An Update on the Clinical Pipelines of New Antibacterial Drugs Developed in China

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.

The effects of the National Drug Pooled Procurement(NDPP)pilot program in China

In 2018,the Chinese government identified four municipalities and seven sub-provincial cities for the implementation of the National Drug Pooled Procurement(NDPP)pilot program(the“4+7”policy).In the present study,we analyzed the effects of the“4+7”policy with data of 25 pilot drugs from the National Healthcare Security Administration(NHSA)from the aspects of drug price,volume,and expenditure.After the implementation of the policy,the average price of total and winning drugs was decreased by 54.47%and 73.82%,respectively,while the DDDc of non-winning drugs was decreased by only 1.54%,and the DDDc of uncertificated generic drugs was increased 83.18%.The DDDs indicating the volume of total and winning drugs was increased by 21.18%and 353.98%,respectively,and the DDDs of non-winning drugs was decreased by 61.35%.The costs of total and non-winning drugs were decreased by 44.83%and 61.94%,respectively,and the cost of winning drugs was increased by 18.87%.The“4+7”policy reduced the price and cost of pilot drugs and improved the affordability and accessibility of drugs.However,there were also problems with unexpected excessive price increases of uncertificated generic drugs and relatively high prices of non-winning products.Therefore,we highly suggested promoting the normalization and institutionalization of pooled drug procurement,enhancing the administrative capacity of local procurement platforms,and strengthening monitoring the price of non-winning,especially for the uncertificated generic drugs.

Brief introduction for application of the USA national drug code

The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.

Factors Influencing the Implementation of Drug Standards Improvement in China

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.

基于史密斯政策执行过程模型的国家医保药品目录准入谈判罕见病药品落地问题及路径研究

目的基于史密斯政策执行过程模型的国家医保药品目录准入谈判(以下简称“国谈”)罕见病药品落地的关键和难点,探索罕见病药品在进入国家基本医疗保险和工伤保险药品目录后政策实施过程中存在的问题并提出对策建议。方法通过文献复习和政策梳理、专家访谈、焦点小组访谈收集资料,结合史密斯政策执行过程模型的理论框架从多角度探索国谈罕见病药品政策执行情况的现状、问题以及解决方案。结果目前我国罕见病药品行业管理尚处于初级阶段;医疗服务提供方在意识、管理等方面仍存在不足;罕见病药品保障渠道有待优化,医疗保险支付机制尚不完善。结论建议进一步加强行业管理,提升罕见病用药保障;加强医疗服务提供方能力建设,取消罕见病用药考核限制;畅通罕见病用药保障渠道,完善医疗保险支付机制。

常州市各级医院带量采购政策实施效果差异研究

目的评价第二批国家集中带量采购(以下简称“集采”)政策在常州市不同等级医院的实施效果。方法基于双组间断时间序列模型和描述性统计,依托江苏省常州市医疗机构药品采购数据,分析第二批国家集采政策实施对江苏省常州市二级及以上医院和基层医疗卫生机构用药影响差异。结果第二批国家集采政策实施后,常州市二级及以上医院和基层医疗卫生机构集采品种均呈现不同程度药品使用频度(defined drug dose numbers,DDDs)上升、采购金额下降和药品日均费用(defined daily dose cost,DDDc)下降的现象,其中对于基层医疗卫生机构集采中选品种使用增长效果更明显,在具体药物种类上,心血管系统类、消化系统类药物受政策影响更明显。结论政府应该根据不同医院的用药特点制定更为灵活、有针对性的集采品种使用考核标准,并将考核细化到不同种类药品的使用情况。此外,政府相关部门应持续性检测各级医院的合理用药情况,并通过奖惩制度提高医疗机构使用集采品种的积极性。

基于利益相关者分析的国家谈判药品“双通道”政策落地症结与对策研究

目的从利益相关者角度分析国家谈判药品“双通道”政策落地的动力及风险因素,为打通政策落地的最后环节提出政策建议。方法从药品目录、药店遴选、医疗保险经办、使用监管维度梳理各省(自治区、直辖市)“双通道”实施方案,结合文献分析和利益相关者访谈,从医疗保障部门、卫生健康行政部门、医疗机构、药品生产企业、药店5方角度分析政策落地的激励和风险因素。结果各省(自治区、直辖市)基本已发文落实建立“双通道”管理机制。该政策有利于医疗保障部门实现药品供应保障多元化,但基金控费风险、协议管理、医疗机构年度医疗保险总额调整等面临更大压力;有助于卫生健康部门实现医药分开,但政策协同性、医疗费用控制等面临更高要求;有利于缓解医院的药品配备和医疗服务压力,但增加了用药安全风险和管理难度,若外配处方不纳入总额预算,可缓解控费压力,否则不利于处方外流;有利于药店增加药品配备,扩大整体市场份额并向“双通道”药房集中,但加价空间减少,信息化、人员配备、药品管理、审核管理压力增大。同时,公众和医疗机构不信任依然存在。结论“双通道”政策的落地需要多方协同发力,采购与需求匹配,完善药品遴选和配备供应;政府与行业合力,优化“双通道”药房管理;药房与医院衔接,规范处方流转和药品使用;医疗保险和医疗协同,强化基金和药品使用监管。

Impact of National Centralized Drug Procurement Policy on Antiviral Utilization and Expenditure for Hepatitis B in China

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.

Brief introduction for application of USA authorized generic drugs

The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.