Beijing Biostar Pharmaceuticals Co., Ltd. (Biostar Pharm-B) reported that four separate clinical studies for its core antitumor candidates—Utidelone Injection (UTD1) and Utidelone Capsule (UTD2)—have been selected for poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held from 29 May to 2 June 2026 in Chicago, USA. The data underline the company’s strategy of broadening utidelone’s indication portfolio and advancing its oral formulation. Key study highlights are as follows:
1. Advanced Breast Cancer – UTD2 + Capecitabine • Phase II trial enrolled 50 metastatic breast-cancer patients previously treated with taxanes or anthracyclines; 44 were efficacy-evaluable. • Outcomes: Objective response rate (ORR) 52.27 %, disease-control rate (DCR) 88.64 %, median progression-free survival (mPFS) 8.25 months, median duration of response (mDoR) 7.62 months, median nine treatment cycles. • Safety: Grade ≥3 peripheral neurotoxicity fell to 2 % versus 25.10 % historically seen with UTD1 + capecitabine, while grade 3/4 hematologic toxicity remained low.
2. Platinum-Resistant Ovarian Cancer – UTD2 + Fruquintinib • Open-label Simon two-stage Phase II trial targets 35 participants; 19 enrolled and 14 evaluable at data cut-off. • Interim results: ORR 64.29 %, DCR 100 %, mPFS 7 months; median overall survival (mOS) not yet reached. • Most treatment-related adverse events (TRAEs) were grade 1–2; no grade 4 events recorded.
3. HER2-Positive Advanced Breast Cancer – UTD1 + Inetetamab + Pyrotinib • Prospective Phase II trial (IPU-trial) completed enrolment with 85 efficacy-evaluable patients receiving first- or second-line therapy. • Efficacy: Complete response (CR) 7.06 %, ORR 82.35 %, mPFS 13.10 months; overall survival rates at 12, 26 and 35 months stood at 94.60 %, 85.20 % and 78.50 % respectively. • Grade ≥3 TRAEs were mainly diarrhea (28.20 %) and peripheral neurotoxicity (4.70 %); both manageable via supportive care or dose modification.
4. Metastatic Castration-Resistant Prostate Cancer – UTD1 Monotherapy • Phase II single-arm study completed enrolment of 43 heavily pre-treated patients. • Results: PSA50 response 23.26 %, PSA30 response 32.56 %; radiographic PFS 6.70 months, mOS 11.40 months. • Main grade 3/4 treatment-emergent adverse events (TEAEs): anemia, peripheral sensory neuropathy, vomiting and diarrhea; majority of TEAEs were grade 1/2 and controllable.
Management states that Utidelone’s broad antitumor activity and high oral bioavailability support continued exploration of new indications and formulations.
Warning: The disclosed therapies remain under clinical development and may not achieve eventual approval or commercialisation. Shareholders and potential investors should exercise caution when dealing in Biostar Pharm-B securities.
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