Huahao Zhongtian Pharmaceutical-B (02563): Administered to the first clinical case of HER2-negative advanced breast cancer in the treatment of advanced HER2 negative stage III breast cancer

Zhitong Finance App News, Huahao Zhongtian Pharmaceutical-B (02563) announced that the company's core pipeline Utilderon capsule (UTD2) treatment of human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer phase III clinical study (BG02-2601) successfully achieved the first patient administration, marking the official launch of the world's first clinical registration of an oral solid microtubule stabilizer.

The study was a randomized, controlled, and non-inferior bridging test for progression-free survival between Utedron capsules and capecitabine (CAP), respectively, in patients with advanced HER2-negative breast cancer who had previously been treated with taxus or anthracyclines. Led by Academician Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences, more than 40 clinical research centers from all over the country participated.

Utilolone has a similar mechanism of action to taxiderone drugs, but unlike yew drugs, which are difficult to develop into oral dosage forms, Utidron is difficult to pump P-glycoprotein out of the blood, has the advantage of oral administration, and breaks the difficulty barrier of traditional microtubule inhibitor oral formulations. According to phase II data disclosed at the 2026 American Society of Clinical Oncology (ASCO) annual meeting, UTD2 combined CAP had an objective response rate (ORR) of 52.3%, disease control rate (DCR) of 88.6%, median progression-free survival (PFS) of 8.25 months, and a median treatment time (DoT) of 9.0 cycles, compared with historical data of UTD1 combined CAP; in terms of safety, UTD2 combined with CAP had outstanding advantages, especially the incidence of peripheral neuropathy of grade 3 and above from UTD1 combined with UTD1 The 25.1% was drastically reduced to only 2.0%, hematologic toxicity remained extremely low, and patient tolerability improved markedly. UTD2 can help patients get rid of long-term intravenous infusion and pre-treatment before treatment, achieve oral anti-tumor treatment at home, improve the quality of life and clinical benefits of patients with tumors. It also provides a foundation for outpatient cancer treatment, and reduces the pressure on medical resources and the burden of patients seeking medical treatment.

The company has carried out a number of phase II and phase III clinical studies on UTD2, covering various indications such as advanced breast cancer, gastric cancer, ovarian cancer, triple-negative breast cancer adjuvant strengthening, and soft tissue sarcoma. From injections to oral dosage forms, from female tumors to gastrointestinal tumors, from advanced stage to adjuvant treatment, from China to global clinical practice, the company is steadily deploying UTD2 related pipelines, hoping to bring patients more and better treatment options.