On May 27, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that orelabrutinib (HIBRUKA) has been approved by the Therapeutic Goods Administration (TGA) in Australia, offering a new treatment option for patients with Mantle Cell Lymphoma (R/R MCL) in the region.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, "The approval of orelabrutinib in Australia marks another important milestone in InnoCare’s global footprint and brings a new treatment option to patients with lymphoma in the region. Beyond oncology, we are also advancing global clinical trials of orelabrutinib in autoimmune diseases."

MCL is a distinct subtype of B-cell non-Hodgkin’s lymphoma (NHL). It is an aggressive and currently incurable disease with rising incidence rate. Patients are often diagnosed at an advanced stage with limited treatment options and poor prognosis.

Orelabrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy.

Orelabrutinib has been approved in Singapore for the treatment of patients with R/R MCL and R/R MZL (marginal zone lymphoma). In China, Orelabrutinib has been approved for the treatment of four lymphoma indications, all of which have been included in China’s National Reimbursement Drug List.

(Press release, InnoCare Pharma, MAY 27, 2026, View Source [SID1234666135])