SAN FRANCISCO, March 29, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their core pipeline product utidelone injectable (UTD1) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of breast cancer brain metastasis (BCBM).

Up to 30% of metastatic breast cancer patients develop brain metastases (BM). Prognosis of patients with BM is poor and long-term survival is rare. Currently the survival duration of BCBM patients is very limited, with the median survival of only about 7.2 months, and even shorter for triple-negative breast cancer (TNBC) BM which is only 3.5 months. Macromolecular drugs usually cannot penetrate the blood-brain barrier (BBB), leading to low therapeutic efficacy. Therefore, local treatments including surgery and radiation therapy are currently considered the standard treatments for BCBM. As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs ^[1].

Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux. This ability has been well demonstrated by both preclinical and clinical studies. A phase II clinical trial of utidelone injectable in combination with etoposide and bevacizumab for HER2 negative BCBM patients (n=17) showed excellent central nervous system (CNS) overall response rate (ORR) and CNS clinical benefit rate (CBR) of 73% and 91%, respectively. Another phase II clinical trial of utidelone injectable in combination with bevacizumab for HER2 negative BCBM patients (n=46) demonstrated median PFS of 7.7 months and 12-month OS rate of 74.4%. The FDA granted ODD to utidelone injectable for the treatment of BCBM based on these promising data.

Considering utidelone's excellent BBB-crossing capability and its therapeutic potential for brain tumors, Biostar Pharma also plans to advance the clinical studies of utidelone injectable for the treatments of other brain tumors such as lung cancer brain metastasis and glioma this year.

About Orphan Drug

An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval.

About Beijing Biostar Pharmaceuticals Co., Ltd.

Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website http://www.biostar-pharm.com/en or by contacting our business development team at [email protected] on partnering with us.