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艾美疫苗(06660.HK):凍乾人用狂犬病在研疫苗(無血清Vero細胞)獲國家藥監局藥物臨牀試驗批准通知書
格隆匯 10-24 07:59

格隆匯10月24日丨艾美疫苗(06660.HK)發佈公吿,公司的全資附屬公司寧波榮安生物藥業有限公司於近日取得國家藥品監督管理局藥品審評中心關於凍乾人用狂犬病在研疫苗(無血清Vero細胞)的藥物臨牀試驗批准通知書。集團計劃於2023年上半年啟動該在研疫苗的III期臨牀試驗。

根據披露,Vero細胞是全球人用狂犬病疫苗的主流製造技術路線。Vero細胞對病毒敏感,可用於培養具有高滴度的病毒株。同時,通過高穩定性的連續傳代可以大規模生產該病毒株,單位成本低,質量控制水平高。

相較目前的人用狂犬病疫苗(Vero細胞),集團的凍乾人用狂犬病在研疫苗(無血清Vero細胞)能夠避免與在生產中使用血清有關的生物安全風險,有望提高安全性及免疫原性並減少不良副作用。此外,用於培養Vero細胞的溶液是人工合成的,因此與血清相比具有更高的穩定性且成分具有一致性,進而提高批間一致性。

2021年,按批簽發量及銷售收入計,集團是全球及中國第二大人用狂犬病疫苗供應商。集團的人用狂犬病疫苗(Vero細胞)為集團的主要產品之一,在市場上佔據領先地位。集團計劃於2025年或之後推出三種新型人用狂犬病疫苗(包括人用狂犬病在研疫苗(無血清Vero細胞)、mRNA人用狂犬病在研疫苗及人用狂犬病在研疫苗(人二倍體細胞)),以繼續幫助集團鞏固市場領導地位,並提高集團在中國人用狂犬病疫苗市場的市場份額。 

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