BIOSTAR PHARM-B (02563.HK): First Patient Dosed in Phase III Trial of Utidelone Capsules; Grade 3+ Peripheral Neuropathy Cut to 2.0%

NewTimeSpace News: On 20 October 2026, Beijing Biostar Pharmaceuticals Co., Ltd. (the "Company") voluntarily announced that the first patient has been dosed in the Phase III clinical study (BG02-2601) of its core pipeline product utidelone capsules (UTD2) in HER2-negative advanced breast cancer, marking the official launch of the world's first pivotal registration trial of an oral solid microtubule stabiliser.

The announcement disclosed that the study is a randomised, controlled, non-inferiority bridging trial of UTD2 versus the marketed utidelone injection (UTD1), each combined with capecitabine (CAP), in HER2-negative advanced breast cancer patients previously treated with taxanes or anthracyclines, with progression-free survival as the endpoint. It is led by Academician Xu Binghe of the Cancer Hospital of the Chinese Academy of Medical Sciences and involves more than 40 clinical research centres nationwide.

The Company stated that utidelone shares a similar mechanism of action with taxanes, but unlike taxanes, which are difficult to develop in oral form, utidelone is not readily pumped out of cells by P-glycoprotein, giving it an oral administration advantage and breaking the development barrier for oral formulations of traditional microtubule inhibitors. Phase II data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed that UTD2 plus CAP achieved an objective response rate (ORR) of 52.3%, a disease control rate (DCR) of 88.6%, a median progression-free survival (PFS) of 8.25 months and a median duration of treatment (DoT) of 9.0 cycles, comparable to or slightly better than historical data for UTD1 plus CAP; on safety, UTD2 plus CAP reduced the incidence of grade 3 or above peripheral neuropathy from 25.1% with UTD1 plus CAP to just 2.0%, with haematological toxicity remaining very low and tolerability markedly improved. The Company has conducted multiple Phase II and Phase III studies of UTD2 covering advanced breast cancer, gastric cancer, ovarian cancer, adjuvant intensification in triple-negative breast cancer and soft tissue sarcoma. The Company cautioned that the combination may not ultimately be successfully developed and commercialised.