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Construction and application of a whole life-cycle multi-dimensional value evaluation model for innovative drugs

Published on Oct. 01, 2026Total Views: 909 times Total Downloads: 357 times Download Mobile

Author: ZHANG Hua 1, 2 LYU Ning 3 ZHENG Peng 4 LIN Rongzhi 5 ZHU Li 1 FEI Rongfu 1

Affiliation: 1.Zhejiang Pharmaceutical Group Co., Ltd., Hangzhou 310016, China 2.School of Pharmacy, Hangzhou Medical College, Hangzhou 310053, China 3.Zhejiang Pharmaceutical Industry Association, Hangzhou 310005, China 4.Planning and Finance Department, Zhejiang College of Construction, Hangzhou 311231, China 5.Zhejiang Shouxiangu Pharmaceutical Co., Ltd., Hangzhou 310020, China

Keywords: Innovative drugs Whole life-cycle value evaluation Multi-criteria decision analysis Preference parameter-based asymmetric combination weighting Hesitant fuzzy set Clinical research phase AI-assisted R&D Drug regulatory system

DOI: 10.12173/j.issn.2097-4922.202606048

Reference: ZHANG Hua,LYU Ning,ZHENG Peng,LIN Rongzhi,ZHU Li,FEI Rongfu. Construction and application of a whole life-cycle multi-dimensional value evaluation model for innovative drugs[J]. Frontiers in Pharmaceutical Sciences,2026,30(9):1557-1569. DOI:10.12173/j.issn.2097-4922.202606048[Article in Chinese]

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Abstract

Objective To construct a multi-dimensional value evaluation model for innovative drugs that covers eight basic dimensions, namely safety, efficacy, economy, scale, equity, accessibility, innovation and patient experience, adds a globalization dimension, and takes artificial intelligence‑assisted research and development as a bonus item.

Methods A multi-criteria decision analysis framework was adopted. The three‑level indicator system was screened via the modified Delphi method. An asymmetric combination weighting method based on preference parameters was used to integrate the subjective analytic hierarchy process and the objective entropy weight method to determine weights. Hesitant fuzzy sets were introduced to address the uncertainty of expert scores. A retrospective empirical analysis was conducted on 12 marketed innovative drugs, and evaluation elements and dynamic weight allocation were set separately for different clinical research cycles.

Results An evaluation system with 3 levels, 10 dimensions, 36 secondary indicators and 84 tertiary indicators was established. The correlation coefficient (R2) between the ten‑dimensional comprehensive score and the actual sales in the third year after marketing was 0.88 (P < 0.01), with an adjusted R² of 0.81, which was significantly superior to the risk-adjusted net present value method (R² = 0.53). The bonus item for AI‑assisted research and development could contribute an additional score of 5%‑20%. The globalization dimension was significantly positively correlated with the amount of overseas licensing transactions (r = 0.82).

Conclusion This model makes up for the deficiency of traditional valuation methods in considering non‑financial values. It provides a systematic and quantifiable decision‑support tool for the whole‑life‑cycle value evaluation of innovative drugs, and offers reference for dynamic value evaluation in China's drug regulatory system.

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References

1. DimasiJA, GrabowskiHG, HansenRW. Innovation in the pharmaceutical industry: New estimates of R&D costs[J]. J Health Econ, 2016, 47: 20-33. DOI: 10.1016/ j.jhealeco.2016.01.012.

2. 国家医疗保障局. 基本医疗保险用药管理暂行办法[EB/OL]. (2020-07-30)[2026-06-10]. https://www.nhsa.gov.cn/attach/0/bab0c20ab5604f69ab84ae22ab520274.pdf.

3. 武霞, 柯朝静, 邵蓉. 创新药物风险投资策略现状研究[J]. 中国新药杂志, 2020, 29(21): 2401-2407.WuX, KeCJ, ShaoR. Current status of venture capital strategies for innovative drugs[J]. Chinese Journal of New Drugs, 2020, 29(21): 2401-2407.  DOI: 10.3969/j.issn.1003-3734.2020.21.001.

4. JayatungaMKP, AyersM, BruensL, et al. How successful are AI-discovered drugs in clinical trials? A first analysis and emerging lessons[J]. Nat Rev Drug Discov, 2024, 23(5): 321-322. DOI: 10.1038/d41573-024-00067-3.

5. 国家药品监督管理局药品审评中心. 2025年度药品审评报告[EB/OL]. (2026-05-13)[2026-06-10]. https://www.nmpa.gov.cn/zwgk/zhpzbg/index.html.

6. 光明网. 创新药出海提速!一季度交易额突破600亿美元[EB/OL]. (2026-05-06)[2026-05-14]. https://yp.gmw.cn/2026-05/06/content_38680573.htm.

7. JarowJP, LavangeL, WoodcockJ. Multidimensional evidence generation and FDA regulatory decision making: defining and using "real-world" data[J]. JAMA, 2017, 318(8): 703-704. DOI: 10.1001/jama.2017.9991.

8. FDA. FDA announces major steps to implement real-time clinical trials[EB/OL]. (2026-04-28)[2026-06-10]. https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials. doi:10.1158/2159-8290.cd-nw2026-0071

9. 国家卫生健康委员会. 药品临床综合评价管理指南(2021年版试行)[S]. 2021. https://www.nhc.gov.cn/cms-search/downFiles/d5e6c29ceff147118d7c266870106c79.pdf.

10. FDA. AI-enabled optimization of early-phase clinical trials pilot program; request for information[EB/OL].(2026-04-29)[2026-06-10]. https://www.federalregister.gov/documents/2026/04/29/2026-08281/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information.

11. 尚俊美, 刘鑫, 陈丽萌, 等. 多准则决策分析在孤儿药综合评价中的应用进展[J]. 中国药学杂志, 2021, 56(22): 1785-1790.ShangJM, LiuX, ChenLM, et al. Application progress of multi-criteria decision analysis in assessment of orphan drugs[J]. Chinese Pharmaceutical Journal, 2021, 56(22): 1785-1790.  DOI: 10.11669/cpj.2021.22.001.

12. AngelisA, LinchM, MontibellerG, et al. Multiple criteria decision analysis for HTA across four EU member states: piloting the advance value framework[J]. Soc Sci Med, 2020, 246: 112595. DOI: 10.1016/j.socscimed.2019.112595.

13. PorterME, TeisbergEO. Redefining health care: creating value-based competition on results[M]. Boston: Harvard Business School Press, 2006: 1-256. doi:10.1007/s11293-007-9091-9

14. FreemanRE. Strategic management: a stakeholder approach[M]. Boston: Pitman, 1984: 1-275.

15. BresnahanTF, TrajtenbergM. General purpose technologies 'Engines of growth'?[J]. J Econom, 1995, 65(1): 83-108. DOI: 10.1016/0304-4076(94)01598-T.

16. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0[EB/OL]. (2017-11-27)[2026-06-10]. https://ctep.cancer.gov/protocoldevelopment/ elec tronic_applications/ctc.htm. doi:10.1016/b978-032303978-9.50028-9

17. 国家药品监督管理局. 抗肿瘤药物临床试验终点技术指导原则[EB/OL]. (2012-05-15)[2026-06-10]. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20190918104601536.html.

18. 中国药学会. 中国药物经济学评价指南2020: T/CPHARMA 003-2020[S]. 北京: 中国药学会, 2020. https://www.cpa.org.cn.

19. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019[J]. Lancet, 2020, 396(10258): 1204-1222. DOI: 10.1016/S0140-6736(20)30925-9.

20. World Health Organization. Equitable access to essential medicines: a framework for collective action[R]. Geneva: WHO, 2004: 1-6. https://iris.who.int/handle/10665/68571.

21. World Health Organization, Health Action International. Measuring medicine prices, availability, affordability and price components, 2nd ed[R]. Geneva: WHO, 2008: 1-293. https://iris.who.int/bitstream/handle/10665/70013/WHO_PSM_PAR_2008.3_eng.pdf.

22. FDA. Breakthrough therapy designation[EB/OL]. (2025-06-15)[2026-06-10]. https://www.fda.gov/patients/fast-track-breakthrough- therapy-accelerated-approval-priority-review/breakthrough-therapy-designation.

23. FDA. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims[EB/OL]. (2009-12)[2026-06-10]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-out come-measures-use-medical-product-development-support-labe ling-claims. doi:10.1186/1477-7525-4-79

24. ICH Harmonised Tripartite Guideline. General considerations for clinical studies E8(R1)[S]. 2021: ii, 1-26. https://database.ich.org/sites/default/files/ICH_E8-R1_Guideline_Step4_2021_1006.pdf. doi:10.46220/2022reg004

25. 张天翔, 黄哲. 美国FDA对原创新药的界定标准研究[J]. 中国药物化学杂志, 2025, 35(5): 399-406.ZhangTX, HuangZ. Research on the definition standards of original innovative drugs by the US FDA[J]. Chinese Journal of Medicinal Chemistry, 2025, 35(5): 399-406. DOI: 10.3969/j.issn.1003-3734.2025.05.001.

26. 国家药品监督管理局. “十四五”国家药品安全及促进高质量发展规划印发[EB/OL]. (2021-12-30)[2026-06-10]. https://www.nmpa.gov.cn/yaowen/ypjgyw/zhyw/20211230145247117.html.

27. 国家药品监督管理局药品审评中心. 以患者为中心的药物临床试验设计技术指导原则(试行)[EB/OL]. (2023-07-27)[2026-06-10]. https://www.cde.org.cn/main/news/viewInfoCommon/42c 008e28f7004cd19b73949142380bd.

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