2014 chemical registration application ranking

For drug registration application, 2014 was a busy year In 2014, drug review center accepted 8789 new registration applications (calculated by acceptance number, excluding reexamination), an increase of 20.8% compared with 2013! Especially in the field of chemical medicine, the new chemical medicine has increased by 45.6% compared with 2013, which is indeed a gratifying thing Let's recognize the companies that have contributed to this data 1 According to the statistics of drug intelligence registration and acceptance database, in 2014, CDE accepted 155 new chemical drugs of category 1.1 (calculated by acceptance number), including 60 applications for APIs The following is the list of chemical drug 1.1 API registration applications Figure 1 In 2014, Jiangsu Hengrui Pharmaceutical Co., Ltd was indeed a big winner in new drug R & D this year It applied for 4 new drugs of category 1.1, and its R & D ability was beyond the reach of most domestic pharmaceutical enterprises Apatinib mesylate, a new national class 1.1 drug independently developed by the company, has been put on the market heavily This marks another major breakthrough in the field of tumor treatment innovation and development in China Zhaoke Pharmaceutical (Hefei) Co., Ltd is a wholly-owned subsidiary of Li's big pharmaceutical Holding Co., Ltd (Hong Kong listed company, code: 00950), which occupies a technical advantage in the field of Biochemistry and biology In 2014, it applied for three new drugs of 1.1 category, i.e Shengfa peptide, thymosin β 4 and celeprasidin In 2014, Guangdong dongyangguang Pharmaceutical Co., Ltd also applied for two new TiNi class 1.1 drugs: lelotinib mesylate and bocitinib hydrochloride Imitavir phosphate is a kind of influenza virus NA inhibitor, and its indications are influenza Lianyungang hongchuang Pharmaceutical Co., Ltd of Jiangsu Haosen Pharmaceutical Group is a subsidiary of Jiangsu Haosen Pharmaceutical Group It is the production base of group's API It is required to produce more than 20 kinds of chemical APIs, such as gemcitabine hydrochloride, cefsalime, olanzapine, and repaglinide In addition to the production of supporting supply preparations, some APIs are also exported to more than 20 countries and regions 2 According to the statistics of drug intelligence registration and acceptance database, in 2014, there were 1618 new drugs (calculated by acceptance number) of class 3.1 chemical drugs accepted by CDE In the following list, preparations were excluded in the statistical process and only APIs were included There are 792 applications for APIs The following is the top 10 in the application list of chemical 3.1 API Figure 2 In 2014, Lianyungang Runzhong Pharmaceutical Co., Ltd became the declaration champion of class 3.1 new drugs in 2014 with 33 projects Lianyungang Runzhong Pharmaceutical Co., Ltd is a subsidiary of Zhengda Tianqing Pharmaceutical Group Relying on the R & D foundation of the parent company, the company has a high starting point of technological innovation, and its main products are at the leading level in China The R & D projects focus on the field of liver disease and seek diversified development, involving eight disease fields such as liver disease, tumor, cardiovascular and cerebrovascular diseases, and infection Qilu Pharmaceutical Co., Ltd., headquartered in Jinan City, Shandong Province, is a large-scale comprehensive modern pharmaceutical enterprise in China, specializing in the research, production and sales of preparations and APIs for the treatment of tumor, cardio cerebrovascular disease, anti infection, mental system, nervous system and ophthalmic diseases Founded in 2000, Nanjing Huawei Pharmaceutical Technology Development Co., Ltd (Huawei pharmaceutical) is a high-tech enterprise specializing in drug discovery, research and technical services The R & D team of the company, with multiple Dr returnees as the core, focuses on the research of many cutting-edge technologies, such as chiral synthesis, slow and controlled release technology, targeted drug delivery system, new molecular drug screening, etc At present, it is a leading pharmaceutical R & D outsourcing service provider in the same industry in China