Jaqbo wins first overseas approval in India

Approval granted 2 months after Phase III trial completion and NDA filing

India's CDSCO authorizes manufacturing and marketing for erosive GERD

Onconic Therapeutics announced on Aug. 6 that its treatment for erosive gastroesophageal reflux disease (GERD), Jaqbo (zastaprazan), was granted manufacturing and marketing authorization from India's Central Drugs Standard Control Organization (CDSCO).

The approval marks Jaqbo’s first regulatory approval outside Korea. Authorized as ‘Zastaprazan Citrate Tablets 20 mg,’ the product can now be manufactured and marketed in India as a treatment for erosive GERD.

Jaqbo completed its Phase III clinical trial in India in June and filed a New Drug Application shortly thereafter. The company received regulatory approval approximately 2 months later.

Last year, Onconic Therapeutics entered into an exclusive licensing agreement with a local Indian pharmaceutical company for Jaqbo. Under the agreement, the local partner is responsible for development, regulatory affairs, manufacturing and commercialization of Jaqbo in India. Following the approval, the company plans to move forward with launch preparations, including post-marketing surveillance (PMS), product registration, packaging, manufacturing and distribution.

Onconic believes the approval marks the transition of the company’s overseas business from technology transfer and development to commercialization. Under the agreement, the approval is expected to trigger milestone payments. Once commercial sales begin in India, the company also expects to generate royalty income based on local sales performance.

With a population of more than 1.4 billion, India is one of the world's largest pharmaceutical markets. Demand for GERD treatments has been on the rise alongside economic development and changing dietary habits. While proton pump inhibitors (PPIs) have traditionally dominated the market, potassium-competitive acid blockers (P-CABs) have recently emerged as an important new treatment option because of their rapid and sustained acid suppression.

Since its launch in Korea in October 2024, Jaqbo has continued to expand its prescription volume. The drug generated KRW 21.2 billion in prescriptions in Q1 this year, followed by KRW 25.6 billion in Q2. It is currently pursuing regulatory approvals and commercialization across 27 countries, including China, India and Latin America.

An Onconic Therapeutics official said, Following the successful completion of the Phase III trial in India and the submission of our marketing application in June, we secured manufacturing and marketing approval in just about 2 months, bringing the local launch into clear view. We will work closely with our partner to ensure a successful launch in India and translate it into global sales growth and royalty revenue."