Onconic Therapeutics' gastroesophageal reflux disease drug Zaquvo has moved a step closer to receiving marketing authorization in India.
The company said Friday that the Subject Expert Committee under India's Central Drugs Standard Control Organization recommended approval of Zaquvo for the treatment of erosive gastroesophageal reflux disease.
Zaquvo completed a local Phase 3 trial last month, after which the company filed a new drug application. Onconic said it expects the drug to receive final marketing authorization before the end of the year following the committee's recommendation.
Onconic is pursuing regulatory approval and commercialization of Zaquvo in India alongside a local partner. If final authorization is granted and a local launch proceeds, the company expects to generate additional milestone payments and product sales royalties under the existing agreement.
"Following the successful Phase 3 trial, the new drug application and now the approval recommendation, commercialization is drawing near," an Onconic official said. "We will accelerate the launch and market expansion of Zaquvo in key overseas markets."
Zaquvo recorded prescription sales of 21.2 billion won ($14.7 million) in the first quarter of this year and 25.6 billion won in the second quarter. The drug has entered 27 countries, including China, India and markets across Latin America, and is regarded as an emerging global pharmaceutical product.
freiheit@heraldcorp.com
