InnoCare Pharma (HKEX: 09969; SSE: 688428) has received approval from Australia’s Therapeutic Goods Administration (TGA) for Hibruka (orelabrutinib) in relapsed or refractory mantle cell lymphoma (R/R MCL), extending the Beijing-based company’s commercial footprint beyond China and Singapore.
Orelabrutinib is a covalent, irreversible Bruton’s tyrosine kinase (BTK) inhibitor that suppresses B-cell receptor signaling, a pathway central to the survival and proliferation of malignant B cells in MCL. The TGA approval adds Australia to a list of markets where InnoCare holds oncology rights to the asset outright, having retained those rights through a 2021 out-licensing deal with Biogen — which covered only autoimmune and neurological indications — and a subsequent 2025 agreement with Zenas BioPharma on the same non-oncology terms.
MCL is an aggressive B-cell non-Hodgkin lymphoma typically diagnosed at an advanced stage. Relapsed or refractory disease carries a poor prognosis and limited treatment options, and BTK inhibitors have become a standard therapeutic backbone in this setting following a series of approvals across global jurisdictions.
The press release does not specify the clinical dataset submitted to the TGA or cite a trial identifier. InnoCare has previously supported regulatory submissions with data from its Phase II ICP-CL-00103 study, which evaluated orelabrutinib in Chinese patients with R/R MCL and formed the basis of earlier approvals in China. The company has not disclosed whether additional or updated data were submitted for the Australian application.
The BTK inhibitor class in R/R MCL is well-established. Zanubrutinib (Brukinsa), developed by BeOne Medicines, received US FDA accelerated approval for R/R MCL in November 2019 as a covalent BTKi and represents a direct mechanism-class comparator. Eli Lilly’s pirtobrutinib (Jaypirca), a non-covalent, reversible BTK inhibitor, received FDA accelerated approval in January 2023 specifically for patients who had received at least two prior lines of therapy including a BTK inhibitor, addressing the post-covalent BTKi setting where C481S-mutant BTK can confer resistance. Orelabrutinib’s positioning relative to these agents in the Australian market will depend on label specifics and clinical practice patterns not detailed in the available data.
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