萬泰生物(603392.SH)：在目前國家藥監政策下，如HPV疫苗接種劑次等進行變更，需要履行一系列臨牀、數據支持及註冊變更手續，需要一定時間，短期內對公司經營業績沒有重大影響
格隆匯4月13日丨萬泰生物(603392.SH)公佈，公司關注到世界衞生組織(“世衞組織”)網站公開信息，4月4日至4月7日，世衞組織免疫戰略諮詢專家組(SAGE)召開會議，對1劑次人乳頭瘤病毒(HPV)疫苗接種的證據進行了審議，得出的結論是：單劑量HPV疫苗即可提供可靠的保護，與2劑或3劑的接種方案效果相當。(網站原文：SAGE’s review concluded that a single-dose Human Papillomavirus (HPV) vaccine delivers solid protection against HPV, the virus thatcauses cervical cancer, that is comparable to 2-dose schedules. )
SAGE建議採用以下免疫程序：9-14歲女性(最優先人羣)接種1劑次或2劑次；15-20歲女性接種1劑次或2劑次；21歲以上女性接種2劑次(間隔6個月)。根據世衞網站鏈接的該會議紀要文件描述：SAGE建議各國現在對於9-14歲女性的HPV疫苗免疫程序可在1劑次或2劑次之間進行選擇；在對WHO關於HPV疫苗的立場文件進行修訂之前，WHO將針對這些重要的政策改變召開一次利害關係人諮詢會議。
為避免對投資者造成誤導，現就相關情況對公司的影響説明如下：
公司的產品是在大量臨牀研究及數據論證下，經國家藥監局批覆注冊的疫苗產品，9-45歲女性3劑次(9-14歲女性可以2劑次)，競品默沙東和GSK全部為3劑次。公司積極響應世衞組織和國家消除宮頸癌行動計劃，通過提升產能的方式向社會提供更多的產品來滿足市場供應，2021年公司已經達成3000萬支/年的能力，積極供應市場讓更多的適齡女性通過接種來預防宮頸癌。
截至目前，公司僅取得了國內疫苗註冊許可，尚未取得境外國家疫苗註冊許可。
公司目前在國內獲批的二價HPV疫苗是3劑次(9-14歲女性可以2劑次)。在目前國家藥監政策下，如進行接種劑次等變更，需要履行一系列臨牀、數據支持及註冊變更手續，需要一定時間，短期內對公司的經營業績沒有重大影響。
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