Glenmark Gets Approval from DGCI for Launching Brukinsa in India

Mumbai, June 9, 2025 – Glenmark Pharmaceuticals Ltd. (NSE: GLENMARK | BSE: 532296), a research-driven global pharmaceutical major has secured regulatory approval from the Drugs Controller General of India (DCGI) to introduce BRUKINSA® (zanubrutinib) in India.

The approval boosts the nation’s development in the oncology landscape, as BRUKINSA becomes India’s first and only Bruton’s Tyrosine Kinase (BTK) inhibitor approved for five B-cell cancers, including:

Developed by Switzerland-based BeOne Medicines (formerly BeiGene), BRUKINSA has global regulatory clearance in over 70 countries and has benefited over 100,000 patients worldwide, based on data from more than 35 clinical trials involving 6,000+ participants.

Differentiated Safety and Dosing Advantage

The BTK inhibitor demonstrated superior outcomes in global trials. For instance, in the head-to-head ALPINE studyon relapsed/refractory CLL, BRUKINSA had:

• Fewer serious cardiac events: 1.9% vs. 7.7% (compared with ibrutinib)
• Lower treatment discontinuation due to cardiac issues: 0.3% vs. 4.3%
• Flexible dosing: Once or twice daily administration for personalized patient care

Strategic Commentary

Alok Malik, President & Business Head – India Formulations, Glenmark Pharmaceuticals Ltd., remarked:

“This launch marks a significant milestone in our innovative oncology portfolio, offering patients in India access to a globally trusted therapy with proven efficacy and safety.”

Adam Roach, SVP and Head of Japan & Asia Pacific, BeOne Medicines, added:

“We are proud to support Glenmark in bringing this therapy to patients in India, furthering our shared commitment to improve healthcare outcomes globally.”

Addressing India’s Blood Cancer Burden

India faces a pressing hematological challenge as a new blood cancer diagnosis occurs every 5 minutes, and over 70,000 annual deaths are attributed to the disease. The launch of BRUKINSA aligns with efforts to bridge this critical treatment gap with advanced, globally validated solutions.

Outlook

The company’s stock had a strong bullish week, rising over 9% from an opening price of ₹1,457.20 on June 2 to ₹1,590.20 by June 6, reflecting strong investor confidence and increased trading activity mid-week. It opened the following week on June 9 at ₹1,590.20 and, by 12:30 PM, had climbed to ₹1,601.0, marking a 0.68% gain intraday.

About Glenmark Pharmaceuticals

Glenmark is a diversified pharmaceutical company with a presence in branded, generics, and OTC markets. With 11 global manufacturing facilities, operations across 80+ countries, and recognized among the Top 100 biopharmaceutical firms, the company emphasizes respiratory, dermatology, and oncology care. It is also among the few Indian pharma companies with SBTi-approved GHG emission targets, showcasing its ESG commitment.

About BeOne Medicines

BeOne, formerly BeiGene, is a global oncology firm committed to making innovative and affordable treatments accessible to cancer patients worldwide. With a strong presence across six continents and a growing workforce of 11,000+ employees, the company continues to build on its legacy of impactful cancer therapeutics.

REF: https://www.bseindia.com/xml-data/corpfiling/AttachLive/b59347c4-c670-48c1-aa0a-633966aa397f.pdf

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