InxMed Receives Approval to Initiate Phase I Clinical Trial in China for IN10018
December 20, 2019
Shanghai, China—InxMed (Shanghai) Co., Ltd.(“InxMed” or “Company”), a clinical stage biotech company dedicated to developing innovative, individualized medicines with international impact, announced today that the Company has obtained IND (Investigational New Drug) clearance for IN10018, a proprietary focal adhesion kinase (FAK) inhibitor, from China National Medical Products Administration (NMPA) to initiate Phase I clinical trial in patients with locally advanced or metastatic gastric cancer. Previously IN10018 has opened IND in the United States in August 2019.
Dr. Zaiqi Wang, InxMed’s Chairman and CEO, said: “We believe IN10018 has broad potential for the treatment of cancer patients and are very excited to receive approval from NMPA to initiate clinical trials of IN10018 in China.This is another important milestone for InxMed, demonstrating our ability to conduct clinical trials in both the U.S. and China and leverage advantages of both countries to create global value.Furthermore, it only took less than two months from IND submission to obtaining IND clearance from NMPA, which again proved the execution excellence of our team.”
As the principal investigator of this clinical study, Professor Jin Li, M.D., Head of the Department of Oncology in Shanghai Tongji University affiliated East Hospital and ex-President of China Society of Clinical Oncology (CSCO), commented: "Gastric cancer is the second most common tumor type in China with huge unmet medical needs. We hope to accelerate the clinical development of IN10018 and provide better treatment option to patients with gastric cancer."
IN10018, formerly known as BI853520, is a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor under clinical development stage in both the United States and China. InxMed owns the exclusive global rights for development and commercialization. Early clinical data of IN10018 has demonstrated a favorable safety profile and promising efficacy signals against a number of tumor types. Emerging science also showed that FAKi like IN10018 potentially overcomes fibrotic barrier and immune tolerance, boosting multi-modalities including targeted therapy, chemotherapy, immune-therapy and radiation therapy.
InxMed is a clinical-stage biotech company focusing on developing “Best-in-Disease Combination” medicines to bring novel treatment option for patients. Our innovations are inspired by patients and driven by in-depth understanding of disease biology and pharmacology. InxMed is committed to building a translational platform equipped with global-level top-notch know how and efficient execution capabilities. Established in the end of 2018, InxMed has raised tens of millions of US dollars in series A round financing, established an integrated high caliber research and clinical development team across Shanghai, Beijing, United States, Canada and Australia. We have built a highly differentiated pipeline, and established licensing or co-development partnership with various multinational pharmaceutical companies.