Biostar Pharma, the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., a synthetic biology–driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative oncology therapies, announced the successful dosing of the first patients in two pivotal Phase II/III multiregional clinical trials of Utidelone Capsule (UTD2).

The first trial, initiated on September 11, 2025, is evaluating UTD2 as a first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The second trial, which began dosing on September 12, 2025, is investigating UTD2 in platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Utidelone has already delivered promising clinical outcomes in gastric cancer. In a completed Phase II trial of Utidelone Injection (UTD1) combined with a PD-1 inhibitor and oxaliplatin for patients with unresectable, locally advanced, or recurrent/metastatic HER2-negative gastric cancer, 23 patients were evaluated for efficacy.

Notably, one patient remained on treatment for 22 cycles. Based on these results, the U.S. Food and Drug Administration granted Utidelone Orphan Drug Designation for advanced gastric cancer.

Utidelone has also demonstrated meaningful activity in ovarian cancer. In a US Phase I trial of UTD2 as monotherapy for advanced solid tumors, one ovarian cancer patient achieved a complete response and another achieved a partial response, despite having undergone seven and nine prior lines of therapy, respectively. In a separate Phase II trial of UTD1 monotherapy in advanced ovarian cancer, 1 patient achieved a partial response and 3 patients achieved stable disease among 10 evaluable participants.

Unlike taxanes, which face challenges in oral formulation and are susceptible to P-glycoprotein–mediated resistance, Utidelone is not affected by this efflux mechanism, offering higher oral bioavailability and a reduced risk of cross-resistance.

Looking ahead, Biostar is actively expanding UTD2’s clinical development across multiple oncology indications, including breast cancer adjuvant intensification therapy, pancreatic cancer, esophageal cancer, and colorectal cancer.