On December 19, Gelonghui Pharmaceutical-B (02616.HK) issued an announcement. The global multi-center phase Ib clinical trial of CS5001 (ROR1 ADC), the company's pipeline 2.0 blockbuster product, successfully completed the first patient enrollment.
CS5001 is currently the first known ROR1 ADC with clinical anti-tumor efficacy observed in both solid tumors and lymphoma, and its clinical development progress is in the top two in the world. Clinical data show that the objective remission rate (ORR) of CS5001 is higher than that of similar competitors as a single agent for aggressive and inert advanced lymphoma, and has the potential to rapidly register for marketing and impact the frontline combination treatment pattern. The CS5001 global multicenter trial is being carried out simultaneously in the US, Australia, and China. It has now advanced to phase Ib for dose optimization, and is potentially extended to phase II single-arm registration studies later.
Dr. Yang Jianxin, CEO, R&D President and Executive Director of Cornerstone Pharmaceuticals, said, “This year, CS5001 clinical results have been presented at international academic conferences many times and received widespread attention from the industry. According to the latest clinical data, CS5001 single-agent treatment of aggressive and inert advanced lymphoma has a higher ORR than similar competitors, and efficacy data shows a steady trend as the number of patients increases. Therefore, we believe CS5001 has the potential to be registered and marketed faster and to impact the first-line combination treatment pattern. We are very pleased to see CS5001 launch a phase iB dose optimization and expansion trial, which is also expected to be further expanded into a phase II single-arm registered clinical trial for relapsing and refractory diffuse large B-cell lymphoma (DLBCL). At the same time, we will also explore the safety and efficacy of CS5001 as a single agent or combined first-line standard therapy in multiple hematomas and solid tumors in phase IB, with a view to bringing greater survival benefits to cancer patients around the world.”
