Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, global pharmaceutical company, has announced the upcoming launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI).

Zanubrutinib will be marketed in India under the brand name BRUKINSA, an innovative therapy developed by BeiGene (now BeOne Medicines). BRUKINSA is the first and only Bruton's tyrosine kinase (BTK) inhibitor approved in India for the treatment of five distinct B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL), the company said in a statement.

Globally, BRUKINSA is approved in more than 70 countries, supported by compelling clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA. This extensive clinical program underscores BRUKINSA's proven efficacy, strong safety profile, and broad therapeutic value.

The introduction of BRUKINSA brings an innovative treatment option at a time when India continues to face a significant burden from serious and difficult-to-treat haematological malignancies. According to various sources, someone in India is diagnosed with blood cancer every five minutes, and an estimated 70,000 people die from the disease each year.

BRUKINSA addresses a critical unmet need with its differentiated pharmacological profile, demonstrating high response rates and durable disease control across multiple B-cell malignancies as shown in pivotal clinical trials. BRUKINSA's flexible dosing regimen (once or twice daily) supports personalised care. In the head-to-head ALPINE study in relapsed/refractory chronic lymphocytic leukemia, BRUKINSA demonstrated a lower rate of serious cardiac events (1.9 percent vs. 7.7 percent) and fewer treatment discontinuations due to cardiac issues (0.3 percent vs. 4.3 percent) compared with ibrutinib.

Alok Malik, President and Business Head – India Formulations, Glenmark Pharmaceuticals Ltd. said, “We look forward to bringing BRUKINSA to India in the coming months as part of our ongoing partnership with BeiGene (now BeOne Medicines). This launch marks a significant milestone in our innovative oncology portfolio, offering patients in India with access to a globally trusted therapy with proven efficacy and safety. It underscores Glenmark’s ongoing commitment to providing effective and advanced treatments for patients with haematological malignancies.”

Adam Roach, Senior Vice President and Head of Japan and Asia Pacific region for BeiGene (to be renamed BeOne Medicines) commented, “The introduction of BRUKINSA in India marks an important step in our ongoing mission to expand patient access to innovative oncology treatments across the Asia Pacific region. We are proud to support Glenmark in bringing this therapy to patients in India, furthering our shared commitment to improve healthcare outcomes globally.”