亚洲社会药学

本期目录

2023年, 第18卷, 第4期　刊出日期：2023-12-20 上一期    下一期

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Research on Incentive Policies for Chinese Innovative Drug R&D - Taking Innovative Anti-tumor Drugs as an Example Wang Yuejun, Yang Yue, Huang Zhe 2023 (4):  303-314.  摘要 ( 135 )   PDF(2658KB) ( 183 )   Objective To provide reference for improving Chinese innovative drug research and development incentive policies. Methods Based on investigating the incentive policies for innovative drug research and development in clinical research, evaluation and approval in China, anti-tumor drugs were taken as the research object to discuss relevant policies from the perspective of clinical trials and registration approval based on data statistics and current situation analysis. Results and Conclusion Driven by a series of incentive policies for innovative drug R&D, great achievements have been made on anti-tumor drugs. However, there are problems such as concentration of drug targets, homogenization of clinical trials, and gaps in some drugs with large clinical needs. To improve incentive policies for innovative drug R&D, China should adhere to the orientation of clinical value, focusing on basic research and translational research, improving evaluation and approval capabilities, and establishing a sound ecosystem for innovative drugs. 相关文章 | 计量指标

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Research on the Impact of Independent R&D and Collaborative Innovation on Economic Performance in China’s pharmaceutical Industry Li Wanting, Qiao Jiahui, Wang Su, Chen Yuwen 2023 (4):  315-325.  摘要 ( 105 )   PDF(406KB) ( 107 )   Objective To study the impact of independent R&D and collaborative innovation on economic performance in the pharmaceutical industry. Methods A panel regression model was established by selecting the panel data of China’s pharmaceutical industry from 2009 to 2019. Results and Conclusion Independent R&D and collaborative innovation of the pharmaceutical industry in eastern, central and western regions of China had a positive effect on economic performance. Besides, the promotion effect of independent R&D was greater than that of collaborative innovation. The positive driving effect of economic performance is the largest among the three regions, followed by the central and western regions. The collaborative innovation has the greatest positive effect on economic performance in the central region, followed by the eastern and western regions. 相关文章 | 计量指标

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Research on the Effect of R&D Investment Intensity and Sales Expense on the Performance of Biomedical Enterprises Wang Lifei, Jia Zheng, Wu Dongming, Xinghua 2023 (4):  326-334.  摘要 ( 129 )   PDF(417KB) ( 152 )   Objective To explore the influence of new drug R&D investment and sales expense on the performance of biomedical enterprises. Methods The financial statements of 76 listed biomedical enterprises for 5 consecutive years were selected, and the data were modeled to study the effect of R&D investment and sales expense on the performance of biomedical enterprises by using financial indicators as tools and statistical methods of multiple linear regression. Results and Conclusion Under the premise that the weak related factors such as enterprise scale, life cycle and asset-liability ratio are set as unrelated variables, the R&D investment intensity of biomedical enterprises is negatively correlated with the current performance, which also shows that the R&D of biomedical enterprises has the characteristics of high risk. Besides, the influence of early R&D investment is delayed. However, the sales expense of leading biomedical enterprises with large scales have higher proportion. Meanwhile the greater sales expense of the same enterprise in different periods, the better the enterprise performance is. Biomedical enterprises should consider their own development stage to develop more patented drugs. Besides, they must formulate plans for allocating reasonable sales personnel and cost expense to ensure that enterprises can obtain better benefits. 相关文章 | 计量指标

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The Status Quo and Enlightenment of the Foreign Extended Clinical Trial System Teng Xinyi, Tian Lijuan 2023 (4):  335-344.  摘要 ( 104 )   PDF(396KB) ( 111 )   Objective To study the extended clinical trial systems in the United States, the European Union and Australia, and to provide a reference for the improvement of China’s extended clinical trial system. Methods Literature research method, risk management analysis method and comparative research were used in this paper to analyze the development history, scope of use, status quo of the extended clinical trial systems in the United States, the European Union, and Australia. Then, the current situation and shortcomings of China’s extended clinical trial system were compare with these foreign countries so as to put forward some suggestions for improvement. Results and Conclusion China should improve existing laws and regulations by establishing a fast application procedure, increasing application channels, and providing an information disclosure platform to meet the needs of patients in extended clinical trials. 相关文章 | 计量指标

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Introduction of PIC/S Accession Procedure and Suggestions for Establishing a Unified Quality Management System in China Hu Shigao, Wu Zhiang 2023 (4):  345-351.  摘要 ( 104 )   PDF(372KB) ( 71 )   Objective To introduce the accession procedure and evaluation of PIC/S, and help relevant departments in China to understand the requirements of PIC/S in detail, and to promote the process of China’s entry into PIC/S. Methods The procedures and steps of joining PIC/S, the evaluation process of PIC/S, and the experience of several countries in joining PIC/S were introduced and analyzed, which could help the relevant personnel in China understand the specific contents. Results and Conclusion According to the requirements of PIC/S, it is necessary to establish a unified GMP quality management system. 相关文章 | 计量指标

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Foreign Experience and Enlightenment of Reimbursement Management of Multi-indication Drugs Wang Huiyan, Yu Hanshuang, Sun Lihua 2023 (4):  352-358.  摘要 ( 103 )   PDF(391KB) ( 134 )   Objective To provide reference for China’s medical insurance reimbursement plan of multi-indication drugs. Methods By referring to relevant foreign literature, the implementation process and conditions of different reimbursement management modes of multi-indication drugs were analyzed to provide suggestions for reimbursement of multi-indication drugs in China. Results and Conclusion It is suggested to further explore the suitable conditions and select the corresponding mode in China. Payment standards should be set according to value pricing and budget impact analysis. Besides, data collection and analysis mechanism must be improved. Lastly, reward and punishment mechanism can be adopted to improve management efficiency. 相关文章 | 计量指标

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Study on Public Health Behavior against the Background of COVID-19 Pandemic - Based on Bandura Reciprocal Determinism Di Haopu, Wang Shuling 2023 (4):  359-364.  摘要 ( 151 )   PDF(378KB) ( 151 )   Objective To explore the factors influencing public health behaviors in China in the context of COVID-19 pandemic, and to propose suggestions and countermeasures for enhancing public health behaviors. Methods A public health behavior system based on Bandura’s reciprocal determinism was constructed, and public health behavior was analyzed from the perspective of the interaction of health awareness, health behavior and environment. Results and Conclusion The public health behavior was analyzed through the public health behavior system based on Bandura’s reciprocal determinism, and the results and conclusions were draw. The public can be urged to develop better health beliefs and form better health behaviors by strengthening publicity and interventions, improving personal awareness, and increasing government investment. 相关文章 | 计量指标

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Inspiration of Foreign Innovative Drug Pricing Methods and Medical Insurance Payment Standards to China Rao Xiuli, Sun Lihua 2023 (4):  365-373.  摘要 ( 119 )   PDF(352KB) ( 107 )   Objective To study the innovative drug pricing methods and medical insurance payment standards in foreign countries and to provide reference for China’s government. Methods The official websites were searched for information and related literature, and literature review was used. Results and Conclusion In foreign countries, the clinical value of innovative drugs and their impact on medical insurance funds were comprehensively evaluated based on factors such as quality-adjusted life years, clinical benefit, and improvement of clinical benefit. Then, the evaluation results were taken as an important basis for whether innovative drugs were admitted to the medical insurance catalog and establishing medical insurance payment standards. By using international experience for reference, innovative drug pricing methods and medical insurance payment standards for China’s national conditions can be improved by establishing a basic database of clinical value and drug economic evaluation of innovative drugs, as well as innovative drug payment models based on decision thresholds. 相关文章 | 计量指标

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Current Situation and Prospect of the Application of Real-World Evidence in Health Care Xiao Feiyi, Zhang Fang, Li Xue, Dong Li 2023 (4):  374-386.  摘要 ( 135 )   PDF(403KB) ( 225 )   Objective To summarize the application of real-world evidence (RWE) in the medical and healthcare field of various countries, including relevant policies, application scenarios and application methods. Methods Relevant policies and application scenarios were obtained by consulting the official websites and public documents of various countries’ healthcare institutions. Systematic literature retrieval was adopted to search PubMed, EMBASE, Cochrane Library, CNKI, CBM and Wanfang databases, and all papers related to real-world study and application were included. Then, these papers were classified and analyzed by country and application method. Results and Conclusion The RWE was mainly applied to supporting the preliminary approval of a new drug, expanding drug indications, accelerating approval or supporting conditional marketing authorizations and drug safety evaluation, etc. The United Kingdom, the United States, Germany, the Netherlands, Italy, Sweden, and France admitted RWE, but they treated the data obtained from RWE with caution. After systematic literature retrieval, a total of 701 articles were obtained, including relevant studies from 36 countries, among which the United States published 264 in total. The most common study was about using real-world data (RWD) to calculate treatment-related costs, which had a total of 259 studies. Secondly, 158 articles were used for epidemiological analysis. Then, 138 articles were about establishing risk models to analyze disease risk factors. A total of 70 articles were real-world efficacy evaluation of the drug treatment schemes, 54 articles were about pharmacoeconomic evaluation with RWD as parameters. A total of 29 articles used RWD to build predictive models, and 15 articles used RWD to evaluate the health-related quality of life in patients. The application of RWE has been used widely in the medical and healthcare field of various countries. The application scenarios are gradually diversified, the application methods of RWD become mature, and the evidence quality of RWE is also improved greatly. 相关文章 | 计量指标

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Research on the Construction of Evaluation Model for the Development of Biopharmaceutical Park in China Zhang Zongjie, Wu Zhiang 2023 (4):  387-397.  摘要 ( 76 )   PDF(464KB) ( 144 )   Objective To study the influencing factors on the development of biopharmaceutical park, and to construct an evaluation model of the influencing factors for biopharmaceutical park in China. Methods By analyzing various factors affecting biopharmaceutical parks, an evaluation index system of biopharmaceutical parks and an evaluation model of influencing factors of biopharmaceutical park development based on fuzzy group decision making were established. Results and Conclusion Factors such as research and development (R&D) funding investment, incentive for transformation of scientific and technological achievements, and industrial clusters have a greater impact on the development of biopharmaceutical industrial parks in China. Local governments should increase the investment in R&D funding. Besides, they should pay attention to the incentive of transformation of scientific and technological achievements to improve the innovation ability of enterprises. Meanwhile, they should promote the clustering of high-tech enterprises to comprehensively enhance the healthy development of biopharmaceutical parks in China. 相关文章 | 计量指标

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Investigation and Countermeasures of the Development of Chinese Pharmaceutical E-commerce in the B2C Model Based on PEST-SWOT Analysis Xiu Yu, Wang Shuling 2023 (4):  398-405.  摘要 ( 159 )   PDF(371KB) ( 149 )   Objective To analyze the problems of pharmaceutical e-commerce and provide strategies for its development in the future B2C mode since drug network management has great potential in China. Methods By collecting, identifying, and conducting literature research, PEST-SWOT identification and positioning of pharmaceutical e-commerce in the B2C mode were carried out. Results and Conclusion A PEST-SWOT analysis matrix was established to analyze the status of B2C pharmaceutical e-commerce, and to summarize its advantages, disadvantages, opportunities and threats from four perspectives of politics, economy, society and technology. Suggestions on cultivating compound talents proficient in medicine and e-commerce, exploring online payment methods for medical insurance, integration of upstream and downstream of the industrial chain and data sharing are put forward to promote the healthy and long-term development of pharmaceutical e-commerce under the background of big data. 相关文章 | 计量指标