BeOne Medicines Granted U.S. FDA Fast Track Designation for BGB-B2033 as Treatment for Hepatocellular Carcinoma
BeOne Medicines Ltd. - American Depositary Shares (ONC)
Company Research
Source: Business Wire
BGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver cancerFDA Fast Track Designation reflects the potential of BGB-B2033 in an area of high unmet need SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment.“The FDA awards Fast Track Designation to therapies that show potential to address an unmet medical need in serious or life-threatening conditions. The FDA’s decision reflects the encouraging profile of BGB-B2033 in advanced hepatocellular carcinoma, where patients continue to face limited treatment options,” said Julie Lepin, Senior Vice President and Chief Regulatory Aff
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ONC
Earnings
- 11/6/25 - Beat
ONC
Sec Filings
- 12/17/25 - Form 4
- 12/12/25 - Form 4
- 12/1/25 - Form 4
- ONC's page on the SEC website