Jinrui Foundation Biotech Co., Ltd. Receives FDA Approval to Conduct Phase I Cli

May27, 2024, Jinrui Foundation Biotech Co., Ltd. announced today that its Investigational New Drug (IND 161353) application for the clinical study of JRF101(Honokiol Liposome for Injection) has been reviewed and approved by the U.S. Food and Drug Administration (FDA). This approval allows the company to proceed with Phase I clinical trials of the drug and acknowledges the Phase I clinical data conducted by the company in China.

The study aims to evaluate the clinical safety, tolerability, and pharmacokinetics of JRF101 in patients with advanced malignant solid tumors. Honokiol is a phytochemical with potential antitumor activity, and Jinrui Foundation Biotech is committed to developing it into an innovative cancer treatment.

During the FDA review process, Jinrui Foundation Biotech demonstrated the scientific and rational basis of its research protocol. The FDA particularly emphasized the importance of conducting dose-ranging studies to support dose selection for future large-scale trials and recommended that Jinrui Foundation Biotech include a pharmacokinetic data analysis plan in the clinical protocol.

Jinrui Foundation Biotech stated that obtaining clinical approval from the FDA will accelerate its global strategic deployment. The company is committed to strictly adhering to the FDA's guidelines to ensure the quality and safety of its research, providing more treatment options for patients worldwide. Moving forward, the company will collaborate closely with international clinical research institutions and maintain close communication with the FDA to ensure the smooth progress of its research.


About JRF101
JRF101(Honokiol Liposome for Injection) are the world's first drugs to use liposomes to encapsulate natural small molecules. The high-purity monomer "Honokiol," extracted and isolated from the traditional Chinese herb Magnolia officinalis, is encapsulated using a novel liposome carrier to formulate the tumor-targeting "Honokiol Liposome Lyophilized Powder." This formulation exhibits significant anti-tumor activity and can overcome resistance to chemotherapy and targeted therapies. JRF101 is a first-in-class innovative drug with independent intellectual property rights. It has applied for 54 patents domestically and internationally, with 29 patents granted, including 12 invention patents. The project has received support from the national Major New Drug Creation programs during the 12th and 13th Five-Year Plans.

About Jinrui Foundation Biotech:
Jinrui Foundation Biotech is a high-tech enterprise dedicated to biopharmaceutical research and development. The company focuses on developing innovative drugs to meet unmet medical needs and improve patients' quality of life.