Luye Pharma Group has announced a partnership between its wholly-owned subsidiary Yantai Luye Drugs Trading Co. Ltd. and Chengdu Biostar Pharmaceuticals Co., Ltd., a wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd.(Biostar). Through this partnership, the two parties will work together to promote Utidelone Injection, a new natural microbial small-molecule anticancer drug, which is also a Class 1 new drug, in 26 provinces across Chinese Mainland.
Utidelone is China's first epothilone-based innovative anticancer drug developed by Biostar. It was approved by the China’s National Medical Products Administration for marketing in 2021 for treating recurrent or metastatic advanced breast cancer. The drug has been included in the Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Breast Cancer (the 2021 Edition) and the Guidelines for Clinical Diagnosis and Treatment of Advanced Breast Cancer in China (the 2020 Edition). In addition, clinical studies for several new indications of Utidelone are also under way, involving the treatment of multiple advanced solid tumors such as non-small cell lung cancer, gastrointestinal cancers, gynecological cancers, and head and neck cancers.
"As China's first and only approved epothilone-based anticancer drug, Utidelone has overcome China's longtime bottleneck in treating advanced breast cancer, making it a new breakthrough in the chemotherapy for breast cancer over the past 30 years," said Dr. Tang Li, Chairman of Biostar. "We're excited to work with Luye Pharma for promoting Utidelone. With many years of presence in oncology, Luye Pharma has an extensive footprint and channel resources. We're looking forward to a win-win partnership, under which we can leverage our respective strengths to bring benefits to more patients with this drug."
"Following the 'patient-first' philosophy, Luye Pharma is committed to addressing the unmet needs of patients. Oncology is one of our long-term strategic focuses. We hope to help as many cancer patients as possible by increasing the breadth and depth of market coverage for Utidelone. This drug will help to supplement Luye Pharma's oncology portfolio and increase the company's strategic edge in this field,” said Yang Rongbing, President of Luye Pharma Group.
About Utidelone Injection
Developed by Biostar, Utidelone Injection is a genetically engineered epothilone derivative and a new non-taxane anticancer agent targeting microtubule polymerization. The drug can inhibit cell mitosis and trigger apoptosis by inducing and promoting microtubule polymerization and inhibiting microtubule depolymerization, to enable anticancer cells to survive.
In 2021, China’s National Medical Products Administration approved Utidelone used in combination with capecitabine for the treatment of patients with recurrent or metastatic breast cancer who have received at least one previous chemotherapy regimen containing an anthracycline or a taxane agent.
Utidelone was found to be effective and safe in treating advanced breast cancer during Phase III clinical trials. Compared with standard regimens, Utidelone was able to significantly increase the overall survival of the subjects and almost double the response rate and the time to progression. The results were orally presented twice at the 2016 and 2018 ASCO annual meetings. The studies were also published in the influential international oncology journals Lancet Oncology and Annals of Oncology. Utidelone was also found to be highly active against the most common tumor models such as breast cancer, lung cancer, liver cancer, gastric cancer, esophagus cancer, colon cancer, and prostate cancer during preclinical studies. The drug was found to be effective against tumors resisting multiple chemotherapeutics including paclitaxel too.
Beijing Biostar Pharmaceuticals Co., Ltd. (Biostar) is a Chinese national high-tech company founded in 2002 by a team of scientists who were studying in the U.S., under the leadership of Dr. Tang Li and Dr. Qiu Rongguo. Relying on an advanced high-tech platform of combinatorial biosynthesis, the company is focused on developing new patented small-molecule anticancer drugs based on natural microorganisms. Currently, Biostar is working on the clinical development of Utidelone for other oncological indications, the development of the oral formulations of Utidelone, and the development of the drug for the overseas markets. Its pipeline also includes a series of investigational anticancer drugs with different targets and mechanisms like BG18, BG22, BG44, BGM57, BGMT8, and BGLP1.