[heavyweight] take a look at the 10-year new drug registration and approval, dig into the R & D layout of 2017 enterprises, dongyangguang, Hengrui, Qilu, Kangyuan

2017 has passed, and we have a new year in 2018 Looking back yesterday, the pharmaceutical industry has gone through a difficult year, but also a harvest year I have prepared a series of articles on drug registration in 2017 I will publish them in the official account in the near future If you love, please read the total situation of new drug application in China 2017 has passed For the pharmaceutical industry, perhaps the most concerned is the annual application of new drugs Let's take a look at it Figure 1 the application of new drugs in 2008-2017 shows the overall application trend of new drugs in recent ten years In 2015, it reached the peak of application, with 2976 (calculated by acceptance number, the same below) In 2016, it dropped significantly The application of new chemical drugs is consistent with the overall trend, which is closely related to the consistency evaluation of chemical drug imitation and the standardized supervision of the food and Drug Administration on the pharmaceutical market As of December 31, 2017, the total number of filings decreased from 2016 to 619 It is worth mentioning that in the past decade, the overall trend of applications for new drugs for biological products has improved, reaching a maximum of 193 this year, which is also in line with the development trend of biomedicine in recent years Application of new drugs in 2017 1 Application of new drugs for biological products 1.1 application of new drugs for biological products in different regions in 2017, the top three in terms of number are Shanghai, Guangdong and Jiangsu Fig 2 Application of new biological products in 2017 1.2 application of new biological products by enterprises in various regions the largest number of new biological products applications is Shanghai Institute of biological products, up to 7; followed by Qilu, Jiangsu Hengrui, Baiao biology, 5 drugs are applied Figure 3 in 2017, the number of enterprises applying for new biological products ranked 1.3, class 1 applications for biological products in 2017, class 1 applications for biological products (therapeutic biological products not marketed at home and abroad, vaccines not marketed at home and abroad) totaled 76, accounting for 39.38% of the total, of which 22 applications (as shown in Table 1) have been approved, and the remaining 54 applications are still under review and approval In addition, there are 28 special approvals and 2 priority reviews in these class 1 new drug applications Table 1 approval of class 1 new drug application for biological products in 2017 In 2017, the highlight of class 1 new drugs for biological products can be said to be the recombinant Ebola virus vaccine, which has attracted wide attention at home and abroad from the beginning to the final approval of production, which is also an initiative of the national drug Audit Center under the new round of policies At this point, kangxinuo biology company has become a hot company in the field of public vision, and laid a solid foundation for future development 1.3.2 five special approval varieties approved by domestic famous clinical enterprises Qilu pharmaceutical, Jiangsu Hengrui, Shanghai Pharmaceutical Group, Nanjing Shunxin and Wuxi pharmaceutical mingkant have obtained clinical approval documents this year Among them, Qilu pharmaceutical's recombinant anti HER2 humanized monoclonal antibody DM1 for injection has also obtained clinical approval, which is a potential biological product of Qilu In addition, Shanghai Pharmaceutical's R & D focus product, recombinant anti HER2 humanized monoclonal antibody combination for injection, was also approved for clinical use this year This drug is a new type of human recombinant monoclonal antibody product, which is intended to be used for HER2 positive metastatic breast cancer The drugs with the same target at home and abroad include: Roche's Herceptin and perjeta However, the recombinant anti HER2 humanized monoclonal antibody composition for injection of Shanghai Pharmaceutical has independent intellectual property rights, and there is no same product on the market in China at present 1.3.3 this year, three drugs of Zhuhai Lizhu mAb have been approved for clinical use They are two specifications of recombinant all human anti RANKL monoclonal antibody injection and recombinant human anti PD-1 monoclonal antibody for injection There are not many leading enterprises that can independently research and develop innovative McAb drugs in China, and Lizhu is one of them PD-1 monoclonal antibody is the first monoclonal antibody to be listed on the market The market scale at home and abroad is huge At present, there are 9 domestic monoclonal antibody drug manufacturers approved to take "PD-1" as the clinical target Although the competition is fierce, Lizhu has solid research and development, deep technical process and good prospects 1.3.4 the h7n9 gene vaccine approved for clinical biological products in Shanghai has attracted wide attention since its successful development, which lays a good foundation for virus prevention and control in the future In September 2017, influenza a h7n9 vaccine was approved for clinical use In addition, the tetravalent subunit influenza vaccine developed by Jiangsu Zhonghui Yuantong was also approved for clinical use in November 2017 Zhonghui Yuantong's vaccine has better safety for the prevention of influenza virus infection and can better protect infants under 3 years old Its products can not only fill the market gap at home and abroad, but also provide better safety and broader protection for the vaccinated population Seedling products 2 Application of new chemical drugs 2.1 application of new chemical drugs in various regions has always been a major category of research and development Although the application of new drugs in 2017 is not as good as before, it still has advantages over traditional Chinese medicine and biological medicine In all regions of the country, we can see that Jiangsu, Guangdong, Shanghai and Zhejiang have a large number of applications All of them are coastal developed cities, and are also the places where large pharmaceutical enterprises gather (as shown in Figure 5) Figure 4: application of new chemical drugs in different regions in 2017 2.2 application of new chemical drugs among the top three enterprises are Jiangsu Hengrui, Guangdong dongyangguang and Zhengda Tianqing (including 14 subsidiaries of Zhengda Tianqing) Jiangsu Hengrui and Zhengda Tianqing have always been famous chemical drug R & D enterprises, but their strength has been enduring This year, the potential of Guangdong East sunshine broke out, catching up with other companies in the application of new chemical drugs, which can be said to be accumulated From 2013 to 2017, dongyangguang applied for 64 new drugs in the drug examination center, including 63 chemical drugs, including 12 special approvals, 4 priority reviews and 3 major special projects: imitavir phosphate API, two specifications of imitavir phosphate capsules, and 53 chemical drugs 1 (1.1) in total In the total new drug application, except for two approvals of esomeprazole enteric coated capsules, all the others were approved clinically It can be seen that although Guangdong dongyangguang is not as good as some enterprises in terms of total quantity, a small number of drugs in its layout are all good drugs in the market, and its R & D strength is increasing Figure 5 in 2017, the number of chemical new drug application enterprises ranked 2.3, and the number of chemical new drug application enterprises in chemical 1 (1.1) was 324, accounting for 83.29% It can be seen that although the number of chemical new drugs decreased in 2017, the number of chemical new drugs in 1 (1.1) increased by 34.57% year on year Among them, 174 drugs (as shown in Table 2) have been approved, 8 drugs have been approved to be approved and 1 drug has been prepared to be approved, accounting for 56.48% of the total It can be seen from the data that the country is no longer pursuing a large number of drugs, but a large country of drug quality At the same time, the national strategy of new drug distribution is gradually mature, and the speed of review and approval is gradually accelerated, so there will be no more accumulated large number of reviews Table 2 approval of chemical medicine class 1 new drug application in 2017 (Note: red is special approval, only drugs that have been reviewed are selected due to limited space, see the annex for details) 2.3.1 chemical medicine class 1 application ranking top three: Dong Yangguang, Hengrui, Guangdong Zhongsheng In 2017, the 20 new chemical drugs of class 1 (calculated according to the acceptance number, the same below) declared by Guangdong dongyangguang were approved for clinical use, which is a remarkable achievement They are respectively ritapiren and its tablets, kangdariwei sodium and its tablets, hec68498 sodium salt and its capsules, hec30654acoh and its capsules, hec74647pa and its capsules; Hengrui has 12 new chemical drugs of class 1 approved for clinical use, namely shr9549 and its tablets, shr9146 tablets, shr0532 tablets, shr8554 injection and shr1459 tablets; Guangdong Zhongsheng pharmaceutical has 10 new drugs of class 1 approved for clinical use Bed, zsp0391 and its tablets, zsp1603 and its capsules 2.3.2117 newly approved clinical drugs of chemical medicine category 1 listed in special approval in 2017, 117 of which were approved clinical drugs, accounting for 96.69% of the total number of special approval, with high evaluation efficiency 2.3.3 chemical drugs of Jilin yinglianshangde 1.1 In 2017, there are relatively few chemical drugs in category 1.1, only two acceptance numbers They are benzodiazepine and its capsules (as shown in Table 3) of Jilin yinglianshangde science and Technology Development Co., Ltd the indications are primary mild and moderate hypertension For patients who are difficult to control blood pressure alone, they can be combined with diuretics, β receptor block, calcium antagonists or ACEI Table 3: application of new drugs of chemical medicine category 1.1 in 2017 (Note: red is special approval) 3 Application of new drugs of traditional Chinese medicine 3.1 application of new drugs of traditional Chinese medicine in various regions: Jiangsu, Shanghai and Beijing, which are also developed regions of traditional Chinese medicine industry Figure 6 Application of new traditional Chinese medicine in 2017 3.2 application of new traditional Chinese medicine enterprises in different regions ranking top are Jiangsu Kangyuan pharmaceutical, Hutchison Huangpu pharmaceutical, Jichuan Pharmaceutical Group, Beijing Zhongyan Tongrentang, Chongqing Qiuwen Although the quantity is less than chemical medicine and biological medicine, it can be said that it is very few, but in the adverse environment of the development of traditional Chinese medicine, it is not easy to still have new research and development of traditional Chinese medicine Figure 7: ranking 3.3 Chinese medicine new drug application enterprises in 2017, the total number of Chinese medicine new drug applications in 2017 was only 37 (as shown in Table 4), only 5 more than in 2016 With the social requirements for drug quality rising, the traceability requirements for drug safety are more and more strict, and traditional Chinese medicine encountered some resistance in the development However, in 2017, the law of traditional Chinese medicine was officially implemented, which is also opening up new development channels for traditional Chinese medicine 2017 is undoubtedly the adaptation period of traditional Chinese medicine in the new era and new policies We also believe that there will be different new situations after the previous trough Table 4 Application of new traditional Chinese medicine in 2017 3.3.1 new development in the new era In December 2017, CDE of Chongqing Qiuwen group 1 undertook the ind application of jnsw10032 and its tablets of Chongqing Qiuwen group 1 new traditional Chinese medicine, which is currently under review and approval This is also the only class 1 new Chinese medicine in 2017 According to the public information, Chongqing Qiuwen company was established on August 1, 2017, to engage in biotechnology research and development, new drugs and medical devices research and development and technology transfer It can be predicted that this product will become the brand of the company in the future 3.3.among the 225 6 (6.1) new Chinese medicine new drug undertakers, there are 6 categories, 25 acceptance numbers, accounting for 67.57% Among them, xiaoerqingzhen oral liquid and peituqingxin granules have been listed as the priority for evaluation, and have been approved for clinical use In addition, Tianhu capsule and Buqi Tongluo granules have also been approved for clinical use Application of new drugs in 2017.xls