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艾美疫苗:自願性公告 - 艾美疫苗mRNA RSV與mRNA帶狀疱疹疫苗向FDA提交臨床試驗預申請

AIM VACCINE: VOLUNTARY ANNOUNCEMENT - PRE-APPLICATIONS FOR CLINICAL TRIALS FOR MRNA RSV AND MRNA SHINGLES/HERPES ZOSTER VACCINES OF AIM VACCINE SUBMITTED TO FDA

HKEX ·  Aug 29 19:57

Summary by Futu AI

艾美疫苗股份有限公司宣布,該公司已於2024年8月向美國食品和藥品監督管理局(FDA)提交了mRNA RSV疫苗和mRNA帶狀皰疹疫苗的臨床試驗預申請。此舉是根據艾美疫苗的國際化戰略,以及在動物試驗中展現出的良好數據。若獲FDA審核通過,將有助於該公司加速疫苗在全球範圍內的臨床試驗和商業化進程。目前,全球尚無mRNA帶狀皰疹疫苗獲批上市,中國也尚無RSV疫苗獲批。艾美疫苗已建立完善的mRNA疫苗研發和生產體系,並取得相關技術專利,致力於滿足核心疾病領域的臨床需求。
艾美疫苗股份有限公司宣布,該公司已於2024年8月向美國食品和藥品監督管理局(FDA)提交了mRNA RSV疫苗和mRNA帶狀皰疹疫苗的臨床試驗預申請。此舉是根據艾美疫苗的國際化戰略,以及在動物試驗中展現出的良好數據。若獲FDA審核通過,將有助於該公司加速疫苗在全球範圍內的臨床試驗和商業化進程。目前,全球尚無mRNA帶狀皰疹疫苗獲批上市,中國也尚無RSV疫苗獲批。艾美疫苗已建立完善的mRNA疫苗研發和生產體系,並取得相關技術專利,致力於滿足核心疾病領域的臨床需求。
Amy Vaccine Co., Ltd. announced that it has submitted a pre-application for clinical trials of mRNA RSV vaccine and mRNA shingles vaccine to the U.S. Food and Drug Administration (FDA) in August 2024. This is in line with Amy Vaccine's international strategy and the good data demonstrated in animal studies. If approved by the FDA, it will help accelerate the clinical trials and commercialization process of the vaccine worldwide. Currently, there is no approved mRNA shingles vaccine on the market globally, and there is also no approved RSV vaccine in China. Amy Vaccine has established a comprehensive mRNA vaccine research and production system, obtained relevant technology patents, and is committed to meeting the clinical needs in core disease areas.
Amy Vaccine Co., Ltd. announced that it has submitted a pre-application for clinical trials of mRNA RSV vaccine and mRNA shingles vaccine to the U.S. Food and Drug Administration (FDA) in August 2024. This is in line with Amy Vaccine's international strategy and the good data demonstrated in animal studies. If approved by the FDA, it will help accelerate the clinical trials and commercialization process of the vaccine worldwide. Currently, there is no approved mRNA shingles vaccine on the market globally, and there is also no approved RSV vaccine in China. Amy Vaccine has established a comprehensive mRNA vaccine research and production system, obtained relevant technology patents, and is committed to meeting the clinical needs in core disease areas.

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