BEIJING, China, July 14, 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 that the first patient has been successfully dosed in its Phase III, multicenter, open-label, randomized, controlled clinical trial (NCT07021261). The study evaluates Utidelone Capsule (UTD2) combined with capecitabine versus capecitabine monotherapy as an adjuvant therapy for patients with early-stage triple-negative breast cancer (TNBC) who did not achieve a pathological complete response (non-pCR) following neoadjuvant therapy. The principal investigator (PI) of this study is Professor Zhimin Shao, Director of the Department of General Surgery and Department of Breast Surgery at Fudan University Shanghai Cancer Center.
Breast cancer is the most common malignant tumor in women globally. In 2020, the age-standardized incidence rate of breast cancer in China reached 39.1 per 100,000, with 416,000 new cases, accounting for 18.4% of the global annual total[1]. In recent years, with the promotion of breast cancer screening programs, the proportion of early-stage cases among newly diagnosed patients has been increasing, offering more patients the opportunity for surgical treatment. Preoperative neoadjuvant therapy and postoperative adjuvant therapy have become crucial components of comprehensive breast cancer treatment. TNBC, as a highly malignant subtype with a poor prognosis, has seen relatively slow treatment progress due to a historical lack of clear therapeutic targets. The recommended neoadjuvant and adjuvant chemotherapy regimens are primarily based on anthracyclines and taxanes[2]. However, due to the inherent toxicity risks of these drugs, the options for adjuvant therapy for patients who do not achieve a pathological complete response (non-pCR) after a full course of treatment are very limited, representing a pressing unmet clinical need.
Utidelone Injection was approved for marketing in 2021, demonstrating dual benefits in both progression-free survival (PFS) and overall survival (OS) for patients with advanced breast cancer. Building on this, the applications for utidelone in earlier lines of breast cancer therapy are being continuously expanded. Its Phase III clinical trial for neoadjuvant therapy in HER2-negative, high-risk early-stage or locally advanced breast cancer is ongoing, with the potential to replace taxanes as the first-choice neoadjuvant chemotherapy for HER2-negative breast cancer.
UTD2 is the oral formulation of utidelone, taking full advantage of its property of not being easily expelled from cells by P-glycoprotein pumps, which allows for oral administration. Its definitive efficacy, good safety profile, and high oral bioavailability have been fully validated in clinical studies in China and the United States, and multiple Phase II/III clinical trials are currently underway. Given that oral administration will significantly enhance patient convenience and compliance, thereby facilitating long-term treatment, UTD2 is anticipated to show enormous potential in the field of adjuvant breast cancer therapy. This will establish a comprehensive strategic layout for utidelone across advanced, neoadjuvant, and adjuvant settings in breast cancer, benefiting a broader population of patients.
About the NCT07021261 Study
This study is a Phase III, multicenter, open-label, randomized, controlled clinical trial evaluating Utidelone Capsule (UTD2) combined with capecitabine versus capecitabine monotherapy as an adjuvant therapy for patients with early-stage TNBC who did not achieve a pathological complete response (non-pCR) after neoadjuvant therapy. The objective is to evaluate the efficacy and safety of UTD2 combined with capecitabine compared to capecitabine monotherapy in this patient population. The study plans to enroll 440 patients, randomized 1:1 to the experimental and control arms. The primary endpoint is the 3-year invasive disease-free survival (IDFS) rate. Secondary endpoints include the 5-year IDFS rate, 3-year OS rate, 5-year OS rate, and safety. The study is led by Professor Zhimin Shao, Director of the Department of General Surgery and Department of Breast Surgery at Fudan University Shanghai Cancer Center.
References
[1] Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, International Medical Exchange Branch of the Chinese Anti-Cancer Association, Breast Cancer Group of the Chinese Society of Clinical Oncology. Clinical Practice Guidelines for Advanced Triple-Negative Breast Cancer in China (2024 Edition) [J]. Chinese Journal of Oncology, 2024, 46(06): 471-480.
[2] Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Breast Cancer, 2024 Edition.