邁威生物(688062.SH):注射用9MW2921的臨牀試驗申請獲得受理
格隆匯2月5日丨邁威生物(688062.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《受理通知書》,注射用9MW2921的臨牀試驗申請獲得受理。
9MW2921是邁威生物基於新型抗體偶聯技術平台IDDCTM (Interchain-Disulfide Drug Conjugate)開發的新一代抗體偶聯藥物分子(ADC分子),用於治療實體瘤。由創新抗體分子,新型連接子以及新型載荷(TOP1i)共同組合而成,具有完全自主知識產權。9MW2921注射入體內後,可與腫瘤細胞表面的抗原結合並進入腫瘤細胞,通過特定酶解作用,定向釋放小分子,從而實現對腫瘤的精準殺傷。
9MW2921具有結構穩定,組分均一,純度高,易於產業化放大等藥學特點。相較國內外同類型在研ADC品種,9MW2921在內吞活性,血漿穩定性,藥物釋放特性,旁觀者殺傷效應等方面均得到顯著改善與提升。體內藥效研究表明,9MW2921顯示了更好的腫瘤殺傷作用。食蟹猴、大鼠等動物安全性評價模型中,9MW2921的靶向相關毒性以及脱靶毒性均得到有效控制,顯示其具有良好的藥物安全性及藥代特性。
上述研究結果表明9MW2921具有臨牀差異化特性以及廣闊的臨牀開發前景。
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