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翰森製藥：自願公告 - B7-H3靶向抗體藥物偶聯物HS-20093用於後線復發或難治性骨肉瘤獲FDA突破性療法認定

HANSOH PHARMA: VOLUNTARY ANNOUNCEMENT - B7-H3-TARGETED ANTIBODY-DRUG CONJUGATE HS-20093 RECEIVEDFDA BREAKTHROUGH THERAPY DESIGNATION IN LATE-LINERELAPSED OR REFRACTORY OSTEOSARCOMA

HKEX ·  Jan 7 19:15

Summary by Moomoo AI

翰森製藥宣佈，其B7-H3靶向抗體藥物偶聯物HS-20093（GSK5764227）獲美國FDA授予突破性療法認定（BTD），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成人患者。此前，翰森製藥已於2023年12月20日與GSK簽訂許可協議，授予GSK全球獨佔許可（不含中國內地、港澳台），以開發、生產及商業化HS-20093。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有效載荷共價連接而成。目前，該藥物在中國正進行多項I期、II期及III期臨床研究，用於治療肺癌、肉瘤、頭頸癌等實體瘤。值得注意的是，HS-20093已於2024年11月1日被中國國家藥品監督管理局納入突破性治療藥物，擬定適應症為經標準一線治療後進展的廣泛期小細胞肺癌。此外，GSK於2024年12月16日宣佈，歐洲藥品管理局授予GSK'227優先藥物認定，用於復發廣泛期小細胞肺癌患者的治療。
翰森製藥宣佈，其B7-H3靶向抗體藥物偶聯物HS-20093（GSK5764227）獲美國FDA授予突破性療法認定（BTD），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成人患者。此前，翰森製藥已於2023年12月20日與GSK簽訂許可協議，授予GSK全球獨佔許可（不含中國內地、港澳台），以開發、生產及商業化HS-20093。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有效載荷共價連接而成。目前，該藥物在中國正進行多項I期、II期及III期臨床研究，用於治療肺癌、肉瘤、頭頸癌等實體瘤。值得注意的是，HS-20093已於2024年11月1日被中國國家藥品監督管理局納入突破性治療藥物，擬定適應症為經標準一線治療後進展的廣泛期小細胞肺癌。此外，GSK於2024年12月16日宣佈，歐洲藥品管理局授予GSK'227優先藥物認定，用於復發廣泛期小細胞肺癌患者的治療。
HANSOH PHARMA announced that its B7-H3 targeted antibody-drug conjugate HS-20093 (GSK5764227) has been granted Breakthrough Therapy Designation (BTD) by the USA FDA for the treatment of adult patients with relapsed or refractory osteosarcoma who have progressed after two or more prior therapies. Previously, HANSOH PHARMA signed a licensing agreement with GSK on December 20, 2023, granting GSK global exclusive rights (excluding mainland China, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize HS-20093.HS-20093 is a novel B7-H3 targeted ADC, composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. Currently, the drug is being studied in multiple phase I, II, and III clinical trials in China for the treatment of solid tumors such as lung cancer, sarcoma...Show More
HANSOH PHARMA announced that its B7-H3 targeted antibody-drug conjugate HS-20093 (GSK5764227) has been granted Breakthrough Therapy Designation (BTD) by the USA FDA for the treatment of adult patients with relapsed or refractory osteosarcoma who have progressed after two or more prior therapies. Previously, HANSOH PHARMA signed a licensing agreement with GSK on December 20, 2023, granting GSK global exclusive rights (excluding mainland China, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize HS-20093.HS-20093 is a novel B7-H3 targeted ADC, composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. Currently, the drug is being studied in multiple phase I, II, and III clinical trials in China for the treatment of solid tumors such as lung cancer, sarcoma, and head and neck cancer. Notably, HS-20093 was included in the list of breakthrough therapeutic drugs by the National Medical Products Administration of China on November 1, 2024, with the proposed indication for extensive stage small cell lung cancer that has progressed after standard first-line therapy. Additionally, GSK announced on December 16, 2024, that the European Medicines Agency has granted GSK '227 priority medicine designation for the treatment of patients with relapsed extensive stage small cell lung cancer.

This announcement is a separate document:

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