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Shilpa Medicare JV gets USFDA approval for IMKELDI drug

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Shilpa Medicare said that its joint venture (JV), Oncosol, along with its partner Shorla Oncology, has received US Food and Drug Administration (USFDA) approval for IMKELDI (imatinib oral solution) to treat leukemia and other cancers.

Oncosol is 50:50 joint venture between Liqmeds Lifecare, a Zydus Group company, and Koana Healthcare, a Shilpa Medicare Group company.

IMKELDI is an advanced liquid formulation of imatinib designed for dosing accuracy. It helps slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML), acute lymphoblastic leukemia, myelodysplastic syndrome (MDS), myeloproliferative disease (MPD), and gastrointestinal tumors (GIST).

In 2024, an estimated 9,280 people will be diagnosed with CML, over 10,000 with MDS/MPD, and up to 6,000 with GIST in the U.S. Despite the proven clinical benefits of imatinib, patient adherence can be an issue, underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system, the company stated in exchange filing.

 

Raichur-based Shilpa Medicare is a vertically integrated manufacturer and distributor of quality drugs to global markets, specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.

The companys consolidated net profit soared to Rs 17.94 crore in Q2 FY25 as against Rs 1.61 crore posted in Q2 FY24. Revenue from operations rose 9.8% to Rs 343.80 crore in the quarter ended 30 September 2024.

The scrip rose 0.42% to Rs 892.50 on the BSE.

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First Published: Nov 27 2024 | 3:47 PM IST

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