奧賽康(002755.SZ):子公司ASKG712注射液獲得臨牀試驗批准通知書
格隆匯1月17日丨奧賽康(002755.SZ)公佈,公司的全資子公司蘇州奧賽康生物醫藥有限公司(以下簡稱“蘇州奧賽康”)於近日收到國家藥監局核准簽發關於ASKG712注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
AMD是一種累及黃斑區視網膜的中心視力進行性減退的疾病,該疾病會導致患者視力不可逆下降,是50歲以上成年人中主要的致盲眼病之一。數據顯示,我國AMD患者約有2140萬,隨着人口老齡化日益嚴重,發病率也將逐年攀升。目前標準治療藥物均為單靶點抗VEGF藥物,需要頻繁(每個月)進行玻璃體腔注射,患者依從性差,治療經濟負擔大。
ASKG712是子公司自主研發的同時靶向VEGF與ANG2的雙特異性抗體。在阻斷VEGF/VEGFR信號通路,控制新生血管形成的同時,可有效抑制ANG-2信號,以改善血管穩定性和減輕視網膜炎症。目前全球尚無同靶點雙特異性抗體上市,全球首家為羅氏開發的Faricimab,於2021年宣佈其四項三期臨牀均達到主要重點,療效顯著,約一半的患者可達到每四個月給藥一次。ASKG712臨牀前結果顯示,其安全性良好,且對VEGF和ANG2均有更強的結合活性,有望臨牀上達到更好療效,減少玻璃體注射給藥次數。
目前子公司已獲得臨牀試驗批准通知書,將按我國藥品註冊相關的法律法規要求,開展關於ASKG712的臨牀試驗研究。該項目將進一步豐富公司的創新藥管線,增強公司市場競爭,填補市場空白。
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