Zhengda Tianqing Pharmaceutical Group was accepted Sakubatrevalsartan sodium tablet is a breakthrough innovative drug in the field of chronic heart failure treatment in the past 20 years It is the world's first angiotensin receptor enkephalinase inhibitor (Arni), which can simultaneously inhibit enkephalinase and block AT1 receptor (Angiotension type II1 receptor) In July 2015, it was approved by FDA In May 2016, Europe and the U.S updated the heart failure guidelines, both of which used Arni as a class I recommendation for reduced ejection fraction heart failure (hfref) The drug entered China for the first time in 2017 At present, three domestic enterprises have applied for the listing of generic drugs The application of Shanghai xuantai Haimen Pharmaceutical Co., Ltd was accepted on November 1, 2018, and that of Sinopharm group Ouyi Pharmaceutical Co., Ltd was accepted on January 30, 2019 Whose home is the first imitation of flowers? It's worth looking forward to Posaconazole enteric coated tablets on February 19, the generic drug listing application of posaconazole enteric coated tablets declared by Shanghai xuantai Haimen Pharmaceutical Co., Ltd was accepted Posaconazole was jointly developed by MSD, and was approved by the US Food and Drug Administration (FDA) on September 15, 2006 It was listed and sold by MSD The product name is noxafil Posaconazole is suitable for the treatment of refractory fungal infections (such as invasive Aspergillus, Fusarium, yeast, Mycobacterium, coccidiosis), and is first used for the treatment and prevention of serious fungal infections in thrush At present, China only has import approval documents, including posaconazole oral suspension and enteric coated tablets There are three enterprises applying for the listing of preparation generic drugs, namely Chengdu shengnuo bio Pharmaceutical Co., Ltd., posaconazole injection applied by Jiangsu aosaikang Pharmaceutical Co., Ltd and posaconazole enteric coated tablets applied by Shanghai xuantai Haimen Pharmaceutical Co., Ltd Among them, posaconazole injection application of orsacom was included in the priority review on February 3, 2019 CDE priority review dynamics this week, the CDE official website announced that there are three drugs to be included in the priority review, a total of seven acceptance numbers Xsatinib hydrochloride capsule x-396 is a brand-new molecular entity compound jointly developed by xsatinib and its holding subsidiary xccoveryholdings, Inc., which has completely independent intellectual property rights It is a new generation of ALK inhibitor with strong effect and high selectivity, which belongs to the category of "innovative drugs not listed at home and abroad", and its registration is classified as chemical drugs category 1 It is intended to be used in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after previous treatment with clozatinib or are resistant to clozatinib As a new generation of ALK inhibitor, the research and development progress of ensatinib hydrochloride is at the leading level in China At present, there are mainly three kinds of ALK inhibitors listed and sold in China, all of which are imported original research drugs, namely, Pfizer's crisotinib (listed in China in January 2013), Novartis's certinib (listed in China in May 2018) and Roche's alectinib (listed in China in August 2018) Among them, crisotinib and alectinib are used for the treatment of local advanced or metastatic NSCLC patients with ALK positive , ceritinib is used in patients with locally advanced or metastatic NSCLC who have progressed after previous treatment with clozatinib or who are ALK positive and are intolerant to clozatinib Sanofi arizumab injection Alirocumab injection was jointly developed by Sanofi and regeneron It was approved by FDA on July 24, 2015, and approved by EMA on September 23, 2015 It was jointly sold by Sanofi and regeneron in the US and European markets The product name is praluent Alirocumab is the first FDA approved PCSK9 inhibitor The drug is used to treat adult heterozygous familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease (such as heart disease or stroke requiring low-density cholesterol reduction) PCSK9, as a new target of attention after statins, not only arizumab, but also evolocumab At present, iloximab has been approved by the State Food and Drug Administration on July 31, 2018, becoming the first PCSK9 inhibitor new drug to be listed in China, and the commercial name is ribea Approved for the treatment of homozygous familial hypercholesterolemia (hofh) in adults or adolescents over 12 years old Familial hypercholesterolemia is one of the first 121 rare diseases in China If the subsequent import application of alizumab is approved, it will open up the domestic competition pattern In 2017, the global sales of ilojumab was RMB 2.154 billion, while that of arizumab was RMB 1.305 billion The company announced that tadalafil's first imitation was approved for listing Recently, Laimei won the exclusive right of sales agent According to the domestic drug information of the State Food and drug administration, Changchun Haiyue tadalafil's first imitation was approved for listing with the approval No of gjzz h20193041 Developed by Eli Lilly, tadalafil was approved by the U.S Food and Drug Administration (FDA) on November 21, 2003, under the trade name of Cialis Tadalafil is a phosphodiesterase 5 (PDE-5) inhibitor It is used to treat erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) According to IMS data, in 2017, the global sales of major ed drugs sildenafil, tadalafil and vardenafil were 3.72 billion US dollars, 3.775 billion US dollars and 401 million US dollars, respectively Although tadalafil was listed later than "Viagra" sildenafil, its global sales have now exceeded that of sildenafil According to the data, in 2017, the sales scale of major ed drugs such as sildenafil and tadalafil in China was about 2 billion yuan On the basis of this potential, the pharmaceutical industry of Laimei has won the sales agency right first, and the 2 billion market competition is about to start 6 Enterprise announcement: 5 drugs passed the consistency evaluation According to the enterprise announcement information, 5 drugs passed the consistency evaluation this week Among them, oseltamivir phosphate capsule, the first influenza first-line drug of dongyangguang Pharmaceutical Co., Ltd., is the first approved variety; there are 2 products with a total of 3 specifications, including risperidone tablets (1mg) of Qilu Pharmaceutical Co., Ltd and Enhua Pharmaceutical Co., Ltd., metformin hydrochloride tablets (0.25g) of Guizhou Tianan Pharmaceutical Co., Ltd.; in addition, the fifth approved enterprise of rosuvastatin calcium tablets, Lunan beiteri Pharmaceutical Co., Ltd., and Jiujiu Pharmaceutical Co., Ltd., Hunan Province The second family of levocetirizine hydrochloride tablets of Diandian pharmaceutical has been evaluated The supplementary application for doxycycline hydrochloride sustained release tablets of Huahai Pharmaceutical Co., Ltd was approved by FDA Recently, Zhejiang Huahai Pharmaceutical Co., Ltd received a notice from the U.S Food and drug administration that the company applied to the U The sustained-release tablets of mycomycin are the broad-spectrum antibiotics of tetracycline The original drug of doxycycline hydrochloride sustained-release tablets was developed by mayneparma company, and was approved to be listed in the United States as early as 2008 At present, in the United States, the manufacturers of doxycycline hydrochloride sustained-release tablets are mylan, heritage, solcohealthcare; doxycycline is commonly used in China, and the approved dosage forms are tablet, capsule, injection and other dosage forms, the manufacturers are mainly Jiangsu Lianhuan Pharmaceutical Co., Ltd., Haikou Qili Pharmaceutical Co., Ltd., etc., but there is no sustained-release tablet in China Tablet type approved for sale According to the query, the sales volume of doxycycline hydrochloride sustained-release tablets in the U.S market in 2018 was about 31.7094 million US dollars (data source: IMS database) The thymus method for injection of Hanyu Pharmaceutical Co., Ltd was newly approved Shenzhen Hanyu Pharmaceutical Co., Ltd recently received the new approval document for drug registration from the State Drug Administration on thymus method for injection Thymus method, as an immunomodulator, is often used in the adjuvant treatment of chronic virus infection, tumor and immune deficiency patients, and as a vaccine enhancer It has a wide range of application value in hepatitis B, hepatitis C, cancer, immune deficiency and other diseases The new original research enterprise of thymus injection method is American saisheng Pharmaceutical Co., Ltd At present, the drug has been listed in the national medical insurance and Pharmacopoeia of the people's Republic of China (2015 Edition), and included in the cancer item in the national formulary of China (2010 Edition), as well as the chronic hepatitis B in China