三生國健(688336.SH)：重組抗VEGF人源化單抗RVO項目完成II期臨牀實驗首例受試者入組
格隆匯3月1日丨三生國健(688336.SH)宣佈，近日，公司自主研發的重組抗VEGF人源化單克隆抗體(研發代號：601A)視網膜靜脈阻塞(RVO)項目II期臨牀實驗首例受試者已順利完成入組。
601A是一種重組人源化全長抗VEGF單克隆抗體，公司目前正在分別推進4個適應症的臨牀實驗，分別為：視網膜靜脈阻塞(RVO)、年齡相關性黃斑變性(AMD)、糖尿病黃斑水腫(DME)、病理性近視的脈絡膜新生血管導致的視力損害(pmCNV)。截止到2020年12月31日，601A累計研發投入金額為1.38億元。
視網膜靜脈阻塞(RVO)是眼科第二大常見的視網膜血管性疾病，患者通常因為繼發黃斑水腫而導致嚴重視力下降。根據其阻塞部位不同，視網膜靜脈阻塞可分為視網膜分支靜脈阻塞(BRVO)和視網膜中央靜脈阻塞(CRVO)，其患病率分別為0.1%—0.4%和0.6%—1.6%。視網膜靜脈阻塞的併發症有黃斑水腫、視網膜及視盤新生血管形成、玻璃體出血及新生血管性青光眼等，其中黃斑水腫是RVO導致視力下降最主要的原因，也是其最常見的併發症，發生率為48%—67%。黃斑水腫早期病變就會對患者的視力產生不良影響，嚴重或長期的黃斑水腫會造成永久性視力損害。若能在黃斑水腫早期病變時使水腫儘快消退，則患者的視力會得到不同程度的恢復。
現階段，公司正在進行“評價601A(眼科)在視網膜分支靜脈阻塞(BRVO)/中央靜脈阻塞(CRVO)所致黃斑水腫病變患者中的安全性和有效性的多中心、隨機、雙盲、陽性藥物對照的II期臨牀試驗”。日前，BRVO和CRVO兩個項目分別順利完成首例受試者入組。
在已經完成的兩項I期臨牀試驗中，包括年齡相關性黃斑變性(AMD)和糖尿病黃斑水腫(DME)病人單劑量和多劑量爬坡試驗，601A顯示出良好的安全性和耐受性，並可不同程度地改善患者視力，提高患者生活質量。
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