[Edaily Reporter KIM SAE-MI ] #Onconic Therapeutics Inc.’s new potassium-competitive acid blocker (P-CAB) drug, “Zastaprazan” (Korean product name: Jacubo), has entered Phase 3 clinical trials for its injectable formulation in China. Accordingly, Onconic Therapeutics Inc. has submitted an additional development milestone payment claim worth $1 million (approximately 1.4 billion won) to its Chinese partner.

Onconic Therapeutics Inc. announced on the 23rd that its Chinese technology transfer partner, Livzon Pharmaceutical Group, began administering the first dose of the Zastaprazan injection to patients in a Phase 3 clinical trial in China this month.

This clinical trial is being conducted to evaluate the efficacy and safety of the Zastaprazan injection in patients with peptic ulcer bleeding. Following the initiation of the Phase 3 clinical trial for the injectable formulation, Onconic Therapeutics Inc. has submitted an additional claim to Livzon Pharmaceutical Group for a development milestone payment of $1 million, in accordance with the terms of the agreement.

In China, the marketing authorization process for the oral formulation of Zastaprazan is proceeding concurrently with efforts to expand its indications and dosage forms. The oral formulation for the treatment of erosive gastroesophageal reflux disease (GERD) was submitted for marketing authorization to the China National Medical Products Administration (NMPA) last August and is currently under review. In May, a Phase 3 clinical trial for Helicobacter pylori (H. pylori) eradication therapy also began.

In addition, with a Phase 3 clinical trial for an injectable formulation targeting bleeding peptic ulcers now in full swing, the company is expanding its product portfolio in China to include both oral and injectable formulations. In its annual report, Livzone Pharmaceuticals outlined a “dual-dosage form” strategy linking the oral and injectable formulations of Zastaprazan.

According to market research firm IQVIA, the global market for gastroesophageal reflux disease (GERD) treatments is valued at approximately 40 trillion won, of which the Chinese market is estimated to be worth between 4 trillion and 6 trillion won. Livzone Pharmaceuticals is a pharmaceutical company generating annual sales of over 600 billion won in the Chinese gastrointestinal treatment sector.

In 2023, Onconic Therapeutics Inc. signed a technology transfer agreement with Livzone Pharmaceutical for Zastaprazan, totaling $127.5 million (170 billion won) for the Greater China region. At that time, the company received a signing fee of $15 million (20 billion won).

Since then, milestone payments tied to development progress have been coming in. Last August, the company secured a $5 million (approximately 7 billion won) milestone payment following the completion of a Phase 3 clinical trial in China and the submission of a marketing authorization application to the NMPA. With milestone revenue now flowing in consecutively, including from the recent Phase 3 clinical trial for the injectable formulation, observers note that the technology transfer is beginning to yield substantial results as indications and dosage forms expand.

An official from Onconic Therapeutics Inc. stated, “Based on our collaboration with Livzone, which has established a business foundation in the Chinese gastroenterology market, we are expanding the indications and formulations of Zastaprazan,” adding, “Moving forward, we plan to enhance the local commercial value of Zastaprazan following the granting of Chinese marketing authorization and further strengthen our partnership with Livzone.”