InnoCare Announces Approval of Orelabrutinib in Australia

BEIJING, May 27, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today 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.

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.

About InnoCare Pharma

InnoCare (SSE: 688428; HKEX: 09969) 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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This 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.

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