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艾美疫苗：自願性公告 - 13價肺炎結合疫苗已提交上市註冊預申請

AIM VACCINE: VOLUNTARY ANNOUNCEMENT - PRE-APPLICATION FOR MARKETING REGISTRATION FOR 13-VALENT PNEUMONIA CONJUGATE VACCINE SUBMITTED

香港交易所 ·  Mar 1 05:37
Summary by Moomoo AI
艾美疫苗股份有限公司於2024年2月29日宣布，其13價肺炎結合疫苗已提交上市註冊預申請，計劃於本年度內完成申報上市。該疫苗主要針對6周齡至5歲嬰幼兒和兒童，用於預防13種肺炎血清型引起的侵襲性疾病。世界衛生組織將兒童肺炎列為高度優先預防疾病，並推薦使用此疫苗。艾美疫苗表示，市場對13價肺炎結合疫苗的需求巨大，上市後預期將供不應求。公司已完成肺炎疫苗GMP車間建設，並按國際標準生產III期臨床樣品。
艾美疫苗股份有限公司於2024年2月29日宣布，其13價肺炎結合疫苗已提交上市註冊預申請，計劃於本年度內完成申報上市。該疫苗主要針對6周齡至5歲嬰幼兒和兒童，用於預防13種肺炎血清型引起的侵襲性疾病。世界衛生組織將兒童肺炎列為高度優先預防疾病，並推薦使用此疫苗。艾美疫苗表示，市場對13價肺炎結合疫苗的需求巨大，上市後預期將供不應求。公司已完成肺炎疫苗GMP車間建設，並按國際標準生產III期臨床樣品。
AMIE VACCINES CO., LTD. ANNOUNCED ON FEBRUARY 29, 2024 THAT IT HAS SUBMITTED A PRE-REGISTRATION APPLICATION FOR ITS 13 PNEUMO-COMBINED VACCINES AND PLANS TO COMPLETE THE LISTING WITHIN THIS YEAR. Primarily targeted at infants and children aged 6 to 5 years, the vaccine is used to prevent 13 invasive diseases caused by serotype pneumonia. The World Health Organization lists childhood pneumonia as a highly preventative disease and recommends the use of this vaccine. AMIE SAYS THE MARKET IS IN HIGH DEMAND FOR THE 13-PRICE PNEUMONIA COMBINATION VACCINE AND IS EXPECTED TO SEE A SHORTAGE OF SUPPLIES AFTER LAUNCH. The company has completed the construction of the Pneumonia Vaccine GMP workshop and produced Phase III clinical samples according to international standards.
AMIE VACCINES CO., LTD. ANNOUNCED ON FEBRUARY 29, 2024 THAT IT HAS SUBMITTED A PRE-REGISTRATION APPLICATION FOR ITS 13 PNEUMO-COMBINED VACCINES AND PLANS TO COMPLETE THE LISTING WITHIN THIS YEAR. Primarily targeted at infants and children aged 6 to 5 years, the vaccine is used to prevent 13 invasive diseases caused by serotype pneumonia. The World Health Organization lists childhood pneumonia as a highly preventative disease and recommends the use of this vaccine. AMIE SAYS THE MARKET IS IN HIGH DEMAND FOR THE 13-PRICE PNEUMONIA COMBINATION VACCINE AND IS EXPECTED TO SEE A SHORTAGE OF SUPPLIES AFTER LAUNCH. The company has completed the construction of the Pneumonia Vaccine GMP workshop and produced Phase III clinical samples according to international standards.
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