Innocare Pharma Limited (688428.SH) announced that it has received notification that orelabrutinib (marketed as Yinuokai® and HIBRUKA®) has been granted marketing authorization by the Australian Therapeutic Goods Administration (TGA). Orelabrutinib is a novel, highly selective BTK inhibitor independently developed by the company, designed to effectively minimize off-target effects and associated adverse reactions, thereby significantly enhancing treatment safety and efficacy. Previously, orelabrutinib has been approved in China for four indications: first-line chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), CLL/SLL in patients who have received at least one prior therapy, relapsed/refractory mantle cell lymphoma (r/r MCL) in patients who have received at least one prior therapy, and relapsed/refractory marginal zone lymphoma (r/r MZL) in patients who have received at least one prior therapy. All four indications are included in China's National Reimbursement Drug List. In the international market, orelabrutinib has also been approved in Singapore for the treatment of adult patients with r/r MCL and r/r MZL.