Innovent Biologics and Spero Therapeutics have entered into an exclusive licence agreement for IBI355, also known as SP001, a Phase 2-ready third-generation Fc-silent anti-CD40L antibody.
Under the agreement, Spero will receive exclusive global rights outside Greater China to develop, manufacture and commercialise IBI355. Innovent retains rights in Greater China and will receive an upfront payment, with potential development, regulatory and commercial milestones totalling approximately $1.1 billion, plus tiered royalties.
CD40L is an upstream immune signalling target with potential relevance across multiple immune-mediated diseases. Targeting upstream pathways may offer broader disease-modifying potential, but safety and selectivity are critical for clinical success.
IBI355 has been evaluated by Innovent in two healthy volunteer Phase 1 studies and a Phase 1b multiple ascending dose study in patients with Sjögren’s disease. Data from the Sjögren’s disease study were presented at EULAR 2026.
Spero expects to initiate a Phase 2 trial in IgG4-related disease in the second quarter of 2027. Innovent plans to begin a Phase 2 trial in China for Sjögren’s disease by early 2027.
The deal is commercially important because it gives Innovent another route to globalise a China-originated biologic asset while allowing Spero to expand into immune-mediated disease with a Phase 2-ready candidate.
