<p>长春高新宣布其子公司药明生物已收到 FDA 的通知，授予 GenSci128 孤儿药资格（ODD），旨在治疗胃癌。根据 Jin10 的报道，GenSci128 被归类为治疗用途的 1 类新化学药物，并属于美国新药注册类别'505b1'。它是一种选择性再激活剂，针对 TP53 Y220C 突变，旨在治疗携带 TP53 Y220C 突变的局部晚期或转移性实体肿瘤，包括胰腺癌、胃癌、卵巢癌、乳腺癌和结直肠癌。</p>

长春高新

<p>长春高新旗下的 GenSci Pharmaceuticals 已获得 FDA 孤儿药认证，针对胃癌的新化学药物 GenSci128。GenSci128 是一种针对 TP53 Y220C 突变的选择性再激活剂，旨在治疗包括胰腺癌、胃癌、卵巢癌、乳腺癌和结直肠癌在内的晚期实体肿瘤。它属于美国新药注册类别'505b1'</p>

<p>Changchun High-tech announced that its subsidiary, GenSci Pharmaceuticals, has received notification from the FDA granting orphan drug designation (ODD) for GenSci128, aimed at treating gastric cancer. According to Jin10, GenSci128 is classified as a new chemical drug under category 1 for therapeutic use and falls under the U.S. new drug registration category '505b1.' It is a selective reactivator targeting the TP53 Y220C mutation, intended for treating locally advanced or metastatic solid tumors carrying the TP53 Y220C mutation, including pancreatic cancer, gastric cancer, ovarian cancer, breast cancer, and colorectal cancer.</p>
<div class="lb-trans"><p>长春高新宣布其子公司药明生物已收到 FDA 的通知，授予 GenSci128 孤儿药资格（ODD），旨在治疗胃癌。根据 Jin10 的报道，GenSci128 被归类为治疗用途的 1 类新化学药物，并属于美国新药注册类别'505b1'。它是一种选择性再激活剂，针对 TP53 Y220C 突变，旨在治疗携带 TP53 Y220C 突变的局部晚期或转移性实体肿瘤，包括胰腺癌、胃癌、卵巢癌、乳腺癌和结直肠癌。</p>
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长春高新的子公司获得 FDA 孤儿药资格认定，GenSci128 用于治疗胃癌