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君實生物(01877.HK):注射用JS203獲得藥物臨牀試驗申請受理通知書

格隆匯5月10日丨君實生物(01877.HK)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JS203(項目代號"JS203")的臨牀試驗申請獲得受理。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,本次臨牀試驗申請能否獲得批准存在不確定性,敬請廣大投資者謹慎決策,注意防範投資風險。

JS203為公司自主研發的重組人源化抗CD20和CD3雙特異性抗體,主要用於復發難治B細胞非霍奇金淋巴瘤的治療。CD20屬於B淋巴細胞限制性分化抗原,是B細胞淋巴瘤最成功的治療靶點之一。CD3是T細胞表面的重要標誌,通過CD3介導T細胞特異性攻擊腫瘤細胞,是T細胞導向的雙特異性抗體的主要作用機制。JS203由抗CD20段和抗CD3段組成,通過聯結並活化T細胞(結合CD3)和淋巴瘤細胞(結合CD20),可有效促進T細胞殺傷淋巴瘤細胞。臨牀前體內藥效試驗顯示,JS203具有顯著的抑瘤效果。此外,動物對JS203的耐受性良好。截至本公吿披露日,國內外尚無同類靶點產品獲批上市

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