Innovent and Spero Strike $1.1 Billion Deal for Third-Generation Anti-CD40L Antibody Targeting IgG4-RD and Sjögren's Disease
核心洞察
Innovent Biologics (搜索) and Spero Therapeutics announced an exclusive global license agreement for IBI355 (SP001) (搜索), a third-generation Fc-silent anti-CD40L (搜索) monoclonal antibody, valued at approximately $1.1 billion.
Spero gains exclusive worldwide rights outside Greater China and plans to initiate a Phase 2 trial in IgG4-related disease (搜索) (IgG4-RD) in Q2 2027.
Innovent retains rights in Greater China and expects to launch a Phase 2 trial for Sjögren's disease (搜索) (SjD) by early 2027, building on Phase 1b data presented at EULAR 2026.
Innovent Biologics (搜索) and Spero Therapeutics have entered into an exclusive license agreement for IBI355 (Spero R&D code: SP001), a third-generation Fc-silent anti-CD40L (搜索) monoclonal antibody, in a deal carrying a total potential value of approximately $1.1 billion. Under the terms announced July 14, 2026, Spero will receive exclusive global rights to develop, research, manufacture, and commercialize the antibody worldwide, excluding Greater China, where Innovent retains all rights.
The agreement provides Innovent with an upfront payment, along with eligibility for development, regulatory, and commercial milestone payments, plus tiered royalties on net sales generated in Spero's licensed territories.
A Differentiated Mechanism Targeting CD40L (搜索)
IBI355 (SP001) (搜索) targets CD40L (搜索), an immune signal protein positioned upstream of multiple immune pathways involved in B-cell, antigen-presenting cell, and platelet biology. By blocking CD40L, the antibody offers a non-B-cell-depleting approach that could address chronic inflammation, relapse, and tissue damage across a range of immune-mediated diseases.
The molecule is specifically designed to overcome platelet activation concerns that have historically challenged earlier anti-CD40L (搜索) antibodies, while preserving key monoclonal antibody properties including FcRn interaction that supports an IgG-like half-life.
"CD40L (搜索) is an important upstream mediator of immune activation and T-cell/B-cell collaboration, both of which are relevant to IgG4-RD progression," said Dr. Arezou Khosroshahi, MD, Professor of Medicine at Emory University School of Medicine. "A non-B cell depleting approach that interrupts CD40L signaling could represent an important area for clinical evaluation in IgG4-RD, where patients need additional options that address chronic inflammation, relapse, and treatment burden."
Clinical Development Strategy
Innovent has already evaluated IBI355 in two healthy volunteer Phase 1 trials — a single ascending dose (SAD) study and a multiple ascending dose (MAD) study — as well as a Phase 1b MAD study in patients with Sjögren's disease (搜索). Data from the Phase 1b SjD study were presented in a poster session at the EULAR 2026 Congress.
Spero plans to advance SP001 into a Phase 2 study in IgG4-related disease (搜索) (IgG4-RD) patients in Q2 2027. Innovent expects to initiate a separate Phase 2 trial in China for Sjögren's disease (搜索) (SjD) by early 2027.
Addressing Significant Unmet Need
IgG4-related disease (搜索) is a serious, chronic fibroinflammatory condition that can affect multiple organs, including the pancreas, salivary glands, lacrimal glands, kidneys, lungs, and lymph nodes. Current treatment approaches include steroids and B-cell-directed therapies, but additional options are needed to support durable disease control, reduce long-term treatment burden, and preserve immune function.
Sjögren's disease (搜索) is one of the most common autoantibody-driven diseases, predominantly affecting women, yet no approved therapies address its underlying systemic nature. More than half of patients develop moderate-to-severe disease, with a burden comparable to other serious autoimmune conditions. The disease carries an increased risk of non-Hodgkin's B-cell lymphoma in some patients.
Strategic Pipeline Expansion
"Having successfully advanced and delivered a therapy for patients with serious infectious diseases, we are now applying the same disciplined development approach to immune-mediated diseases," said Esther Rajavelu, President and Chief Executive Officer of Spero Therapeutics. "This in-licensing transaction establishes the foundation of our new pipeline and positions Spero to pursue potentially transformative therapies for patients living with chronic, debilitating conditions."
Rajavelu further noted that Spero views CD40L (搜索) as a clinically validated pathway with broad applicability, and sees opportunities to explore CD40L inhibition beyond IgG4-RD across multiple autoimmune and inflammatory conditions.
Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent Biologics (搜索), emphasized the collaborative nature of the partnership: "By combining Innovent and Spero's immunology expertise and development commitment, we aim to accelerate the delivery of differentiated therapies to patients living with these chronic conditions. Our shared goal is to bring meaningful new options to patients in need, wherever they are."