Chipscreen received a Phase 1b/2 clinical trial of Chiauranib/CS2164 IND clearance from the US Food and Drug Administration (FDA)
SHENZHEN,China,April 16,2021 --Shenzhen Chipscreen Biosciences,a China headquartered biopharmaceutical company developing and marketing novel drugs basedon its unique technology of Chemical Genomics Drug discovery platform,today announces that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with a Phase1b/2clinical trial of Chiauranib/CS2164,a potential treatment for multiple oncological indications including Small Cell Lung Cancer (SCLC),Ovarian Cancer,Liver Cancer,and Breast Cancer,etc. Chiauranib is the third novel drug candidate discovered and developed by Chipscreen to be marketed,submitted NDA or in the late-stage phases of clinical studies.
Chiauranib isan innovative,3-pathway targeted kinase small molecule inhibitor with high selectivity against Auroa B /VEGFRs/CSF1R currently entering Phase III clinical trials in China. Its treatments to SCLC and Ovarian Cancer have been just designated as "breakthrough therapies" by National Medical Products Administration(NMPA) of China in the past months. The molecular mechanism of Chiauranib is to inhibit the rapid proliferation of tumor cells via targeting novel DNA replication pathway,as well as enhancement of antitumor immunity and inhibition of tumor angiogenesis concomitantly.
The primary objective of this Phase Ib/2 study in the USA is to demonstrate safety,tolerability and efficacy of Chiauranib as a monotherapy in 24 to 36 patients with SCLC.
"With this clearance of US FDA IND application for CS2164,it will certainly increase success of our global development strategy based on early efficacy and safety data obtained from China trials,"saidDr. Xianping Lu,Chairman and President of Chipscreen.
Contacts
Shenzhen Chipscreen Biosciences
Jiawen Zhang
Business Development Director,Based in Shanghai
Zhangjiawen@chipscreen.com
Chipscreen Biosciences (United State) Limited
Stephen Xue
Director of Operation
stephen_xue@chipscreen.com
ir@chipscreen.com
Tel: +86 0755-26952070
About CHIPSCREEN BIOSCIENCES
Shenzhen Chipscreen Biosciences Co.,Ltd. (Chipscreen Biosciences,Stock Symbol: 688321.SH) was founded inShenzhenin 2001,specializing in the research and development of novel small molecule drugs. Within house-built proprietary chemical genomics-based drug discovery and early evaluation platform as its core competitiveness,integratedChipscreen Biosciences has now become one ofChina'sleading innovative drug enterprises,forming a modern biopharmaceutical group company inShenzhen,as its headquarter,research and development center and GMP production base,Chengdu,as a regional headquarter,second research and development center,and a large scale GMP production base for both drug substances and products,Beijingclinical research center,Shanghaicommercial center,and CHIPSCREEN BIOSCIENCES (United States) Limited. At present,the company has developed several original new drug product lines for oncology,metabolic diseases,autoimmune diseases,central nervous diseases,and antiviral diseases.
