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北京时间·🕒 发布 01:09:57时区推断·⟳ 抓取 01:14:15·⚡ 决策 07-29 01:15:52 +1m37s·91.0 天前
翰森制药B7-H3 ADC骨肉瘤III期试验达到主要终点
Ris-Rez在中国复发/进展骨肉瘤III期ARTEMIS-011达到PFS主要终点，支持翰森制药推进中国BLA。
📄 原文Seeking Alpha↗ 原文
GSK partner Hansoh posts late-stage trial win for bone cancer therapy
China-based Hansoh Pharma (HNSPF) on Tuesday announced a late-stage trial win for risvutatug rezetecan, an antibody dru…
不做 翰森制药（03692.HK）
事件方向利好但骨肉瘤适应症罕见且未披露关键疗效和商业化量级，同一资产7月10日已有SCLC III期阳性，当前不追；等完整数据或BLA受理/获批等更硬节点。
不做 GSK（GSK.US）
GSK仅持中国以外权益且海外仍在早期/扩展试验阶段，本次中国骨肉瘤阳性对GSK市值级短线增量不足，不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
消息传播链
- 翰森制药一手公告ARTEMIS-011达到IRC评估PFS主要终点，并计划与CDE沟通推进中国BLA。
- Seeking Alpha在美股盘中转述该试验成功，并强调GSK持有中国以外全球权益。
- Investing.com同日转发Reuters口径，说明事件已进入主流财经信息流。
关键理由
- Ris-Rez在中国复发/进展骨肉瘤III期ARTEMIS-011达到PFS主要终点，支持翰森制药推进中国BLA。
- 该药中国权益归翰森制药，海外权益已授权GSK，协议含1.85亿美元首付款、最高15.25亿美元里程碑及海外销售分级 royalty。
- 量级上骨肉瘤是罕见适应症，本次尚未披露HR、PFS绝对获益、定价和可触达患者数；对GSK这类大市值药企更偏管线确认而非短线市值级增量。
主要风险
- Ris-Rez在7月10日已披露小细胞肺癌III期阳性，本次是同一资产的第二个中国III期阳性，部分B7-H3 ADC价值可能已提前重估。
- 完整数据需等医学会议披露，且中国BLA沟通到获批商业化仍有监管、定价和放量不确定性。
反向证据
- 做多前查反向 · 来源 web · 日期 2026-07-10 · 影响 weakens
同一药物两周前已出现更大适应症SCLC的III期OS阳性，当前骨肉瘤阳性更像追加确认而非首次价值发现。
检索:Ris-Rez HS-20093 prior positive Phase 3 small cell lung cancer July 2026 GSK Hansoh 原文 ↗ - 做多前查反向 · 来源 web · 影响 weakens
骨肉瘤为罕见肿瘤，当前公告未披露患者规模、定价、HR或PFS绝对获益，难以把新增销售额量化到足以支撑追高。
检索:osteosarcoma rare cancer incidence market size risvutatug rezetecan 原文 ↗
原文全文
展开原文 · 1,214 字
China-based Hansoh Pharma (HNSPF) on Tuesday announced a late-stage trial win for risvutatug rezetecan, an antibody drug conjugate developed with GSK (GSK) for a range of solid tumors, including osteosarcoma, a rare bone cancer.
Based on topline data, Hansoh said its ARTEMIS-011 Phase 3 trial for patients with osteosarcoma met its primary endpoint of progression-free survival with a statistically significant effect versus chemotherapy.
The China-based trial, which was designed to evaluate Ris-Rez versus chemotherapy in patients with osteosarcoma who received two or more prior systemic therapies, also indicated consistent benefits across secondary endpoints, including overall survival.
The tolerability profile for the experimental therapy was consistent with prior data for this tumor indication with no new safety signals, the Hong Kong-listed company said, adding it plans a regulatory submission for Ris-Rez in China based on ARTEMIS-011 data.
GSK (GSK) holds global rights to the candidate outside China and associated regions. The British drugmaker is conducting a global phase 1a/2b trial to test Ris-Rez in unresectable advanced or metastatic sarcomas, including osteosarcoma as a late-line option.
Based on topline data, Hansoh said its ARTEMIS-011 Phase 3 trial for patients with osteosarcoma met its primary endpoint of progression-free survival with a statistically significant effect versus chemotherapy.
The China-based trial, which was designed to evaluate Ris-Rez versus chemotherapy in patients with osteosarcoma who received two or more prior systemic therapies, also indicated consistent benefits across secondary endpoints, including overall survival.
The tolerability profile for the experimental therapy was consistent with prior data for this tumor indication with no new safety signals, the Hong Kong-listed company said, adding it plans a regulatory submission for Ris-Rez in China based on ARTEMIS-011 data.
GSK (GSK) holds global rights to the candidate outside China and associated regions. The British drugmaker is conducting a global phase 1a/2b trial to test Ris-Rez in unresectable advanced or metastatic sarcomas, including osteosarcoma as a late-line option.
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