Nanjing Leads Biolabs Opamtistomig Phase II
Analysis based on 6 articles · First reported Apr 08, 2026 · Last updated Apr 09, 2026
The positive clinical trial results for Opamtistomig are expected to have a positive impact on Nanjing Leads Biolabs' stock price and market valuation. The advancement of the drug into the expansion phase, along with its various designations from the United States — Food and Drug Administration and the International — European Commission, signals strong potential for future commercialization and addresses unmet medical needs in oncology.
Nanjing Leads Biolabs announced that its proprietary bispecific antibody, Opamtistomig (LBL-024), has successfully completed the safety run-in stage of a Phase II clinical trial for the first-line treatment of advanced biliary tract cancer (BTC). The study, led by Jian Zhou from Zhongshan Hospital, Fudan University, showed favorable safety and encouraging preliminary efficacy data, leading to its progression into the expansion phase. Opamtistomig is designed to block PD-1/L1-mediated immune suppression and activate the 4-1BB co-stimulatory pathway, aiming for more potent anti-tumor activity. The drug has also received Breakthrough Therapy Designation from China's National Medical Products Administration, Orphan Drug Designation from the United States — Food and Drug Administration and the International — European Commission, and Fast Track Designation from the United States — Food and Drug Administration for extrapulmonary neuroendocrine carcinoma (EP-NEC).
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