BEIJING, China, September 11, 2025 – Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar" or the "Company", HKEX: 2563), a biopharmaceutical company leveraging a synthetic biology R&D platform to develop innovative anti-cancer drugs with proprietary intellectual property, today announced that the first patient has been dosed in its international, multicenter Phase II/III clinical study (BG02-2502) of Utidelone Capsule (UTD2) for the treatment of patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. This is the first global, multicenter clinical study initiated for UTD2 following its Phase I clinical trial in the United States for advanced solid tumors.
Ovarian cancer is the fifth leading cause of cancer-related death among women, and most patients are diagnosed at an advanced stage. The standard first-line treatment for ovarian cancer after surgery is platinum-based chemotherapy combined with a taxane. However, 55% to 75% of patients experience a recurrence within two years of completing treatment, and most will develop resistance to platinum-based therapy. Patients with platinum-resistant ovarian cancer have a poor prognosis, with an objective response rate (ORR) to subsequent chemotherapy of less than 15% and a median progression-free survival (PFS) of only 3 to 4 months. Therefore, there is an urgent need for new treatment options for these patients.
Utidelone has shown considerable potential for treating ovarian cancer in previous clinical studies. A Phase II clinical study (BG01-2002) of Utidelone Injection (UTD1) as a monotherapy for patients with advanced solid tumors enrolled 15 patients in its advanced ovarian cancer cohort, who had received a median of 4 prior lines of therapy. Among the 10 evaluable patients, there was 1 partial response (PR) and 3 with stable disease (SD), resulting in a clinical benefit rate (CBR) of 40%. A US Phase I clinical study (BG02-2201) of Utidelone Capsule (UTD2) as a monotherapy for advanced solid tumors had 12 evaluable patients, including one ovarian cancer patient with a complete response (CR) and another with a partial response (PR), who had previously undergone 7 and 9 lines of therapy, respectively. These results demonstrate a favorable efficacy and clinical benefit trend for utidelone in patients with advanced ovarian cancer.
Unlike taxanes, which are difficult to formulate as oral drugs, utidelone is not easily effluxed by P-glycoprotein, giving it an advantage for oral administration. Biostar has developed the Utidelone Capsule (UTD2) using its unique synthetic biology technology platform. It has successfully completed a Phase I clinical trial in the US and a pivotal clinical trial in China, with its safety and efficacy being fully validated. UTD2 is also expected to significantly improve patient convenience and compliance, reduce treatment costs, and demonstrate immense application potential and commercial prospect. In addition to gynecological tumors, Biostar is actively planning and advancing multiple clinical studies to expand UTD2's indications, including advanced gastric cancer, adjuvant-intensified therapy for breast cancer, esophageal cancer, pancreatic cancer, and colorectal cancer.
About the BG02-2502 Study
This study is an international, multicenter, open-label, randomized, controlled Phase II/III clinical trial of Utidelone Capsule (UTD2) for the treatment of patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Phase II part plans to enroll approximately 84 subjects. Its primary objective is to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of UTD2 under different dosing regimens in the target patient population and to recommend a dose for Phase III. The Phase III part plans to enroll 480 subjects and is planned to be conducted in multiple countries and regions worldwide. Its primary objective is to evaluate the efficacy and safety of UTD2 compared to the investigator's choice of chemotherapy in the target patient population. The primary endpoint is PFS, with secondary endpoints including overall survival (OS), ORR, and others.