Hansoh Pharmaceutical Presents Promising Phase I Data for B7-H3 ADC Risvutatug Rezetecan Combined with Adebrelimab at AACR 2026 – 47.1% ORR and 14.0-Month PFS in Solid Tumors
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) unveiled Phase I clinical trial results for risvutatug rezetecan (HS-20093/GSK5764227), a B7-H3-targeting antibody-drug conjugate (ADC), in combination with adebrelimab, a fully human anti-PD-L1 monoclonal antibody, at the American Association for Cancer Research Annual Meeting (AACR 2026) in San Diego. The open-label, multi-center study demonstrated encouraging anti-tumor activity with a 47.1% confirmed objective response rate (ORR) and 14.0-month median progression-free survival (PFS), validating Hansoh’s strategic partnership with GSK following their exclusive global licensing agreement in December 2023.
Clinical Trial Results Summary
Efficacy Parameter
Result
Objective Response Rate (ORR)
47.1% (confirmed)
Disease Control Rate (DCR)
94.1%
Median Duration of Response (DoR)
12.6 months
Median Progression-Free Survival (PFS)
14.0 months (32.4% event rate)
Overall Survival (OS)
Immature data
Study Design
Open-label, multi-center Phase I
Presentation Venue
AACR Annual Meeting 2026 (April 17–22, San Diego)
Drug Profile & Mechanism
Risvutatug Rezetecan: B7-H3-targeting antibody-drug conjugate (ADC) under investigation for multiple solid tumors
Adebrelimab: Fully human anti-PD-L1 IgG4 monoclonal antibody, approved in China for first-line extensive-stage small cell lung cancer
B7-H3 Target: Expressed on various solid tumors with limited expression in normal tissues, providing favorable therapeutic window
Safety Profile – Manageable Toxicity
Safety Parameter
Result
Treatment-Related Deaths
None reported
Grade ≥3 Adverse Events
Primarily hematological: decreased white blood cell count, decreased neutrophil count, decreased lymphocyte count, and anemia
Discontinuation Rate
Not specified, but manageable overall profile
Safety Conclusion
Combination demonstrated manageable safety profile consistent with expected profiles of individual agents
Strategic Partnership Context
Partnership Element
Detail
Licensing Agreement
December 2023 between Hansoh and GSK
Territory
Exclusive global license to GSK (excluding mainland China, Hong Kong, Macau, and Taiwan)
Development Rights
GSK responsible for Phase I and III trials outside Greater China
Commercial Rights
GSK holds global commercialization rights excluding Greater China
Hansoh Retention
Full rights in Greater China market
Market Implications & Competitive Positioning
B7-H3 ADC Market: Emerging target class with multiple competitors in development across major pharmaceutical companies
Combination Therapy Trend: PD-(L)1 combinations with ADCs represent next-generation approach to enhance efficacy beyond monotherapy
Solid Tumor Opportunity: Broad applicability across multiple B7-H3-expressing solid tumors including lung, breast, prostate, and ovarian cancers
China Market Advantage: Hansoh retains full commercial rights in Greater China, the world’s second-largest pharmaceutical market
Development Roadmap & Next Steps
Phase II/III Planning: Data supports advancement to later-stage trials based on robust efficacy signals
Tumor Type Expansion: Potential expansion into specific B7-H3-high tumor populations for enhanced efficacy
Regulatory Strategy: Parallel development pathways in Greater China (Hansoh-led) and global markets (GSK-led)
Forward‑Looking Statements This brief contains forward-looking statements regarding clinical development, regulatory pathways, and commercial potential. Actual results may differ due to risks including later-stage trial outcomes, regulatory decisions, competitive dynamics, and market adoption rates.-Fineline Info & Tech
By Fineline Cube