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Mumbai-based Glenmark Pharmaceuticals, 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), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide.
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).
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 programme underscores BRUKINSA’s proven efficacy, strong safety profile, and broad therapeutic value.
“We look forward to bringing BRUKINSA to India in the coming months as part of our ongoing partnership with BeiGene (now BeOne Medicines),” said Alok Malik, President and Business Head - India Formulations, Glenmark Pharmaceuticals Ltd. “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."
