翰森制药授权给 GSK 的 B7-H3 ADC Ris-Rez 中国 III 期肺癌研究达到总生存终点

Hansoh Pharmaceutical Group, the licensor of GSK's investigational therapy Ris-Rez, announced positive Phase III results from its ARTEMIS-008 study in China, marking a major milestone in small-cell lung cancer research.
The trial met its primary endpoint, showing statistically significant and clinically meaningful improvements in overall survival (OS) compared with the current standard of care, Topotecan.
Conducted in patients with advanced or relapsed in small-cell lung cancer (SCLC), the study also demonstrated consistent benefits across secondary endpoints, including progression-free survival, with a safety profile in line with earlier findings and no new safety signals. These results represent the first pivotal Phase III overall survival data for a B7-H3-targeted antibody-drug conjugate (ADC) in any tumor type—a significant step forward for this emerging class of targeted therapies.
GSK holds exclusive global rights to develop and commercialize Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan. The company is advancing a broad clinical program that includes studies in lung, prostate, and other solid tumors, with pivotal data from the global Phase III EMBOLD SCLC-301 trial expected next year.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said the results reinforce the potential of B7-H3 as a promising target across multiple tumor types and support continued development of Ris-Rez to improve outcomes in areas of high unmet need.
Ris-Rez is a novel B7-H3 targeted ADC composed of a fully human monoclonal antibody linked to a topoisomerase inhibitor payload. It has received multiple regulatory designations, including orphan drug and breakthrough therapy status from the U.S. FDA, Japan's Ministry of Health, and European Medicines Agency for relapsed or refractory SCLC and osteosarcoma.
The positive ARTEMIS-008 results strengthen the growing body of evidence supporting Ris-Rez's clinical activity and manageable safety profile, offering new hope for patients with extensive-stage SCLC who face limited treatment options and poor prognosis.
GSK has traded between $35.45 and $61.70 over the past year. The stock is currently trading at $52.47, down 0.02%.
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