[Market Focus] Onconic's 37th Korean New Drug 'Zacubo' Succeeds in Phase 3 Trials... Chinese Market Entry Imminent

Onconic Therapeutics is showing strong performance. This appears to be influenced by news that its gastroesophageal reflux disease (GERD) treatment 'Zacubo' has succeeded in Phase 3 clinical trials and is now on the verge of entering the Chinese market.

As of 3:08 p.m. on August 18, Onconic Therapeutics was trading at 25,550 won, up 800 won (3.23%) from the previous trading day.

On this day, Onconic Therapeutics announced that Livzon Pharmaceutical Group, the leading company in the GERD field in China, has successfully completed Phase 3 clinical trials of its P-CAB new drug 'Zastaprazan' (marketed as 'Zacubo' in Korea) and has submitted a New Drug Application (NDA) to the National Medical Products Administration (NMPA) of China.

Zastaprazan is a P-CAB (potassium-competitive acid blocker) class GERD treatment developed directly by Onconic Therapeutics, which received approval as Korea's 37th locally developed new drug from the Ministry of Food and Drug Safety in April last year. Within just six months of its launch in October last year, it achieved cumulative out-of-hospital prescriptions totaling 10 billion won. In only its third quarter since launch, it recorded 10.5 billion won in out-of-hospital prescriptions for the quarter. Additionally, Zacubo has so far signed four overseas technology transfer and distribution agreements.

Meanwhile, Onconic is also on the verge of clinical trials for a pancreatic cancer treatment. The company announced in a disclosure on this day that it has submitted an amendment to the clinical trial plan for Nesuparib (JPI-547) for Phase 1b/2 clinical trials in pancreatic cancer. Nesuparib is an anticancer drug candidate that received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for pancreatic cancer in 2021, and in May of this year, for gastric cancer and gastroesophageal junction cancer.

In its disclosure, the company explained, "The application for clinical trial plan approval is for an IND amendment for Nesuparib, an anticancer drug candidate being developed by Onconic Therapeutics, for pancreatic cancer," and added, "With the completion of Phase 1b, we have confirmed the appropriate dosage and are applying for a change approval to proceed with Phase 2."