[Edaily Reporter Hong Ju-yeon ] #Onconic Therapeutics Inc. is accelerating its expansion into India. Onconic Therapeutics Inc.’s new drug for gastroesophageal reflux disease (GERD), Jacubo, has received a recommendation for marketing approval in India, bringing the company one step closer to commercialization in the country.

On the 31st, Onconic Therapeutics Inc. announced that the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organization (CDSCO) recommended marketing approval for Jacubo (active ingredient: zastafrasan) for the treatment of erosive gastroesophageal reflux disease.

This recommendation for approval follows last month’s successful completion of Jacubo’s Phase 3 clinical trial in India and the submission of a New Drug Application (NDA). With final marketing approval expected within the year following this recommendation, the commercialization of Jacubo in India is becoming increasingly likely. India, the world’s most populous country with over 1.4 billion people, is seeing growing demand for GERD treatments due to economic growth and changes in dietary habits.

Onconic Therapeutics Inc. is working with its local partner in India to pursue the approval and commercialization of Jacubo. Once final marketing authorization is granted and the local launch begins in earnest, this is expected to contribute to the expansion of global revenue through additional milestone payments under the agreement and royalties from product sales.

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

An official from Onconic Therapeutics Inc. stated, “Following the success of the Phase 3 clinical trial in India, the submission of a new drug application, and the subsequent recommendation for approval, the local commercialization of Jacubo has moved one step closer,” adding, “We will accelerate the launch and market expansion of Jacubo in key overseas markets, including India, to grow global sales and generate royalty revenue.”