Analysis report on drug acceptance in Jiangsu Province in 2019

Influenced by clinical verification, consistency evaluation and new policies on drug registration, the number of drug acceptances across the country plunged significantly in 2016 and 2017, with the total number of drug acceptances significantly reduced In 2018, the total acceptance volume of the whole country basically returned to normal, and in 2019, it was on the rise What was the situation of Jiangsu in the field of drug declaration in 2019? 1、 According to the latest statistics of drug intelligence registration and acceptance database, in 2019, CDE undertook 930 new drug registration applications in Jiangsu Province with acceptance number (excluding reexamination, the same below), an increase of 17.57% compared with 2018, accounting for 11.54% of the total accepted amount in China In terms of the number of registration applications, although Jiangsu pharmaceutical companies have not fully stepped out of the impact, they have shown a trend of recovery Note: data as of December 31, 2019 Figure 1 drug acceptance in Jiangsu Province in 2011-2019 the number of drug applications accepted by CDE in Jiangsu Province in 2019 (calculated by acceptance number) ranks the first in drug applications of all provinces and municipalities directly under the central government (see Figure 2) Note: data as of December 31, 2019 Figure 2 drug acceptance of CDE in 2019 in all provinces and cities across the country According to the application of various drug types, the acceptance of chemical drugs is the main one, with 857, followed by biological products, with 49 Note: data as of December 31, 2019 Figure 3 below the acceptance of drug types in Jiangsu in 2011-2019, let's specifically analyze the acceptance and review of registration of chemical drugs, traditional Chinese medicine and biological products In 2019, 857 chemical drugs will be accepted, including 198 new drugs, 226 generic drugs and 380 supplementary applications (see Figure 4) Note: data as of December 31, 2019 Figure 4 acceptance of chemical drugs in Jiangsu Province of CDE in 2011-2019 1.1 consistency evaluation Influenced by the general trend of consistency evaluation, from the perspective of acceptance, it is mainly generic drugs and supplementary applications, including 177 consistency evaluations included in supplementary applications, accounting for 17.05% of the total acceptance of national consistency evaluation in that year (if you want to know the specific situation, please pay attention to the acceptance database of pharmaceutical intelligence registration) Note: data as of December 31, 2019 (only the top 20 companies are shown due to space constraints) Figure 5 the number of acceptances of consistency evaluation of enterprises in Jiangsu Province in 2019 in Jiangsu chemical medicine consistency evaluation declaration list of this year, Yangzijiang Pharmaceutical Group Co., Ltd leads the list with 25 acceptances, Zhengda Tianqing Pharmaceutical Group Co., Ltd and Jiangsu Hengrui Pharmaceutical Co., Ltd are tied for the second place, and Jiangsu Enhua Pharmaceutical Co., Ltd is in the third place According to the consistency evaluation, pioglitazone hydrochloride tablets of Jiangsu Deyuan Pharmaceutical Co., Ltd., lenalidomide capsules of Zhengda Tianqing Pharmaceutical Group Co., Ltd., youzopiclone tablets of Jiangsu Tianshili Diyi Pharmaceutical Co., Ltd., risperidone dispersible tablets and clozapine tablets of Jiangsu Enhua Pharmaceutical Co., Ltd Please pay attention to the database of drug intelligence registration and acceptance for specific acceptance 2 in 2019, CDE undertook 23 applications for Jiangsu traditional Chinese medicine registration with acceptance number, including 15 supplementary applications, 1 imitation and 7 new drugs Note: data as of December 31, 2019 Figure 6 list of accepted quantities of traditional Chinese medicine in Jiangsu Province from 2011 to 2019 note: data as of December 31, 2019 3 in 2019, 14 acceptance numbers of biological products in Jiangsu were accepted by CDE, including 38 new drugs and 9 supplementary applications Note: data as of December 31, 2019 Figure 7 Acceptance quantity of biological products in Jiangsu Province from 2011 to 2019 Table 2 acceptance of biological products in Jiangsu Province No drug name registration and classification application type acceptance date enterprise name processing status start date cxsl1900011 recombinant anti PD-L1 all human monoclonal antibody injection biological products 1 new drug 2019-02-12 cornerstone Pharmaceutical (Suzhou) Co., Ltd In the review and approval, 2019-02-11 cxsl1900017 recombinant anti-PD-L1 all human monoclonal antibody injection treatment biological products 1 new drug 2019-03-07 cornerstone Pharmaceutical (Suzhou) Co., Ltd in the review and approval, 2019-03-06 cxsl1900143 recombinant anti PD-L1 all human monoclonal antibody injection treatment biological products 1 new drug 2019-12-20 cornerstone Pharmaceutical (Suzhou) Co., Ltd in the review and approval 2019-12-18 CXSL1900119 recombinant anti PD-L1 all human monoclonal antibody for injection biological products for treatment 1 new drug 2019-10-30 Jiangsu Huaiyu Pharmaceutical Co., Ltd in the review and approval 2019-10-29 CXSL1900001 QX002N biological products for injection treatment 1 new drug 2019-01-11 Jiangsu Quanxin Biological Medicine Co., Ltd in the review and approval 2019-01-10 CXSB1900017 Application for supplement of biological products for treatment of recombinant human serum albumin human granulocyte colony stimulating factor (I) fusion protein for injection Jiangsu Taikang biopharmaceutical Co., Ltd is in the process of review and approval on August 12, 2019 cxsl1900149 biological products for treatment of lilalutide injection 7 new drugs December 26, 2019 Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd is in the process of review and approval on December 25, 2019 cxsl1900060 biological products for treatment of all human BCMA chimeric antigen receptor autot cell injection 1 new drug June 21, 2019 Nanjing reindeer Medical Technology Co., Ltd in review and approval 2019-06-20 jxsl1900023 cd24fc biological products for injection treatment imported 2019-03-04 Suzhou Ankang Immune Technology Co., Ltd in review and approval 2019-03-02 cxsl1900121 cbp-201 biological products for injection treatment 1 new drug 2019-11-06 Suzhou kangnaide Biological Medicine Co., Ltd in review and approval 2019-11-04 Cxsl1900023 recombinant human PDL1 single domain antibody Fc fusion protein injection treatment biological product 1 new drug 2019-03-18 Suzhou Corning Jerry Biological Technology Co., Ltd in review and approval 2019-03-15 cxsl1900141 kn057 injection treatment biological product 1 new drug 2019-12-21 Suzhou Corning Jerry Biological Technology Co., Ltd in review and approval 2019-12-19 cxsl1900009 New biological products for treatment of carrizumab for injection 1 new drug 2019-02-03 Suzhou shengdia biomedical Co., Ltd in review and approval 2019-02-02 cxsl1900030 biological products for treatment of carrizumab for injection 1 new drug 2019-03-26 Suzhou shengdia biomedical Co., Ltd in review and approval 2019-03-25 cxsl1900036 carrizumab for injection New biological products for therapeutic use 1 new drug 2019-04-24 Suzhou shengdia Biological Medicine Co., Ltd is in the process of review and approval 2019-04-22 cxsl1900037 new biological products for therapeutic use 1 new drug 2019-04-24 Suzhou shengdia Biological Medicine Co., Ltd is in the process of review and approval 2019-04-22 cxss1900023 new biological products for therapeutic use 1 new drug 2019-05-16 Suzhou shengdia biomedical Co., Ltd is in the process of review and approval On May 15, 2019, cxsl1900054, new biological products for treatment of carrelizumab for injection On June 21, 2019, Suzhou shengdia biomedical Co., Ltd is in the process of review and approval On June 20, 2019, new biological products for treatment of cxsl1900055, new biological products for treatment of carrelizumab for injection On June 21, 2019, Suzhou shengdia biomedical Co., Ltd In the process of review and approval, the supplementary application for biological products for the treatment of cxsb1900013 carrelizumab for injection on June 20, 2019, the certificate of Suzhou shengdia biomedical Co., Ltd has been completed - approval document 2019-07-08, 2019, cxsl1900063 biological products for the treatment of carrelizumab for injection 1 new drug 2019-07-01, Suzhou shengdia biomedical Co., Ltd is in the process of review and approval on June 28, 2019 Cxsb1900021 supplementary application for biological products for treatment of carrelizumab for injection September 12, 2019 Suzhou shengdia biomedical Co., Ltd certificate preparation completed - approval document issued November 28, 2019 cxss1900034 biological products for treatment of carrelizumab for injection 1 new drug September 12, 2019 Suzhou shengdia biomedical Co., Ltd is under review and approval September 10, 2019 cxss1900035 New biological products for treatment of carrizumab for injection 1 new biological products for treatment 1 new biological products for injection 1 new biological products for treatment of cxsl1900106 shr-1316 injection 1 new drug 2019-09-25 Suzhou shengdia Biological Medicine Co., Ltd new biological products for treatment of cxsl1900113 shr-1316 injection 1 new drug 2019-09-24 On October 24, 2019, Suzhou shengdia biomedical Co., Ltd is in the process of review and approval On October 23, 2019, cxsl1900123, new biological products for treatment of carrizumab for injection On November 5, 2019, Suzhou shengdia biomedical Co., Ltd is in the process of review and approval On November 4, 2019, cxsl1900148, new biological products for treatment of carrizumab for injection 1, new biological products for treatment of 2019-12-24 Suzhou shengdia biomedical Co., Ltd is in the process of review and approval On December 23, 2019, cxsb1900001 supplementary application for biological products for trepril mAb injection treatment On January 10, 2019, Suzhou Zhonghe Biomedical Technology Co., Ltd has completed the preparation of certificate The approval document 2019-01-25, cxsl1900038, trepril mAb injection treatment biological products 1, new drug 2019-04-29 Suzhou Zhonghe Biomedical Technology Co., Ltd is in the process of review and approval On April 28, 2019, cxsb1900018 supplementary application for biological products for treatment of trepril mAb injection on August 6, 2019 Suzhou Zhonghe Biomedical Technology Co., Ltd has completed the examination and approval - to be certified on October 15, 2019, cxsl1900086 biological products for treatment of trepril mAb injection on August 13, 2019 Suzhou Zhonghe Biomedical Technology Co., Ltd is in the process of review and approval 2019-08-12 cxss1900041 adamumumab injection treatment biological products 2 new drugs 2019-11-13 Suzhou Zhonghe Biomedical Technology Co., Ltd is in the process of review and approval 2019-11-12 cxsl1900128 lp002 injection treatment biological products 1 new drugs 2019-11-20 Taizhou Houde Aoke Technology Co., Ltd is in the process of review and approval 2019-11-19 jxsl1900073 ban2401 biological products for treatment imported 2019-08-24 Weicai (China) Pharmaceutical Co., Ltd in review and approval 2019-08-23 cxsl1900111 wbp3425 biological products for injection treatment 1 new drug 2019-10-23 Wuxi Zhikang Hongyi Biological Technology Co., Ltd in review and approval 2019-10-22 cxsl1900052 ibi315 biological products for treatment 1 new drug 2019-05-28 Xinda biopharmaceutical (Suzhou) Co., Ltd is in the process of review and approval on May 27, 2019 cxss1900004 biological products for bevacizumab injection treatment 2 new drugs 2019-01-31 Xinda biopharmaceutical (Suzhou) Co., Ltd is in the process of review and approval on January 30, 2019 cxsl1900025 biological products for xindilithumab injection treatment 1 new drugs 2019-03-14 Xinda biopharmaceutical (Suzhou) Co., Ltd In the process of review and approval, 2019-03-13 cxsl1900040 ibi110 therapeutic biological products, 1 new drug, 2019-04-26 Xinda biological pharmaceutical (Suzhou) Co., Ltd in the process of review and approval, 2019-04-25 cxsb1900010 supplementary application for biological products for treatment of cindilimab injection, 2019-05-16 Xinda biological pharmaceutical (Suzhou) Co., Ltd has completed the preparation and certification of the approval document, 2019-06-05 cxsl1900053 ibi306 New biological products for treatment 1 new drug 2019-06-12 Xinda biological pharmaceutical (Suzhou) Co., Ltd is under review and approval 2019-06-10 cxss1900030 rituximab injection biological products for treatment 2 new drug 2019-07-01 Xinda biological pharmaceutical (Suzhou) Co., Ltd is under review and approval 2019-06-28 cxsl1900114 ibi939 new biological products for treatment 1 new drug 2019-10-23 Xinda biopharmaceutical (Suzhou) Co., Ltd is in the process of review and approval on October 21, 2019 cxsl1900125 ibi322 therapeutic biological products 1 new drug November 7, 2019 Xinda biopharmaceutical (Suzhou) Co., Ltd is in the process of review and approval