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BackGC녹십자, 코로나19 mRNA 백신 임상 2상 IND 승인 획득
GC녹십자, 코로나19 mRNA 백신 임상 2상 IND 승인 획득
Developing
연합뉴스2 hours agoHealth1 min readSouth KoreaView translation

GC녹십자, 코로나19 mRNA 백신 임상 2상 IND 승인 획득

gc녹십자mrna 백신코로나19

Quick Look

GC녹십자가 식품의약품안전처로부터 코로나19 예방을 위한 mRNA 백신의 임상 2상 시험계획을 승인받았다고 밝혔다. 임상 2상은 19~85세 건강한 성인을 대상으로 진행되며, 연내 환자 투약을 시작하고 내년에 임상 3상 시험계획을 제출할 계획이다. mRNA 백신은 바이러스의 유전 정보를 활용해 변이에 신속하게 대응할 수 있는 장점이 있다.

AI-generated summary

Why It Matters

GC녹십자는 2028년 국산 mRNA 백신 자급화를 목표로 질병관리청 등이 주관하는 정부 국책 과제를 진행하고 있다. mRNA 백신은 화이자와 모더나 등이 개발한 코로나19 백신의 대표적인 기술이다.

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(서울=연합뉴스) 박상현 기자 = GC녹십자는 코로나19 예방을 위한 메신저 리보핵산(mRNA) 백신의 임상 2상 시험계획(IND)을 식품의약품안전처로부터 승인받았다고 11일 밝혔다.

임상 2상은 19∼85세의 건강한 성인을 대상으로 진행된다. GC녹십자는 연내 환자 투약을 시작하고 내년에 임상 3상 시험계획을 제출할 방침이다.

mRNA 백신은 바이러스의 유전 정보가 담긴 mRNA를 활용한 백신이다. 화이자와 모더나 등이 개발한 코로나19 백신이 대표적인 mRNA 백신이다.

mRNA 기술을 토대로 만들어진 백신은 개발이 까다로운 대신 한번 만들어두면 바이러스의 유전 정보만 갈아 끼워 넣는 식으로 변이에 신속하게 대응할 수 있는 장점이 있다.

GC녹십자는 2028년 국산 mRNA 백신 자급화를 목표로 질병관리청 등이 주관하는 정부 국책 과제를 진행하고 있다.

GC녹십자 관계자는 "감염병 예방에 집중됐던 mRNA 플랫폼 기술의 적용 영역이 빠르게 확장되고 있다"며 "자체 플랫폼을 바탕으로 코로나19 백신 상용화, 파이프라인 확대를 추진해 나갈 것"이라고 말했다.

What to Watch

AI outlook — possibilities, not facts

  • GC녹십자가 내년에 임상 3상 시험계획을 제출할 것

    Likely · Within months

  • GC녹십자가 2028년 국산 mRNA 백신 자급화 목표를 향해 정부 국책 과제를 계속 진행할 것

    Likely · Within years

Open Questions

  • 임상 2상의 구체적인 참가자 수는 몇 명인가?
  • 임상 3상 시험계획 제출 시기는 언제로 구체적으로 정해졌는가?
  • GC녹십자의 mRNA 백신 개발에 투입된 연구 개발 비용은 얼마인가?

Related Topics

gc녹십자
People박상현GC녹십자 관계자
OrganizationsGC녹십자식품의약품안전처질병관리청연합뉴스
Places서울대한민국
Topicsmrna 백신코로나19임상 2상식품의약품안전처질병관리청백신 개발
This article was originally published by 연합뉴스.

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