艾美疫苗(06660.HK):不排除進軍歐美市場 三款疫苗料明年申請註冊上市
艾美疫苗(06660.HK)公布,於上周五(22日)舉辦了2023年投資者開放日活動,向近40家投資機構重點介紹集團即將上市的重磅創新疫苗產品及其生產車間建設情況,以及集團產品管線佈局和規劃。
公司指出,在實施國際化過程中,目前主要開發的國際市場集中在東南亞、非洲、南美、中東等地區,今後不排除進軍歐美市場的可能。數據顯示該產品目前全球市場缺口大約為1.2億劑,公司有信心在滿足國內需求之後逐步滿足國際需求。
關於13價肺炎結合疫苗,公司在進行工藝設計時,已對有關問題做了全面而富有前瞻性的考慮,不存在業由於生產地工藝變更等問題影響產品上市進程的該類問題。目前產品生產線已完成生產驗證,用於三期臨床試驗的樣品均由該生產線生產,可免去後續橋接試驗環節,整個產品的上市進程將大大加快。
集團的無血清迭代狂犬疫苗、13價肺炎結合疫苗、23價肺炎多糖疫苗預計於明年申請註冊上市。預計再過5年,集團將會擁有超過20款疫苗產品獲批上市。隨著新產品的陸續上市,集團的業務有望迎來新的增長點。
此外,集團率先開發迭代升級換代產品20價肺炎結合疫苗和24價肺炎結合疫苗,目前20價肺炎結合疫苗已處於CDE預溝通階段。集團藉此機會重申,集團的營運、財務和現有產品的銷售情況均正常,在研管線疫苗的研發均按計劃正常推進。
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