《生命科学》 2024, 36(1): 94-101

2023年新药研发发展现状与未来趋势

韩　佳¹ , 曾文晔¹ , 史　彤² , 陈　琪³ , 谢运飞² , 张　华² , 陈大明^1,4,*

¹中国科学院上海生命科学信息中心，中国科学院上海营养与健康研究所，上海 200031 ²上海市生物医药科技发展中心，上海 201203 ³中国生物技术发展中心，北京 100039 ⁴中国科学院大学，北京 100049

摘　要：

    新药研发是制药行业的核心活动之一，成功发现和开发对疾病具有疗效的新药物需要跨学科的合作、大量的投资和对创新的不断追求。近年来全球新药研发竞争格局不断加速演变，我国众多创新药企寻求深层次变革与转型发展，并加快拓展海外市场。2023 年，全球获批上市的创新药数量持续增长，同比增长17%，临床研究管线数量亦不断扩大；生物技术和基因疗法的发展日新月异，罕见病药物研发逐渐增多，免疫疗法领域研发取得显著成果。本研究从创新药物的类别和研发新格局等角度出发，对2023 年新药研发发展态势进行梳理与总结，并展望未来发展趋势。

通讯作者：陈大明 , Email:chendaming@sinh.ac.cn

R&D status and future trends of new drugs in 2023

HAN Jia¹ , ZENG Wen-Ye¹ , SHI Tong² , CHEN Qi³ , XIE Yun-Fei² , ZHANG Hua² , CHEN Da-Ming^1,4,*

¹Shanghai Information Center for Life Sciences, Shanghai Institute of Nutrition and Health, Chinese Academy of Sciences, Shanghai 200031, China ²Shanghai Center of Biomedicine Development, Shanghai 201203, China ³China National Center for Biotechnology Development, Beijing 100039, China ⁴University of Chinese Academy of Sciences, Beijing 100049, China

Abstract:

    New drug research and development are the core activities of the pharmaceutical industry. The successful discovery and development of new drugs that are effective for diseases requires interdisciplinary cooperation, massive investments, and continuous pursuit of innovation. In recent years, the global evolution of new drug research and experimental development  (R&D)and competition landscape has accelerated. In China, many innovative pharmaceutical companies were also seeking in-depth changes, and transformational developments, and accelerated their overseas expansion. In 2023, the number of innovative drugs approved for marketing in the world continued to grow, with a year-on-year increase of 17%. The number of clinical research pipelines also continued to expand. In this review, we summarized and provided insights into future development trends in light of the rise of biotechnology and gene therapy, the gradual increase in drug research and development for rare diseases, and the significant progress of research and development in the field of immunotherapy. From the perspective of the categories of innovative drugs and the new pattern of R&D status, we sorted out the development trends of new drugs in 2023 and prospect the future trends in this field.

Communication Author：CHEN Da-Ming , Email:chendaming@sinh.ac.cn