BeOne Medicines has been awarded an Innovation Passport for its investigational bispecific antibody BGB‑B2033, marking a significant step in the company’s plans to advance new treatment options for hepatocellular carcinoma.
The designation provides entry to the UK’s Innovative Licensing and Access Pathway, intended to speed development and patient access for therapies targeting life‑threatening or seriously debilitating conditions.
London‑based BeOne Medicines said the Medicines and Healthcare products Regulatory Agency granted the passport for BGB‑B2033, which targets GPC3 and 4‑1BB and is being developed for patients with advanced or metastatic hepatocellular carcinoma.
James Harris, Interim General Manager, BeOne Medicines UK & Ireland Ltd., said: “Patients with hepatocellular carcinoma continue to face a poor prognosis, underscoring the urgent need for new treatment options.
“We believe BGB‑B2033 has the potential to make a meaningful difference for this patient population, and we welcome the opportunity to participate in the Innovative Licensing and Access Pathway, which promotes early collaboration with UK health authorities to accelerate patient access. We look forward to working closely with the MHRA and ILAP Partners as we advance the development of this investigational medicine.”
The Innovation Passport enables developers to work with ILAP Partners throughout medical development and may provide access to regulatory and development tools that support timely patient access.
BGB‑B2033 is designed to target GPC3, a protein highly expressed in hepatocellular carcinoma, and 4‑1BB, an immune co‑stimulatory receptor. The company plans to begin a global, potentially registration‑enabling clinical trial by the end of 2026.
The therapy has already received Fast Track Designation and Orphan Drug Designation from the Food and Drug Administration in the United States.
In the UK, around 7,000 people are diagnosed with liver cancer each year, with hepatocellular carcinoma accounting for 85% of cases. Incidence has risen by almost 25% over the past decade, with 75% of patients diagnosed at advanced stages and five‑year survival rates below 15%.
