SHANGHAI, China, July 10, 2026
Hansoh Pharmaceutical Group Co., Ltd. has announced that its Phase III ARTEMIS-008 clinical trial evaluating risvutatug rezetecan (Ris-Rez/HS-20093) achieved its primary endpoint of overall survival (OS) in patients with advanced or relapsed small-cell lung cancer (SCLC) following prior platinum-based therapy. The pivotal study demonstrated statistically significant and clinically meaningful improvements in overall survival compared with the current standard treatment, topotecan, while also delivering consistent improvements in important secondary endpoints, including progression-free survival (PFS). The trial marks the first positive Phase III study to demonstrate an overall survival benefit for a B7-H3-directed antibody-drug conjugate (ADC) in any tumour type, representing a major milestone in targeted oncology research. Based on these encouraging results, Hansoh Pharma plans to initiate regulatory discussions with China’s National Medical Products Administration (NMPA) to support a future Biologics License Application (BLA) while presenting the complete clinical data at an upcoming international oncology congress.
ARTEMIS-008 Trial Demonstrates Landmark Survival Benefit in SCLC
The ARTEMIS-008 Phase III trial evaluated Ris-Rez, a novel B7-H3-targeted antibody-drug conjugate, in patients with advanced or relapsed small-cell lung cancer, an aggressive malignancy characterized by rapid progression, high recurrence rates, and poor long-term survival. At the predefined interim analysis, the investigational therapy achieved a clinically meaningful and statistically significant improvement in overall survival, successfully meeting the study’s primary endpoint while also demonstrating favorable improvements in progression-free survival compared with topotecan, the current standard second-line treatment.
Importantly, the safety profile remained consistent with previous clinical studies, with no new safety signals identified, reinforcing confidence in the therapy’s tolerability. Since the majority of patients with small-cell lung cancer relapse after platinum-based chemotherapy and have limited treatment options, the positive Phase III findings represent an important breakthrough that could establish Ris-Rez as a promising new treatment option for one of the most difficult-to-treat forms of lung cancer.
B7-H3 Targeted ADC Expands Global Oncology Development
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Risvutatug rezetecan is a fully human B7-H3-directed antibody-drug conjugate developed by Hansoh Pharma that combines a highly specific monoclonal antibody with a topoisomerase I inhibitor payload through an advanced cleavable linker technology. The targeted design enables selective delivery of chemotherapy directly to B7-H3-expressing tumour cells, maximizing anti-cancer activity while minimizing systemic toxicity. The therapy is currently being evaluated across multiple tumour types, including small-cell lung cancer, non-small cell lung cancer, osteosarcoma, head and neck cancer, prostate cancer, esophageal squamous cell carcinoma, and colorectal cancer. In December 2023, GSK obtained exclusive worldwide rights outside mainland China, Hong Kong, Macau, and Taiwan to develop and commercialize Ris-Rez, with global Phase I and Phase III clinical studies currently underway. The positive ARTEMIS-008 results further strengthen confidence in B7-H3 as a high-value therapeutic target and reinforce the growing role of antibody-drug conjugates in precision oncology.
Hansoh Pharma Advances Regulatory Strategy for Innovative Lung Cancer Therapy
Following the successful completion of ARTEMIS-008, Hansoh Pharma will engage with the NMPA Center for Drug Evaluation (CDE) to prepare for a Biologics License Application in China. The company also plans to present the full dataset at a major international oncology conference, providing additional insights into the clinical performance of Ris-Rez. The study represents a significant achievement not only for Hansoh Pharma but also for the broader oncology community, demonstrating for the first time that a B7-H3-targeted antibody-drug conjugate can significantly improve overall survival in a Phase III trial. As the global demand for more effective treatments for small-cell lung cancer continues to grow, the success of Ris-Rez highlights the potential of next-generation targeted ADC therapies to transform standards of care, improve survival outcomes, and address major unmet medical needs in patients with aggressive solid tumours.
Source: Hansoh Pharma press release
