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艾美疫苗:自願性公告 - 迭代無血清狂犬病疫苗臨床III期數據揭盲達到臨床預設目標,免疫原性和安全性良好

AIM VACCINE: VOLUNTARY ANNOUNCEMENT - UNBLINDING OF DATA FROM PHASE III CLINICAL TRIAL OF ITERATIVE SERUM-FREE RABIES VACCINE: PRE-DEFINED CLINICAL OBJECTIVES MET WITH GOOD IMMUNOGENICITY AND SAFETY

HKEX ·  Oct 6 19:35

Summary by Futu AI

艾美疫苗股份有限公司(「艾美疫苗」)近日宣布,其研發的無血清迭代狂犬病疫苗III期臨床試驗數據已完成揭盲及統計分析,並顯示疫苗具有良好的免疫原性和安全性,達到臨床預設目標。該疫苗不含動物血清,能顯著提高安全性,降低不良反應概率,有望成為全球首個上市的無血清狂犬病疫苗。艾美疫苗已完成生產車間建設,符合國際化標準,並進行了符合上市規模及質量要求的工藝驗證。目前,公司正在積極推進臨床總結報告的獲得,以便向國家藥品監督管理局(NMPA)遞交藥品上市註冊申請。艾美疫苗作為全球第二大狂犬病疫苗供應商,其技術迭代升級將為市場提供更優質、更安全的疫苗產品。
艾美疫苗股份有限公司(「艾美疫苗」)近日宣布,其研發的無血清迭代狂犬病疫苗III期臨床試驗數據已完成揭盲及統計分析,並顯示疫苗具有良好的免疫原性和安全性,達到臨床預設目標。該疫苗不含動物血清,能顯著提高安全性,降低不良反應概率,有望成為全球首個上市的無血清狂犬病疫苗。艾美疫苗已完成生產車間建設,符合國際化標準,並進行了符合上市規模及質量要求的工藝驗證。目前,公司正在積極推進臨床總結報告的獲得,以便向國家藥品監督管理局(NMPA)遞交藥品上市註冊申請。艾美疫苗作為全球第二大狂犬病疫苗供應商,其技術迭代升級將為市場提供更優質、更安全的疫苗產品。
Mei Vaccine Co., Ltd. (Mei Vaccine) recently announced that the Phase III clinical trial data of its developed serum-free iterative rabies vaccine has completed unblinding and statistical analysis, showing good immunogenicity and safety, achieving clinical preset goals. The vaccine does not contain animal serum, significantly improving safety and reducing the probability of adverse reactions, with the potential to become the world's first serum-free rabies vaccine on the market. Mei Vaccine has completed the construction of production workshops, meeting international standards, and has conducted process verifications that meet the requirements for listing scale and quality. Currently, the company is actively progressing towards obtaining the clinical summary report for submission to the National Medical Products Administration (NMPA) for drug registration. As the world's second-largest rabies vaccine supplier, Mei Vaccine's technological iteration upgrade will provide the market with higher quality and safer vaccine products.
Mei Vaccine Co., Ltd. (Mei Vaccine) recently announced that the Phase III clinical trial data of its developed serum-free iterative rabies vaccine has completed unblinding and statistical analysis, showing good immunogenicity and safety, achieving clinical preset goals. The vaccine does not contain animal serum, significantly improving safety and reducing the probability of adverse reactions, with the potential to become the world's first serum-free rabies vaccine on the market. Mei Vaccine has completed the construction of production workshops, meeting international standards, and has conducted process verifications that meet the requirements for listing scale and quality. Currently, the company is actively progressing towards obtaining the clinical summary report for submission to the National Medical Products Administration (NMPA) for drug registration. As the world's second-largest rabies vaccine supplier, Mei Vaccine's technological iteration upgrade will provide the market with higher quality and safer vaccine products.

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