Pursuant to Regulation 30 of Listing Regulations, please find enclosed Press Release titled, Indian drug regulator grants marketing authorization to Wockhardt's breakthrough antibiotic, ZAYNICH® (Zidebactam/ Cefepime), for treatment of complicated urinary tract infections including pyelonephritis with concurrent Gram-negative bacteremia.
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India's Central Drugs Standard Control Organisation (CDSCO) has approved Wockhardt's first-in-class antibiotic ZAYNICH® for treating complicated urinary tract infections (cUTI) including pyelonephritis with concurrent Gram-negative bacteremia in adults. The approval is based on the Phase 3 ENHANCE-1 trial where ZAYNICH® demonstrated statistical superiority over meropenem, achieving 89% composite response rate (clinical cure and microbiological eradication) versus 68.4% for meropenem. Among patients with concurrent bacteremia, response rates were 89% vs 44%. The drug is indigenously developed and addresses carbapenem-resistant infections including metallo-β-lactamase (MBL) producing pathogens where current options like colistin are limited. NDAs are also under review with the US FDA and EU authorities.
This approval marks Wockhardt's entry into the high-value cUTI antibiotic market with a differentiated, clinically superior product, potentially driving revenue growth from domestic and eventual export markets.