Onconic Therapeutics, a subsidiary of JEIL PHARMACEUTICAL, has begun preparations to expand the domestic clinical trial of the next-generation dual-target anticancer drug "Nesuparib" into a global trial that includes the United States.
Onconic Therapeutics said on the 25th that it is preparing to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) within the year to expand Nesuparib's phase 2 trial from Korea to a global study.
Chief Executive Kim Jon on June 25 (local time) in San Diego, United States, presented at "BIO USA 2026," the world's largest bio partnering event, outlining Nesuparib's development strategy and plans for global commercialization, including this update.
In particular, Kim emphasized the clinical performance of the dual-target anticancer candidate Nesuparib and its potential as a pan-tumor therapy.
Based on the ongoing phase 2 trial in Korea, the company plans to submit an FDA IND in the United States and expand into a global phase 2 that includes the U.S. Through this, it aims to broaden the scope of clinical development to the global stage. It also plans to actively leverage regulatory incentives such as conditional approval and priority review (fast track) associated with orphan drug designation.
Onconic Therapeutics said interest from global corporations has risen significantly since it unveiled Nesuparib's clinical results at the American Society of Clinical Oncology (ASCO 2026) last month. In response, it has dispatched a large delegation that includes its business development (BD) team, researchers, and executives, and is holding partnering meetings with numerous global pharmaceutical companies.
Nesuparib is a dual-target anticancer drug that simultaneously inhibits "PARP," which is responsible for repairing DNA damage in cancer cells, and "Tankyrase," which is involved in cancer growth. It is drawing attention as it is expected to overcome resistance, a limitation associated with existing PARP inhibitors.
Nesuparib is currently in a domestic phase 2 trial for four cancer types: pancreatic cancer, endometrial cancer, ovarian cancer, and gastric cancer. Among these, it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) in pancreatic cancer and gastric cancer/gastroesophageal junction cancer.
Phase 1b results unveiled at ASCO 2026 on the 25th also drew attention. Among patients with metastatic pancreatic cancer, there was a case in which complete response (CR), meaning the cancer cells had completely disappeared, was maintained for more than 40 months, and the median overall survival (mOS) was 14.2 months. The company said this indicates the potential to extend survival in patients with metastatic pancreatic cancer, which is considered difficult to treat.
Onconic Therapeutics plans to accelerate the out-licensing and global commercialization of Nesuparib based on the global business development experience accumulated through its gastroesophageal reflux disease treatment "Ja Q Bo." Ja Q Bo has signed technology export and supply contracts with 27 countries, and the approval process is underway in key markets including China and India.
Chief Executive Kim Jon said, "Through BIO USA, we reaffirmed Nesuparib's global competitiveness," adding, "We will solidify global collaboration based on the business development experience accumulated with Ja Q Bo, and pursue expansion into a global phase 2 trial by submitting an FDA IND within the year."