Shares of pharmaceutical major Wockhardt Ltd rose 9.2% in intraday trade to hit a 52-week high on Friday after India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), approved the company’s new treatment for bacterial pneumonia in adults.

Miqnaf is an ultra-short course, once-a-day, 3-day treatment for e Community-Acquired Bacterial Pneumonia (CABP) including those caused by multi-drug resistant (MDR) pathogens, the Mumbai-based drugmaker says.

The approval follows a favourable recommendation for manufacture and marketing of Nafithromycin from the Subject Expert Committee (SEC) of CDSCO.

Reacting to the development, shares of Wockhardt opened higher at ₹1,510.05 against their previous closing price of ₹1445.75. The stock hit a fresh 52-week high of ₹1,580 in intraday trade on the BSE, taking the company’s market cap past ₹25,000 crore mark.

CABP affects millions of people worldwide with 23% of the global disease burden borne by India. CABP and other respiratory infections could be caused by several bacterial pathogens, the dominant being S. pneumoniae and H. influenzae and also by atypical respiratory pathogens such as Mycoplasma, Chlaymydia and Legionella.

The current oral antibiotics such as azithromycin face significant resistance challenges, while amoxicillin/clavulanate lack the coverage of atypicals, as a result, patients often require hospitalisation to take intravenous treatment, which enhances the risk of hospital-acquired infections and imposes higher cost.

For over 15 years, Miqnaf underwent non-clinical and clinical studies which include human trials in the U.Ss, Europe, South Africa and India, the drugmaker says. “It represents a new macrolide based treatment for CABP in India almost after a gap of 30 years. Moreover, the ultra-short course regimen enhances the patients’ compliance to treatment resulting in favourable outcome,” it claims.

In India, antibiotic resistance is a burning issue including in community pneumonia cases. “A key feature of Miqnaf is its coverage of entire range of community respiratory pathogens including pneumococci resistant to azithromycin and amoxicillin/clavulanate, making it a promising monotherapy option for community-acquired bacterial pneumonia,” the company claims.