China Approves Utidelone as Primary New Drug of Epothilone Class for Breast Cancer

China NMPA announced on that Utidelone injection (UTD1), applied by Chengdu Biostar Pharmaceuticals Ltd., has been approved to market on Mar 15th, 2021, which provides a new treatment option for metastatic breast cancer patients.

China NMPA announced on that Utidelone injection (UTD1), applied by Chengdu Biostar Pharmaceuticals Ltd., has been approved to market on Mar 15th, 2021, which provides a new treatment option for metastatic breast cancer patients.

Utidelone Injection Mechanism of Action

Inhibition of microtubule function is the principal mechanism of the epothilone class medicines[1]Goodin S, Kane MP, Rubin EH (May 2004). “Epothilones: mechanism of action and biologic activity”. J. Clin. Oncol. 22 (10): 2015–25. . Utidelone is a derivative of epothilones, which induce cell apoptosis by promoting tubulin polymerization and stabilizing microtubule structure. It is an innovative drug developed by China with independent intellectual property rights.

According the research, combination use of utidelone injection and capecitabine work well for patients with recurrent or metastatic breast cancer who have received at least one previous chemotherapy regimen.

Development of Utidelone

There was no news chemotherapy drug except paclitaxel for the treatment metastatic breast cancer in the past 30 years. As the first and only epothilones antineoplastic drug approved in China, Utidelone Injection breaks the long-term bottleneck for the treatment of in China, and will bring new hope for such patients.

Dr Qiu, co-founder and general manager of Chengdu Biostar Pharmaceuticals Ltd., introduced that the project of Utidelone was started in 2003. The IND application of Utidelone is submitted in 2006 after pre-clinical study. Clinical approval was obtained in 2007. And the clinical trial is done afterwards. Phase II and III clinical study were started in 2009.

In the past 30 years, there have been few good chemotherapy drugs after paclitaxel.
Clinical results of Utidelone have been highly recognized by international and domestic experts. The research papers have been published in top oncology journals “Lancet Oncology” and “Annals of Oncology”, and have been included in the recommendation of CSCO guidelines for the diagnosis and treatment of breast cancer in 2020. The team is quite confident for the future market performance.

China-Approves-Utidelone-Injection

About Chengdu Biostar Pharmaceuticals Ltd

Chengdu Biostar Pharmaceuticals, Ltd.is a Chinese company focusing on providing innovative drugs for cancer patients. Based on high-tech biosynthetic platform, Chengdu Biostar mainly develop new natural microbial small molecule anti-tumor drugs with independent intellectual property rights. Except for utidrolone injection, Chengdu Biostar has other development pipeline including demethilone, tumor stem cell inhibitors, protein phosphatase specific inhibitors, signal transduction pathway mTOR inhibitors, etc.

References

1 Goodin S, Kane MP, Rubin EH (May 2004). “Epothilones: mechanism of action and biologic activity”. J. Clin. Oncol. 22 (10): 2015–25.
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