Wockhardt Advances India's Antibiotic Frontier: MAA Filed for Game Changing WCK 5222 with EMA

WCK 5222, branded Zaynich®, combines zidebactam a β-lactam enhancer with cefepime to combat MDR and XDR Gram-negative pathogens, overcoming resistance via a novel mechanism. Developed fully in India, it addresses critical global antimicrobial resistance gaps. Phase 3 ENHANCE-1 trial showed 96.8% clinical efficacy in 530 cUTI patients across global sites.
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Key Highlights

• EMA's Accelerated Assessment confirms potential to meet unmet needs in complicated UTIs (incl. pyelonephritis), hospital-acquired/ventilator-associated pneumonia, intra abdominal infections, and bacteraemia.
• ​First India originated NCE for EMA pan European MAA, highlighting Indian innovation in antimicrobials.
• ​Supports US FDA NDA (filed Oct 2025) and Indian filings; over 50 compassionate use successes.

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Strategic Impact
This filing positions Wockhardt for broader revenue from high-need therapies amid rising resistance threats. EMA review could accelerate launch, boosting stock and global pharma leadership.
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Sources: Business Upturn, TipRanks, Wockhardt Press Releases, Medical Dialogues.