AstraZeneca Pharma India Limited has informed the Exchange about General Updates

Regulatory product approvalBusiness Updates View source PDF Explain this filing

ASTRAZEN · price

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Price reactionminutes from the announcement price · days from the prior close

-0.2%Reaction day

₹8592.00

prior close

₹8679.50

announcement price

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Nifty Microcap 250market · in no size index; the smallest one is used+1.1%-1.3% vs market

Pharmaceuticals peers, median of 160sector+0.2%-0.3% vs sector

On the reaction day the stock moved 1.3 pts less than Nifty Microcap 250 and 0.3 pts less than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

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Next day

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UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 160Pending

Minute windows have no benchmark: there is no intraday index history to compare against.

AI summary

AstraZeneca Pharma India has received permission from CDSCO (Central Drugs Standard Control Organization) to import and distribute Acalabrutinib maleate 100mg tablets (brand: Calquence®) for an additional indication. The new approval allows the drug to be used in combination with Bendamustine and Rituximab (BR) for previously untreated mantle cell lymphoma (MCL) patients who are not eligible for autologous stem cell transplant. This expands the drug's therapeutic use in India and paves the way for marketing in this new indication, subject to related statutory approvals.

Likely market impact

This approval expands Calquence®'s addressable patient population in India, potentially increasing revenue contribution from this drug as it targets a specific unmet medical need in mantle cell lymphoma treatment.