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石藥集團(01093.HK):首創在研藥物JMT601獲中國臨牀試驗批准
格隆匯 03-25 18:19

格隆匯 3 月 25日丨石藥集團(01093.HK)宣佈,公司附屬公司上海津曼特生物科技有限公司("上海津曼特")開發的首創在研藥物JMT601的新藥臨牀試驗(IND)申請已獲國家藥品監督管理局(NMPA)批准,就非霍奇金氏淋巴瘤(NHL)開展臨牀試驗。

非霍奇金氏淋巴瘤是由B淋巴細胞、T淋巴細胞或NK細胞引起的一組淋巴細胞增生性疾病。儘管大部分患者在診斷患有惰性NHL後可生存20年,但侵襲性淋巴瘤患者的預後或會惡化,整體五年生存率約為60%。具有CD20表達的B細胞淋巴瘤佔NHL的大多數。

JMT601是全球首個進入臨牀階段的具有協同靶向結合效應的雙特異性SIRP α融合蛋白,是一種基於已批准的抗CD20抗體奧法木單抗並透過加入CD47結合片段SIRP α而合理設計的新型雙特異性融合蛋白。其有效結合腫瘤細胞表面的CD20,以誘發抗體依賴性細胞介導的細胞毒作用(ADCC)及補體依賴的細胞毒作用(CDC)。其隨後與腫瘤細胞上表達的CD47協同結合,向巨噬細胞發出"別吞噬"的信號,JMT601對阻斷腫瘤細胞上CD47與巨噬細胞上表達的SIRP α的相互作用顯著優於SIRP α-Fc融合蛋白。透過干擾CD47/SIRP α的相互作用,JMT601已增強抗體依賴性細胞吞噬作用(ADCP)。與傳統的CD20靶向抗體相比,多項人類B細胞淋巴瘤模型顯示JMT601的療效更為明顯。已進行的非臨牀毒理學研究顯示JMT601對CD20陰性的細胞無明顯結合,100mpk劑量下未見紅細胞、血小板等CD47強陽性細胞顯著受累,安全狀況理想並可支持其臨牀研究。

集團亦正計劃於美國進行I期臨牀研究。該等研究的臨牀數據將引領JMT601治療非霍奇金氏淋巴瘤及其他血液惡性腫瘤的進一步開發批准。

上海津曼特位於上海市浦東新區張江科學城,是迅速成長中的國家高新技術企業,也是上海市商務委認定的上海外資研發中心;為集團在上海的核心生物藥創新研發中心,致力於腫瘤靶向、免疫調節、代謝等領域的治療性生物大分子新藥研發,具備完整的生物藥研發技術平台。在研新藥研發項目超過10項,自主研發的抗腫瘤專利產品JMT101及JMT103均已順利進入臨牀後期;而JMT601為上海津曼特新型免疫增強型雙功能融合蛋白專利技術平台的首個品種。

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