Objective To explore the factors influencing the implementation of drug standards improvement in China,and to offer some suggestions for improving drug standards.Methods Factor analysis was used to investigate the inf...Objective To explore the factors influencing the implementation of drug standards improvement in China,and to offer some suggestions for improving drug standards.Methods Factor analysis was used to investigate the influencing factors by referring to the literatures,experts’interview and collecting data through questionnaire,and then data were analyzed by SPSS21.0 statistical software.Results and Conclusion The results showed that there were four factors that affecting the plan of the national drug standards improvement.They were mechanism factor,design factor,constraint factor and motivation factor.And corresponding management suggestions for improving the efficiency of the plan were put forward.展开更多
Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being dis...Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and developed.Although several high-quality reviews on clinical antibacterial drug pipelines from a global perspective were published recently,none provides comprehensive information on original antibacterial drugs at clinical stages in China.In this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since 2019.Information was obtained by consulting official websites,searching commercial databases,retrieving literature,asking personnel from institutions or companies,and other means,and a considerable part of the data covered here has not been included in other reviews.As of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and updated.Among them,two new antibacterial drugs that belong to traditional antibiotic classes were approved by the National Medical Products Administration(NMPA)in China in 2019 and 2021,respectively,and 18 antibacterial agents are in clinical development,with one under regulatory evaluation,five in phase-3,six in phase-2,and six in phase-1.Most of the clinical candidates are new analogs or monocomponents of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibiotics and a recombinant antibacterial protein.Overall,despite there being 17 antibacterial clinical candidates,our analysis indicates that there are still relatively few clinically differentiated antibacterial agents in stages of clinical development in China.Hopefully,Chinese pharmaceutical companies and institutions will develop more innovative and clinically differentiated candidates with good market potential in the future research and development(R&D)of original antibacterial drugs.展开更多
Background and Aims:The National Centralized Drug Procurement(NCDP)policy was launched in China's Mainland in April 2019,with entecavir(ETV)and tenofovir disoproxil fumarate(TDF)being included in the procurement l...Background and Aims:The National Centralized Drug Procurement(NCDP)policy was launched in China's Mainland in April 2019,with entecavir(ETV)and tenofovir disoproxil fumarate(TDF)being included in the procurement list.We conducted the current study to investigate the impact of the NCDP policy on the utilization and expenditures of antiviral therapy for chronic hepatitis B(CHB)in China.Methods:Procurement records,including monthly purchase volume,expenditure,and price of nucleos(t)ide analogs(NAs),were derived from the National Healthcare Security Administration from April 2018 to March 2021.The changes in volumes and expenditures of the first-line NAs and bid-winning products were calculated.The effects of price,volume,and structure related to drug expenditure were calculated by the Addis and Magrini(AM)Index System Analysis.Results:The purchase volume of NAs significantly increased from 134.3 to 318.3 million DDDs,whereas the expenditure sharply decreased from 1,623.41 to 490.43 million renminbi(RMB)or 241.94 to 73.09 million US dollars(USD).The proportions of firstline NAs rose from 72.51%(ETV:69.00%,TDF:3.51%)to 94.97%(ETV:77.42%,TDF:17.55%).AM analysis showed that the NCDP policy decreased the expenditure of all NAs(S=0.91)but increased that of the first-line NAs in the bidwinning list(S=1.13).Assuming the population size of CHB patients remains stable and a compliance rate of≥75%,the proportion of CHB patients receiving first-line antiviral therapy would increase from 6.36–8.48%to 11.56–15.41%.Conclusions:The implementation of the NCDP policy significantly increased the utilization of first-line NAs for CHB patients at a lower expenditure.The findings provided evidence for optimizing antiviral therapy strategy and allocating medical resources in China.展开更多
文摘Objective To explore the factors influencing the implementation of drug standards improvement in China,and to offer some suggestions for improving drug standards.Methods Factor analysis was used to investigate the influencing factors by referring to the literatures,experts’interview and collecting data through questionnaire,and then data were analyzed by SPSS21.0 statistical software.Results and Conclusion The results showed that there were four factors that affecting the plan of the national drug standards improvement.They were mechanism factor,design factor,constraint factor and motivation factor.And corresponding management suggestions for improving the efficiency of the plan were put forward.
基金supported by the National Natural Science Foundation of China(32141003 and 82330110)the CAMS Innovation Fund for Medical Sciences(CIFMS+2 种基金2021-I2M-1-039)the National Science and Technology Infrastructure of China(National Pathogen Resource Center-NPRC-32)the Fundamental Research Funds for the Central Universities(2021-PT350-001).
文摘Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and developed.Although several high-quality reviews on clinical antibacterial drug pipelines from a global perspective were published recently,none provides comprehensive information on original antibacterial drugs at clinical stages in China.In this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since 2019.Information was obtained by consulting official websites,searching commercial databases,retrieving literature,asking personnel from institutions or companies,and other means,and a considerable part of the data covered here has not been included in other reviews.As of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and updated.Among them,two new antibacterial drugs that belong to traditional antibiotic classes were approved by the National Medical Products Administration(NMPA)in China in 2019 and 2021,respectively,and 18 antibacterial agents are in clinical development,with one under regulatory evaluation,five in phase-3,six in phase-2,and six in phase-1.Most of the clinical candidates are new analogs or monocomponents of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibiotics and a recombinant antibacterial protein.Overall,despite there being 17 antibacterial clinical candidates,our analysis indicates that there are still relatively few clinically differentiated antibacterial agents in stages of clinical development in China.Hopefully,Chinese pharmaceutical companies and institutions will develop more innovative and clinically differentiated candidates with good market potential in the future research and development(R&D)of original antibacterial drugs.
基金This work was supported by the National Healthcare Security Administration,The Key Technical and Executive Measures to Improve Early Phase Clinical Trials on Innovative Drugs for Liver Diseases(No.Z191100007619037)High-level Public Health Technical Talents of the Beijing Municipal Health Commission(XUEKEGUGAN-010-018).
文摘Background and Aims:The National Centralized Drug Procurement(NCDP)policy was launched in China's Mainland in April 2019,with entecavir(ETV)and tenofovir disoproxil fumarate(TDF)being included in the procurement list.We conducted the current study to investigate the impact of the NCDP policy on the utilization and expenditures of antiviral therapy for chronic hepatitis B(CHB)in China.Methods:Procurement records,including monthly purchase volume,expenditure,and price of nucleos(t)ide analogs(NAs),were derived from the National Healthcare Security Administration from April 2018 to March 2021.The changes in volumes and expenditures of the first-line NAs and bid-winning products were calculated.The effects of price,volume,and structure related to drug expenditure were calculated by the Addis and Magrini(AM)Index System Analysis.Results:The purchase volume of NAs significantly increased from 134.3 to 318.3 million DDDs,whereas the expenditure sharply decreased from 1,623.41 to 490.43 million renminbi(RMB)or 241.94 to 73.09 million US dollars(USD).The proportions of firstline NAs rose from 72.51%(ETV:69.00%,TDF:3.51%)to 94.97%(ETV:77.42%,TDF:17.55%).AM analysis showed that the NCDP policy decreased the expenditure of all NAs(S=0.91)but increased that of the first-line NAs in the bidwinning list(S=1.13).Assuming the population size of CHB patients remains stable and a compliance rate of≥75%,the proportion of CHB patients receiving first-line antiviral therapy would increase from 6.36–8.48%to 11.56–15.41%.Conclusions:The implementation of the NCDP policy significantly increased the utilization of first-line NAs for CHB patients at a lower expenditure.The findings provided evidence for optimizing antiviral therapy strategy and allocating medical resources in China.
