石藥集團(01093.HK):JMT203(抗GFRAL單克隆抗體)獲美國臨牀試驗批准
格隆匯4月22日丨石藥集團(01093.HK)公吿,公司附屬公司上海津曼特生物科技有限公司自主研發的抗體藥物JMT203已獲美國食品藥品監督管理局(FDA)批准,可以在美國開展臨牀研究。此前,該產品已經於2023年6月獲得中國國家藥品監督管理局批准,並正在中國開展臨牀試驗。
該產品為集團自主研發的抗GDNF家族受體蛋白(GFRAL)重組人源化單克隆抗體,能有效拮抗GDF15-GFRAL/RET信號,具有食慾和代謝調節作用,可潛在逆轉或者減輕由腫瘤以及化療藥物引起的體重降低、厭食和肌肉萎縮等惡病質症狀,從而有效提高腫瘤病人的生活品質。本次獲批的臨牀適應症為腫瘤惡病質,臨牀前研究顯示該產品具有良好的安全性,可顯著抑制惡病質小鼠的體重下降、增加其非空腹血糖和前爪握力,從而改善惡病質症狀,進而提高惡病質小鼠的帶瘤存活率,與抗腫瘤治療聯用顯着增加治療耐受性、延長生存期。
目前,全球範圍內尚未有GDF15或GFRAL靶點藥物上市,該產品有望成為治療腫瘤惡病質的有效藥物,具有較高的臨牀開發價值。
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