邁威生物(688062.SH):9MW3011的新藥臨牀試驗申請獲得FDA批准通知書
格隆匯11月20日丨邁威生物(688062.SH)公佈,近日,公司收到美國食品藥品監督管理局(以下簡稱"FDA")簽發的《臨牀研究繼續進行通知書》(Study May Proceed Notification),9MW3011 的新藥臨牀試驗申請正式獲得 FDA 批准。由於藥品的研發週期長、審批環節多,容易受到一些不確定性因素的影響,敬請廣大投資者謹慎決策,注意防範投資風險。
據悉,9MW3011 為一款由公司在美國 San Diego 的創新分子發現實驗室自主研發的創新靶點單克隆抗體,治療用生物製品 1 類。其靶點主要表達在肝細胞膜表面,9MW3011 可通過特異性結合,上調肝細胞表達鐵調素(Hepcidin)的水平,抑制鐵的吸收和釋放,降低血清鐵水平,從而調節體內的鐵穩態。
9MW3011 已於上月收到國家藥品監督管理局核准簽發的《受理通知書》,臨牀試驗申請獲得受理。適應症擬包括多種在全球不同地區被列為罕見病的疾病,如 β-地中海貧血、真性紅細胞增多症等與鐵穩態相關的疾病。目前,相關適應症領域尚無成熟有效的大分子治療藥物,因此,9MW3011 有望在未來獲得孤兒藥資格,並有望成為全球範圍內首個調節體內鐵穩態的大分子藥物。
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