Pursuant to Regulation 30 of Listing Regulations, please find enclosed Press Release -"Wockhardt's Zaynich® (Zidebactam/Cefepime) Receives Favourable Recommendation from CDSCO's Subject Expert Committee for Treatment of Gram-Negative Infections".
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Wockhardt's novel antibiotic Zaynich® (Zidebactam/Cefepime) has received a favourable recommendation from the Subject Expert Committee of India's drug regulator CDSCO for marketing permission to treat Gram-negative infections. This paves the way for final approval from the DCGI. The drug was developed over 15 years by 150+ scientists and showed superiority over meropenem in a global Phase 3 study of 530 patients across 64 sites, plus over 97% efficacy in real-world cases of meropenem-resistant infections. Separately, the product's New Drug Application in the US and Marketing Authorisation Application in the EU are already in advanced stages of review.
This is a significant positive milestone that brings Zaynich® closer to commercial launch in India, addressing a critical unmet need for drug-resistant infections. A favourable CDSCO recommendation substantially raises the likelihood of final DCGI approval, which could be a meaningful revenue driver for Wockhardt given the drug's novel mechanism and QIDP status from the US FDA.