AstraZeneca secures approval to market cancer therapy Enhertu in India for new indication

Drug firm AstraZeneca Pharma India Limited on Friday (October 3) said it has received approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, to import, sell, and distribute trastuzumab deruxtecan 100mg/5mL vial lyophilised powder for concentrate for solution for infusion (brand name: Enhertu) for an additional indication.

Under this approval, Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive

(IHC3+) solid tumours, who have received prior systemic treatment and have no satisfactory alternative treatment options.

The company stated that the approval paves the way for marketing of Enhertu in India for the specified additional indication, subject to receipt of other related statutory approvals, if any.

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Fourth Quarter Results

AstraZeneca Pharma India posted a sharp 47.7% year-on-year jump in net profit to ₹58.2 crore for the fourth quarter ended March 2025, up from ₹39.4 crore a year earlier. The robust performance was underpinned by solid growth in revenue and a significant expansion in operating margin.

Revenue for the quarter rose 25.4% to ₹480.4 crore, compared with ₹383.2 crore in the same period last year, driven by continued demand across its key therapy areas and improved market penetration.

Earnings before interest, tax, depreciation and amortisation (EBITDA) surged 74.7% to ₹86.3 crore from ₹49.4 crore a year ago, reflecting better cost controls and favourable product mix. The company’s EBITDA margin expanded to 17.96%, up from 12.89% in the corresponding quarter last year.

Also Read: AstraZeneca Pharma India shares rise 8% after revenue, margin jump in Q4

Shares of Astrazeneca Pharma India Ltd ended at ₹9,320.00, up by ₹98.75, or 1.07%, on the BSE.