Inventory of potential application enterprises of class 1.1 new drugs in the first three quarters of 2014

I according to the statistics of insight - China Pharma data database of DXY, in 2014, there were 134 applications for q1-q3 chemical drugs (calculated by acceptance number, the same below) involving 51 enterprises Except that p-toluenesulfonamide of Tianjin HongRi and benzcycloquinium bromide of Yingu pharmaceutical are applied for production, other varieties are applied for clinical application 1 Jiangsu Hengrui and Zhaoke Pharmaceutical Co., Ltd ranked first in the number of applications: compared with Jiangsu Hengrui in the first half of the year, Zhaoke Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Li's pharmaceutical factory, ranked first in terms of the number of three varieties of Shengfa peptide, thymosin β 4 and celeprasidine The specific application varieties and conditions of the two companies are shown in the table below: the shr3680 and shr6390 declared by Jiangsu Hengrui are anti-tumor drugs, and the relevant information of the other variety shr4640 is unknown According to insight data, the application time point of class 1.1 new drugs of Jiangsu Hengrui in 2011-2013 was also in the first three quarters Compared with the same period of the past three years, Jiangsu Hengrui has applied for the number of new drugs of category 1.1 this year, although the number has dropped compared with the same period of 2013 (as shown in Figure 1), but it still ranks top in China Among them, umadeji, a PI3K / mTOR dual inhibitor, stopped development due to fierce competition in research and development of the same target Apatinib mesylate for gastric cancer has completed the on-site inspection in September this year, which is the fastest in the approval process of class 1.1 tinib new drug application in China Except for flumatinib mesylate from hausen, Jiangsu Province, other tinib new drugs with clinical approval have not yet been applied for production, and hausen's flumatinib will continue clinical trials at present Pyrrolidine maleate was clinically approved in 2012 and has not yet been applied for production Other drugs under further development include hae472, an anti-tumor drug, and SGLT2, an antidiabetic The three varieties declared by Zhaoke pharmaceutical industry are thymosin β 4, germinal peptide and celeprasidine The indications are corneal injury repair, hair loss and vulvovaginal candidiasis According to insight database, the application history of Zhaoke pharmaceutical's class 1.1 new drug is only that of jimatekang applied in August last year Jimatekang is a kind of exclusive franchise product obtained by Li's pharmaceutical factory from sigma tau company in Italy It is a camptothecin derivative anti-tumor drug used to treat ovarian cancer However, according to insight database, this drug has not passed clinical approval in China 2 Jiangsu Haosen and Guangdong Dongguang applied for the second place: according to the statistics of dingxiangyuan insight - China Pharma data database, in 2014, Jiangsu Haosen and Guangdong Dongguang applied for two new drugs of category 1.1 Hs-10234 is an antiviral nucleoside analogue of the two varieties declared by Jiangsu Haosen, and the specific information of hs-10220 compounds and targets is not available According to insight data, the application time of class 1.1 new drugs in 2011-2013 of Jiangsu Haosen is also in the first three quarters Compared with the same period of the past three years, Jiangsu Haosen has applied for 2-3 class 1.1 varieties in the past four years, which is relatively stable (as shown in Figure 2) Among them, morpholinidazole used for surgical and gynecological infection obtained clinical approval in 2005 and production approval in February 2014; carfuraseti, PLK inhibitor used for leukemia, its similar drug is volacertib of bringlingham, and volacertib was recognized as a breakthrough drug by FDA in 2014 At present, volacertib has completed phase II clinical research; other declared 1.1 They also include AT1 receptor antagonists, GLP-1 analogues and TiNi antitumor drugs At the beginning of this year, Guangdong dongyangguang declared two varieties, namely, imitavir phosphate and lelotinib mesylate The target of imitavir phosphate is NS5A, and the indication is hepatitis C; the target of lelotinib mesylate is EGFR, HER2 and HER4 According to insight database, Guangdong dongyangguang Pharmaceutical Co., Ltd has also applied for two new drugs of class 1.1 in the past three years, namely mofetidine for chronic hepatitis B and ningetinib for glioma The two drugs are currently in phase I and phase II clinical trials respectively 2、 According to the statistics of Insight China pharmadata database, in 2014, q1-q3 approved 24 new chemical drugs of category 1.1, involving 22 enterprises 1 Jiangsu Hengrui and Jiangsu Haosen are the leading innovation leading enterprises in terms of the number of clinical approved varieties, and they have obtained two clinical approval documents for class 1.1 new drugs The specific data are shown in Table 3: flumatinib mesylate tablet of Jiangsu hausen is a new generation of chronic myeloid leukemia treatment drug developed on the basis of the second generation of imatinib Compared with the first generation of imatinib, the second generation of imatinib and flumatinib can better solve the problem of drug resistance Flumatinib mesylate was originally declared for production, but it was not approved for production at last Instead, the clinical approval was sent, and the clinical trial still needs to be continued Another clinically approved drug, hs-10182, is an EGFR / HER2 inhibitor, which may be used for lung cancer In May this year, Jiangsu Hengrui obtained the clinical approval documents of two 1.1 varieties, namely, cimetidine and furoglitazone Cimetidine is a hedgehog pathway inhibitor, which can be used for gastric cancer and lung cancer; furoglitazone is a gpr-40 agonist, which is used to treat type II diabetes mellitus Takeda pharmaceutical's tak-875 is also a gpr-40 agonist, which was forced to stop clinical trials in 2013 due to its liver toxicity Therefore, the performance of Jiangsu hengruifuroglitazone clinical trials will be more concerned 2 The innovation potential of Shandong xuanzhu and Zhejiang Haizheng highlights that in 2014, q1-q3 enterprises obtained the clinical approval documents for chemical drugs of category 1.1, except that Jiangsu Hengrui and Jiangsu Haosen obtained two clinical approval documents, other enterprises only obtained one Among them, Shandong xuanzhu and Zhejiang Haizheng have demonstrated their innovation potential with their outstanding application achievements in recent years Shandong xuanzhu, the holding subsidiary of Sihuan Pharmaceutical Group, received the clinical approval of thalidomide in September this year According to insight database, from 2010 to 2014, Shandong xuanzhu has applied for 8 new drugs of class 1.1, 5 of which have obtained clinical approval Among these 1.1 new drugs, there are some popular antineoplastic drugs, DPP-4 inhibitors and hypoglycemic drugs In addition, there are also penem antibiotics, calcium antagonists, PPIs and SGLT2 inhibitors and hypoglycemic drugs with wide antibacterial spectrum (as shown in Table 4) In addition, there are two new drugs in Shandong xuanzhu, which are in the phase of content determination and preclinical research In July this year, Zhejiang Haizheng obtained the clinical approval of the third generation of anti-tumor photosensitizer HPPH According to insight database, Zhejiang Haizheng also declared a new class 1.1 camptothecin derivative peg-sn38 for breast cancer, colorectal cancer and pediatric cancer in March this year In the past three years, Zhejiang Haizheng has applied for 5 new drugs of class 1.1, of which 2 are approved for clinical application and 3 are under review Another drug that has been approved for clinical use is the cholesterol absorption inhibitor Heyzer cereal In addition to peg-sn38, the new drugs under review include hebofenamine and ad-35 for Alzheimer's disease In addition, the clinical trials of hezemab, HPPH and AD35 were also carried out in the United States The first two drugs were in phase II clinical trials, and AD35 was approved by the US ind application in July this year 3 In terms of application speed, in 2014, q1-q3 was approved as class 1.1 new drug application, the slowest time for new drug varieties to obtain clinical approval was 3 years, most of which took 9-17 months, and the fastest one was mehuatinib, a tyrosine kinase inhibitor of Hangzhou East China medicine, which took only 6 months To sum up, looking back on the overall situation of application and approval of q1-q3 chemical medicine class 1.1 new drugs in 2014, Jiangsu Hengrui is still far ahead, followed by Jiangsu Haosen Zhaoke Pharmaceutical Co., Ltd and Guangdong dongyangguang Co., Ltd are behind by the number of application varieties In addition, Shandong xuanzhu and Zhejiang Haizheng also showed the potential of new drug research and development It remains to be seen whether there will be any enterprises emerging in the application of chemical 1.1 new drugs in the next quarter.