[Edaily Reporter Hong Ju-yeon ] #Onconic Therapeutics Inc.’s new drug for gastroesophageal reflux disease, Zacuvo, has received its first overseas marketing approval in India, accelerating the company’s global expansion.

Onconic Therapeutics Inc. announced on the 6th that its in-house developed new drug, Jacubo (active ingredient: zastafrasan), has obtained a license from India’s Central Drugs Standard Control Organization (CDSCO) for local manufacturing and sales as a treatment for erosive gastroesophageal reflux disease.

This marketing authorization allows for the manufacture and sale of Zastaprazan Citrate Tablets 20mg in India as a treatment for erosive gastroesophageal reflux disease (GERD). Following the successful completion of a Phase 3 clinical trial in India last June and the submission of a New Drug Application, Jacubo obtained marketing authorization in approximately two months, thereby completing the key regulatory procedures for local commercialization.

Onconic Therapeutics Inc. signed an exclusive licensing agreement for Zacuvo with a local Indian pharmaceutical company in 2024. The local partner is responsible for development, regulatory approval, production, and commercialization within India. Following the granting of this marketing authorization, the local partner plans to proceed with follow-up procedures for the product launch, including preparations for Post-Marketing Surveillance (PMS), as well as product registration, packaging, production, and distribution.

India, the world’s most populous country with over 1.4 billion people, is seeing growing demand for treatments for gastroesophageal reflux disease (GERD) due to economic growth and changes in dietary habits. While proton pump inhibitors (PPIs) have long dominated the local GERD treatment market, potassium-competitive acid blockers (P-CABs)—which are characterized by rapid and sustained gastric acid suppression—have recently been gaining attention as a new treatment option.

Onconic Therapeutics Inc. anticipates additional milestone payments linked to the approval stage under the technology transfer agreement, and is also expected to generate royalty revenue based on sales performance once local sales begin.

Meanwhile, since its domestic launch in October 2024, Jacubo has rapidly expanded its prescription market, continuing its growth trajectory with prescription sales of 21.2 billion won in the first quarter of 2026, followed by 25.6 billion won in the second quarter. The company has entered 27 countries, including China, India, and Latin America, and is expanding its business foundation as a global new drug as approvals and commercialization progress in overseas markets.

An official from Onconic Therapeutics Inc. stated, “Following the successful completion of the Phase 3 clinical trial in India last June and the submission of a new drug application, we have obtained manufacturing and marketing approval in just about two months, making the launch of Jacubo in India even more imminent.” The official added, “We will proceed smoothly with launch preparations alongside our local partner to ensure Jacubo’s stable entry into the Indian market, which will lead to expanded global sales and the generation of royalty revenue.”