Wockhardt Limited has announced a significant regulatory milestone for its novel antibiotic Zaynich (Zidebactam/Cefepime), which has received a favourable recommendation from the Central Drugs Standard Control Organization's Subject Expert Committee for marketing permission to treat Gram-negative infections. This positive regulatory opinion represents a crucial step toward final approval by the Drugs Controller General of India.

Comprehensive Clinical Development Program

The favourable recommendation follows an extensive review of the product dossier encompassing robust clinical and non-clinical data. The evaluation included comprehensive evidence from nine Phase 1 studies, a multi-indication Phase 2 study in meropenem-resistant infections, a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis, and data from 85 compassionate-use cases.

Novel Mechanism and Development Timeline

Developed over 15 years by a team of 150+ scientists across 10 disciplines, Zaynich features a novel β-lactam enhancer-based mechanism. This innovative approach enables potentially unprecedented coverage of multi-drug resistant and extensively drug-resistant Gram-negative pathogens prevalent in India. The antibiotic represents one of the most comprehensively evaluated antibiotics globally in recent years, supported by over 100 national and international publications and presentations, with the majority contributed by independent experts.

Clinical Efficacy Results

In the Phase 3 study, Zidebactam/Cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure rates, highlighting the impact of its novel mechanism of action. The drug showed remarkable efficacy with over 97.00% clinical success in a real-world study of meropenem-resistant infections conducted across 15 leading tertiary care hospitals in India.

Regulatory Recognition and Global Applications

Zaynich also demonstrated strong efficacy in 85 extensively drug-resistant Gram-negative infection cases treated under compassionate use across India, US, Malaysia and France, where no safe and efficacious alternatives were available. This highlights the global unmet medical need in treating resistant Gram-negative infections and Zaynich's potential to address this critical healthcare challenge.

The Clinical and Laboratory Standards Institute has granted Zidebactam/Cefepime an investigational susceptible breakpoint of 64 mg/L, indicating its potential to comprehensively cover clinically important extensively drug-resistant Gram-negative pathogens in critically ill patients. The company has already submitted a New Drug Application in the United States and a Marketing Authorisation Application in the European Union, both currently in advanced stages of regulatory review.

Wockhardt Limited has received an ESG rating of 65 (Aspiring) from NSE Sustainability Ratings and Analytics Limited for the year 2025. The pharmaceutical company disclosed this development through a regulatory filing dated 19th February, 2026, pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

ESG Rating Breakdown

The overall ESG score of 65 reflects a comprehensive assessment across three key sustainability parameters. NSE Sustainability Ratings and Analytics Limited, a SEBI-registered ESG rating provider, conducted this evaluation as part of its voluntary ESG assessment process.

Independent Assessment Process

Wockhardt clarified that the company did not engage NSE Sustainability Ratings and Analytics Limited for this rating purpose. The assessment was conducted independently by the rating agency, utilizing the company's public disclosures and other publicly available information. This voluntary rating process demonstrates the growing emphasis on ESG evaluation in the Indian corporate landscape.

Company's ESG Commitment

According to the regulatory filing, the rating scores underscore Wockhardt's strong ESG commitment with steady progress and solid disclosures. The Governance parameter received the highest score at 74, followed by Social at 70, while Environmental scored 51. The company has made this information available on its official website at www.wockhardt.com for stakeholder reference.

Regulatory Compliance

The disclosure was made in compliance with SEBI Master Circular SEBI/HO/CFD/PoD2/CIR/P/0155 dated 11th November, 2024, which mandates listed companies to inform stock exchanges about ESG ratings received from SEBI-registered providers. This regulatory framework ensures transparency in ESG reporting and helps investors make informed decisions based on sustainability metrics.