Onconic Therapeutics has submitted a regulatory application to expand the therapeutic scope of its P-CAB drug Jaqbo (zastaprazan citrate), seeking approval for gastric ulcer treatment from the Ministry of Food and Drug Safety (MFDS). This milestone comes just three months after the drug's commercial launch for erosive GERD in October 2023.
The application is supported by compelling Phase 3 clinical trial data, which demonstrated exceptional efficacy in gastric ulcer treatment. Under the leadership of Professor Park Jong-jae from Korea University Guro Hospital's Department of Gastroenterology, the study enrolled 329 patients across 40 medical institutions in Korea.
The randomized, double-blind trial compared 20mg of Jaqbo against 30mg of lansoprazole, a conventional proton pump inhibitor (PPI), over treatment periods of four and eight weeks. Notably, Jaqbo achieved a remarkable 100% cumulative healing rate at the primary endpoint of eight weeks, while maintaining a favorable safety profile.
Market Impact and Global Expansion
The potential approval of this additional indication, expected in the first half of 2024, would position Jaqbo as a versatile therapeutic option for both erosive GERD and gastric ulcers. This dual-indication status could significantly enhance the drug's market potential and accelerate its path toward becoming a global blockbuster.
Onconic Therapeutics, the only Korean biotech company to commercialize a new drug before going public, has already begun its international expansion efforts. The company secured a $127.5 million technology transfer agreement with China's Livzon Pharmaceutical Group in 2023. The successful Phase 3 results for gastric ulcers are expected to positively influence the ongoing Phase 3 trial in China.
"The rapid progression from launch to new indication filing, supported by successful Phase 3 trial results, validates both Jaqbo's therapeutic value and our technological capabilities," stated Shin Jong-kil, COO and CFO of Onconic Therapeutics. "We will leverage Jaqbo's stable revenue stream to fuel our continued focus on innovative drug research and development."
