沃森生物(300142.SZ):二價HPV疫苗Ⅲ期臨牀試驗獲得臨牀試驗報告
格隆匯4月30日丨沃森生物(300142.SZ)公佈,公司子公司上海澤潤生物科技有限公司於近日收到擁有自主知識產權研發的“重組人乳頭瘤病毒雙價(16/18型)疫苗(酵母)”(“二價HPV疫苗”)的《Ⅲ期臨牀試驗報告》和《重組人乳頭瘤病毒雙價(16/18型)疫苗(酵母)在青少年(9-14歲)女性二針免疫程序的免疫原性研究臨牀試驗報告》。
該疫苗用於預防由HPV16型和18型病毒感染及其導致的子宮頸癌。《Ⅲ期臨牀試驗報告》顯示該疫苗Ⅲ期臨牀試驗結果全面達到預設目標。該疫苗Ⅲ期臨牀試驗採用隨機、盲法、多中心、安慰劑對照設計,該試驗樣本量為12,000人,在廣西、河北、河南、山西四省共10個臨牀試驗現場開展。研究結果顯示二價HPV疫苗在目標人羣中具有良好的保護效力、免疫原性和安全性。
該疫苗二針程序臨牀試驗是比爾及梅琳達·蓋茨基金會支持的項目,《二針程序臨牀試驗報告》研究結果顯示該疫苗在9-14歲青少年女性中按0、6月免疫程序進行接種具有良好的免疫原性和安全性。
隨着二價HPV疫苗獲得上述兩個臨牀試驗報告,標誌着公司已完成二價HPV疫苗臨牀研究階段工作,也表明該疫苗具備了申請新藥生產的必備條件。
該疫苗獲得《Ⅲ期臨牀試驗報告》和《二針程序臨牀試驗報告》對公司近期業績不會產生重大影響。後續該疫苗申請上市許可及藥品註冊審評審批的進度和時間尚具有一定的不確定性。
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