vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2025-752vedomostiregmed-752Research ArticleРАЗРАБОТКА ЛЕКАРСТВЕННЫХ СРЕДСТВDEVELOPMENT OF MEDICINESСтратегические индикаторы в разработке оригинальных препаратов в 2024 году: анализ пайплайнов международных фармацевтических лидеровStrategic Indicators in the Development of Original Medicinal Products in 2024: Analysis of Pipelines of International Pharmaceutical Leadershttps://orcid.org/0000-0002-2229-1078ЛитвинЛ. С.LitvinL. S.

Литвин Лолиана Стефановна - канд. мед. наук.

ул. Добролюбова, д. 11, Москва, 127254

Loliana S. Litvin - Cand. Sci. (Med.).

11 Dobrolyubov St., Moscow 127254

litvinls@mednet.ruhttps://orcid.org/0009-0007-6003-7461КуликоваЕ. А.KulikovaE. A.

Куликова Екатерина Александровна.

ул. Добролюбова, д. 11, Москва, 127254

Ekaterina A. Kulikova.

11 Dobrolyubov St., Moscow 127254

kulikovaea@mednet.ruФедеральное государственное бюджетное учреждение «Центральный научно-исследовательский институт организации и информатизации здравоохранения» Министерства здравоохранения Российской ФедерацииРоссияRussian Research Institute of HealthRussian Federation202528082025154471484Copyright © Литвин Л.С., Куликова Е.А., 20252025Литвин Л.С., Куликова Е.А.Litvin L.S., Kulikova E.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/752ВВЕДЕНИЕ

ВВЕДЕНИЕ. Ключевое влияние на планирование разработки оригинальных лекарственных препаратов оказывают крупнейшие зарубежные фармацевтические компании. Для определения направлений развития разработки оригинальных препаратов в России актуален анализ мировых трендов и слабых сигналов (тенденций) — ранних индикаторов значимых в будущем инноваций.

ЦЕЛЬ

ЦЕЛЬ. Выявление трендов и тенденций, способных оказать влияние на фармацевтическую разработку в России, путем анализа спектра разрабатываемых оригинальных препаратов крупнейшими зарубежными компаниями.

МАТЕРИАЛЫ И МЕТОДЫ

МАТЕРИАЛЫ И МЕТОДЫ. Проведен анализ планов разработки препаратов на 2024 г. 20 крупнейших на мировом рынке зарубежных фармацевтических компаний, имеющих наиболее высокие бюджеты на исследования и разработки. Проанализированы оригинальные препараты, запланированные к изучению в клинических исследованиях I фазы за период январь — май 2024 г. Применена концепция описательного исследования, которая базируется на ретроспективном анализе вторичных данных. Измерениями проведенного анализа являлись номенклатура разрабатываемых оригинальных препаратов, направления разработки, целевые классы, виды и группы препаратов. На основании количественной и качественной оценки проводилось определение трендов и тенденций (слабых сигналов) в разработке оригинальных препаратов.

РЕЗУЛЬТАТЫ

РЕЗУЛЬТАТЫ. За анализируемый период 17 из 20 крупнейших фармацевтических компаний включили в исследования I фазы 84 оригинальных препарата. Больше всего разрабатываемых молекул определено в направлениях: «онкология», «эндокринология и обмен веществ», «сердечно-сосудистая система», «иммунология». 40 препаратов включены в исследования I фазы в направлении «онкология». Наибольшее количество препаратов (42%) относится к молекулам с относительно высокой молекулярной массой. На основании выявленного количества препаратов у нескольких разработчиков сделано предположение о наличии трендов разработки для следующих классов: «Большая молекула» — биспецифическое антитело (10 препаратов, 5 разработчиков); моноспецифическое антитело (8 препаратов, 7 разработчиков); конъюгат «антитело — лекарственное средство» (8 препаратов, 3 разработчика); «Малая молекула» — ингибиторы ферментов (9 препаратов, 6 разработчиков); «Препарат клеточной терапии» — препараты на основе CAR-T технологии (6 препаратов, 2 разработчика).

ВЫВОДЫ

ВЫВОДЫ. Актуальными трендами в развитии таргетной терапии является разработка биспецифических антител и конъюгатов «антитело–лекарство» нового поколения, параллельно с разработкой САR-T препаратов на основе аутологичных Т-клеток, преимущественно для терапии злокачественных новообразований. Исследование препаратов группы мультиспецифических антител формирует тенденцию разработки препаратов для таргетной терапии рака. Создание низкомолекулярных ингибиторов ферментов определяет тренд разработки препаратов в различных терапевтических областях. Разработка ингибиторов ферментов, воздействующих на мишени, основанные на принципе синтетической летальности (такие как WRN и PRMT5), является тенденцией в разработке малых молекул для прицельной терапии злокачественных опухолей.

INTRODUCTION

INTRODUCTION. Major international pharmaceutical companies play a crucial role in the development of original medicines. To determine the directions for original medicines development in Russia, it is essential to analyse global trends and emerging weak signals (tendencies) — early indicators of future-significant innovations. OBJECTIVE. To identify trends and emerging weak signals that could shape pharmaceutical development in Russia through an analysis of the pipeline of original medicines being developed by global pharma leaders.

MATERIALS AND METHODS

MATERIALS AND METHODS. An analysis was conducted on the medicinal product development plans for 2024 of the 20 largest pharmaceutical companies globally, which have the highest research and development budgets. The focus was on original medicines scheduled for clinical trials Phase 1 from January to May 2024. A descriptive research approach was applied, based on retrospective analysis of secondary data. The study measured the number of original medicines under development, research directions, target classes, medicine types, and groups. Both quantitative and qualitative evaluations were used to identify key trends and tendencies (emerging weak signals) in pharmaceutical development of medicines.

RESULTS

RESULTS. During the analysed period, 17 out of 20 leading pharmaceutical companies initiated Phase 1 trials for a total of 84 original medicines. The most active research areas included oncology, endocrinology and metabolism, cardiovascular system, and immunology. Notably, 40 medicines entered Phase 1 trials in oncology. The largest share (42%) of the medicines in development consists of high molecular weight molecules. Based on the number of medicines developed by multiple companies, trends were identified for the following medicine classes: “Large molecule” — bispecific antibodies (10 medicines, 5 developers); monospecific antibodies (8 medicines, 7 developers); antibody-drug conjugates (8 medicines, 3 developers); “Small molecule” — enzyme inhibitors (9 medicines, 6 developers); “Cell therapy” — CAR-T-based therapies (6 medicinal products, 2 developers).

CONCLUSIONS

CONCLUSIONS. Current trends in targeted therapy development include the creation of bispecific antibodies and next-generation antibody-drug conjugates, alongside CAR-T therapies based on autologous T cells, predominantly for the treatment of malignant neoplasms. The study of multispecific antibodies is shaping a new direction in targeted cancer therapy. The development of low-molecular-weight enzyme inhibitors is establishing a trend in various therapeutic areas. Specifically, enzyme inhibitors targeting synthetic lethal vulnerabilities like WRN and PRMT5 are emerging as a key tendency in small-molecule medicine development for targeted cancer therapy.

оригинальные лекарственные препаратымировые трендытенденциислабые сигналыпайплайнклинические исследования I фазыoriginal medicinal productsglobal trendstendenciesemerging weak signalspipelinePhase Iclinical trialsdrug developmentИсследование проведено при финансовой поддержке Минздрава России, направленной на обеспечение деятельности координационного центра исследований и разработок в области медицинской науки ФГБУ «ЦНИИОИЗ» Минздрава России в рамках реализации федерального проекта «Медицинская наука для человека».The study was supported by the Russian Ministry of Health through funding for the Coordination Center for Research and Development in Medical Science at the RIH (Russian Research Institute of Health) under the federal project 'Medical Science for Humanity'.ReferencesSchuhmacher A, Gassmann O, Hinder M, Hartl D. Comparative analysis of FDA approvals by top 20 pharma companies (2014-2023). Drug Discov Today. 2024;29(9):104128. https://doi.org/10.1016/j.drudis.2024.104128Schuhmacher A, Gassmann O, Hinder M, Hartl D. Comparative analysis of FDA approvals by top 20 pharma companies (2014-2023). Drug Discov Today. 2024;29(9):104128. https://doi.org/10.1016/j.drudis.2024.104128Yao Y, Hu Y, Wang F. Trispecific antibodies for cancer immunotherapy. Immunology. 2023;169(4):389–99. https://doi.org/10.1111/imm.13636Yao Y, Hu Y, Wang F. Trispecific antibodies for cancer immunotherapy. Immunology. 2023;169(4):389–99. https://doi.org/10.1111/imm.13636Tapia-Galisteo A, Compte M, Álvarez-Vallina L, Sanz L. When three is not a crowd: Trispecific antibodies for enhanced cancer immunotherapy. Theranostics. 2023;13(3):1028–41. https://doi.org/10.7150/thno.81494Tapia-Galisteo A, Compte M, Álvarez-Vallina L, Sanz L. When three is not a crowd: Trispecific antibodies for enhanced cancer immunotherapy. Theranostics. 2023;13(3):1028–41. https://doi.org/10.7150/thno.81494Mullard A. Trispecific antibodies take to the clinic. Nat Rev Drug Discov. 2020;19(10):657–8. https://doi.org/10.1038/d41573-020-00164-3Mullard A. Trispecific antibodies take to the clinic. Nat Rev Drug Discov. 2020;19(10):657–8. https://doi.org/10.1038/d41573-020-00164-3Shim H. Bispecific antibodies and antibody-drug conjugates for cancer therapy: technological considerations. Biomolecules. 2020;10(3):360. https://doi.org/10.3390/biom10030360Shim H. Bispecific antibodies and antibody-drug conjugates for cancer therapy: technological considerations. Biomolecules. 2020;10(3):360. https://doi.org/10.3390/biom10030360Lu RM, Hwang YC, Liu IJ, Lee CC, Tsai HZ, Li HJ, Wu HC. Development of therapeutic antibodies for the treatment of diseases. J Biomed Sci. 2020;27(1):1. https://doi.org/10.1186/s12929-019-0592-zLu RM, Hwang YC, Liu IJ, Lee CC, Tsai HZ, Li HJ, Wu HC. Development of therapeutic antibodies for the treatment of diseases. J Biomed Sci. 2020;27(1):1. https://doi.org/10.1186/s12929-019-0592-zLu J, Ding J, Liu Z, Chen T. Retrospective analysis of the preparation and application of immunotherapy in cancer treatment (Review). Int J Oncol. 2022;60(2):12. https://doi.org/10.3892/ijo.2022.5302Lu J, Ding J, Liu Z, Chen T. Retrospective analysis of the preparation and application of immunotherapy in cancer treatment (Review). Int J Oncol. 2022;60(2):12. https://doi.org/10.3892/ijo.2022.5302Pineda C, Illades-Aguiar B, Flores-Alfaro E, Leyva-Vázquez MA, Parra-Rojas I, Del Moral-Hernández O, et al. Mechanisms of action and limitations of monoclonal antibodies and single chain fragment variable (scFv) in the treatment of cancer. Biomedicines. 2023;11(6):1610. https://doi.org/10.3390/biomedicines11061610Pineda C, Illades-Aguiar B, Flores-Alfaro E, Leyva-Vázquez MA, Parra-Rojas I, Del Moral-Hernández O, et al. Mechanisms of action and limitations of monoclonal antibodies and single chain fragment variable (scFv) in the treatment of cancer. Biomedicines. 2023;11(6):1610. https://doi.org/10.3390/biomedicines11061610Ruan DY, Wu HX, Meng Q, Xu RH. Development of antibody-drug conjugates in cancer: Overview and prospects. Cancer Commun (Lond). 2024;44(1):3–22. https://doi.org/10.1002/cac2.12517Ruan DY, Wu HX, Meng Q, Xu RH. Development of antibody-drug conjugates in cancer: Overview and prospects. Cancer Commun (Lond). 2024;44(1):3–22. https://doi.org/10.1002/cac2.12517Степанова ЕО, Моисеенко ФВ, Моисеенко ВМ. Конъюгированные моноклональные антитела. Практическая онкология. 2023;24(1):7–18. https://doi.org/10.31917/2401007Stepanova EO, Moiseenko FV, Moiseyenko VM. Antubody-drug conjugates. Practical Oncology. 2023;24(1):7–18 (In Russ.). https://doi.org/10.31917/2401007Василевич НИ, Честков АВ, Янг М, Сан Л. Химерные конъюганты на основе белков и пептидов в таргетной противораковой терапии. Лаборатория и производство. 2023;23(1):56–64. https://doi.org/10.32757/2619-0923.2023.1.23.56.64Vasilevich NI, Chestkov AV, Yang M, Sun L. Chimeric conjugants based on proteins and peptides in targeted anticancer therapy. Laboratory and Manufacturing. 2023;23(1):56–64 (In Russ.). https://doi.org/10.32757/2619-0923.2023.1.23.56.64Fu Z, Li S, Han S, Shi C, Zhang Y. Antibody drug conjugate: the «biological missile» for targeted cancer therapy. Signal Transduct Target Ther. 2022;7(1):93. https://doi.org/2010.1038/s41392-022-00947-7Fu Z, Li S, Han S, Shi C, Zhang Y. Antibody drug conjugate: the «biological missile» for targeted cancer therapy. Signal Transduct Target Ther. 2022;7(1):93. https://doi.org/2010.1038/s41392-022-00947-7Ma Y, Huang Y, Zhao Y, Zhao S, Xue J, Yang Y, et al. BL-B01D1, a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study. Lancet Oncol. 2024;25(7):901–11. https://doi.org/10.1016/S1470-2045(24)00159-1Ma Y, Huang Y, Zhao Y, Zhao S, Xue J, Yang Y, et al. BL-B01D1, a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study. Lancet Oncol. 2024;25(7):901–11. https://doi.org/10.1016/S1470-2045(24)00159-1Солопова ОН, Мисюрин ВА. Биспецифические антитела в клинике и клинических исследованиях (обзор литературы). Клиническая онкогематология. 2019;12(2):125–44. https://doi.org/2010.21320/2500-2139-2019-12-2-125-144Solopova ON, Misyurin VA. Bispecific antibodies in clinical practice and clinical trials (literature review). Clinical Oncohematology. 2019;12(2):125–44 (In Russ). https://doi.org/2010.21320/2500-2139-2019-12-2-125-144Kuchnio A, Samakai E, HugE, BalmañaM, JanssenL, Amorim R, et al. Discovery of JNJ-88549968, a novel, first-in-class CALRmutxCD3 T-cell redirecting antibody for the treatment of myeloproliferative neoplasms. Blood. 2023;142(1):1777. https://doi.org/10.1182/blood-2023-173430Kuchnio A, Samakai E, HugE, BalmañaM, JanssenL, Amorim R, et al. Discovery of JNJ-88549968, a novel, first-in-class CALRmutxCD3 T-cell redirecting antibody for the treatment of myeloproliferative neoplasms. Blood. 2023;142(1):1777. https://doi.org/10.1182/blood-2023-173430Saura-Esteller J, de Jong M, King L, Ensing E, Winograd B, de Gruijl T, et al. Gamma delta T-cell based cancer immunotherapy: Past — present — future. Front Immunol. 2022;13:915837. https://doi.org/10.3389/fimmu.2022.915837Saura-Esteller J, de Jong M, King L, Ensing E, Winograd B, de Gruijl T, et al. Gamma delta T-cell based cancer immunotherapy: Past — present — future. Front Immunol. 2022;13:915837. https://doi.org/10.3389/fimmu.2022.915837Scaletta L, Kuriakose T, Nanda S, Collins M, Darrah E, McInnes I, et al. Blockade of soluble and cell surface PAD activity prevents the generation of citrullinated autoantigens recognized by RA patients’ serum [abstract]. Arthritis Rheumatol. 2024;76(9).Scaletta L, Kuriakose T, Nanda S, Collins M, Darrah E, McInnes I, et al. Blockade of soluble and cell surface PAD activity prevents the generation of citrullinated autoantigens recognized by RA patients’ serum [abstract]. Arthritis Rheumatol. 2024;76(9).Keri D, Walker M, Singh I, Nishikawa K, Garces F. Next generation of multispecific antibody engineering. Antib Ther. 2023;7(1):37–52. https://doi.org/10.1093/abt/tbad027Keri D, Walker M, Singh I, Nishikawa K, Garces F. Next generation of multispecific antibody engineering. Antib Ther. 2023;7(1):37–52. https://doi.org/10.1093/abt/tbad027Amash A, Volkers G, Farber P, Griffin D, Davison K, Goodman A, et al. Developability considerations for bispecific and multispecific antibodies. mAbs. 2024;6(1):2394229. https://doi.org/10.1080/19420862.2024.2394229Amash A, Volkers G, Farber P, Griffin D, Davison K, Goodman A, et al. Developability considerations for bispecific and multispecific antibodies. mAbs. 2024;6(1):2394229. https://doi.org/10.1080/19420862.2024.2394229Stone J, Pear Fish K, Ashok D, McKay L. Abstract ND01: ABBV-303: A novel NK and CD8 T cell engager specific for c-Met-expressing tumors. Cancer Research. 2024;84(7_Supplement):ND01. https://doi.org/10.1136/jitc-2024-SITC2024.1282Stone J, Pear Fish K, Ashok D, McKay L. Abstract ND01: ABBV-303: A novel NK and CD8 T cell engager specific for c-Met-expressing tumors. Cancer Research. 2024;84(7_Supplement):ND01. https://doi.org/10.1136/jitc-2024-SITC2024.1282Motolani A, Martin M, Sun M, Lu T. The structure and functions of PRMT5 in human diseases. Life (Basel). 2021;11(10):1074. https://doi.org/10.3390/life11101074Motolani A, Martin M, Sun M, Lu T. The structure and functions of PRMT5 in human diseases. Life (Basel). 2021;11(10):1074. https://doi.org/10.3390/life11101074Kalev P, Hyer ML, Gross S, Konteatis Z, Chen CC, Fletcher M, et al. MAT2A inhibition blocks the growth of MTAP-deleted cancer cells by reducing PRMT5-dependent mRNA splicing and inducing DNA damage. Cancer Cell. 2021;39(2):209-24. e11. https://doi.org/10.1016/j.ccell.2020.12.010Kalev P, Hyer ML, Gross S, Konteatis Z, Chen CC, Fletcher M, et al. MAT2A inhibition blocks the growth of MTAP-deleted cancer cells by reducing PRMT5-dependent mRNA splicing and inducing DNA damage. Cancer Cell. 2021;39(2):209-24. e11. https://doi.org/10.1016/j.ccell.2020.12.010Ikushima H, Watanabe K, Shinozaki-Ushiku A, Oda K, Kage H. Pan-cancer clinical and molecular landscape of MTAP deletion in nationwide and international comprehensive genomic data. ESMO Open. 2025;10(4):104535. https://doi.org/10.1016/j.esmoop.2025.104535Ikushima H, Watanabe K, Shinozaki-Ushiku A, Oda K, Kage H. Pan-cancer clinical and molecular landscape of MTAP deletion in nationwide and international comprehensive genomic data. ESMO Open. 2025;10(4):104535. https://doi.org/10.1016/j.esmoop.2025.104535Engstrom L, Aranda R, Waters L, Moya K, Bowcut V, Vegar L, et al. MRTX1719 is an MTA-cooperative PRMT5 inhibitor that exhibits synthetic lethality in preclinical models and patients with MTAP-deleted cancer. Cancer Discov. 2023;13(11):2412–31. https://doi.org/10.1158/2159-8290.CD-23-0669Engstrom L, Aranda R, Waters L, Moya K, Bowcut V, Vegar L, et al. MRTX1719 is an MTA-cooperative PRMT5 inhibitor that exhibits synthetic lethality in preclinical models and patients with MTAP-deleted cancer. Cancer Discov. 2023;13(11):2412–31. https://doi.org/10.1158/2159-8290.CD-23-0669Chan E, Shibue T, McFarland J, Gaeta B, Ghandi M, Dumont N, et al. WRN helicase is a synthetic lethal target in microsatellite unstable cancers. Nature. 2019;568(7753):551–6. https://doi.org/10.1038/s41586-019-1102-xChan E, Shibue T, McFarland J, Gaeta B, Ghandi M, Dumont N, et al. WRN helicase is a synthetic lethal target in microsatellite unstable cancers. Nature. 2019;568(7753):551–6. https://doi.org/10.1038/s41586-019-1102-xWainberg ZA. WRN helicase: Is there more to MSI-H than immunotherapy? Cancer Discov. 2024;14(8):1369–71. https://doi.org/10.1158/2159-8290.CD-24-0771Wainberg ZA. WRN helicase: Is there more to MSI-H than immunotherapy? Cancer Discov. 2024;14(8):1369–71. https://doi.org/10.1158/2159-8290.CD-24-0771Mengoli V, Ceppi I, Sanchez A, Cannavo E, Halder S, Scaglione S, et al. WRN helicase and mismatch repair complexes independently and synergistically disrupt cruciform DNA structures. EMBO J. 2023;42(3):e111998. https://doi.org/10.15252/embj.2022111998Mengoli V, Ceppi I, Sanchez A, Cannavo E, Halder S, Scaglione S, et al. WRN helicase and mismatch repair complexes independently and synergistically disrupt cruciform DNA structures. EMBO J. 2023;42(3):e111998. https://doi.org/10.15252/embj.2022111998Morales-Juarez D., Jackson S. Clinical prospects of WRN inhibition as a treatment for MSI tumours. NPJ Precis Oncol. 2022;6(1):85. https://doi.org/10.1038/s41698-022-00319-yMorales-Juarez D., Jackson S. Clinical prospects of WRN inhibition as a treatment for MSI tumours. NPJ Precis Oncol. 2022;6(1):85. https://doi.org/10.1038/s41698-022-00319-yZhou D, Liu T, Rao X, Jie X, Chen Y, Wu Z, et al. Targeting diacylglycerol kinase α impairs lung tumorigenesis by inhibiting cyclin D3. Thorac Cancer. 2023;14(13):1179–91. https://doi.org/10.1111/1759-7714.14851Zhou D, Liu T, Rao X, Jie X, Chen Y, Wu Z, et al. Targeting diacylglycerol kinase α impairs lung tumorigenesis by inhibiting cyclin D3. Thorac Cancer. 2023;14(13):1179–91. https://doi.org/10.1111/1759-7714.14851Fu L, Li S, Xiao W, Yu K, Li S, Yuan S, et al. DGKA mediates resistance to PD-1 blockade. Cancer Immunol Res. 2021;9(4):371–85. https://doi.org/10.1158/2326-6066.cir-20-0216Fu L, Li S, Xiao W, Yu K, Li S, Yuan S, et al. DGKA mediates resistance to PD-1 blockade. Cancer Immunol Res. 2021;9(4):371–85. https://doi.org/10.1158/2326-6066.cir-20-0216Sabnis R. Novel CDK2 inhibitors for treating cancer. ACS Med Chem Lett. 2020;11(12):2346–7. https://doi.org/10.1021/acsmedchemlett.0c00500Sabnis R. Novel CDK2 inhibitors for treating cancer. ACS Med Chem Lett. 2020;11(12):2346–7. https://doi.org/10.1021/acsmedchemlett.0c00500Jensen L, Attfield K, Feldmann M, Fugger L. Allosteric TYK2 inhibition: Redefining autoimmune disease therapy beyond JAK1-3 inhibitors. EBioMedicine. 2023;97:104840. https://doi.org/10.1016/j.ebiom.2023.104840Jensen L, Attfield K, Feldmann M, Fugger L. Allosteric TYK2 inhibition: Redefining autoimmune disease therapy beyond JAK1-3 inhibitors. EBioMedicine. 2023;97:104840. https://doi.org/10.1016/j.ebiom.2023.104840Nogueira M, Puig L, Torres T. JAK inhibitors for treatment of psoriasis: Focus on selective TYK2 inhibitors. Drugs. 2020; 80(4):341–52. https://doi.org/10.1007/s40265-020-01261-8Nogueira M, Puig L, Torres T. JAK inhibitors for treatment of psoriasis: Focus on selective TYK2 inhibitors. Drugs. 2020; 80(4):341–52. https://doi.org/10.1007/s40265-020-01261-8Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88(1):29–39. https://doi.org/10.1016/j.jaad.2022.07.002Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88(1):29–39. https://doi.org/10.1016/j.jaad.2022.07.002Jagannath A, Taylor L, Ru Y, Wakaf Z, Akpobaro K, Vasudevan S, et al. The multiple roles of salt-inducible kinases in regulating physiology. Physiol Rev. 2023;103(3):2231–69. https://doi.org/10.1016/j.jaad.2022.07.002Jagannath A, Taylor L, Ru Y, Wakaf Z, Akpobaro K, Vasudevan S, et al. The multiple roles of salt-inducible kinases in regulating physiology. Physiol Rev. 2023;103(3):2231–69. https://doi.org/10.1016/j.jaad.2022.07.002Меркулова ОВ, Меркулов ВА, Меркулова ОВ. Регуляторные механизмы внедрения генной и клеточной терапии в медицинскую практику в странах Восточной Азии. Ведомости Научного центра экспертизы средств медицинского применения. Регуляторные исследования и экспертиза лекарственных средств. 2024;14(1):29–41. https://doi.org/10.30895/1991-2919-2024-14-1-29-41Melnikova EV, Merkulov VA, Merkulova OV. Regulation for the translation of gene and cell therapy into medical practice in East Asian countries. 2024;14(1):29–41 (In Russ.). https://doi.org/10.30895/1991-2919-2024-14-1-29-41Водякова МА, Покровский НС, Семенова ИС, Меркулов ВA, Мельникова ЕВ. Классификация продуктов клеточной терапии по степени манипулирования клеток и выполняемым функциям: анализ международных регуляторных подходов. Регуляторные исследования и экспертиза лекарственных средств. 2024;14(5):533–46. https://doi.org/10.30895/1991-2919-2024-14-1-29-41Vodyakova MA, Pokrovsky NS, Semenova IS, Merkulov VA, Melnikova EV. Classification of cell therapy products by cell manipulation degree and functions performed: Analysis of international regulatory approaches. Regulatory Research and Medicine Evaluation. 2024;14(5):533–46 (In Russ.). https://doi.org/10.30895/1991-2919-2024-14-1-29-41Uscanga-Palomeque AC, Chávez-Escamilla AK, Alvizo-Báez CA, Saavedra-Alonso S, Terrazas-Armendáriz LD, Tamez-Guerra RS, et al. CAR-T cell therapy: From the shop to cancer therapy. Int J Mol Sci. 2023;24(21):15688. https://doi.org/10.3390/ijms242115688Uscanga-Palomeque AC, Chávez-Escamilla AK, Alvizo-Báez CA, Saavedra-Alonso S, Terrazas-Armendáriz LD, Tamez-Guerra RS, et al. CAR-T cell therapy: From the shop to cancer therapy. Int J Mol Sci. 2023;24(21):15688. https://doi.org/10.3390/ijms242115688Jones LA, Conway GE, Nguyen-Chi A, Burnell S, Jenkins GJ, Conlan RS, Doak SH. Investigating STEAP2 as a potential therapeutic target for the treatment of aggressive prostate cancer. Cell Mol Biol (Noisy-le-grand). 2023;69(4):179–87. https://doi.org/10.14715/cmb/2023.69.4.28Jones LA, Conway GE, Nguyen-Chi A, Burnell S, Jenkins GJ, Conlan RS, Doak SH. Investigating STEAP2 as a potential therapeutic target for the treatment of aggressive prostate cancer. Cell Mol Biol (Noisy-le-grand). 2023;69(4):179–87. https://doi.org/10.14715/cmb/2023.69.4.28Zanvit P, van Dyk D, Fazenbaker C, McGlinchey K, Luo W, Pezold J, et al. Antitumor activity of AZD0754, a dnT-GFβRII-armored, STEAP2-targeted CAR-T cell therapy, in prostate cancer. J Clin Invest. 2023;133(22):e169655. https://doi.org/10.1172/JCI169655Zanvit P, van Dyk D, Fazenbaker C, McGlinchey K, Luo W, Pezold J, et al. Antitumor activity of AZD0754, a dnT-GFβRII-armored, STEAP2-targeted CAR-T cell therapy, in prostate cancer. J Clin Invest. 2023;133(22):e169655. https://doi.org/10.1172/JCI169655

The authors declare that there are no conflicts of interest present.