BEIJING, China, May 15, 2025 – Beijing Biostar Pharmaceuticals Co., Ltd. ("Biostar", HKEX: 2563), a biopharmaceutical company leveraging a synthetic biology R&D platform to develop innovative anti-cancer drugs with proprietary intellectual property, today announced one of its core global pipeline assets, Utidelone capsule (UTD2) has received implicit approval for clinical trial from the Center for Drug Evaluation (CDE). This study is a Phase II/III, multicenter, open-label, randomized, controlled clinical study (BG02-2501) of Utidelone Capsule (UTD2) versus the investigator's choice of chemotherapy for patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Ovarian cancer is the fifth leading cause of cancer-related death in women [1], and most patients are diagnosed at an advanced stage [2]. The standard first-line treatment for ovarian cancer after surgery is a combination of platinum-based chemotherapy and a taxane [3]. However, 55% to 75% of patients experience a recurrence within two years of completing treatment [4], 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 [5]. 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 enrolled 18 patients. Among the 12 evaluable patients, there was 1 complete response (CR), 1 PR, and 8 with SD, for a CBR of 83.3%. The patients who achieved CR and PR were both ovarian cancer patients 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.
Utidelone shares a similar mechanism of action with taxanes. However, 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 oral Utidelone Capsule (UTD2) using its unique synthetic biology technology platform. It has successfully completed a Phase I clinical trial in the US, with its safety and superior efficacy being fully validated. UTD2 is expected to significantly improve patient convenience and compliance, facilitate long-term adjuvant and maintenance therapy, reduce treatment costs, and demonstrate substantial application potential and commercial prospects. This study is Biostar's second international, multicenter Phase II/III registrational clinical trial for UTD2, following the trial for the first-line treatment of gastric cancer, which further solidifies the international development strategy for UTD2.
About the BG02-2501 Study
The BG02-2501 study refers to the "Phase II/III, multicenter, open-label, randomized, controlled clinical study of Utidelone Capsule (UTD2) versus investigator's choice of chemotherapy for the treatment of patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer." The Phase II part plans to enroll 72 subjects and will be conducted at multiple centers in China and the United States. Its primary objective is to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of UTD2 monotherapy under different dosing regimens in ovarian cancer and to recommend a dose for Phase III. The Phase III part plans to enroll 480 subjects and will be conducted at multiple centers in China, the United States, Europe, and other countries and regions. The primary endpoint is PFS, with secondary endpoints including overall survival (OS), ORR, and others.
References
[1] American Cancer Society. Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015.
[2] Cannistra SA. Cancer of the ovary. N Engl J Med. 2004 Dec 9;351(24):2519-29.
[3] Du Bois A, Pfisterer J, Meier W, Wagner U. Improving first-line therapy of advanced ovarian cancer - the AGO Ovarian Cancer Study Group perspective. Int J Gynecol Cancer. 2003 Nov-Dec;13 Suppl 2:169-71.
[4] Edwards SJ, Barton S, Thurgar E, Trevor N. Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation. Health Technol Assess. 2015;19(7):1-480.
[5] Davis A, Tinker AV, Friedlander M. "Platinum resistant" ovarian cancer: what is it, who to treat and how to measure benefit? Gynecol Oncol. 2014 Jun;133(3):624-31.