Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012.
Phase I Study Design and Objectives
The drug is slated to undergo an open-single-arm, dosage escalation Phase I study to assess its safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity in patients with pancreatic cancer. This trial marks a significant step in the development of PR00012, as it will provide crucial data on the drug’s performance in a clinical setting.
Unique Positioning of PR00012 in Global Market
Notably, no similar product to PR00012 has been approved worldwide, highlighting the potential innovation and novelty of the drug. While the target of PR00012 remains undisclosed, its development underscores the company’s commitment to advancing new therapeutic options for pancreatic cancer, a disease with significant unmet medical needs.-Fineline Info & Tech
