
Glenmark to launch cancer drug Zanubrutinib in India
New Delhi: Glenmark Pharmaceuticals on Monday said it will launch cancer treatment drug zanubrutinib in India following approval by the Drugs Controller General of India (DCGI).
Zanubrutinib will be marketed in India under the brand name Brukinsa.
It 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, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma.
"We look forward to bringing Brukinsa to India in the coming months as part of our ongoing partnership with BeiGene (now BeOne Medicines)," Glenmark Pharmaceuticals President and Business Head - India Formulations Alok Malik said.
The 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, he added. Glenmark shares on Monday ended 0.68 per cent up at ₹ 1,600.85 apiece on BSE.
In March, Glenmark Pharmaceuticals had launched a medication for glycemic control and weight-loss for diabetes patients.
The Mumbai-based drug firm launched Empagliflozin, a widely recognised SGLT2 inhibitor, under the brand name Glempa (Empagliflozin 10/25 mg), along with its fixed-dose combinations (FDCs)''Glempa-L (Empagliflozin 10/25 mg Linagliptin 5 mg) and Glempa-M (Empagliflozin 12.5 mg Metformin 500/1000 mg).
The medications are designed to improve glycemic control in adults with type 2 diabetes mellitus while also reducing cardiovascular outcomes in patients with cardiovascular risk.
Studies have demonstrated several benefits of Empagliflozin, including effectively improving glycemic control, supporting weight-loss, and reducing cardiovascular-renal risks in patients with type 2 diabetes mellitus.
Empagliflozin has also demonstrated benefits in heart failure patients by lowering the cardiovascular death or hospitalisation.
"The launch of Glempa range reinforces this commitment by providing a comprehensive and affordable solution that empowers healthcare professionals and patients to manage type 2 diabetes mellitus with established cardiovascular disease more effectively," Glenmark Pharmaceuticals President and Head of India Formulations Business Alok Malik had said.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
&w=3840&q=100)

Business Standard
3 hours ago
- Business Standard
AMR crisis: Centre asks states to monitor antibiotic use in animals
In an effort to tackle the growing problem of antimicrobial resistance (AMR), which is estimated to claim 2 million lives in India by 2050, the Central Drugs Standard Control Organisation (CDSCO) has asked all state drug controllers to support the development of an antimicrobial use (AMU) reporting framework. The aim is to strengthen monitoring of antibiotic use in animals. For the first time, a joint working group will be formed, comprising representatives from the CDSCO, state licensing authorities (SLAs), and the Department of Animal Husbandry and Dairying (DAHD), to facilitate the implementation of the framework. Officials in the know said the framework will focus on the systematic collection of data on the sale, manufacture, and import of antibiotics for veterinary use. This move follows the Centre's release of the Standard Veterinary Treatment Guidelines for Livestock and Poultry (SVTG) in October last year. The guidelines emphasise minimising antibiotic use to prevent AMR in animals, mirroring similar efforts in human health. They provide symptomatic treatment guidance until a disease is laboratory-confirmed, ensuring minimal or no antibiotic use unless necessary. AMR occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines used to treat humans and animals. According to the World Health Organisation (WHO), around 10 million deaths are projected globally by 2050, with India expected to account for 2 million. In 2019, AMR was directly responsible for 1.27 million deaths globally, while 4.95 million were associated with drug-resistant infections. The WHO notes that the emergence and spread of AMR is accelerated by human activity — mainly the misuse and overuse of antimicrobials to treat, prevent, or control infections in humans, animals, and plants. Vegetables, poultry, and dairy products may contain antibiotic residues, which can enter the human bloodstream when consumed, further aggravating exposure. A recent study published in The Lancet Planetary Health stated that there are bidirectional associations between antibiotic consumption and AMR rates in humans and animals — that is, antibiotic use in animals can lead to AMR in humans, and vice versa. A separate study from 2015 estimated that nearly two-thirds of global antibiotic sales were for animal agriculture, with consumption projected to rise by another 67 per cent by 2030 due to increased demand for livestock products in low- and middle-income countries (LMICs). Coordinated action needed on new framework, says DCGI In a letter to all state and Union Territory (UT) drug controllers, Drug Controller General of India (DCGI) Rajeev Raghuvanshi called for coordinated action on AMU, specifically in the veterinary sector. The letter instructed all SLAs to nominate a nodal officer, not below the rank of assistant or joint drugs controller, to act as the point of contact for AMU data collection and coordination with the joint working group. It also asked state regulators to provide a comprehensive list of pharmaceutical companies involved in the manufacturing, distribution, and sale of veterinary antibiotics within their respective jurisdictions. In a separate letter dated 5 June, the DCGI also asked all zonal and sub-zonal offices of the CDSCO to share a list of approved drugs — including antibiotics, fixed drug combinations (FDCs), and their premixes — for veterinary use. A framework for AMU reporting is being seen as another key step to address AMR. Just last month, the central drug regulator released a draft guidance document for the safe disposal of unused or expired drugs, aimed at preventing AMR and other public health risks. The Centre had also urged pharmacists last year to dispense antibiotics only on the prescription of a qualified doctor, thereby limiting over-the-counter (OTC) sales. Under the Drugs and Cosmetics Rules, antibiotics are included in Schedule H — a list of drugs that may be sold by retail only on the prescription of a Registered Medical Practitioner (RMP).
&w=3840&q=100)

Business Standard
6 hours ago
- Business Standard
Glenmark set to launch blood cancer treatment drug Brukinsa in India
Glenmark Pharmaceuticals Ltd, a global pharmaceutical company, is set to introduce zanubrutinib in India under the brand name Brukinsa, following approval from the Drugs Controller General of India (DCGI). Brukinsa, developed by global oncology company BeOne Medicines (formerly BeiGene), is an orally available Bruton's tyrosine kinase (BTK) inhibitor designed to treat multiple types of B-cell blood cancers. It is the first and only BTK inhibitor approved in India for five types of B-cell malignancies. Approved in over 70 countries Brukinsa has already been approved in more than 70 countries, with clinical efficacy demonstrated through trials such as ALPINE, ASPEN and SEQUOIA. Its entry into the Indian market addresses a critical need for new and effective blood cancer treatments. The drug offers a unique pharmacological profile with high response rates and durable disease control across multiple B-cell malignancies. It allows a flexible dosing schedule—once or twice daily—tailored to patient needs. In the ALPINE trial for relapsed or refractory chronic lymphocytic leukaemia (CLL), Brukinsa showed a lower incidence of serious cardiac side effects compared to ibrutinib, a widely used targeted therapy. Fewer patients discontinued Brukinsa due to heart-related complications. "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. '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. It underscores Glenmark's ongoing commitment to providing effective and advanced treatments for patients with haematological malignancies," he added. Global partnership expands to India Adam Roach, Senior Vice President and Head of the Japan and Asia Pacific region at BeiGene, 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,' he said.


Mint
7 hours ago
- Mint
Glenmark to launch cancer drug Zanubrutinib in India
New Delhi: Glenmark Pharmaceuticals on Monday said it will launch cancer treatment drug zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). Zanubrutinib will be marketed in India under the brand name Brukinsa. It 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, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma. "We look forward to bringing Brukinsa to India in the coming months as part of our ongoing partnership with BeiGene (now BeOne Medicines)," Glenmark Pharmaceuticals President and Business Head - India Formulations Alok Malik said. The 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, he added. Glenmark shares on Monday ended 0.68 per cent up at ₹ 1,600.85 apiece on BSE. In March, Glenmark Pharmaceuticals had launched a medication for glycemic control and weight-loss for diabetes patients. The Mumbai-based drug firm launched Empagliflozin, a widely recognised SGLT2 inhibitor, under the brand name Glempa (Empagliflozin 10/25 mg), along with its fixed-dose combinations (FDCs)''Glempa-L (Empagliflozin 10/25 mg Linagliptin 5 mg) and Glempa-M (Empagliflozin 12.5 mg Metformin 500/1000 mg). The medications are designed to improve glycemic control in adults with type 2 diabetes mellitus while also reducing cardiovascular outcomes in patients with cardiovascular risk. Studies have demonstrated several benefits of Empagliflozin, including effectively improving glycemic control, supporting weight-loss, and reducing cardiovascular-renal risks in patients with type 2 diabetes mellitus. Empagliflozin has also demonstrated benefits in heart failure patients by lowering the cardiovascular death or hospitalisation. "The launch of Glempa range reinforces this commitment by providing a comprehensive and affordable solution that empowers healthcare professionals and patients to manage type 2 diabetes mellitus with established cardiovascular disease more effectively," Glenmark Pharmaceuticals President and Head of India Formulations Business Alok Malik had said.