Highlights of new drugs approved in China in 2013 / 2014

At the end of the year, all major enterprises are busy with a year's work summary For pharmaceutical enterprises, business income, operating cost, net profit and other vital data inventory are naturally the first priority, but obtaining new drug production approval is equally important, which means that a new market layout is about to start Through sorting out the drug review database of minenet and comparing the drug production approvals obtained in 2013 and 2014, we found some interesting information to share with you Through the comparison of data, it is found that the total number of approved drug production approvals in 2014 is higher than that of last year, in which the number of chemical approvals has increased significantly, while the number of traditional Chinese medicine and biological products has declined Although the total approvals obtained in 2014 are higher than last year, the number of new drug approvals has decreased, but this does not affect innovation, because the gold content of approved new drugs has increased In 2013, only one class 1.1 new drug was approved, while in 2014, four drugs obtained nine class 1 new drug approvals, three of which were class 1.1 new drugs The first class of new drug approved in 2013 is "palamivir sodium chloride injection", which is produced by Guangzhou Nanxin Pharmaceutical Co., Ltd palamivir is a new type of anti influenza virus drug The existing clinical test data prove that it is effective for influenza A and B Its dosage form is injection It can be treated more timely and quickly for the critically ill patients with influenza and the patients with poor efficacy for other drugs As clinical data show that the efficacy of palamivir is better than that of the mainstream varieties in the current market, on April 5, 2013, palamivir sodium chloride injection was approved by CFDA "Apatinib mesylate" of Jiangsu Hengrui is the most attractive new drug approved in 2014 As a small molecule vascular endothelial growth factor tyrosine kinase inhibitor with independent intellectual property rights, apatinib can be used to treat advanced non-small cell lung cancer, gastric cancer, liver cancer and breast cancer Today, tyrosine kinase inhibitors targeting cancer are widely used After having our own "Kemena" (trade name of exetane hydrochloride) in 2011, it's not easy to obtain the approval of "aitan" (trade name of apatinib mesylate) this year, because we are willing to It is rare for a company to make a new drug with a huge amount of money Moreover, it needs to bear the pressure to invest in all the risks in the early stage of development failure New drug development is like sailing against the current If we don't advance, we will fall back Once we go with the current, China's new drug market can only rely on people's nose forever In 2013 and 2014, there were few new drugs in other categories, but some of them are worth aftertaste Chemical drugs are mainly in three categories, mostly in the form of 3 + 5 or 3 + 6 (i.e API 3 and preparation 5 or 6); traditional Chinese medicine is mainly in six categories in 2014, while in 2013, it is relatively scattered; biological products are less attractive for new drugs Through the comparative analysis of the data, we found that the decline of new drug approvals in 2014 was mainly due to the significant decrease of 3 types of chemical approvals, from 58 in 2013 to 42 in 2014; Chinese medicine also contributed, from 2 categories 5, 7 categories 6 and 6 categories 8 in 2013 to 6 categories 6 in 2014; biological products did not change much, from 1 in 6, 7 and 12 in 2013 to 1 in 2014 One production approval document for each of the two categories 7, 9 and 13 in the year From the point of view of new drug category, chemical drugs category 5 is a small innovation that domestic enterprises are keen on Unfortunately, in the past two years, such innovation is only limited to simple modified dosage forms, and there is no trace of slow and controlled-release preparations with a little technical content In 2013, six enterprises in Hangzhou, Central America and East China, etc obtained the approval of chemical drugs, which was somewhat interesting Non bustard is a new molecular entity approved by the FDA in February 2009 by Takeda company It is a product developed by Tokyo Imperial company Febuxostat is a xanthine oxidase (XO) inhibitor, which can block the synthesis of uric acid, so as to reduce the concentration of uric acid in blood and the deposition of urate in bone, joint and kidney After more than 30 years of rapid development, China's food structure has changed a lot Once rich people's food "patents", such as drinking and eating meat, have entered the family life of ordinary people According to relevant data, the number of gout patients in China is on the rise every year In addition, people who suffer from hyperlipidemia, hypertension, diabetes and obesity will automatically become the high-risk group of high uric acid Facing such a huge gout potential market, the smell of domestic enterprises is still quite sensitive Table 1 domestic approval of non bustard: from the perspective of innovation provinces, Jiangsu and Zhejiang won the top two places in 2013, followed by Beijing; from the perspective of enterprise innovation, Yangzijiang group won the first place and obtained 8 new drug production approvals and 8 new drug certificates In 2014, Jiangsu and Shandong ranked the top two, and Sichuan caught up with them; the highlight of enterprise innovation was in Haosen, Jiangsu Province In 2014, the enterprise obtained 4 new drug certificates, and two of them were full of gold containing chemical medicine 1.1 The product "morpholine nitrazole" was a new third-generation nitromidazole drug, and the indications were surgical infection caused by anaerobic bacteria sensitive to morpholine nitrazole and gynecological infection Infection, the drug has been the Ministry of science and technology national major new drug development special funding support Jiangsu and Zhejiang area has become the bridgehead of new drug development in China There are a large number of innovative enterprises such as Hengrui, hausen, Haizheng, etc we have formed a good atmosphere of chasing each other with courage and wisdom, and gradually jumped out of the low-level me too product battle circle Therefore, many products are sold overseas Today, in the global economic downturn, the export of domestic low value-added products is also facing the situation of gradually shrinking, how to spend the current winter for domestic pharmaceutical enterprises, these enterprises have set an example.