Pivotal phase III clinical trial IND submission of the original innovative anticancer drug Chiauranib for the treatment of small cell lung cancer was accepted by the Center of Drug Evaluation of the NMPA.

SHENZHEN,China,Jan. 11,2021 -- On January 8,2021,Shenzhen Chipscreen Biosciences Co.,Ltd. (Chipscreen Biosciences,Stock Symbol: 688321.SH)submitted its pivotal phase III clinical trial application (IND)of national class I innovative drug Chiauranib to NMPA,for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. The submission has been accepted by the Center of Drug Evaluation of the NMPA. (Acceptance number:CXHL2100009).

The population of SCLC patients account for about 15-20% of all lung cancer patients. Comparing to Non-Small Cell Lung Cancer(NSCLC),it is still not clear about tumor driving gene in the development of SCLC,and thus it is lacking of targeted therapeutic treatment for this life threaten disease. For the moment,the main clinical treatment methods of SCLC are radiotherapy and chemotherapy,which may only have short-term effect,and the disease is easy to relapse. The current efficacy of treatments to SCLC is far behind that of NSCLC. There is an urgent need for innovative drugs to treat SCLC.

Chiauranib has a new chemical structure which is under global patent protection. The compound is independently designed and developed by Chipscreen Biosciences.It is a highly-selective Aurora B,CSF1R,VEGFR/PDGFR/c-Kit inhibitor,which exerts a comprehensive anti-tumor effect by simultaneously inhibiting tumor angiogenesis,inhibiting tumor cell mitosis and regulating tumor microenvironment. Chiauranib has shown pharmacological activity superior to that of other similar drugs in animal studies. In the meantime,it has an excellent safety profile despites being a multi-target kinase inhibitor. Chiauranib as a single agent therapy inhibits the overactive Aurora Bpathway existed in and related to molecular mechanism of SCLC,which is an important feature of Chiauranibdistinct to other antiangiogenic drugs. In the previous clinical trials,compared with the historical control data,the monotherapy of Chiauranibhas achieved promising results in the treatment of SCLC patients who have failed other multi-line therapies. As an innovative drug with obvious clinical advantages among the treatments of SCLC,on December 25 2020,Chiauranibhas been designated as a "Breakthrough Treatment" by CDE for the indications of SCLC.

The accepted IND submission is a pivotal phase III,randomized controlled,double-blind,multicenter study,which aims to confirm the efficacy and safety of Chiauranib monotherapy to treat SCLC after 2nd-line systemic chemotherapy and recurrence afterwards. Professor Shi Yuankai from the Cancer Hospital of Chinese Academy of Medical Sciences is the leading principle investigator of the trial.

Dr. Lu Xianping,Founder,Chairman and General Manager of Chipscreen Biosciences,says:

"The designation of Chiauranib as a"Breakthrough Treatment" and acceptance of its pivotal phase III clinical trial design by NMPA,have fully reflected Chinese drug regulatory authorities' attention and efficient execution to facilitate the development of innovative drugs in China. This also lays a good start for the further development of Chiauranib,which is the third original innovative drug discovered and developed by Chipscreen. Chipscreen will start the phase III clinical trial of Chiauranibin the treatment of SCLC as soon as possible while its submission to start clinic trial in US is underway. We believe Chiauranib will eventually provide innovative treatments to the needed cancer patients in the future because of its unique mechanism of action ."

At the same time,Chipscreen Biosciences is completing a number of phase II clinical trials of Chiauranib in China for the treatments of some other indications,including ovarian cancer,non Hodgkin's lymphoma,and liver cancer,which the trials have showing positive clinical efficacy and excellent safety.

At present,Chiauranib has globally applied for more than 40 patents of invention.

About CHIPSCREEN BIOSCIENCES

Shenzhen Chipscreen Biosciences Co.,Stock Symbol: 688321.SH) was founded inShenzhenon 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 (USA) Co.,Ltd. At present,the company has developed a number of original new drug product lines for oncology,metabolic diseases,autoimmune diseases,central nervous diseases,and antiviral diseases.