The board of directors of the Company announced that the Company has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In addition, the company are in the process of EU and FDA regulatory interaction. Gastric cancer (GC) is the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality.

The five year survival rate for gastric cancer is still around 30%. Nivolumab, an anti-PD-1 antibody, has been approved globally for the first-linetreatment of patients with advanced or metastatic HER2-negative G/GEJ adenocarcinoma cancer. Osemitamab is a second generation humanized CLDN18.2 targeting antibody with enhanced ADCC.

It has shown anti-tumor activities in preclinical models with a broad range of CLDN18.2 expression. Recently, the Company presented efficacy data of Osemitamab ("TST001") in combination with CAPOX as the first-line treatment of G/GEJ adenOCarcinoma cancer at 2023 ASCO annual meeting and 2023 ESMO GI. Among 64 patients with CLDN18.2 positive (defined as: IHC membrane staining =10% tumor cells with =1+ intensity per LDT assay, selecting approximately 55% of the screened patients) were treated, 49 at the dose of 6mg/kg.

The data showed that the estimated median progression-free survival was 9.5 months from all dose groups, consistent across all CLDN18.2 expression levels, with a median duration of response of 9.9 months. So far, the combination is well tolerated. TranStar301 is a global randomized, double-blind, placebo-controlled Phase III trial designed to evaluate Osemitamab (TST001) in combination with Nivolumab plus chemotherapy as the first-line treatment for patients with locally advanced or metastatic HER2 negative, CLDN18.2 expressing G/GEJ adenocarcinoma.