BEIJING, Oct. 16, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that three studies of orelabrutinib, its novel BTK inhibitor, have been selected for oral presentations at the 88th Annual Meeting of the Japanese Society of Hematology (JSH 2026).
The studies focused on real-world data of orelabrutinib monotherapy for chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), preliminary Phase II results of an orelabrutinib regimen as first-line treatment for marginal zone lymphoma (MZL), as well as Phase II results of an orelabrutinib regimen as first-line treatment for diffuse large B cell lymphoma (DLBCL). Professor Huayuan Zhu from Jiangsu Provincial Hospital, and professor Wenyu Shi from Affiliated Hospital of Nantong Hospital, delivered the oral presentations at the meeting. Key highlights are summarized below:
1. Orelabrutinib Monotherapy in Chinese Patients with CLL/SLL: A Multicenter Real-world Study (Presentation No.: O3-18D-2)
Real-world data support orelabrutinib monotherapy in both first-line and relapsed/refractory (R/R) CLL/SLL.
The retrospective study included 211 patients. At a median follow-up of 33.5 months, median progression free survival (PFS) and median overall survival (OS) were not reached, with 36-month PFS 80.0% and OS 91.3%, demonstrating durable survival benefits of orelabrutinib monotherapy in real-world Chinese patients with CLL/SLL.
The first- and second-line pooled patient group exhibited significantly better PFS than the patients initiated orelabrutinib ≥3rd-line, with 36-month PFS rate of 81.8% vs. 70.3% respectively, suggesting that earlier initiation of orelabrutinib may yield superior progression-free survival benefits.
The study also showed that the safety profile is manageable.
2. Orelabrutinib+Zebetuzumab+Lenalidomide (OZL) in Newly Diagnosed MZL: Phase 2 Preliminary Results (Presentation No.: O3-18D-3)
The chemo-free orelabrutinib+zebetuzumab+lenalidomide regimen demonstrated high response rates with deep remissions and a manageable safety profile in newly diagnosed MZL.
Of evaluable patients, all (100%) achieved overall response (OR) after 6 cycles of induction, including 62.5% complete responses (CRs). Among patients who were Minimal Residual Disease (MRD)-positivity at baseline, 70% achieved MRD negativity at the end of induction.
The safety profile was manageable, with no new safety signals identified.
The study’s primary endpoint is 3-year progression free survival. Recruitment is currently ongoing.
3. PRO Regimen (Polatuzumab, Orelabrutinib, Rituximab) in Frail DLBCL Frontline Setting (Presentation No.: O2-6C-5)
The chemo free orelabrutinib, polatuzumab and rituximab regimen showed high efficacy and manageable safety and is a promising frontline option for elderly and frail DLBCL patients including those over 80 years.
The median age of patients was 78, with 43.6% over 80 and 74.3% with comorbidities. Among patients who completed 6 cycles of efficacy assessment, the complete response (CR) rate was 91.7%, and the overall response rate (ORR) was 95.8%. At a median follow up of 7.0 months, median PFS and OS were not reached and the estimated 9-month PFS rate was 92.8%. Outcomes were similar in patients over 80.
The safety profile is manageable.
The 88th Annual Meeting of the JSH 2026 is hosted by the Japanese Society of Hematology, which was held from Oct. 9-11 at Kyoto, Japan.
More information can be found at JSH official website.
About InnoCare Pharma
InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.
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