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Release time：2026-06-04 13:25:26 Reading：
November 18, 2024(EST), Jinrui Foundation Biotech Co., Ltd. announced that its globally first-in-class drug, JRF101 (Magnolol Liposome for Injection), was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). this recognition marks a significant milestone for JRF101, following the FDA’s approval of its Investigational New Drug (IND) application early this year.
JRF101 is an innovative therapeutic candidate designed to address critical unmet needs in the treatment of brain tumors. The FDA’s Orphan Drug Designation highlights the drug’s potential to provide meaningful benefits to patients suffering from this rare and challenging condition. With this designation, JRF101 is now eligible for key development incentives, including 7 years of market exclusivity, tax credits for clinical trial costs, and a waiver of FDA application fees.
We are honored that JRF101 has received Orphan Drug Designation from the FDA,” said the Dr. Lai, Chairman and Founder of Jinrui Foundation Biotech. “This milestone reinforces our commitment to advancing innovative therapies for life-threatening conditions like brain tumors. We are dedicated to accelerating the clinical development of JRF101 and bringing new hope to patients and their families.”
The Orphan Drug Designation further supports JRF101’s global development and commercialization and solidifies Chengdu Jinrui Foundation’s role as a leader in the field of innovative oncology therapeutics.
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. JRF101 has 67 patent applications filed domestically and internationally, with 34 patents already granted. The project has received support from the national Major New Drug Creation programs during the 12th and 13th Five-Year Plans.