<p>長春高新宣佈其子公司藥明生物已收到 FDA 的通知，授予 GenSci128 孤兒藥資格（ODD），旨在治療胃癌。根據 Jin10 的報道，GenSci128 被歸類為治療用途的 1 類新化學藥物，並屬於美國新藥註冊類別'505b1'。它是一種選擇性再激活劑，針對 TP53 Y220C 突變，旨在治療攜帶 TP53 Y220C 突變的局部晚期或轉移性實體腫瘤，包括胰腺癌、胃癌、卵巢癌、乳腺癌和結直腸癌。</p>

長春高新

<p>長春高新旗下的 GenSci Pharmaceuticals 已獲得 FDA 孤兒藥認證，針對胃癌的新化學藥物 GenSci128。GenSci128 是一種針對 TP53 Y220C 突變的選擇性再激活劑，旨在治療包括胰腺癌、胃癌、卵巢癌、乳腺癌和結直腸癌在內的晚期實體腫瘤。它屬於美國新藥註冊類別'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>長春高新宣佈其子公司藥明生物已收到 FDA 的通知，授予 GenSci128 孤兒藥資格（ODD），旨在治療胃癌。根據 Jin10 的報道，GenSci128 被歸類為治療用途的 1 類新化學藥物，並屬於美國新藥註冊類別'505b1'。它是一種選擇性再激活劑，針對 TP53 Y220C 突變，旨在治療攜帶 TP53 Y220C 突變的局部晚期或轉移性實體腫瘤，包括胰腺癌、胃癌、卵巢癌、乳腺癌和結直腸癌。</p>
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長春高新的子公司獲得 FDA 孤兒藥資格認定，GenSci128 用於治療胃癌