Livzon Group Livzon Medical Research Centre, the wholly-owned subsidiary of Livzon Pharmaceutical Group Inc. announced that it has recently received the Notice of Drug Clinical Trial Approval issued by China National Medical Products Administration, approving to conduct the clinical trials of JP-1366 Tablet. Name of Drug: JP-1366 Tablet. Dosage Form: Tablet.

Application: Clinical trial application. Registration Classification: Chemical drug in Category 1. Applicant: Livzon Group Livzon Medical Research Centre. Review conclusion: According to the Pharmaceutical Administration Law of the People's Republic of China and the relevant regulations, upon review, the clinical trial application for JP-1366 Tablet accepted on 4 December 2023 satisfied the relevant requirements for drug registration, and this product was approved to conduct the clinical trials.

JP-1366 Tablet is an innovative potassium competitive acid blockers (P-CAB) initially developed by Onconic Therapeutics Inc. ("Onconic") from South Korea, and a new drug application of which has been submitted in South Korea. It has the advantages of fast onset, excellent acid suppression, long-lasting effects, and fewer adverse reactions. The Company entered into a License Agreement with Onconic on 10 March 2023.

Pursuant to the License Agreement, the Company may develop, manufacture and commercialize Zastaprazan (also known as JP-1366), a potassium competitive acid blocker (P-CAB) in the licensed territory (mainland China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and Taiwan region), and shall pay corresponding milestone payments and sales royalties for the development and commercialization of JP-1366 at relevant stages. The indication for the clinical trial applied by Livzon Research Centre is reflux esophagitis. As at the disclosure date of this announcement, the accumulated direct expenses in R&D of the JP-1366 Tablet is approximately RMB 6.0783 million.

Due to the special nature of drug R&D, and the long cycle from clinical trials to manufacturing and marketing involving many stages which are susceptible to many unpredictable factors, there are many uncertainties in the progress and results of clinical trials and the competition in the future product market.