OpenLB
Open Library of Bioscience
Advanced Search
Therapeutic innovation & regulatory science
Feb 13, 2025;

Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review.

Beibei Zhu, Jing Li, Qi Ni, Shuo Yang, Zheng Yin, Xueyuan Yang
Author Information
  1. Beibei Zhu: Chinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China.
  2. Jing Li: Chinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China.
  3. Qi Ni: Chinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China.
  4. Shuo Yang: IQVIA Solutions Enterprise Management Consulting Shanghai Co Ltd, Shanghai, 200124, China.
  5. Zheng Yin: IQVIA Solutions Enterprise Management Consulting Shanghai Co Ltd, Shanghai, 200124, China.
  6. Xueyuan Yang: Chinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China. yangxueyuan@medmail.com.cn.
PMID: 39948234 DOI: 10.1007/s43441-025-00743-9

Abstract

INTRODUCTION: Policy reforms in drug regulation and reimbursement have encouraged drug research and development in China. However, there is a lack of insights on industry trends for dermatology research. We aim to describe trends and features of clinical trials for dermatology drugs in China, understand recent achievements, and forecast development trends.
METHODS: Clinical trial records posted on the Registration and Information Disclosure Platform of Center for Drug Evaluation (CDE) were screened. All trials for dermatological drugs, posted on platform between 2016 and 2022 were included.
RESULTS: A total of 1172 trial records were identified, among which studies for skin infection, immune-mediated and inflammatory skin disease (IMIDs) and skin malignancy accounted for 48.9% (n���=���573), 42.0% (n���=���492) and 9.1% (n���=���107), respectively. Most trials focused on generic drugs (n���=���728, 62.1%). Multi-regional clinical trials (MRCTs) accounted for less than 6% of all trials. The number of trials on dermatology drugs increased sharply from 2016 to 2018 followed by a decline, which is mainly driven by the drop in bioequivalence evaluation (BE) studies for generic drugs indicated for skin infection. A growing trend in the number of trials for innovative drugs was observed. After removing duplicated drugs based on generic name, a total of 607 tested dermatology drugs were identified among which 51.9% were indicated for IMIDs. The number of innovative drugs exceeded generic drugs from 2020 to 2022. The geographic distribution of lead sites (the site where the principal investigator being employed) was uneven, with most of them located in east China. Of 1,068 trials sponsored by Chinese firms, most were BE (n���=���692, 64.8%) and generic drugs (n���=���722, 67.6%), while among 104 trials sponsored by multinational corporations (MNC), a majority were phase III (n���=���53, 51.0%) trials and focused on innovative drugs (n���=���94, 90.4%).
CONCLUSION: Findings demonstrated positive consequences of reforms in the healthcare industry in China. Nevertheless, long-term policies are expected to enhance the innovative capabilities of Chinese pharmaceutical companies while ensuring accessible and affordable drug supply with generics, encourage early participation in global drug R&D activities to shorten "drug lag", and promote investment in innovative drugs.

Keywords

Clinical trial Dermatological disease Dermatological drug Pipeline Research and development Skin disease

References

  1. James SL, Abate D, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990���2017: a systematic analysis for the global burden of disease study 2017. Lancet. 2018;392:1789���858. [DOI: 10.1016/S0140-6736(18)32279-7]
  2. Peng D, Sun J, Wang J, et al. Burden of skin disease���China, 1990���2019. CCDCW. 2021;3:472���5.
  3. Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990���2017: a systematic analysis for the global burden of disease study 2017. Lancet. 2019;394:1145���58. [DOI: 10.1016/S0140-6736(19)30427-1]
  4. Wu JH, Cohen BA. The stigma of skin disease. Curr Opin Pediatr. 2019;31:509���14. [DOI: 10.1097/MOP.0000000000000792]
  5. Jafferany M, Pastolero P. Psychiatric and psychological impact of chronic skin disease. Prim Care Companion CNS Disord. 2018. https://doi.org/10.4088/PCC.17nr02247 . [DOI: 10.4088/PCC.17nr02247]
  6. Imafuku S, Zheng M, Tada Y, et al. Asian consensus on assessment and management of mild to moderate plaque psoriasis with topical therapy. J Dermatol. 2018;45:805���11. [DOI: 10.1111/1346-8138.14338]
  7. Kong Y, Xing P, Huai P, et al. The burden of skin diseases in China: global burden of disease study 2019. Arch Dermatol Res. 2024;316:277. [DOI: 10.1007/s00403-024-03046-5]
  8. Ujiie H, Rosmarin D, Sch��n MP, et al. Unmet medical needs in chronic non-communicable inflammatory skin diseases. Front Med. 2022. https://doi.org/10.3389/fmed.2022.875492 . [DOI: 10.3389/fmed.2022.875492]
  9. Chen S, Chen X, Liu M, et al. Regulation of generic drugs in China: progress and effect of the reform of the review and approval system. J Pharm Innov. 2023;18:340���8. [DOI: 10.1007/s12247-022-09655-9]
  10. Zhong H, Ouyang D. The gap analysis between Chinese pharmaceutical academia and industry from 2000 to 2018. Scientometrics. 2020;122:1113���28. [DOI: 10.1007/s11192-019-03313-7]
  11. Sun J, Hu CJ, Stuntz M, et al. A review of promoting access to medicines in China���problems and recommendations. BMC Health Serv Res. 2018;18:125. [DOI: 10.1186/s12913-018-2875-6]
  12. Wang M. Clinical trials and drug approvals continue to accelerate in China. Lancet Oncol. 2017;18:855. [DOI: 10.1016/S1470-2045(17)30406-0]
  13. Zhou Q, Chen X-Y, Yang Z-M, et al. The changing landscape of clinical trial and approval processes in China. Nat Rev Clin Oncol. 2017;14:577���83. [DOI: 10.1038/nrclinonc.2017.10]
  14. The State Council of the People���s Republic of China. Opinions of the State Council on the Reform of the Review and Approval Process for Drugs and Medical Devices (in Chinese), https://www.nmpa.gov.cn/directory/web/nmpa/zhuanti/ypqxgg/ggzhcfg/20150818101201640.html (2015, accessed 30 September 2024).
  15. General Office of the CPC Central Committee and the General Office of the State Council. Opinions on Deepening the Reform of the Evaluation and Approval Systems to Encourage Innovation on Drugs and Medical Devices [in Chinese], http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm (2017, accessed 25 September 2022).
  16. Zhao Z, Pei Z, Hu A, et al. Analysis of incentive policies and initiatives on orphan drug development in China: challenges, reforms and implications. Orphanet J Rare Dis. 2023;18:220. [DOI: 10.1186/s13023-023-02684-8]
  17. People���s Daily. National Major Scientific and Technological Special Project for ���Significant New Drugs Development��� Achives Fruitful Results, https://www.gov.cn/xinwen/2019-08/01/content_5417723.htm (2019, accessed 28 November 2024).
  18. Su X, Wang H, Zhao N, et al. Trends in innovative drug development in China. Nat Rev Drug Discov. 2022;21:709���10. [DOI: 10.1038/d41573-022-00077-3]
  19. Su L, Liu S, Li G, et al. Trends and characteristics of new drug approvals in China, 2011���2021. Ther Innov Regul Sci. 2023;57:343���51. [DOI: 10.1007/s43441-022-00472-3]
  20. China Food and Drug Administration. Announcement of the State Food and Drug Administration on the information platform for drug clinical studies (no. 28) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20130906120001263.html?type=pc&m = (2013, accessed 29 September 2024).
  21. National Medical Products Administration. Requirements for Registration Classification and Application Dossiers of Chemical Drugs (No. 44 of 2020) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20200630180301525.html?type=pc&m = (accessed 27 November 2024).
  22. National Medical Products Administration. Requirements for Registration Classification and Application Dossiers of Biological Products (No. 43 of 2020) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20200630175301552.html?type=pc&m = (accessed 27 November 2024).
  23. The Office of the State Council of China. Opinions of the General Office of the State Council on the Consistency Evaluation of the Quality and Efficacy of Generic Drugs [2016] No. 8. (in Chinese), https://www.gov.cn/zhengce/zhengceku/2016-03/05/content_5049364.htm (2016, accessed 28 November 2024).
  24. Patel SS, Huang KE, Fleischer AB, et al. Five-year trend in the number of dermatologic clinical drug trials registered on clinical trials.gov. J Drugs Dermatol. 2015;14:497���500. [PMID: 25942669]
  25. Hu H, Lu X, Xu H, et al. Analysis of new drug registration and review in China in 2021. Acta Pharm Sin B. 2022;12:2127���8. [DOI: 10.1016/j.apsb.2022.02.018]
  26. Agten S, Wu B. Innovation in the Chinese Biopharma Sector: From Me-too to First-in-Class. In: Agten S, Wu B, editors. Biopharma in China: Innovation Trends and Dealmaking. Springer; 2024. p. 71���99. [DOI: 10.1007/978-981-97-1471-1_4]
  27. Hu Y, Chen S, Qiu F, et al. Will the volume-based procurement policy promote pharmaceutical firms��� R&D investment in China? an event study approach. Int J Environ Res Public Health. 2021;18:12037. [DOI: 10.3390/ijerph182212037]
  28. Wang N, Yang Y, Xu L, et al. Influence of Chinese national centralized drug procurement on the price of policy-related drugs: an interrupted time series analysis. BMC Public Health. 2021;21:1883. [DOI: 10.1186/s12889-021-11882-7]
  29. Chen L, Yang Y, Luo M, et al. The impacts of national centralized drug procurement policy on drug utilization and drug expenditures: the case of Shenzhen, China. Int J Environ Res Public Health. 2020;17:9415. [DOI: 10.3390/ijerph17249415]
  30. Wang J, Yang Y, Xu L, et al. Impact of ���4+7��� volume-based drug procurement on the use of policy-related original and generic drugs: a natural experimental study in China. BMJ Open. 2022;12:e054346. [DOI: 10.1136/bmjopen-2021-054346]
  31. National Medical Products Administration. Guidelines for International Multicenter Drug Clinical Trials (Draft) (No. 2 of 2015) (in Chinese), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20150130120001641.html?type=pc&m = (2015, accessed 28 November 2024).
  32. Ramamoorthy A, Pacanowski MA, Bull J, et al. Racial/ethnic differences in drug disposition and response: review of recently approved drugs. Clin Pharmacol Ther. 2015;97:263���73. [DOI: 10.1002/cpt.61]
  33. Lo C, Nguyen S, Yang C, et al. Pharmacogenomics in Asian subpopulations and impacts on commonly prescribed medications. Clin Transl Sci. 2020;13:861���70. [DOI: 10.1111/cts.12771]
  34. Ferguson JE, Seger EW, White J, et al. Racial/ethnic differences in treatment efficacy and safety for moderate-to-severe plaque psoriasis: a systematic review. Arch Dermatol Res. 2023;315:41���50. [DOI: 10.1007/s00403-022-02324-4]
  35. Kaufman BP, Guttman-Yassky E, Alexis AF. Atopic dermatitis in diverse racial and ethnic groups-variations in epidemiology, genetics, clinical presentation and treatment. Exp Dermatol. 2018;27:340���57. [DOI: 10.1111/exd.13514]
  36. Shenoy P. Multi-regional clinical trials and global drug development. Perspect Clin Res. 2016;7:62���7. [DOI: 10.4103/2229-3485.179430]
  37. Huang N, Huang W, Luo Y, et al. China���s drug clinical trial institution record-keeping system: qualification requirements for PI are the key. Front Pharmacol. 2023. https://doi.org/10.3389/fphar.2023.1052977 . [DOI: 10.3389/fphar.2023.1052977]
  38. Langan SM, Bourke JF, Silcocks P, et al. An exploratory prospective observational study of environmental factors exacerbating atopic eczema in children. Br J Dermatol. 2006;154:979���80. [DOI: 10.1111/j.1365-2133.2006.07153.x]
  39. Wang X, Li L-F, Zhao D-Y, et al. Prevalence and clinical features of atopic dermatitis in China. Biomed Res Int. 2016;2016:2568301. [DOI: 10.1155/2016/2568301]
  40. Li J, Mao D, Liu S, et al. Epidemiology of urticaria in China: a population-based study. Chin Med J (Engl). 2022;135:1369���75. [DOI: 10.1097/CM9.0000000000002172]
  41. Xu L, Zhang L, Tian X, et al. Epidemiological research on inpatients with skin cancer in China (in Chinese). ������������������������ 2020; 20: 1280���1283.
  42. Qu J, Huang Y, Lv X. Crisis of antimicrobial resistance in China: now and the future. Front Microbiol. 2019. https://doi.org/10.3389/fmicb.2019.02240 . [DOI: 10.3389/fmicb.2019.02240]
  43. Wang H. Current and future landscape of the antimicrobial resistance of nosocomial infections in China. CCDCW. 2022;4:1101���4.
  44. Zhang X, Song X, Zhang M, et al. Prevalence and risk factors of chronic urticaria in China: a nationwide cross-sectional study. Allergy. 2022;77:2233���6. [DOI: 10.1111/all.15287]
  45. Zhao Z, Cai T, Chen H, et al. Expert consensus on the use of omalizumab in chronic urticaria in China. World Allergy Organ J. 2021;14:100610. [DOI: 10.1016/j.waojou.2021.100610]

Grants

  1. 2021-I2M-1-045/Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences
  2. 2021-I2M-1-045/Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences
  3. 2021-I2M-1-045/Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences
  4. 2021-I2M-1-045/Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences
Journal Article Review

Word Cloud

Created with Highcharts 10.0.0drugstrialsdrugChinagenericinnovativedermatologyskindevelopmenttrendsClinicaltrial2016amongdiseasenumberDermatologicalreformsresearchindustryclinicalrecordsposted2022totalidentifiedstudiesinfectionIMIDsaccounted9%0%1%focused6%BEindicated51sponsoredChineseINTRODUCTION:PolicyregulationreimbursementencouragedHoweverlackinsightsaimdescribefeaturesunderstandrecentachievementsforecastMETHODS:RegistrationInformationDisclosurePlatformCenterDrugEvaluationCDEscreeneddermatologicalplatformincludedRESULTS:1172immune-mediatedinflammatorymalignancy48n���=���57342n���=���4929n���=���107respectivelyn���=���72862Multi-regionalMRCTslessincreasedsharply2018followeddeclinemainlydrivendropbioequivalenceevaluationgrowingtrendobservedremovingduplicatedbasedname607testedexceeded2020geographicdistributionleadsitessiteprincipalinvestigatoremployedunevenlocatedeast1068firmsn���=���692648%n���=���72267104multinationalcorporationsMNCmajorityphaseIIIn���=���53n���=���94904%CONCLUSION:FindingsdemonstratedpositiveconsequenceshealthcareNeverthelesslong-termpoliciesexpectedenhancecapabilitiespharmaceuticalcompaniesensuringaccessibleaffordablesupplygenericsencourageearlyparticipationglobalR&Dactivitiesshorten"druglag"promoteinvestmentChangesTrialsDrugsMainland2022:NarrativeReviewPipelineResearchSkin

Similar Articles

Cited By