Onconic Therapeutics Advances Global Expansion of GERD Drug Jakubo with Mexico NDA Filing and U.S. Manufacturing Partnership
核心洞察
Onconic Therapeutics (搜索) has submitted a New Drug Application for Jakubo (搜索) (zastaprazan) in Mexico for erosive GERD (搜索), utilizing a fast-track abbreviated review pathway through partner Laboratorios Sanfer (搜索).
The company signed a manufacturing agreement with Bora Pharmaceuticals (搜索) to support U.S. Phase 3 clinical development of JAQBO tablets, with production at Bora's Maple Grove, Minnesota facility.
Jakubo (搜索) has demonstrated strong commercial performance in Korea, recording 21.2 billion won in Q1 2025 prescription sales and is on track to reach 100 billion won within two years of launch.
Onconic Therapeutics (搜索) is rapidly advancing its global footprint for Jakubo (搜索) (active ingredient: zastaprazan), a potassium-competitive acid blocker (P-CAB) for erosive gastroesophageal reflux disease (GERD), with two major developments: a New Drug Application (NDA) submission in Mexico and a manufacturing agreement with Bora Pharmaceuticals (搜索) to support planned U.S. Phase 3 clinical trials.
Mexico NDA Submission via Fast-Track Pathway
On June 9, Onconic Therapeutics (搜索) announced that its independently developed drug Jakubo (搜索) has been submitted for NDA approval in Mexico for the treatment of erosive GERD (搜索). The submission is being processed through a new abbreviated pathway, a fast-track review system introduced by Onconic's Mexican partner, Laboratorios Sanfer (搜索), which is expected to shorten the review period compared to the traditional process.
Mexico represents a high-potential market within the global erosive GERD (搜索) segment due to dietary habits that include consumption of spicy foods and coffee, leading to an increasing prevalence of GERD. Along with Brazil, Mexico is regarded as a representative country in the Central and South American market, and entry into Mexico is seen as a strategic gateway for further expansion into the region.
Laboratorios Sanfer (搜索), established in 1941, ranks first in Mexico in terms of sales and market share within the specialty pharmaceuticals sector and holds subsidiaries in 19 countries across Central and South America. Through a technology transfer agreement signed in September 2024, Onconic Therapeutics (搜索) has expanded into a total of 19 countries in the region—including Mexico, Argentina, Chile, and Colombia—and is currently preparing regulatory submissions for the remaining 18 countries following the initial application in Mexico.
U.S. Manufacturing Partnership with Bora Pharmaceuticals (搜索)
In a parallel development, Bora Pharmaceuticals (搜索) and Onconic Therapeutics (搜索) announced on July 23 a manufacturing agreement to support the U.S. clinical development of JAQBO tablets. Under the agreement, Bora's newest oral solid dose (OSD) facility in Maple Grove, Minnesota, will manufacture and package clinical trial drug product, and will also support quality control, stability testing, and the preparation of related chemistry, manufacturing, and controls documentation for Onconic's planned U.S. Phase 3 clinical trial.
GERD affects approximately 20% of the U.S. population, and P-CAB therapies are gaining attention for their rapid and sustained acid suppression profile as treatment needs continue to evolve.
"For companies preparing for U.S. clinical development and commercialization, the right manufacturing partner can make a meaningful difference in how quickly a program moves forward," said Bobby Sheng, Chairman of Bora Group and CEO of Bora. "We are proud to support Onconic as it prepares JAQBO for planned U.S. clinical development, and this collaboration reflects Bora's commitment to helping innovative companies move with confidence into highly regulated markets."
A representative from Onconic Therapeutics (搜索) stated, "This collaboration with a global CDMO is an important preparatory step in establishing the manufacturing, quality, and stability data package required for JAQBO's U.S. clinical development. Based on our prescription growth in Korea and overseas commercialization achievements, we will proceed with U.S. development preparation without delay and strengthen JAQBO's global competitiveness."
Strong Domestic Commercial Performance
Jakubo (搜索) has continued its rapid growth in the domestic P-CAB market since its launch in Korea in October 2024, following approval in April 2024 as Korea's 37th domestically developed new drug. The drug recorded prescription sales of 21.2 billion won in the first quarter of this year. According to UBIST data, it achieved 8.5 billion won in April and 8.1 billion won in May, with expectations that second-quarter prescription sales will surpass 24 billion won.
A representative from Onconic Therapeutics (搜索) noted, "Jakubo (搜索) is the fastest-growing GERD treatment in Korea and is on track to reach the 100 billion won prescription milestone within just two years of launch."
Global Expansion Across Multiple Markets
Onconic Therapeutics (搜索) has been accelerating its global expansion through multiple partnerships. In August of last year, the company completed a regulatory application for erosive GERD (搜索) in partnership with Livzon Pharmaceutical (搜索) in China, and on May 29 entered Phase 3 clinical trials for a new indication in the Chinese market. Earlier this month, the company submitted a product license application in India.
Onconic expects that additional milestone payments associated with the Mexico regulatory submission and product launch will contribute to its revenue and operating profit for the year. As commercialization in Mexico draws closer, analysts anticipate that the company will begin to generate royalty income from the global GERD market, estimated at 40 trillion won, including China, India, and Central and South America.