On September 11, 2025, Beijing Huahaizhongtian Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huahaizhongtian," stock code: 2563.HK) announced that the first patient has been dosed in an international multicenter Phase II/III clinical study (BG02-2502) evaluating Utidelone capsules (UTD2) for the treatment of patients with platinum-resistant advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This is the first international multicenter clinical study initiated globally for UTD2 in the treatment of advanced solid tumors, following its Phase I clinical trial in the United States.

Ovarian cancer is the fifth leading cause of cancer death among women, with the majority of patients diagnosed at an advanced stage. Platinum-based chemotherapy combined with paclitaxel is the standard first-line treatment after ovarian cancer surgery. However, 55% to 75% of patients relapse within two years of completing treatment, and most develop resistance to platinum-based therapies. Patients with platinum-resistant ovarian cancer have a poor prognosis, with objective response rates (ORR) to subsequent chemotherapy below 15% and a median progression-free survival (PFS) of only 3-4 months. Therefore, there is an urgent need for new treatments for patients with platinum-resistant ovarian cancer.

Utidelone has demonstrated considerable potential in the treatment of 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 the advanced ovarian cancer cohort, with a median of 4 prior lines of therapy. Among the 10 evaluable patients, 1 achieved partial remission (PR) and 3 had stable disease (SD), resulting in a clinical benefit rate of 40%. A US-based Phase I clinical study (BG02-2201) of Utidelone capsules (UTD2) as a monotherapy for advanced solid tumors had 12 evaluable patients for efficacy, including one ovarian cancer patient with complete remission (CR) and one with PR, who had received 7 and 9 prior lines of therapy, respectively. These results collectively 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 agents, Utidelone is not easily pumped out of cells by P-glycoprotein, offering the advantage of oral administration. Huahaizhongtian has developed Utidelone oral capsules (UTD2) using its proprietary synthetic biology technology platform, successfully completing a Phase I clinical trial in the US and a pivotal clinical trial in China, where safety and efficacy were fully validated. UTD2 is also expected to significantly improve patient convenience and compliance, reduce treatment costs, and demonstrate substantial application potential and market space. In addition to gynecological tumors, Huahaizhongtian is actively planning and advancing clinical studies for UTD2 to expand its indications, including advanced gastric cancer, adjuvant intensification for breast cancer, esophageal cancer, pancreatic cancer, and colorectal cancer.