---
title: "翰森制药：B7-H3 靶向抗体药物偶联物 HS-20093 用于后线复发或难治性骨肉瘤获 FDA 突破性疗法认定"
description: "翰森制药宣布，其 B7-H3 靶向抗体药物偶联物 HS-20093 获得美国 FDA 的突破性疗法认定，适用于后线复发或难治性骨肉瘤患者。该药物由全人源抗 B7-H3 单抗与拓扑异构酶抑制剂有效载荷共价连接而成，目前在中国进行多项临床研究，涵盖肺癌、肉瘤、头颈癌等多种实体瘤。"
type: "news"
locale: "zh-CN"
url: "https://longbridge.com/zh-CN/news/224183949.md"
published_at: "2025-01-07T11:20:03.000Z"
---

# 翰森制药：B7-H3 靶向抗体药物偶联物 HS-20093 用于后线复发或难治性骨肉瘤获 FDA 突破性疗法认定

> 翰森制药宣布，其 B7-H3 靶向抗体药物偶联物 HS-20093 获得美国 FDA 的突破性疗法认定，适用于后线复发或难治性骨肉瘤患者。该药物由全人源抗 B7-H3 单抗与拓扑异构酶抑制剂有效载荷共价连接而成，目前在中国进行多项临床研究，涵盖肺癌、肉瘤、头颈癌等多种实体瘤。

智通财经 APP 讯，翰森制药 (03692) 公布，GSK 就 GSK5764227(GSK’227，亦称 HS-20093) 获美国食品药品监督管理局 (FDA) 授予突破性疗法认定 (BTD)，此 B7-H3 靶向抗体药物偶联物 (ADC) 正在评估用于治疗既往经二线及以上治疗进展的复发或难治性骨肉瘤 (骨癌) 成人患者。

HS-20093 是一种新型 B7-H3 靶向 ADC，由全人源抗 B7-H3 单抗与拓扑异构酶抑制剂 (TOPOi) 有效载荷共价连接而成，正于中国开展用于治疗肺癌、肉瘤、头颈癌以及其他实体瘤的多项 I 期、II 期及 III 期临床研究。

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