On July 2, the new anti-tumor drug FNX006, jointly developed by Chengdu FANXI Biopharma Co., Ltd. (hereinafter referred to as "FANXI") in Tianfu Life Science Park and Sichuan University, was awarded the Clinical Trial Notice approved and issued by the National Food and Drug Administration (NMPA) and would be brought into the Phase I clinical trials in China. FNX006 tablets can be used to treat advanced malignant solid tumors, such as triple-negative breast cancer (TNBC), melanoma, etc. Preclinical research data show that it exhibits very obvious anti-TNBC activity in vivo and in vitro and has better anti-tumor effect than that of the listed drugs.

Breast cancer is the most common malignant tumor for women in the West countries and China, and the triple-negative breast cancer (TNBC) is one of the breast cancer types, which can be the most difficultly treated over the world and takes the incidence rate of 20% among breast cancers. Currently, there are still no specific targeted and effective therapeutic drugs and therapies, and the lives of patients can only be prolonged through chemotherapy of cytotoxic anti-tumor drugs, surgery and radiotherapy. 

Liu Xiaoyu 

Liu Xiaoyu, founder, chairman and president of FANXI, introduced that the drugs currently commonly used for treating the triple-negative breast cancer included anthracyclines, paclitaxel, dasatinib, etc., but they are not highly targeted and have poor efficacy, and the 5-year survival of patients is relatively low, only about 20%. Every year, there are about 40,000 to 50,000 new cases in China and at least 200,000 cases worldwide. Based on the annual treatment cost of RMB 100,000 per capita, there is a market of at least RMB 20 billion in the world. Therefore, it is an urgent clinical and market demand to develop the drug that can control the triple-negative breast cancer.

FNX006 is a novel tumor-targeted kinase inhibitor acting on Src/RAF/KDR/Fra-1 and other multi-targets. As a new original drug targeting the triple-negative breast cancer, there is currently no combination drug with the same target on the market.

FNX006 was introduced from the laboratories of Academician Wei Yuquan and Professor Yang Shengyong of Sichuan University. After 3 years of FANXI Team's further research and development, FNX006 was finally awarded with the clinical trial license by the NMPA. At present, its compound PCT patents have been obtained in 6 European and American countries. In addition, FNX006 tablets have also shown a good effect on the treatment of metastatic malignant melanoma, and its effect is better than that of Roche's Vemurafenib in preclinical animal models and cell levels.

"If everything goes well, it is expected to complete clinical trials of FNX006 tablets and launch them in the market within 4-6 years." said by Liu Xiaoyu. In the future, through single administration or in combination with anti-tumor immune drugs and traditional cytotoxic chemotherapeutics, FNX006 would become a significant drug for treating triple-negative breast cancer and malignant melanoma so as to bring good news to the patients. 

Chengdu FANXI Biopharma Co., Ltd.

FANXI, a high-tech enterprise specialized in the research of innovative drugs, was established in March 2017 and is currently located in Tianfu Life Science Park. Its team members came from well-known domestic and foreign pharmaceutical companies, such as GSK, Eli Lilly, Hisun and so forth and had many years of experience in research and development of new drugs. Many innovative drug projects of FANXI in the treatment of cancer and liver diseases are in different stages of pre-clinical research, of which 4 projects are expected to be approved for clinical use in 2021.