Wockhardt shares surged nearly 7% in early trade on Friday after the company announced that India’s drug regulator has granted marketing authorisation for its breakthrough antibiotic, Zaynich (Zidebactam/Cefepime), marking a significant milestone for the pharmaceutical company.
The stock was trading at ₹1,894.20 on the NSE at around 9:38 AM, up 6.96% from its previous close of ₹1,771. The stock touched an intraday high of ₹1,974, which also marked a fresh 52-week high.
In a press release dated May 28, Wockhardt said the Central Drugs Standard Control Organisation (CDSCO) has approved the import and marketing of Zaynich in India. The antibiotic has been approved for the treatment of adult patients suffering from complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases involving concurrent Gram-negative bacteremia.
According to the company, Zaynich is an indigenously discovered and developed first-in-class breakthrough antibiotic and represents a major advancement in the treatment of drug-resistant bacterial infections.
The approval is backed by findings from the pivotal ENHANCE-1 Phase III clinical trial, a multinational, randomised, double-blind study that evaluated Zaynich against meropenem, one of the most widely used antibiotics for severe bacterial infections.
The study showed that Zaynich achieved the primary composite endpoint of clinical cure and microbiological eradication in 89% of patients, significantly higher than the 68.4% recorded in the meropenem arm. Among patients with concomitant bacteremia, the response rate stood at 89% for Zaynich compared with 44% for meropenem.
Wockhardt noted that prior to the Phase III study, the drug had been evaluated through nine Phase I studies and a Phase II clinical trial involving patients with meropenem-resistant Gram-negative infections. The Phase II study reportedly demonstrated over 97% clinical efficacy across severe infections, including hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, bloodstream infections, complicated intra-abdominal infections and urinary tract infections.
The company believes Zaynich could emerge as an important treatment option for carbapenem-resistant infections, an area where current therapies often face limitations due to toxicity concerns and suboptimal efficacy. The antibiotic has also been positioned to address metallo-beta-lactamase (MBL)-mediated resistance, one of the most challenging forms of antimicrobial resistance.
Further strengthening its profile, the Clinical and Laboratory Standards Institute (CLSI) has assigned Cefepime/Zidebactam an investigational susceptibility breakpoint of 64 mg/L, highlighting its potential against extensively drug-resistant (XDR) Gram-negative pathogens.
Meanwhile, Wockhardt shares were trading 6.96% higher at ₹1,894.20 on the NSE at the time of publishing this article, after hitting a fresh 52-week high of ₹1,974 earlier in the session.
Disclaimer: This article is for informational purposes only and should not be construed as investment advice. The views and developments mentioned are based on company disclosures. Investors should consult qualified financial advisers before making investment decisions.