InnoCare Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Marginal Zone Lymphoma in Singapore

BEIJING, Sept. 07, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL).

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “We are excited to obtain a second indication approval in Singapore. As a highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy and safety in the treatment of R/R MZL. The approval in Singapore will offer a new treatment option to local lymphoma patients. In addition to lymphoma, we are advancing global clinical trials for orelabrutinib in autoimmune diseases.”

Orelabrutinib is a novel 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.

Marginal zone lymphoma (MZL) is an indolent B-cell non-Hodgkin's lymphoma (NHL) that primarily affects middle-aged and elderly patients. The annual incidence of MZL is rising globally. After first-line treatment, patients with R/R MZL lack effective treatment options.

In April 2025, orelabrutinib received approval in China for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL). Orelabrutinib has been also approved for the treatment of three other indications in China, including relapsed and refractory (R/R) CLL/SLL, r/r mantle cell lymphoma (R/R MCL) and r/r marginal zone lymphoma (R/R MZL), all of which have been covered in China’s National Reimbursement Drug List.

About InnoCare

InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.

Forward-looking Statement
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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/67a6f0fe-bbe4-4a61-adbd-600f1c7a09f9

HIBRUKA (Orelabrutinib)

Approval of HIBRUKA (Orelabrutinib) for the Treatment of R/R MZL in Singapore

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.