摘要
目的促进我国生物医药创新发展水平的提升。方法回顾我国医药发展百年历史,盘点2021年我国生物医药创新发展的成绩、问题与挑战,提出关于生物医药创新发展形势与模式的认识和展望。结果与结论百年发展史展现了中国医药发展从无到有、从小到大、从仿到创、从无序竞争到有序竞争、从多头管理走向科学管理的历程,在党的领导下,历经70多年奋斗,我国医药创新能力大大提高。2021年,国产新药申请上市数量达76件,主要涉及肿瘤、自身免疫系统、病毒和感染等疾病用药,其中有不少“中国新”甚至“全球新”的创新产品,已接近发达国家水平;中医药特色发展有亮点,12个中药新药获批上市,数量为近年新高;制药企业从内卷需求向国际循环发展转变,许可引进(License-in)项目再创新高,达到100余起,且国产新药对外许可(License-out)已成大势;国家鼓励创新和监管科学提升、创新药企业专注研发创新与仿制药企业专注质提高量、发展模式创新这三大发展红利有力支撑了医药创新发展。为积极有效应对世界医药创新竞争带来的挑战,我国医药行业(包括产业、商业、医疗、投资的整合)必须为可持续发展做好顶层设计,构建可持续的创新生态环境,促进和提升创新主体活力,认清我国制药企业发展的短板,定位好我国创新药领域的目标,才能为我国医药产业进入全球产业链从而提高全球市场份额提供保障。
Objective To promote the innovation and development level of China's biomedicine.Methods The century of the developmental history of China's biomedicine was reviewed,as well as the achievements,problems and challenges of China's biomedical innovation and development in 2021,and the understanding and prospect of the situation and model of biomedical innovation and development were put forward.Results and Conclusion The century of the developmental history of China's biomedicine shows the process of China's pharmaceutical development starts from scratch,from small to large,from imitation to innovation,from disorderly competition to orderly competition,and from bull management to scientific management.Under the leadership of the party,China's pharmaceutical innovation ability has been greatly improved after more than 70 years of struggle.In 2021,76 domestic new drugs have applied for listing,mainly involving drugs for diseases such as tumor,autoimmune system,virus and infection,many of which are innovative products with"Chinese Innovation"or even"Global Innovation"labels,which are close to the level of developed countries.There are bright spots in the characteristic development of traditional Chinese medicine,12 new traditional Chinese medicines have been approved for listing,and the number has reached a record high in recent years.Pharmaceutical enterprises have changed from internal demand to international circular development.License-in projects have reached a record high of more than 100 projects,and the License-out projects of domestic new drugs have become a general trend.The three development dividends of national policies of encouraging innovation and improvement of regulatory science,innovative drug enterprises focusing on research and development(R&D)innovation,generic drug enterprises focusing on quality improvement,and innovation of development model strongly support the development of pharmaceutical innovation.In order to actively and effectively respond to the challenges caused by the world pharmaceuti
作者
刘昌孝
LIU Changxiao(Tianjin Institute of Pharmaceutical Research·State Key Laboratory of Drug Release Technology and Pharmacokinetics·Tianjin Research Society for Drug Regulatory Science,Tianjin,China 300462)
出处
《中国药业》
CAS
2022年第4期1-7,共7页
China Pharmaceuticals
基金
中医药国际合作专项基金[0610-2040NF020928]。
关键词
百年回顾
生物医药
发展成就
发展模式
发展挑战
centennial review
biomedicine
development achievements
development model
development challenges
