Onconic Therapeutics (476060) said Tuesday it has recently completed the filing for Mexican approval of "Zacuvo" (active ingredient zastaprazan) through its Mexican partner Laboratorios Sanfer.
Zacuvo is a P-CAB (potassium-competitive acid blocker) class treatment for gastroesophageal reflux disease, developed by Onconic and approved in April 2024 as Korea's 37th new drug. Its parent company, Jeil Pharmaceutical, researched the initial candidate substance, with Onconic carrying out subsequent development.
Earlier, in September 2024, Onconic signed a technology transfer agreement with Laboratorios Sanfer covering 19 Latin American countries, including Argentina, Chile, and Colombia. Founded in 1941, Laboratorios Sanfer has subsidiaries in 19 Latin American countries including Mexico, and ranks No. 1 in prescription drug sales and market share in Mexico.
Onconic is paying attention to the growing number of gastroesophageal reflux disease patients in Mexico, attributed to dietary habits such as enjoying spicy foods and coffee. In addition to Mexico, the remaining 18 countries are also preparing approval filing procedures. Onconic expects to receive milestone payments from this approval filing and product launch within the year, allowing them to be reflected in revenue and operating profit.
A latecomer in Korea's P-CAB market, Zacuvo is fiercely pursuing competing drugs such as HK inno.N's K-CAB and Daewoong Pharmaceutical's Fexuclue. Since its domestic launch in October 2024, it recorded 21.2 billion won in prescription sales in the first quarter of 2026. Based on UBIST data, it posted 8.5 billion won in prescription sales in April and 8.1 billion won in May, raising expectations of surpassing the 24 billion won range in second-quarter prescription sales. In August 2025, it partnered with its Chinese local partner Livzon Pharmaceutical to complete a marketing approval filing for erosive gastroesophageal reflux disease, followed by entry into Phase 3 clinical trials for a new additional indication in China last month, accelerating its pace of global expansion.
"Zacuvo is the fastest-growing gastroesophageal reflux disease treatment in Korea, and is on the verge of achieving 100 billion won in prescription sales within two years of launch," an Onconic official said. "We will strive to continue the global success story of a domestically developed original new drug."
