Glenmark Pharmaceuticals Ltd has launched Tevimbra (tislelizumab), an anti-PD-1 monoclonal antibody for treating lung and esophageal cancers, marking the Indian pharmaceutical company's first entry into immuno-oncology following approval by the Central Drugs Standard Control Organization (CDSCO).
The therapy, developed by BeiGene (now BeOne Medicines), is indicated for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy and second-line treatment of locally advanced or metastatic NSCLC and esophageal squamous cell carcinoma (ESCC) as monotherapy.
Addressing Critical Cancer Burden in India
NSCLC represents the most common type of lung cancer, accounting for over 80% of all lung cancer cases. Similarly, ESCC is the most common histological subtype of esophageal cancer in India. Tevimbra addresses the needs of this significant patient population by offering a differentiated and proven treatment option for these cancers.
"With the launch of Tevimbra, Glenmark is delivering on its commitment to transform cancer care in India by making globally benchmarked immunotherapies more accessible," said Alok Malik, president and business head – India formulations, Glenmark Pharmaceuticals Ltd.
Unique Mechanism of Action
Tevimbra is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. The drug is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors.
The therapy selectively binds to PD-1 receptors, restoring T-cell function while minimizing off-target immune suppression. It has demonstrated robust efficacy with a favorable safety profile across diverse solid tumor types in multiple pivotal phase 3 studies and through a comprehensive global clinical development program.
Global Clinical Development and Market Presence
Tevimbra serves as the foundational asset of BeiGene's (now BeOne Medicines) solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global Tevimbra clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies.
The drug is approved and marketed in multiple leading global markets including the United States, European Union, Australia and China. Tevimbra is approved in 46 countries, and more than 1.5 million patients have been treated globally. In 2024, the drug recorded total worldwide sales of around $625 million (approximately ₹5,300 crore).
Strategic Partnership and Future Outlook
Last year, Glenmark and BeiGene entered into a marketing and distribution agreement for 'Tislelizumab' and 'Zanubrutinib' in India. This launch represents a major milestone in expanding Glenmark's innovative oncology portfolio.
"Immuno-oncology offers a promising future for the treatment of various types of advanced cancers which are difficult to treat. Our foray in this area marks a significant inflection point in our journey to build a world-class oncology portfolio that is innovative, inclusive and at the same time life-changing for patients," Malik added.
