Hengrui has a wide distribution, and the application data of Zhengda Tianqing and dongyanghua drugs in Category 1 & new category 4 are eye-catching: analysis of drug registration trend in 2017

2017 is about to pass With the in-depth implementation of drug registration reform, what is the change of enterprise declaration strategy? Which varieties are more popular? What are the characteristics? As of November 22, 2017, in the domestic product registration application for 2017, 77% of the registration applications are for chemical drugs, 15% for biological products for treatment, and 4% for biological products for prevention and 4% for traditional Chinese medicine Among the chemical drug applications, 44% are registered in Category 1, and 31% are registered in Category 4 of new registration and category 6 of old registration It can be seen that the reporting of generic drugs on the market in China has recovered Due to the fierce competition of generic drugs, the enthusiasm of drug companies to compete for category 1 chemicals is still high Since this year, the application of category 1 Chemicals has been kept at a high temperature Dongyangguang, Hengrui and Zhengda Tianqing are the three major enterprises applying for the acceptance number of new chemical drugs of category 1 in 2017, with the acceptance number close to 20 The proportion of class 1 new chemical drugs declared by the three enterprises is 29% The products declared by dongyangguang Pharmaceutical Co., Ltd include the raw materials and capsules of hec30654acoh, the new anti Alzheimer's drug, and kangdariwei sodium and tablets The products of hec68498 sodium salt and capsules, hec74647pa raw materials and capsules, and ritapiren raw materials and tablets have not been known about the indications The above products are not included in the priority review and approval list The products declared by Hengrui system include shr0532 raw materials and tablets, shr9549 raw materials and tablets with undetermined indications, shr7280 raw materials and tablets for the treatment of endometriosis, shr8554 raw materials and injection, shr9146 raw materials and tablets for the treatment of pain, pyrrolidine maleate raw materials and tablets for the treatment of breast cancer Among them, the production declaration of pyrrolidine maleate raw materials and tablets has been included in the priority review and approval list In addition, Hengrui's c-met ADC (antibody drug conjugate) injection has applied for class 1 new biological product for treatment, which has been approved by FDA in the United States The products declared by Zhengda Tianqing system include tq05105 raw materials and tablets, tq05510 raw materials and capsules, tq-a3326 raw materials and tablets, tqb3455 raw materials and tablets, tqb3456 raw materials and tablets, tqb3616 raw materials and capsules, and the raw materials and capsules for the treatment of thyroid medullary cancer, non-small cell lung cancer and other tumors Among them, the production declaration of androtinib hydrochloride capsule has also been included in the priority review and approval list In addition to pyrrolidine maleate from Hengrui and enrotinib hydrochloride from Zhengda Tianqing, the products reported for the first class of new drugs are also the raw materials and capsules of farobojin (China) and Rosa Sita for the treatment of renal anemia, the raw materials and capsules of Hutchison Huangpu fuquitini for the treatment of non-small cell lung cancer, and the injection of nanofloxacin malate and sodium chloride from Zhejiang medicine Among them, Hutchison Huangpu fuquitinib was also included in the priority review and approval list The raw materials and capsules of nanofloxacin malate were approved in 2016 The newly registered classification of chemicals that have been put on the market is 4 categories, which refers to the drugs that the domestic applicants copy the original drugs that have been put on the market in China This kind of drugs should be consistent with the quality and efficacy of the original drugs, which mainly corresponds to the old registration classification of chemical drugs (6 categories) Compared with the four categories of new registration of chemical drugs, the three categories of new registration of chemical drugs have higher requirements, more complex clinical trials and higher costs Therefore, the relatively low-cost chemical drugs newly registered and classified 4 categories of projects have attracted many pharmaceutical enterprises The same is true from the declaration data Since CFDA issued the record system of generic be, in 2017, a total of 115 acceptance numbers of new 4 categories of chemical drugs applied for production According to the statistics of the declaration of new 4 categories (old 6 categories) of chemical drugs in 2017, it can be found that tenofovir fumarate dipivoxil tablets have the largest number of manufacturers, including Shijiazhuang Longze Pharmaceutical Co., Ltd., Anhui ankehengyi Pharmaceutical Co., Ltd., Suzhou Teri Pharmaceutical Co., Ltd., Anhui Baker bio pharmaceutical Co., Ltd and Hangzhou SUPOR Nanyang Pharmaceutical Co., Ltd Tenofovir dipivoxil fumarate tablets have been listed in Chengdu Beite, Qilu pharmaceutical, Anhui Baker and Zhengda Tianqing in China, the latter three were approved in 2017, and so many enterprises have applied for listing in the future, with fierce competition Moxifloxacin hydrochloride tablets, viagliptin tablets and gefitinib tablets have four applications respectively The manufacturers of moxifloxacin hydrochloride tablets are Chongqing Huabang pharmaceutical, Nanjing Youke pharmaceutical, Guangdong dongyangguang pharmaceutical and Nanjing Shenghe pharmaceutical Moxifloxacin hydrochloride tablets have not been approved by the first manufacturer Moxifloxacin hydrochloride injection has been listed in two domestic markets, Tiantaishan of Chengdu and Youke of Nanjing After 2016, the clinical enterprises started include Sichuan Guowei, Zhejiang Haizheng, Guilin Nanyao, Hunan Tianji Caotang, Shenzhen xinlitai and Jiangsu Tianyi At present, Beijing Wansheng Pharmaceutical Co., Ltd is the enterprise that moxifloxacin hydrochloride tablets have been included in the priority review and approval list The corresponding manufacturers of viagretin tablets are Qilu pharmaceutical, Nanjing Youke pharmaceutical, Beijing Taide pharmaceutical and Jiangsu Haosen pharmaceutical At present, no first manufacturer has been approved to imitate the tablets Yantai Wanrun Pharmaceutical Co., Ltd has been put on record as be, and Shandong Luoxin and Yangzijiang Pharmaceutical Group Sichuan Hailong have started clinical practice Gefitinib tablets are applied by Zhengda Tianqing pharmaceutical, Nanjing Youke pharmaceutical, Hunan Kelun pharmaceutical and Jiangsu Hengrui pharmaceutical At present, gefitinib is only the first generic product of Qilu pharmaceutical, which has been included in the priority review and approval list After 2016, the clinical enterprises of gefitinib tablets started include Ouyi pharmaceutical, Shanghai chuangnio pharmaceutical, Sichuan medacom Huakang pharmaceutical, Jiangsu Tianshili Diyi pharmaceutical, Dalian Zhenao pharmaceutical, Suzhou Teri pharmaceutical, Zhejiang Huahai pharmaceutical and Yangtze River Pharmaceutical According to the number of application acceptance, the enterprises are ranked first in Ouyi pharmaceutical industry of Petrochemicals Group In 2017, the products applied for are dasatinib tablets, metformin hydrochloride tablets and sustained-release tablets, pramipexole hydrochloride tablets, clopidogrel bisulfate tablets, sunitinib malate capsules and tegrilol tablets Among them, metformin hydrochloride tablets, sustained-release tablets and clopidogrel bisulfate tablets have been included in the priority review and approval list, which is expected to be a double reporting product approved quickly In 2017, Zhejiang Huahai pharmaceutical declared duloxetine hydrochloride enteric coated capsules, donepezil hydrochloride monohydrate and donepezil hydrochloride tablets, voriconazole tablets, celadoxin capsules and valsartan hydrochlorothiazide tablets Zhengda Tianqing and Foshan Derui can be tied for the third place Zhengda Tianqing declared lenalidomide capsule, saggliptin tablets, gefitinib tablets, alisentan tablets, apixaban tablets and abiolone acetate tablets Among them, at present, only the original research drug for the treatment of prostate cancer has been listed in China Dr redI Laboratory of India, Chengdu Shengdi pharmaceutical, Jiangxi Shanxiang pharmaceutical and Qilu pharmaceutical have applied for clinical application through be filing, and Chengdu Shengdi pharmaceutical has also produced the tablet in 2017 annual report Foshan derico Pharmaceutical Co., Ltd is a subsidiary of fadesheng Technology Co., Ltd and won shares of Sihuan Pharmaceutical Co., Ltd in 2017 Sihuan Pharmaceutical Co., Ltd can further develop the international distribution of preparations by manufacturing the drugs developed by its affiliated research institute of generic drugs in line with the European and American markets, registering and applying to the United States and the European Union In 2017, Foshan derico applied for 2 products, including quetiapine fumarate sustained release tablets and glibenclamide tablets Table 1 in 2017, the top five enterprises (data source: Xianda data v3.2) in the number of new category 4 / old category 6 application acceptance of chemical drugs are the two hot spots of biological products project: the hottest vaccine category and the monoclonal antibody category In the vaccine field where the imported products are obviously superior, the domestic products are also starting to make efforts Domestic declaration of biological products for prevention is mainly vaccine, especially influenza vaccine Shanghai Institute of biological products and Changchun Haiji sub organism have the largest number of applications There are many enterprises applying for the split vaccine of influenza virus, including Hualan biology, Changchun Haiji sub biology and Changchun Changsheng biology The application products of biological products for treatment are mainly McAb Among them, PD-1 antibody drugs and PD-L1 antibody drugs are hot spots PD-1 antibody drugs have been listed in 2 products, PD-L1 antibody drugs have been listed in 3 products in the world, and PD-1 antibody drugs in China have also successively entered phase III clinical, such as Xinda's ibi-308 In 2017, the enterprises applying for a large number of biological products for treatment included Jiahe biopharmaceutical, Sichuan Kelun Botai biopharmaceutical and Jiangsu Hengrui pharmaceutical, each with three product applications McAb R & D can be described as blooming everywhere, and the main pressure will come from drug price and project cost In addition, due to more projects and fewer patients, the clinical recruitment of the project will face competition Chinese patent medicine production report is the research and development of traditional Chinese medicine, which has been sluggish in recent years, and finally shows signs of recovery this year At present, the main focus of the research project is the change of dosage form, mainly oral preparations, especially for children According to the data of the Chinese medicine projects being applied for, the applying enterprises include Hutchison Huangpu pharmaceutical, Jichuan pharmaceutical, Yangzijiang pharmaceutical, Hangzhou Zhongmei Huadong pharmaceutical, Jiangsu Kangyuan pharmaceutical and Yunnan Baiyao group The products are basically oral drugs Jichuan pharmaceutical changed its superior products into syrup, and declared the dandilan antiphlogistic syrup and xiaoerdaiqiaoqingre syrup in 2017 Summary: in 2017, the reporting of chemical drugs on the market in China finally recovered From the perspective of application, the reform of registration laws and regulations can not prevent enterprises from applying for products with great sales potential From the application data of enterprises in 2017, we can see which enterprises actively respond to the reform of registration laws and regulations, and adjust their own product R & D application strategies For example, Hengrui, the first enterprise with a market value of more than 200 billion yuan, has a layout in the hot fields of chemical drugs category 1, category 3, new category 4 and therapeutic biological products In 2017, Zhengda Tianqing and dongyangguang declared class 1 and new class 4 data of chemical drugs Collen is in chemical medicine category 3, biological products for treatment How to win in homogeneous competition will be the next step for enterprises to think about.