HANSOH PHARMA: B7-H3 targeted antibody-drug conjugate HS-20093 received FDA breakthrough therapy designation for relapsed or refractory osteosarcoma in later lines of treatment

智通財經
2025.01.07 11:20
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翰森製藥宣佈，其 B7-H3 靶向抗體藥物偶聯物 HS-20093 獲得美國 FDA 的突破性療法認定，適用於後線復發或難治性骨肉瘤患者。該藥物由全人源抗 B7-H3 單抗與拓撲異構酶抑制劑有效載荷共價連接而成，目前在中國進行多項臨牀研究，涵蓋肺癌、肉瘤、頭頸癌等多種實體瘤。

智通財經 APP 訊，翰森製藥 (03692) 公佈，GSK 就 GSK5764227(GSK’227，亦稱 HS-20093) 獲美國食品藥品監督管理局 (FDA) 授予突破性療法認定 (BTD)，此 B7-H3 靶向抗體藥物偶聯物 (ADC) 正在評估用於治療既往經二線及以上治療進展的復發或難治性骨肉瘤 (骨癌) 成人患者。

HS-20093 是一種新型 B7-H3 靶向 ADC，由全人源抗 B7-H3 單抗與拓撲異構酶抑制劑 (TOPOi) 有效載荷共價連接而成，正於中國開展用於治療肺癌、肉瘤、頭頸癌以及其他實體瘤的多項 I 期、II 期及 III 期臨牀研究。

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