The latest report of China US drug approval in 2015 (the second quarter)

Source: minenet 2015-07-28 has passed half of 2015 unconsciously The scene of the domestic drug market is that the bidding for basic drugs, non-basic medical insurance and non-basic non-medical insurance drugs is booming As a result, some people are happy and others are sad The international pharmaceutical industry seems calm but actually flows secretly All kinds of large-scale transactions are to be concluded and acquisitions are to be acquired Regardless of the nature of the disturbance, what we pursue is nothing more than the most competitive product For products, entrepreneurs compare the vision of finding drugs with market value, market personnel compare the ability to grasp the mainstream market direction, and R & D personnel compare the strength of developing new products To this end, we spare no effort to pursue new drugs, in order to obtain such a super heavy bomb as the hepatitis C drug sovaldi For this reason, we will show you the approved drugs in the second season to see which ones have the potential to weigh heavily From April to June 2015, FDA published 875 pieces of approval information In April, 327 pieces of approval information, including 250 pieces of NDA (new drug application), 7 pieces of bla (biological product application), and 70 pieces of Anda (abbreviated new drug application); among them, 55 pieces of approval information are included The drug with the most approval information is the nervous system drug aripiprazole (anda) Because of the expiration of its U.S patent, a total of 4 pieces are included, including TILVA, etc The generic drugs of enterprises have been approved In addition, 6 enterprises have obtained temporary approval in the past few years A total of 10 generic drug enterprises have obtained approval documents This product is an antipsychotic heavyweight drug of Squibb and Otsuka, which has made brilliant achievements In addition, there are 19 temporary approval information, the rest are label changes, supplementary clinical data and other relevant information In May, there were 253 pieces of approval information, including 181 pieces of NDA information, 16 pieces of BLA information and 31 pieces of Anda information, including 48 pieces of approval information, 14 pieces of temporary approval information and other relevant information In June, there were 295 pieces of approval information, including 222 pieces of NDA, 4 pieces of BLA and 69 pieces of Anda Among them, there were 63 pieces of approval information, 6 pieces of temporary approval information, and the rest were other relevant information Four new molecular entities were approved in the second quarter, but no new biological products were approved Table 1 in the second quarter of 2015, although the number of new molecular entities approved by FDA was less than that in the first quarter, two of the four new molecular entities approved had the potential of blockbuster drugs One was kybella, the world's first approved "double chin" lipolysis needle, and the other was corlanor, a drug for heart failure, which had obtained the priority review Given that heart failure is the leading cause of death and disability in adults, corlanor is believed to be the first approved product in this drug category through its heart rate lowering effect and thus has been given a huge market imagination In the past July 7, the drug giant Novartis was approved by FDA six weeks in advance It is a great breakthrough in the field of heart failure treatment in the past 25 years The industry predicted that its annual sales peak will exceed 6 billion US dollars As the first and only non-surgical treatment product, kybella fat dissolving needle can be used in moderate to severe "double chin" adults, and it has also become the first injection approved for beauty in similar products As its original research company, kythera biopharmaceuticals was also acquired by Elgin, a new medical carrier, for us $2.1 billion The new Elgin is a company established by atweis for us $70.5 billion to acquire Elgin, a Botox manufacturer, which has created a market value of 1170 Billion dollars and more than the pharmaceutical giant Bristol Myers Squibb, Lilly and a new aircraft carrier of Aberdeen With the successful sales experience and team of Botox, kybella has a high probability of becoming a blockbuster Although no innovative biopharmaceuticals were approved in this quarter, two chemicals with temporary approval attracted our attention One of them is Kaba Sai, who is treating prostate cancer Because prostate cancer incidence rate in Europe and America is higher, Sanofi's original research medicine JEVTANA KIT (Kaba) has been given priority in the review in June 2010, and the annual report shows that this variety earned 273 million euros for Sanofi in 2014 As its patent expires next year, accord hlthcare's products are approved, which not only provides the market with an opportunity to choose, but also allows pharmaceutical companies to layout ahead of time Another temporarily approved drug is India's lopinavir and ritonavir, which treat HIV It is a new formulation of micro pill As a new formulation with good fluidity and high bioavailability, micro pill has recently been sought after by everyone Although several enterprises such as tablet have approval documents in the market, there is no doubt that sipura has the greatest market determination It has approval documents of tablet, solution and micro pill Table 2 after a series of drug bidding baptisms in the domestic market of new drugs temporarily approved by FDA in the second quarter of 2015, all enterprises are in urgent need of competitive fresh blood to supplement their product library What are the highlights of the approved drugs in the second quarter According to the drug evaluation database of minenet, as of June, domestic pharmaceutical enterprises have obtained 110 production approvals (biological drugs do not include products for prevention), including 55 approvals in April, 37 in May and 18 in June; 31 of the 110 approvals involve supplementary applications; while 79 new approvals, including 37 for traditional Chinese medicine and 3 for biological drugs for treatment The rest are chemical approval documents Nearly half of the new approvals are for new drugs However, in the approval documents for new drugs, except for Haizheng's biological drugs, most of them are ordinary, and most of them have made some changes in the dosage form Table 3 in the second quarter of 2015, CFDA approved some new drug varieties of state-owned enterprises (biological drugs do not include prevention products) in the domestic drug registration, some phenomena are worthy of attention For example, in the field of imported drug registration, we found that more and more pharmaceutical giants are bringing some new drugs that are not listed to the domestic market for application Based on the data of the first quarter of 2015, it can be found that there are many truly innovative drugs applying for clinical application in China, most of which are in the field of anti-tumor For example, ly2157299 of Lilly and lee011 of Novartis are anti-tumor drugs Ly2157299 (gallisertib) is a TGF - β receptor kinase inhibitor The product was declared in China at the end of 2013 and was approved for clinical use in April this year Ly2157299 is also in full swing in foreign clinical practice, some projects have been completed, some projects are still in the process of recruitment Some foreign enterprises have entered our country to declare, and some state-owned enterprises have gone abroad Bgb-3111, which is used to treat malignant tumors in Baiji Shenzhou, declared clinical application in China in February this year Meanwhile, bgb-3111 and bgb-290 have also been approved to conduct clinical trials in the United States In terms of registration of local innovative drugs, Jiangsu Heng Rui applies for a class of drugs such as repaglinide and benjrutier, a kind of biological medicine produced by Shanghai Heng Hui We should give applause For professionals who have been engaged in drug research and development for a long time, we all understand the fact that generally speaking, a new type of new drug is relatively easy to declare, and has successfully completed the clinical trials of large capital investment After entering the application for production, it reflects the strength and determination of the enterprise, so we must praise such enterprises We should also have respect for the enterprises that are brave in innovation and exploration Geli bio's all oral interferon free treatment of chronic hepatitis C drug asc16 has applied for clinical application, which is another application to CDE after the successful application of similar drug asc08 last year Gilead's oral interferon free treatment program attracted global attention last year, which triggered a boom in research and development of such drugs Geli is the first one in China to launch such a program, which is of great significance to promote the prevention and treatment of hepatitis C in China Table 4 approval of class I new drugs in China in the second quarter of 2015 (chemical drugs only include class 1.1, biological drugs do not include products for prevention)