智通财经APP讯，石药集团(01093)发布公告，公司附属公司上海津曼特生物科技有限公司自主研发的抗体药物JMT203已获美国食品药品监督管理局(FDA)批准，可以在美国开展临床研究。此前，该产品已经于2023年6月获得中国国家药品监督管理局批准，并正在中国开展临床试验。
该产品为集团自主研发的抗GDNF家族受体蛋白(GFRAL)重组人源化单克隆抗体，能有效拮抗GDF15-GFRAL/RET信号，具有食欲和代谢调节作用，可潜在逆转或者减轻由肿瘤以及化疗药物引起的体重降低、厌食和肌肉萎缩等恶病质症状，从而有效提高肿瘤病人的生活品质。本次获批的临床适应症为肿瘤恶病质，临床前研究显示该产品具有良好的安全性，可显著抑制恶病质小鼠的体重下降、增加其非空腹血糖和前爪握力，从而改善恶病质症状，进而提高恶病质小鼠的带瘤存活率，与抗肿瘤治疗联用显着增加治疗耐受性、延长生存期。
目前，全球范围内尚未有GDF15或GFRAL靶点药物上市，该产品有望成为治疗肿瘤恶病质的有效药物，具有较高的临床开发价值。
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