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’)10.30895/1991-2919-2026-856vedomostiregmed-856Research ArticleГЛАВНАЯ ТЕМА: ИННОВАЦИИ В ФАРМАЦЕВТИКЕ: ПУТЬ ОТ НАУЧНОЙ ИДЕИ К ТЕХНОЛОГИЧЕСКОМУ ЛИДЕРСТВУMAIN TOPIC: INNOVATION IN PHARMACEUTICS: FROM SCIENTIFIC IDEA TO TECHNOLOGICAL LEADERSHIPЛекарственный суверенитет Китая в терапии серьезных или угрожающих жизни заболеваний: анализ номенклатуры препаратов, зарегистрированных в 2024 годуChina’s Medicinal Sovereignty in the Therapy of Serious and Life-Threatening Conditions: Analyzing the List of Medicinal Products Registered in 2024https://orcid.org/0009-0007-7284-9723ШпеерЕ. Л.ShpeerE. L.

Шпеер Евгений Львович, канд. мед. наук

ул. Добролюбова, д. 11, Москва, 127254

Evgeny L. Shpeer, Cand. Sci. (Med.)

11 Dobrolyubov St., Moscow 127254

shpeerel@mednet.ruhttps://orcid.org/0000-0003-2947-6398ЗарубинаК. И.ZarubinaK. I.

Зарубина Ксения Игоревна, канд. мед. наук

ул. Добролюбова, д. 11, Москва, 127254

Kseniia I. Zarubina, Cand. Sci. (Med.)

11 Dobrolyubov St., Moscow 127254

ksenijazarubina@mail.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.ruhttps://orcid.org/0000-0001-9063-0601ГусевА. Б.GusevA. B.

Гусев Александр Борисович, канд. экон. наук

ул. Добролюбова, д. 11, Москва, 127254

Alexander B. Gusev, Cand. Sci. (Econ.)

11 Dobrolyubov St., Moscow 127254

gusevab@mednet.ruФедеральное государственное бюджетное учреждение «Центральный научно-исследовательский институт организации и информатизации здравоохранения» Министерства здравоохранения Российской ФедерацииРоссияRussian Research Institute of HealthRussian Federation202604072026163265279Copyright © Шпеер Е.Л., Зарубина К.И., Куликова Е.А., Гусев А.Б., 20262026Шпеер Е.Л., Зарубина К.И., Куликова Е.А., Гусев А.Б.Shpeer E.L., Zarubina K.I., Kulikova E.A., Gusev A.B.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/856ВВЕДЕНИЕ

ВВЕДЕНИЕ. Деятельность дружественных государств по достижению и укреплению государственного суверенитета в области лекарственной безопасности востребована при формировании стратегии развития фармацевтической отрасли в Российской Федерации. В условиях ускоренного развития биомедицинских технологий и усиления роли национальных регуляторных механизмов представляет интерес опыт Китая по разработке и выводу инновационных лекарственных препаратов на локальный рынок.

ЦЕЛЬ

ЦЕЛЬ. Анализ номенклатуры лекарственных препаратов 1-го класса по классификации Национальной администрации по медицинским продуктам КНР (NMPA), разработанных китайскими компаниями для терапии серьезных или угрожающих жизни заболеваний и зарегистрированных в Китае в 2024 г., для оценки их потенциала отнесения к first-in-class medicine, наличия ключевых технологических решений и потенциальной клинической значимости.

МАТЕРИАЛЫ И МЕТОДЫ

МАТЕРИАЛЫ И МЕТОДЫ. Оценка лекарственных препаратов, разработанных в Китае по программе «прорывной терапии» и зарегистрированных в 2024 г., проведена по данным отчета Национальной администрации по контролю за лекарственными средствами Китая (National Medical Products Administration, NMPA) за 2024 г.

РЕЗУЛЬТАТЫ

РЕЗУЛЬТАТЫ. Сформирован перечень из 9 препаратов, отнесенных при регистрации к 1 классу, предназначенных для терапии серьезных или угрожающих жизни заболеваний, разработанных национальными компаниями, включая препараты таргетной терапии, иммунной терапии, конъюгаты антитело — лекарственное средство и CAR-T-препараты. Для каждого препарата проанализированы механизм действия, технологические особенности разработки, наличие зарубежных аналогов и клинические данные регистрационных исследований. Показано, что один препарат (ивонесцимаб) может быть отнесен к категории «первый в классе», тогда как остальные относятся к категории «следующий в классе». Для ряда препаратов (ивонесцимаб, талетректиниб, цилтакабтаген аутолейцел) выявлен потенциал достижения характеристик категории «лучший в классе» на основании данных пострегистрационного периода. Отмечено, что ключевые технологические решения направлены на повышение селективности, преодоление резистентности, улучшение фармакокинетических свойств и профиля безопасности.

ВЫВОДЫ

ВЫВОДЫ. Результаты анализа свидетельствуют о формировании в Китае зрелой модели ускоренной разработки инновационных лекарственных препаратов с высоким потенциалом клинической значимости. Полученные данные могут представлять интерес для российских разработчиков в свете действующих национальных программ для достижения технологического суверенитета в области фармацевтических разработок.

INTRODUCTION

INTRODUCTION. The policy of friendly states aimed at achieving and maintaining the state sovereignty regarding drug safety is essential when forming Russian strategy of pharmaceutical development. Considering rapid advancement of biomedical technologies and the growing role of national regulatory frameworks, China’s experience in developing and launching innovative medicinal products to the local market is of interest.

AIM

AIM. This study aimed to analyze the list of Class 1 medicinal products classified by National Medical Products Administration of China (NMPA) and developed by Chinese companies to treat serious and life-threatening conditions and registered in China in 2024, focusing on their potential first-in-class status, degree of innovation, key technological solutions, and potential clinical significance.

MATERIALS AND METHODS

MATERIALS AND METHODS. Medicinal products developed in China within the breakthrough therapy program and registered in 2024 according to NMPA data were assessed. The analysis included the 2024 NMPA report.

RESULTS

RESULTS. Nine medicinal products first approved in China and developed by Chinese companies were identified that were registered as Class 1 medicinal products aimed at treating serious or life-threatening conditions. These included targeted therapies, immunotherapies, antibody–drug conjugates, and CAR-T cell therapies developed by Chinese manufacturers. For each product, the mechanism of action, process cha racteristics, availability of similar foreign preparations, and clinical evidence from approval trials were examined. One medicinal product (ivonescimab) may be classified as first-in-class, whereas the remaining products were categorized as next-in-class. For several products (ivonescimab, taletrectinib, and ciltacabtagene autoleucel), post-registration data indicated a potential best-in-class profile. The analysis highlights that the key process strategies were primarily aimed at enhancing target selectivity, overcoming resistance mechanisms, optimizing pharmacokinetic properties, and improving safety profiles.

CONCLUSIONS

CONCLUSIONS. The findings demonstrate the emerging mature and structured model for the accelerated development of innovative medicinal products in China, characterized by a high potential for clinical impact. The obtained results may be of interest to Russian developers considering the current national programs aimed at achieving technological sovereignty in pharmaceutical development.

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