萬泰生物(603392.SH):子公司二價HPV疫苗通過WHO的PQ認證
格隆匯10月15日丨萬泰生物(603392.SH)公佈,近日,公司全資子公司廈門萬泰滄海生物技術有限公司(“萬泰滄海”)收到世界衞生組織出具的公函,確認其自主研發的雙價人乳頭瘤病毒疫苗(大腸桿菌)(“二價HPV疫苗”)通過了WHO Prequalification(即WHO疫苗資格預審,簡稱WHOPQ認證)。
二價HPV疫苗為萬泰滄海自主研發的預防用生物製品,2019年12月30日獲得國家藥品監督管理局批准取得藥品註冊批件,並於2020年5月在中國境內(不包括港澳台地區)正式上市銷售,是國內首個、世界第四支預防宮頸癌產品。該藥品主要適用於9-45歲女性,用於預防因高危型人乳頭瘤病毒(HPV)16、18型所致宮頸癌、2級與3級宮頸上皮內瘤樣病變(CIN2/3)和原位腺癌(AIS)、1級宮頸上皮內瘤樣病變(CIN1),以及HPV16型、18型引起的持續性感染。
國內已獲批上市銷售的宮頸癌疫苗主要有葛蘭素史克公司的二價宮頸癌疫苗,以及默沙東公司的四價、九價宮頸癌疫苗。
2020年度,公司二價HPV疫苗銷售收入為6.93億元人民幣,佔總收入的29.44%。以上數據已經審計。截至公吿日,公司在二價HPV疫苗上投入的研發費用約為2.94億元人民幣(未經審計)。
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