Beijing, China, September 12, 2025 - Beijing Biostar Pharmaceuticals Co., Ltd., ("Beijing Biostar", Stock Code: 2563.HK), a biopharmaceutical company leveraging its synthetic biology R&D platform to focus on developing novel anti-cancer drugs with independent intellectual property rights, today announced that the first patient has been dosed in its Phase II/III MRCT (BG02-2404) for Utidelone Capsules (UTD2), one of its core product's indication, as a first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The principal investigator for the study in China is Professor Ruihua Xu, Chief of Sun Yat-sen University Cancer Center.

Gastric cancer is a highly aggressive and heterogeneous malignancy, posing a severe global health challenge. In 2022, approximately 810,000 deaths worldwide were attributed to gastric cancer, ranking it as the fourth leading cause of cancer mortality globally. In the United States, the five-year survival rate for gastric cancer is only 31.1%, indicating a poor prognosis [1]. In China, the incidence and mortality rates of gastric cancer rank 2nd and 3rd, respectively, among all malignant tumors. The Chinese gastric cancer drug market is also expected to grow to RMB 57.2 billion by 2026 [1].

Utidelone has demonstrated excellent data in clinical studies targeting gastric cancer: in a completed Phase II study of utidelone combined with PD-1 inhibitor and oxaliplatin for the first-line treatment of unresectable locally advanced or recurrent/metastatic HER2-negative gastric cancer [2], as of the publication date, 23 patients had completed efficacy evaluation. Among them, 15 achieved partial response (PR) and 8 achieved stable disease (SD), resulting in an objective response rate (ORR) of 65.2% and a clinical benefit rate (CBR) of 100%. The median progression-free survival (mPFS) was 6.1 months. Regarding safety, the combination regimen was generally well-tolerated. Most treatment-related adverse events (TRAEs) were Grade 1-2, reversible, and manageable. The longest treatment duration received by a patient was 22 cycles. These results were presented in a poster session at this year's ASCO Annual Meeting. Consequently, Utidelone Capsules received Orphan Drug Designation from the U.S. FDA for the treatment of advanced gastric cancer.

Unlike taxanes, which are difficult to develop into oral formulations, Utidelone is not easily effluxed by P-glycoprotein, granting it an advantage for oral administration. Utilizing its proprietary synthetic biology technology platform, Beijing Biostar developed the Utidelone Capsule (UTD2), which has completed a U.S. Phase I clinical trial and a pivotal clinical trial in China, with its safety and efficacy fully validated. UTD2 is expected to significantly improve patient convenience and compliance, facilitate long-term adjuvant and maintenance therapy, reduce treatment costs for patients, and demonstrate substantial application potential and commercial prospects. Beyond gastric cancer, Beijing Biostar is actively planning and advancing multiple clinical studies for expanding UTD2's indications, including breast cancer adjuvant intensification therapy, ovarian cancer, pancreatic cancer, esophageal cancer, colorectal cancer, and so on.

About BG-02-2404 Study

The BG02-2404 study refers to the "multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with capecitabine and oxaliplatin to evaluate the efficacy and safety in patients with PD-L1-negative locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, untreated with systemic treatment in the advanced setting." For the Phase II part, 78 subjects are planned to be enrolled at 12 centers in the United States and 15 centers in Asia. Its primary objectives are to evaluate the safety, efficacy, and pharmacokinetic profile of UTD2 in combination therapy. The Phase III part plans to enroll 700 subjects and will be conducted at 30 centers in the United States, 53 centers in Asia, and 47 centers in Europe and other countries/regions. The primary endpoint is overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and safety.

Reference

[1] Frost & Sullivan Analysis

[2] Meili Sun, et al. Efficacy and Safety Results of a Multi-center Phase II Study of Utidelone Injection in Combination with PD-1 Inhibitor and Chemotherapy for the First-line Treatment of Advanced Gastric and Esophagus cancers. 2025 ASCO Abstract #: 4040