Medicilon Assisted – The IND application of BIOT-001, the first self-developed new drug of Biotime Biotechnology, was approved by the FDA
On July 14, the IND application for the BIOT-001 project targeting the S1P1 target declared by Biotime Biotechnology obtained the US FDA’s clinical implied license and agreed to carry out phase I clinical trials. The indication is ulcerative colitis.
Shanghai Medicilon Inc, as a strategic partner of Biotime Biotechnology, provided preclinical R&D services from target to IND declaration for the R&D of BIOT-001, and made every effort to complete the project with high quality and efficiency.
BIOT-001 is an innovative small-molecule drug independently developed by Biotime Biotechnology with global intellectual property rights. BIOT-001 is an orally active receptor agonist targeting S1P1. Preclinical studies have shown that BIOT-001 can selectively bind to S1P receptor subtype 1 (S1P1) with high affinity, thereby inducing the isolation of peripheral blood lymphocytes, reducing the migration of activated circulating lymphocytes to the gastrointestinal tract, and has the effect of treating inflammatory bowel disease. At the same time, preclinical toxicology studies have shown that the drug has the characterize of good safety.
About Biotime Biotechnology
Biotime Biotechnology is a high-tech enterprise specializing in the research, development, production and sales of in vitro diagnostic reagents and instruments in China. In recent years, Biotime Biotechnology has gradually extended its industry to the field of new drugs, and has successively obtained dozens of honorary qualifications and titles such as the National Specialized and New “Little Giant” Enterprise, China’s Top 500 Manufacturing Private Enterprises, Fujian Province Excellent Private Enterprises, Fujian Province Industrial Leading Enterprises, Fujian Province Top 100 Private Enterprises, Fujian Province Top 50 Manufacturing Enterprises, Fujian Province New R&D Institutions, Fujian Province Science and Technology Little Giant Leading Enterprises, and Fujian Province High Growth Enterprises in the Field of Industry and Information Technology.
About Medicilon
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. By the end of 2022, Medicilon has provided new drug R&D services to more than 1,840 clients around the world, and participated in the R&D of 330 new drug projects that have been approved for clinical trials. Medicilon is proud to contribute to human health in the globe.
