SP001 / Innovent Biologics, Spero Therap - LARVOL DELTA

In July 2026, Spero entered into an exclusive license agreement with Innovent Biologics, Inc. for SP001 (GlobeNewswire) - "Spero gained exclusive rights to develop, research, manufacture, and commercialize SP001 worldwide, excluding Greater China (Mainland China, Hong Kong, Macau, and Taiwan), where Innovent retains rights....Spero plans to advance SP001 into a Phase 2 study in IgG4-related disease (IgG4-RD), a serious, rare chronic fibroinflammatory disease with significant treatment burden and limited therapeutic options."

Licensing / partnership • New P2 trial • Immunology

Clinical Safety and Pharmacodynamics of IBI355 in Patients with Sjögren's Disease: a Randomized, Phase 1, Placebo-Controlled, Double-Blind Trial (EULAR 2026) - P1 | "During the treatment period, 4.2% of patients who received IBI355 developed anti-IBI355 antibodies. Conclusions IBI355 demonstrated a favorable safety profile and led to improvements in disease activity and B-cell-related biomarkers in Chinese patients with SjD, supporting the potential role of targeted B-cell modulation in its pathogenesis."

Clinical • IO biomarker • P1 data • PK/PD data • Dyslipidemia • Infectious Disease • Respiratory Diseases • Sjogren's Syndrome • CD40LG

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: Jan 2025 ➔ Jun 2025

Trial completion • Trial primary completion date • Immunology • Sjogren's Syndrome

Safety and Tolerability of IBI355 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2025

Trial completion • Trial completion date

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Sjogren's Syndrome

Safety and Tolerance Study of IBI355 in Health Volunteers (clinicaltrials.gov) - P1 | N=53 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion

Safety and Tolerability of IBI355 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed

Safety and Tolerability of IBI355 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Safety and Tolerance Study of IBI355 in Health Volunteers (clinicaltrials.gov) - P1 | N=53 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Sjogren's Syndrome

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1 trial • Immunology • Sjogren's Syndrome

Safety and Tolerability of IBI355 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1 trial

Safety and Tolerance Study of IBI355 in Health Volunteers (clinicaltrials.gov) - P1 | N=53 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1 trial