InnoCare Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial

Author of the article:You can save this article by registering for free here. Or sign-in if you have an account.BEIJING, Dec. 14, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the phase IIb clinical study of novel BTK inhibitor orelabrutinib has met the primary endpoint in patients with systemic lupus erythematosus (SLE). InnoCare has also received approval from the Center for Drug Evaluation (CDE) to conduct a phase III registrational clinical trial.Subscribe now to read the latest news in your city and across Canada.Subscribe now to read the latest news in your city and across Canada.Create an account or sign in to continue with your reading experience.Create an account or sign in to continue with your reading experience.Orelabrutinib demonstrated outstanding efficacy and well-tolerated safety profile in patients with SLE who had received 48 weeks of treatment in the phase IIb study. A total of 187 patients were enrolled and randomized (1:1:1) into three groups: orelabrutinib 75 mg once-daily (QD), orelabrutinib 50 mg QD, and placebo.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againInterested in more newsletters? Browse here.The primary endpoint of this study was the SLE Response Index-4 (SRI-4) response rate at week 48. At week 48, the orelabrutinib 75 mg QD group achieved a statistically significant improvement in SRI-4 response rate compared with placebo (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. Additionally, the efficacy of the orelabrutinib 75 mg QD group was better than that of the 50 mg QD group, indicating a dose-dependent improvement trend in efficacy.At week 48, the orelabrutinib 75 mg QD group demonstrated significantly higher SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates compared to the placebo group (p < 0.05), meeting the secondary endpoint.In the subgroup of patients with baseline BILAG ≥1A or ≥2B, the placebo-adjusted difference in SRI-4 response rate for orelabrutinib 75 mg QD was 35%. In the subgroup of patients with baseline BILAG ≥1A or ≥2B and a clinical SLEDAI-2K score ≥4, the placebo-adjusted difference in SRI-4 response rate for orelabrutinib 75 mg QD was 43%.The study showed that orelabrutinib was well tolerated in SLE patients. The safety profile was consistent with the mechanism of action of BTK inhibition and the underlying disease biology of SLE.Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a phase II clinical trial for SLE. Phase IIa clinical data on orelabrutinib for SLE was previously presented as a late breaking oral presentation at the European Union Congress of Rheumatology (EULAR). Orelabrutinib is expected to become a first-in-class oral BTK inhibitor for the treatment of SLE.Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “SLE patients have huge unmet clinical needs, requiring long-term or even lifelong medication that severely impact their quality of life. We are happy to see that the phase IIb study of orelabrutinib for SLE has met its primary endpoint with outstanding efficacy and has received approval to conduct phase III registrational trial. We will continuously accelerate clinical development to provide better treatment options for patients with SLE and other autoimmune diseases.”SLE is a systemic autoimmune disease that often leads to damage to multiple organs, particularly the kidneys and musculoskeletal system, nervous system, skin, blood system, and respiratory system; almost all systems can be affected. According to Frost & Sullivan, there are approximately 8 million people with SLE worldwide. According to the “China SLE Development Report 2020”, there are approximately 1 million SLE patients in China, ranking first globally in total number and second in incidence rate. Most SLE patients are young and middle-aged women, requiring long-term management for years or even decades, resulting in huge unmet medical needs.About InnoCareInnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.InnoCare Forward-looking StatementsThis report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.ContactPostmedia is committed to maintaining a lively but civil forum for discussion. Please keep comments relevant and respectful. Comments may take up to an hour to appear on the site. You will receive an email if there is a reply to your comment, an update to a thread you follow or if a user you follow comments. Visit our Community Guidelines for more information.