BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB‑B2033, its GPC3x4‑1BB bispecific antibody, for adult patients with hepatocellular carcinoma (HCC) who progressed on or after prior systemic treatment. BeOne is conducting a global, multi‑center Phase 1 trial (NCT06427941) evaluating BGB‑B2033 alone and in combination with PD‑1 inhibitor TEVIMBRA (tislelizumab).
Regulatory Milestone
Item
Details
Designation Date
19 Dec 2025
Agency
U.S. FDA
Product
BGB‑B2033 (GPC3x4‑1BB bispecific antibody)
Designation
Fast Track Designation (FTD)
Indication
HCC with disease progression on or after prior systemic therapy
Innovation
First GPC3x4‑1BB bispecific to receive FTD for HCC
Clinical Study
NCT06427941 (Phase 1), monotherapy and combination with TEVIMBRA
Clinical Development & Mechanism
Study Design
Details
Phase
Phase 1
Population
HCC patients post‑systemic therapy
Treatment Arms
BGB‑B2033 monotherapy; BGB‑B2033 + TEVIMBRA
Primary Objectives
Safety and anti‑tumor activity
Mechanism
Bispecific targeting of GPC3 (tumor antigen) and 4‑1BB (T‑cell costimulatory receptor)
Market Opportunity
Metric
Value
Context
Global HCC Market
$1.5‑2.0 billion (2025)
High unmet need in third‑line+ setting
GPC3 Expression
70‑80% of HCC tumors express GPC3
Ideal tumor‑associated target
Bispecific Advantage
Dual GPC3/4‑1BB targeting
Novel immuno‑oncology mechanism
Peak Sales Potential
$300‑500 million
15‑20% share of 3L+ HCC market
Competition
TKIs and PD‑1 combos dominate
BGB‑B2033 offers differentiated approach
Forward‑Looking Statements This brief contains forward‑looking statements regarding BGB‑B2033’s clinical development, market potential, and competitive positioning. Actual results may differ due to regulatory feedback, clinical risks, or competitive responses.-Fineline Info & Tech
By Fineline Cube 