CSTONE PHARMA-B(02616): CS5007(EGFR/HER3 bispecific ADC) global multicenter phase I clinical trial initiated.

CSTONE PHARMA-B (02616) announced that the global multi-center Phase I clinical trial of its core candidate drug CS5007 (EGFR/HER3 bispecific antibody-drug conjugate [ADC]) has officially obtained approval from the Australian Human Research Ethics Committee (HREC). This marks the full-scale initiation of global clinical development for CS5007 and signifies that the company's Pipeline 2.0 strategy is accelerating, with significant resources entering the fast lane of clinical development, providing confidence for long-term growth. Dr. Frank Jiang, CEO, President of Research and Development, and Executive Director of CStone Pharma, stated, "The official initiation of the global Phase I clinical trial for CS5007 is another important milestone in the Pipeline 2.0 process. It once again validates the innovative strength and global competitiveness of our proprietary ADC technology platform and clearly signals that the new generation of innovative pipelines at CStone Pharma is transitioning from a period of technical reserves to clinical realization, with subsequent resources accelerating and gaining momentum. In the short-term fluctuations of the capital market, the company is steadily building a differentiated value moat based on its robust self-developed platform, orderly pipeline progress, and clear global pathways. With its differentiated dual-target design for EGFR/HER3 and solid preclinical data, CS5007 directly targets the core challenges of tumor resistance and heterogeneity in the late-stage solid tumor treatment field. We believe that CS5007 has the potential to become the best-in-class innovative ADC product in this field. In the future, CStone Pharma will continue to focus on clinical value, accelerate the global development of its innovative pipeline, and strive to provide transformative therapies for patients while creating long-term returns for investors." Dr. Jason Yang, Chief Medical Officer of CStone Pharma, stated, "CS5007 is a highly representative asset in CStone Pharma's innovative Pipeline 2.0 for oncology. By targeting both the EGFR and HER3 key signaling pathways simultaneously, CS5007 may overcome the limitations of traditional single-target therapy and provide more comprehensive and sustained pathway inhibition, leading to deeper and more durable anti-tumor activity in various solid tumors. It is worth mentioning that CS5007 utilizes a highly active and clinically validated topoisomerase I inhibitor payload, with significant bystander effects, which expands its therapeutic potential to tumors with different levels of antigen expression. The encouraging efficacy and safety profile demonstrated in preclinical studies provide a solid scientific foundation for upcoming clinical development. With the official launch of the global Phase I first-in-human study, we will systematically evaluate the safety, pharmacokinetic/pharmacodynamic (PK/PD) characteristics, and initial anti-tumor activity of CS5007 in late-stage solid tumor patients, providing precise evidence for subsequent development decisions."