Biostar Pharma Initiates Advancement in Cancer Treatment with New Clinical Trials of Utidelone Capsule

Biostar Pharma's Commitment to Cancer Treatment

Biostar Pharma, a prominent player in the biopharmaceutical landscape, has recently made strides in cancer treatment by successfully initiating patient dosing in two Phase II/III multiregional clinical trials for its groundbreaking Utidelone Capsule (UTD2). These trials aim to explore the efficacy and safety of UTD2 as a first-line treatment for locally advanced or metastatic gastric and gastroesophageal cancers, as well as for platinum-resistant advanced epithelial ovarian cancers.

Overview of Recent Clinical Trials

On September 11 and 12, 2025, the first patients were dosed in two significant studies: one focusing on gastric cancer (NCT06841679) and the other on ovarian cancer (NCT07044349). These pivotal trials signify Biostar's commitment to advancing innovative oncology treatments aimed at improving patient outcomes in these challenging cancer types.

Utidelone, which has exhibited promising results in previous studies, aims to provide more effective treatment options to patients. In fact, a Phase II study of Utidelone Injection (UTD1) demonstrated remarkable results—65.2% of patients experienced a partial response, with an impressive retention of clinical benefits.

Clinical Study Insights

Gastric Cancer Study (NCT06841679)

This multinational, open-label, randomized study is designed to test the effectiveness of UTD2 in patients suffering from advanced gastric cancer who have not previously received systemic treatment. The trial plans to recruit 78 subjects across China, the United States, Europe, and Japan for its Phase II part, with a subsequent Phase III enrollment of 700 subjects across multiple countries. Key objectives include evaluating both the safety and efficacy of UTD2 in combination with standard treatments, with the primary endpoint being overall survival rate.

Ovarian Cancer Study (NCT07044349)

In tandem, the ovarian cancer study will assess 84 subjects for efficacy and safety of UTD2 in patients with platinum-resistant advanced epithelial ovarian cancer. The primary endpoint is progression-free survival (PFS), with a secondary focus on overall survival (OS) and other efficacy measures. The Phase III segment plans to further evaluate 480 subjects, setting the groundwork for a potential breakthrough in treatment paradigms for this tough-to-treat cancer.

Unique Properties of Utidelone

Utidelone is a next-generation microtubule inhibitor that holds several advantages over traditional taxane treatments. Its unique formulation allows for enhanced oral bioavailability and a significantly lower risk of developing drug resistance. This makes it a compelling option for patients, providing them with an easier treatment regimen and the potential for better adherence to therapy.

Additionally, Utidelone has shown efficacy against multidrug-resistant tumors and exhibits favorable safety profiles, including minimal hematologic toxicity, thereby opening new avenues for patients who have limited options left.

Future Applications

Biostar continues to build on its impressive portfolio, with plans to expand clinical studies for UTD2 to treat other cancers, including breast, pancreatic, and colorectal cancers. This indicates a promising future for the product and highlights Biostar’s ongoing commitment to revolutionizing cancer therapy.

About Biostar

Biostar Pharmaceuticals, Inc., a U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd., is at the forefront of synthetic biology-driven biopharmaceutical innovation. With a robust pipeline and strong research foundations, the company is poised to play a significant role in the oncology landscape, driven by its mission to develop and commercialize groundbreaking drugs that address unmet medical needs in cancer treatment. For more information about partnership opportunities, potential investors are encouraged to reach out to their business development team.

In summary, Biostar’s dedication is clear: through persistent innovation and clinical exploration, they aim to make a tangible difference in the lives of cancer patients worldwide.