瑞科生物-B(02179.HK)新佐劑重組帶狀皰疹疫苗REC610啟動中國III期臨牀研究
格隆匯10月23日丨瑞科生物-B(02179.HK)宣佈，公司自主研發的新佐劑重組帶狀皰疹疫苗REC610，已於近日正式啟動中國III期臨牀研究並完成首批受試者入組。中國III期臨牀研究採用隨機、雙盲、安慰劑對照設計，在中國境內招募24,640例40歲及以上健康受試者，以評價REC610的保護效力、安全性及免疫原性。
帶狀皰疹是一種常見的病毒感染性疾病，患者可能併發帶狀皰疹後神經痛，這種劇烈的神經疼痛嚴重影響患者生活質量。據統計，中國每年約有600萬帶狀皰疹病例，且近年來其發病有逐步年輕化的趨勢。根據全球已上市的帶狀皰疹疫苗研究數據，相比減毒活疫苗，新佐劑重組帶狀皰疹疫苗能提供更強的細胞免疫和保護效力。REC610搭載由公司自主研發的新型佐劑BFA01，可促進產生高水平的VZV糖蛋白E(gE)特異性CD4+T細胞和抗體，擬用於在40歲及以上成人中預防帶狀皰疹。據統計，中國40歲及以上的人口數約為7億左右。目前，中國地區新佐劑重組帶狀皰疹疫苗僅有葛蘭素史克Shingrix®上市銷售，國產替代需求強烈。
REC610已於2023年10月獲得國家藥品監督管理局簽發的藥物臨牀試驗批准通知書(通知書編號：2023LP02151)，予以准許作為預防用3.3類生物製品，在中國開展I期和III期臨牀研究。REC610分別在菲律賓和中國開展以Shingrix®為陽性對照的I期臨牀研究，均取得預期的滿意結果。中國I期研究階段性數據顯示，在40歲及以上健康受試者中，接種兩劑REC610總體安全性良好，未觀察到與研究用疫苗接種相關SAE、AESI或導致提前退出研究的TEAE。REC610可誘導較強的gE特異性細胞免疫應答，免疫應答在首劑接種後即出現，並在兩劑接種後30天達到高峯，其水平與Shingrix®組相當。
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