Shanghai-based Oricell Therapeutics Holdings Limited announced that its GPC3 CAR-T therapy, Ori-C101, has received clearance from China's National Medical Products Administration to proceed into a confirmatory Phase II randomised registration trial in patients with GPC3-positive advanced hepatocellular carcinoma who have failed at least two prior lines of therapy. The clearance positions Ori-C101 as the first GPC3-directed immune cell therapy globally to enter a confirmatory trial and the first CAR-T product for a liver cancer indication to reach a Phase II randomised controlled study.
Ori-C101 is a GPC3-targeted autologous CAR-T therapy engineered to redirect T cells against glypican-3, a cell-surface proteoglycan overexpressed in more than 70% of hepatocellular carcinomas.
The confirmatory trial milestone follows Phase I BEACON study data presented as an oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting, and comes roughly two months after Oricell closed a pre-IPO financing round exceeding USD 110 million co-led by Vivo Capital and Qiming Venture Partners to fund global clinical development.
The BEACON study enrolled patients with advanced HCC who had failed at least two prior lines of systemic therapy, including both tyrosine kinase inhibitors and immune checkpoint inhibitors. As of the April 2026 data cutoff, 18 patients were evaluable for efficacy. The overall objective response rate was 50% across the evaluable population, rising to 66.7% in the recommended Phase II dose cohort and 100% in the highest dose cohort. Of responders, 89% had achieved objective response by their first post-infusion assessment. Median overall survival in the overall population was 21.4 months, with a 12-month survival rate of 69.3% — compared with a historical median of approximately 10.6 months with available second-line agents.
Competitive context