INNOCARE (09969): The phase IIb clinical trial of olokizumab in the treatment of systemic lupus erythematosus has achieved positive results and the phase III clinical trial has been initiated.

INNOCARE (09969) announced that the Center for Drug Evaluation (CDE) has approved the initiation of a Phase III clinical trial for obutinib to treat Systemic Lupus Erythematosus (SLE). Building on solid data from the Phase IIb clinical trial, the Phase III study will evaluate the daily dosing regimen of 75 mg. The Phase IIb clinical results showed that in SLE patients treated for 48 weeks, obutinib demonstrated excellent efficacy and good tolerability and safety. A total of 187 patients were enrolled in this study and were randomly assigned to three groups in a 1:1:1 ratio, with two dosages of obutinib (75 mg and 50 mg daily) and a placebo group. The primary endpoint of this study was the SLE Responder Index-4 (SRI-4) response rate at 48 weeks. At week 48, the SRI-4 response rate in the 75 mg daily obutinib dosage group was significantly higher than the placebo group (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. Additionally, the efficacy of obutinib in treating SLE showed a dose-dependent trend for both the 75 mg and 50 mg daily dosages. At week 48, the SRI-6 response rate and the British Isles Lupus Assessment Group (BILAG) response rate in the 75 mg daily obutinib dosage group were significantly higher than the placebo group (p < 0.05), meeting secondary endpoints. In the subset of patients with baseline BILAG 1A or 2B, the SRI-4 response rate improved by 35% in the 75 mg daily obutinib dosage group compared to the placebo group. In the subset of patients with baseline BILAG 1A or 2B and clinical SLEDAI-2K scores 4, the SRI-4 response rate in the 75 mg daily obutinib dosage group increased by 43% compared to the placebo group. The study suggests that obutinib is well-tolerated in SLE patients, and its safety profile is consistent with the mechanism of action of BTK inhibitors and the related disease biology of SLE. Obutinib is the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. Previous clinical data for obutinib in the treatment of SLE were presented at the Annual European Congress of Rheumatology (EULAR) through a recent keynote presentation. Obutinib is expected to become the first oral BTK inhibitor for the treatment of SLE in its class. The company will continue to accelerate the clinical development of obutinib to provide innovative and accessible treatment options for patients with autoimmune diseases. Obutinib (Innocare) is a late-stage clinical oral small molecule bruton's tyrosine kinase (BTK) inhibitor with high central nervous system penetration, selectivity, and irreversibility, offering potential best-in-class advantages. In the field of SLE, obutinib has shown positive results in Phase IIb trials, with clinical benefits and good safety features validated. The Phase III trial for SLE has been approved for initiation, with the first patient expected to be enrolled in the first quarter of 2026 (FPI). In other autoimmune disease areas, its Phase III registration trial for the treatment of Immune Thrombocytopenic Purpura (ITP) in China has completed patient enrollment and is planned to submit a new drug application in the first half of 2026. The company retains rights to obutinib in the Greater China region and Southeast Asia for SLE and other autoimmune indications, with international rights granted to Zenas. In the field of Multiple Sclerosis (MS), a Phase III trial for Primary Progressive MS (PPMS) was initiated in the third quarter of 2025, and a Phase III trial for Secondary Progressive MS (SPMS) is expected to start in the first quarter of 2026. The Phase III trial protocols for MS have received guidance and consensus from the FDA and EMA, with global rights for the treatment of MS with obutinib granted to Zenas. In the field of hematologic malignancies, obutinib has gained significant clinical recognition and market penetration since its launch in mainland China. The drug was included in the National Reimbursement Drug List (NRDL) in 2022, covering adult patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) who have previously received at least one treatment, and adult patients with Mantle Cell Lymphoma (MCL) who have previously received at least one treatment, expanding in 2024 to include adult patients with Marginal Zone Lymphoma (MZL) who have previously received at least one treatment, becoming the first and only BTK inhibitor approved for MZL in China. In April 2025, the CDE approved obutinib for a new drug application for first-line CLL/SLL, and this indication was also included in the National Reimbursement Drug List.