SHENZHEN, China, Jan. 5, 2021 /RPNewswire/ -- Last December 25, the anti-tumor drug candidate Chiauranib, developed by Shenzhen Chipscreen Biosciences Co., Ltd., was granted with the "Breakthrough Therapy Designation Drug" by the Center for Drug Evaluation (CDE) and currently enter a phase III clinical trial for treatment of patients with small cell lung cancer (SCLC) with disease progression or recurrence after two lines of prior systematic chemotherapy.
Chiauranib is a new chemical entity designed and developed independently by Chipscreen, with global patent protection. Chiauranib selectively inhibits multiple kinase targets such as aurora B kinase (AURKB), colony-stimulating factor 1 receptor (CSF1R), and vascular endothelial growth factor receptor (VEGFR)/platelet-derived growth factor receptor (PDGFR)/c-Kit, thereby inhibiting the rapid proliferation of tumor cells, enhancing the antitumor immunity, and inhibiting tumor angiogenesis, to achieve the anti-tumor efficacy through multi-pathway mechanisms.Targeting abnormal Aurora B signaling pathway in SCLC is one of efficacy basis of Chiauranib monotherapy and also an important mechanistic difference between it and other anti-angiogenic therapies.
Chiauranib obtained Phase I clinical trial approval from the former China Food and Drug Administration (CFDA) in August 2013, and completed multiple Phase II clinical trials with monotherapy or combined therapy for different types of malignant tumors in China, showing positive clinical efficacy and well tolerance in tumor patients. In addition, a Pre-IND communication with the FDA for clinical trial of Chiauranib against SCLC in US has been conducted.
SCLC accounts for about 15-20% of total lung cancer patients. In contrast to non-small cell lung cancer, SCLC urgently requires new therapeutic mechanisms due to a lack of identified tumor driver genes and corresponding targeted therapeutics. Treatment is dominated by chemoradiotherapy, characterized by short-term efficacy but frequent relapse, making the long-term survival rate far less than that of non-small cell lung cancer. In preliminary clinical trials on patients with multiline treatment failure, Chiauranib obtained encouraging efficcay as monotherapy by comparing with the historical control data, which may bring a better treatment option for SCLC patients.
Dr. Lu Xianping, Chairman of Chipscreen, said that the "Breakthrough Therapy Designation Drugs" review and approval procedures initiated by NMPA this year will further accelerate the development of drugs with significant clinical advantages and accelerate their clinical application to meet the treatment needs of patients in China with major diseases. This also represents a significant improvement in China's medical innovation management. Chiauranib's incorporation into the list means that Chipscreen's third originally developed drug is expected to bring patients new treatment options soon. Chipscreen will also continue to develop new drugs for major diseases such as tumors, metabolic diseases, autoimmune diseases, central nervous system disorders, and viral infections to meet clinical demands.
About the Breakthrough Therapy Designation
The "Breakthrough Therapy Designation" is part of the Review Procedures for Breakthrough Therapy Designation Drugs issued by the National Medical Products Administration (NMPA), aiming to accelerate development and review of new drugs for serious or life-threatening diseases. The designated drugs are used to prevent and treat diseases that seriously endanger life or seriously affect life quality, with no existing effective means of prevention and treatment, or no innovative drug or modified new drug with sufficient evidence from clinical trials to show significant clinical advantages over existing treatments. Applicants for such drugs can apply for applicable procedures in Phase I or II clinical trials, generally no later than the commencement of Phase III.