Pursuant to Regulation 30 of Listing Regulations, please find enclosed Press Release - "Indian drug regulator grants marketing authorization to Wockhardt''s breakthrough antibiotic , ZAYNICH ....
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Indian drug regulator CDSCO has granted marketing authorization for Wockhardt's first-in-class antibiotic ZAYNICH® (Zidebactam/Cefepime) for treating complicated urinary tract infections including pyelonephritis with concurrent Gram-negative bacteremia. The approval is backed by Phase 3 ENHANCE-1 trial data showing ZAYNICH® achieved statistical superiority over meropenem with an 89% composite response rate versus 68.4%. Among patients with bacteremia, response rates were 89% versus 44% for meropenem. The drug is already under regulatory review in the US and EU, and has received QIDP designation from the US FDA. ZAYNICH® addresses a significant unmet need in carbapenem-resistant infections, particularly metallo-β-lactamase-mediated resistance which is prevalent in India.
This approval marks Wockhardt's first major commercial launch of an indigenously developed antibiotic, potentially creating a new revenue stream. The drug addresses a high unmet need in resistant infections, giving it strong market differentiation in India. International regulatory approvals pending in the US and EU could further accelerate growth.