创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

mRNA肿瘤疫苗研发的挑战和前景展望

Challenges and Prospect of mRNA Tumor Vaccine Research and Development

  • 摘要: 随着新型冠状病毒信使RNA(mRNA)疫苗研发的巨大成功,mRNA疫苗这一革命性的技术受到了科学界、产业界和资本的认同和追捧。同时应用mRNA疫苗技术研发新型治疗性和预防性肿瘤疫苗,也为肿瘤治疗带来了新的机会。虽然目前还没有临床上市的mRNA肿瘤疫苗,但是许多制药企业已经开展了肿瘤疫苗研发管线,相当一部分产品也已进入Ⅰ期和Ⅱ期临床试验阶段。肿瘤疫苗为肿瘤的治疗带来新的突破,也是继肿瘤化疗、放疗、细胞免疫治疗之后的新型治疗方式。当然肿瘤疫苗的研发和生产涉及很多因素,作为一种新型的生物制品或者药物,肿瘤疫苗距离临床使用还有一段比较曲折和艰难的道路。通过对目前肿瘤疫苗研发过程遇到的技术瓶颈、疫苗制备过程中的政策法规挑战以及肿瘤疫苗研发的临床前景进行分析,期待为肿瘤疫苗的研发提供参考,希望其能够尽快进入临床为肿瘤患者带来更好的防治手段。

     

    Abstract: With the great success of novel coronavirus mRNA vaccine, mRNA as a transformative technology for vaccine development, has been recognized with much popularity in the scientific, industrial and capital-related communities. The application of mRNA technology to develop new therapeutic and preventive tumor vaccines has brought new opportunities for tumor treatment. At present, there is no mRNA tumor vaccine on the market, but many pharmaceutical enterprises have already had their tumor vaccine pipelines, and a considerable number of products have entered clinical phase I/II trials. Tumor vaccine will bring new breakthroughs in tumor treatment, which is a new approach after tumor chemotherapy, radiotherapy and cellular immunotherapy. Of course, the R & D and production of tumor vaccines involve many aspects. As a new biological product or drug, tumor vaccine still faces many challenges before it can be approved for clinical application. This paper analyzes the technological bottlenecks in the research and development of tumor vaccines, policy and regulation challenges in their preparation, and the clinical prospect of their research and development, in order to provide reference for the research and development of tumor vaccines, hoping tumor vaccines entering clinical application as soon as possible with better prevention and treatment methods for tumor patients.

     

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