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Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for First Line Treatment of HER2-positive Breast Cancer

Innovent dosed the first participant in the HeriCare-Breast01 trial, a multicenter, randomized, open-label study comparing IBI354 to the THP regimen.
To address urgent unmet needs in advanced HER2-positive disease, Innovent is exploring IBI354 in a Phase 3 trial due to no ADC targeting HER2 being fully approved for first-line treatment in China, and based on promising early efficacy data from previous studies.
Phase 1/2 results showed cORR 59.1% and DCR 90.9%, with safety metrics including grade 3 or higher TRAEs 21.0%, ILD incidence 1.2%, and no DLT up to 18mg/kg.
The Phase 3 could advance IBI354's potential as a new first-line treatment for HER2-positive breast cancer, which affects about 30% of cases and roughly 1.3 million women annually, say investigators and Innovent.
Innovent will explore IBI354 in additional solid tumors, supported by global partners and pipeline, and continue advancing its SoloTx ADC platform for improved outcomes.

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Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for First Line Treatment of HER2-positive Breast Cancer

SAN FRANCISCO and SUZHOU, China, Feb. 12, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent",HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major…

5 days ago·Missoula, United States

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