[Edaily Reporter Hong Ju-yeon ] #Onconic Therapeutics Inc. has entered a phase of rapid growth, led by its gastroesophageal reflux disease (GERD) treatment, Jacubo (active ingredient: zastafrazan). Market expectations are rising further as significant momentum is expected in the second half of this year, including global approval results and the increased value of its oncology pipeline.

Record First-Quarter Performance… Zacuvo Prescriptions Set New Records Every Quarter

According to the Financial Supervisory Service’s electronic disclosure system on the 23rd, Onconic Therapeutics Inc. recorded revenue of 22.98 billion won and operating profit of 4.59 billion won in the first quarter of this year. These figures represent increases of 151% and 190.6%, respectively, compared to the same period last year. With an operating profit margin of 20.0%, the company is seen as having demonstrated both profitability and growth potential. The company is aiming for annual revenue of 111.8 billion won and operating profit of 26.5 billion won this year, targeting double the growth compared to the previous year.

Zacubo is cited as the key driver of this growth. Excluding revenue from technology transfers, domestic prescription sales of Zacubo in the first quarter reached 21.2 billion won, a 229% surge compared to the same period last year. Since its launch in October 2024, it has been setting new records for prescription volume every quarter.

Zacubo is a new drug in the potassium-competitive acid blocker (P-CAB) class developed in-house by Onconic Therapeutics Inc. and was approved in April 2024 as South Korea’s 37th domestically developed new drug. Highlighting its rapid onset of action and stable gastric acid suppression compared to existing proton pump inhibitors (PPIs), it is quickly becoming the drug of choice for both healthcare professionals and patients.

According to the pharmaceutical research firm Ubiest, domestically developed P-CAB drugs recorded prescription sales of 3685억 won last year. This represents a 28.7% increase from the 2864억 won recorded in 2024. In January of this year, the company launched a new oral disintegrating tablet (ODT) formulation that can be taken without water, thereby broadening its prescription base to include the elderly and patients with chronic diseases.

Final Stages of Approval in China, Entry into Indonesia… Key Global Battles Ahead in the Second Half of the Year

The market is looking forward to Onconic Therapeutics Inc.’s performance in the

second half of

the year. The most closely watched factor is China. Onconic Therapeutics Inc. signed a technology export agreement worth approximately 1600억 won with its local partner, Livzone Pharmaceuticals, in 2023, and submitted an application for approval to China’s National Medical Products Administration (NMPA) in August of last year; the application is currently in the final stages of review.

Upon receiving marketing approval, the company is expected to receive milestone payments and secure sales royalties. The company anticipates obtaining approvals in China and India by the end of this year. Recently, the first patient was enrolled in a local Phase 3 clinical trial to expand the indication for Helicobacter pylori eradication therapy, securing an additional milestone payment of approximately 1.5 billion won.

An Onconic Therapeutics Inc. official stated, “China is the world’s largest market for gastroesophageal reflux disease, accounting for approximately 6 trillion won of the 40 trillion won market,” adding, “In particular, as China is in the early stages of establishing the P-CAB market, we can expect significant growth for Jacubo.” KIWOOM Securities mentioned the potential for additional milestone payments upon NMPA approval and projected that milestone payments related to Jacubo would reach approximately 10 billion won this year.

The company is also ramping up its expansion into the Southeast Asian market. Onconic Therapeutics Inc. announced that it signed a license and supply agreement for Jacubo this month with Dexam Medica, a leading pharmaceutical company in Indonesia. With a population of approximately 280 million, Indonesia is the world’s fourth-most populous country and hosts the largest market for peptic ulcer drugs within the ASEAN region.

Dexa Medica, a leading local pharmaceutical company with a nationwide distribution network spanning 38 provinces, is expected to accelerate the approval and commercialization of Jacubo. The company anticipates that it will complete the regulatory filing in Indonesia by the end of the year, as Indonesia is a country where Phase 3 clinical trials are exempt. It has also completed the new drug application in Mexico and plans to sequentially expand regulatory filings to 18 countries in Central and South America based on the Mexican approval. The company aims to obtain approval in Mexico by the first half of next year.

An Onconic Therapeutics Inc. official emphasized, “Just as Nexium—the quintessential PPI—has generated trillions of won in cash flow annually for over 40 years, Jacubo is also expected to secure a significant market share in the global market over the next 30 to 40 years,” adding, “It is one of the few candidates capable of achieving success as an original drug in the global market as a domestically developed new drug.”

Nesuparib Data Released… Value of Oncology Pipeline Comes into Sharp Focus

The new anti-cancer drug candidate Nesuparip is driving up Onconic Therapeutics Inc.’s medium- to long-term value. Onconic Therapeutics Inc.’s Nesuparip is a dual-mechanism anti-cancer drug candidate that simultaneously inhibits PARP and tenkirase. The company presented Phase 1b clinical data for pancreatic cancer at the American Society of Clinical Oncology (ASCO) conference held last month, marking its first presentation of human clinical results since its IPO.

Long-term survival and safety data for patients with metastatic disease have been confirmed, and the results from the ongoing Phase 2 trials for endometrial cancer and ovarian cancer, as well as the Phase 1b/2 trial for gastric cancer, are being evaluated as promising in terms of efficacy and safety. Previously, at the American Association for Cancer Research (AACR) meeting held in April, the company also presented positive data for small cell lung cancer and the mechanism of metastasis suppression in pancreatic cancer.

Nesuparib has received Orphan Drug Designation from the FDA three times for pancreatic cancer, gastric and gastroesophageal junction cancers, and small cell lung cancer, securing various administrative benefits. The company is accelerating its Phase 2 trials while simultaneously engaging in discussions for global technology transfer partnerships.

An Onconic Therapeutics Inc. official stated, “Since the company’s IPO, market attention has been focused on Jacubo’s earnings growth, and Nesuparip’s value has not been fully reflected in the company’s market valuation,” adding, “As data for each cancer type will be continuously disclosed, starting with the ASCO presentation, we anticipate a revaluation driven by expectations for this new drug.”

Analysts in the securities industry also note that Onconic Therapeutics Inc.’s current enterprise value reflects only the initial results of Jacubo. The consensus is that there is a high likelihood of further revaluation if the results of the Chinese approval in the second half of the year, the inflow of overseas milestone payments, and progress in the development of Nesuparip all align.