Beijing, China, June 11, 2026 — Beijing Biostar Pharmaceuticals Co., Ltd. (hereinafter referred to as "Biostar", stock code: 2563.HK), a biopharmaceutical company leveraging a synthetic biology R&D platform to focus on developing proprietary anticancer drugs, today announced that its core pipeline product, utidelone capsules (UTD2), has received clinical trial approval (Notice No.: 2026LP01769) from the National Medical Products Administration (NMPA) for a randomized, controlled Phase III clinical study (BG02-2601) in the treatment of HER2-negative advanced breast cancer.
The promising potential of utidelone capsules (UTD2) in treating advanced breast cancer has been strongly demonstrated in previous clinical studies. At this year's just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting, Biostar presented the results of a Phase II clinical study of UTD2 in combination with capecitabine (CAP) for metastatic breast cancer, led by Academician Xu Binghe of the Cancer Hospital, Chinese Academy of Medical Sciences (see news link: Phase II Clinical Data of the World's First Oral Solid Microtubule Stabilizer Utidelone Capsule (UTD2) Shines at ASCO 2026 — Dual Breakthroughs in Efficacy and Safety, New Experience of Oral Convenience).
The data showed that for patients with metastatic breast cancer previously treated with taxanes or anthracyclines, the UTD2 plus CAP regimen demonstrated excellent antitumor efficacy and a significantly improved safety profile. The objective response rate (ORR) reached 52.3%, the disease control rate (DCR) reached 88.6%, the median progression-free survival (PFS) was 8.25 months, and the median duration of treatment (DoT) was 9.0 cycles. Compared with historical data from the Phase III clinical study of utidelone injection (UTD1) plus CAP, the efficacy was comparable or slightly superior. The safety advantages of UTD2 plus CAP were particularly prominent, notably reducing the incidence of grade 3 or higher peripheral neuropathy from 25.1% with UTD1 plus CAP to just 2%, while hematologic toxicity remained at very low levels. The overall tolerability was excellent, offering a new oral treatment option for patients with advanced breast cancer.
Utidelone shares a similar mechanism of action with taxanes, but unlike taxanes, which are difficult to formulate into oral dosage forms, utidelone is less likely to be pumped out of cells by P-glycoprotein, conferring an advantage for oral administration. The utidelone oral capsules developed by Biostar utilizing its proprietary synthetic biology technology platform represent the world's first oral solid microtubule stabilizer. This is not merely an upgrade in formulation but a revolution in treatment philosophy and quality of life. The oral capsule frees patients from the burden of daily intravenous infusions, enabling a higher quality of life while living with tumors. The enhanced convenience and tolerability support longer treatment durations to achieve better survival outcomes. Furthermore, utidelone capsules offer the possibility of outpatient-based treatment, optimizing the allocation of medical resources, reducing societal and individual medical burdens, and demonstrating immense application potential and market space.
EFUNG Capital participated in the investment in Biostar in 2020. Looking ahead, EFUNG will continue to deeply cultivate the biopharmaceutical, be a friend of time, accompany high-quality enterprises as they grow, and witness and propel China's transformation from a major pharmaceutical country into a pharmaceutical powerhouse.