PhiloRivers Announces IND Approval for PR00012, a Novel Class 1 Drug for Pancreatic Cancer

November 25,「PHIL RIVERS」Dr. Jianfei Yang, Chief Scientific Officer of PHIL RIVERS TECHNOLOGY Co., Ltd., announced that the company's self-developed Class 1 innovative drug, PR00012, has received clinical trial application approval from the Center for Drug Evaluation of the National Medical Products Administration.（IND）Approved for the treatment of malignant solid tumors such as pancreatic cancer.

The clinical trial approved this time is an open, single-arm, dose-escalation Phase I study conducted for the first time in humans. It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity of PR00012 in patients with malignant tumors such as pancreatic cancer. There are currently no drugs targeting the same target that have been approved for marketing worldwide.

「PHIL RIVERS」Dr. Yang Jianfei, Chief Scientific Officer, pointed out: "The challenges in pancreatic cancer treatment mainly stem from the extreme complexity of this disease and the limitations of human understanding of its mechanisms."

He believes that the treatment challenges of malignant tumors such as pancreatic cancer,「PHIL RIVERS」Breaking through traditional drug research and development thinking, successfully constructed the "AI4S + Disease" new paradigm. This paradigm adopts a knowledge and data dual-driven artificial intelligence approach, directly establishing a digital twin of patients based on real disease data from pancreatic cancer patients, building a comprehensive disease profile, understanding complex disease mechanisms, identifying potential therapeutic targets and their efficacy biomarkers, and conducting virtual clinical trials.