Onconic Therapeutics’ first domestically developed drug, Zacubo, is rapidly growing in Korea and has now entered the regulatory process in China, the world’s largest gastroesophageal reflux disease (GERD) market. Adding momentum, the company’s second drug candidate, Nesuparib, is making progress in clinical trials. The company is drawing attention in the pharmaceutical industry for the unprecedented strategy of building its portfolio almost entirely on self-developed drugs.
On August 19, Onconic Therapeutics disclosed that its Chinese partner, Livzon Pharmaceutical Group, completed a Phase 3 clinical trial of Zastaprazan (marketed in Korea as Zacubo) and submitted a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA). Following this, Onconic filed a claim for a milestone payment of USD 5 million (KRW 6.9 billion).
This represents the largest single milestone payment the company has received in the course of its global expansion. The payment is expected within 30 business days. To date, Zastaprazan has been licensed or distribution-partnered in 26 countries, supporting its continued global rollout.
In the domestic market, Zacubo is already showing strong momentum. Since its launch in October 2023, Zacubo surpassed KRW 10 billion (USD 7.2 million) in quarterly prescriptions in Q2 2024, quickly securing a foothold in the market. Backed by Zacubo’s growth, Onconic’s overall performance has also improved. First-half revenue in 2024 reached KRW 18.6 billion (USD 13.4 million), already exceeding the full-year 2023 revenue of KRW 14.8 billion (USD 10.7 million). This included approximately KRW 16.4 billion (USD 11.8 million) in Zacubo sales and KRW 2.1 billion (USD 1.5 million) in licensing revenue.
Notably, the company exceeded all financial forecasts it had presented at the time of its IPO in December 2023. For 2024, revenue came in at KRW 14.8 billion (USD 10.7 million) versus a projection of KRW 9.6 billion (USD 6.9 million), while operating loss narrowed to KRW 4.8 billion (USD 3.5 million), less than half of the projected KRW 11.3 billion (USD 8.1 billion). For 2025, the first-half results alone already surpassed the full-year revenue forecast of KRW 16.2 billion (USD 11.7 million), and operating profit turned positive at KRW 2.7 billion (USD 1.9 million), compared to an expected loss of KRW 3.4 billion (USD 2.4 million). With additional milestone inflows from China expected in the second half, earnings are set to improve further.
The company is now positioning Zacubo as a springboard to establish its business foundation while preparing to make a new leap forward with its next-generation oncology candidate, Nesuparib. Recently, Onconic submitted an Investigational New Drug (IND) application to Korea’s Ministry of Food and Drug Safety (MFDS) to initiate a Phase 2 trial of Nesuparib in pancreatic cancer. The plan is to complete Phase 1b and begin patient enrollment in Phase 2, targeting the first-line treatment market for advanced and metastatic pancreatic cancer—an area of significant unmet medical need worldwide.
Nesuparib is a dual-target anti-cancer candidate that simultaneously inhibits PARP (poly ADP-ribose polymerase), which is essential for DNA damage repair, and tankyrase, which promotes cell growth and division. By blocking both pathways, it prevents cancer cells from proliferating or recovering. In 2021, the U.S. Food and Drug Administration (FDA) granted Nesuparib Orphan Drug Designation (ODD) for pancreatic cancer, and Korea’s MFDS also designated it as a development-stage orphan drug. These designations are expected to enable benefits such as fast-track review and potential conditional approval based on Phase 2 results.
Onconic Therapeutics stated, “Unlike most domestic biotech companies that concentrate on early-stage out-licensing, we are being recognized as a new model by directly developing and obtaining approval for innovative drugs, and then expanding them into global markets.”
