Beijing, China, February 5, 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, announced today that its U.S. subsidiary, Biostar Pharma, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for a Phase II/III registration MRCT (BG02-2404). This study will evaluate one of its key overseas pipelines, the Utidelone Capsule (UTD2), in combination with capecitabine and oxaliplatin for the first-line treatment of PD-L1-negative locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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]. Chemotherapy remains a cornerstone treatment for gastric cancer, widely used across various subtypes and lines of therapy.

Beijing Biostar developed UTD2 utilizing its proprietary synthetic biology technology platform. The U.S. Phase I clinical study has been completed successfully, fully validating its safety and efficacy. Concurrently, 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, as of the publication date, 23 patients had completed efficacy evaluation. Among them, 15 achieved PR (partial response) and 8 achieved SD (stable disease), resulting in an objective response rate (ORR) of 65.2% and a clinical benefit rate (CBR) of 100%. Consequently, the Utidelone Capsule received Orphan Drug Designation from the FDA for the treatment of advanced gastric cancer.

Utidelone shares a similar mechanism of action with taxanes. However, unlike taxanes, which are difficult to develop into oral formulations, utidelone is not easily effluxed from cells by P-glycoprotein, granting it the advantage of oral administration. 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 market prospects. This study represents the first Phase II/III MRCT conducted by Beijing Biostar for UTD2, further solidifying the company's global development strategy.

About BG02-2404 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] Source: Frost & Sullivan Analysis