Beijing Biostar Pharmaceuticals Co., Ltd. is a national high-tech enterprise focusing on the development of oncology products with independent intellectual property through state-of-the-art synthetic biology technology platforms. Beijing Biostar has become an integrated biopharmaceutical company encompassing R&D, manufacturing and commercialization capabilities.

Utidelone injectable (UTD1), an innovative product independently developed by Beijing Biostar, is the new-generation microtubule inhibitor produced by microbial fermentation process, and has been approved by the NMPA in March 2021 for the treatment of metastasis breast cancer. Utidelone is a lead product developed by our key technology platforms. Utidelone has a broad anti-cancer spectrum. Preclinical studies showed that the anti-tumor activity of Utidelone against the most common tumor models such as breast cancer, lung cancer, liver cancer, colon cancer and prostate cancer is significantly better than that of paclitaxel. Utidelone also demonstrated good efficacy against tumors that are resistant to multiple chemotherapeutics including paclitaxel. The Phase III clinical trial of Utidelone Injectable for the treatment of advanced breast cancer showed excellent efficacy and safety profile. Compared with standard regimens, Utidelone significantly increased the PFS and OS of patients, and almost doubled the response rate and time to progression. The results were twice selected for oral presentations at the 2016 and 2018 ASCO annual meetings, and rated as major research progress at the 2016 ASCO annual meeting. Related papers were published in the top international oncology journals Lancet Oncology and Annals of Oncology. Currently Utidelone has been selected by “2024 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer” as Class I recommendation, with the potential to become the new chemotherapy standard for the metastasis breast cancer treatment in the near future.

Beijing Biostar's enriched R&D pipeline involves one commercialized product and a pipeline of 19 programs, covering Utidelone injectable indication expansion trials (including two multinational clinical studies including US), Utidelone oral capsules (UTD2) and nano-formulation developments, and multiple in-house projects in pre-clinical stage. We are proactively expanding our pipeline via both in-licensing and co-development.

Beijing Biostar has an outstanding management team composed of high-level talents with overseas pharmaceutical R&D background and extensive commercialization experience. We strive to enrich the product pipeline with first- and best –in-class oncology drugs with high druggability and expansibility to meet the needs of patients in China and around the world.