美国时间 2024年11月18日 ，金瑞基业生物科技有限公司研发的全球首创药—JRF101（注射用和厚朴酚脂质体）获得美国食品药品监督管理局（FDA）授予的罕见病药物资格（Orphan Drug Designation, ODD）。这一认定是继JRF101今年初获得FDA临床试验批准（IND Clearance）后的又一重大里程碑。
JRF101是一款针对脑部肿瘤的新型治疗药物，旨在满足这一罕见且高危疾病领域的未被满足的医疗需求。此次获得ODD，表明FDA认可了JRF101在治疗脑部肿瘤方面的潜力。根据FDA的相关政策，JRF101将享受一系列激励措施，包括7年的市场独占权、临床研发税收减免以及FDA申请费用的豁免。
金瑞基业生物科技有限公司董事长和创始人赖新天博士表示：“我们非常荣幸JRF101能够获得FDA的罕见病药物资格。这是对我们团队在创新药物研发领域努力的高度认可，也激励我们加快推进JRF101的临床开发，为脑部肿瘤患者提供全新的治疗希望。”
此次罕见病药物资格的授予，不仅为JRF101的全球开发和商业化奠定了坚实基础，也进一步巩固了金瑞基业在创新肿瘤药物研发领域的领先地位。
关于JRF101
JRF101是首个用脂质体包裹天然小分子的全球首创药；从中药厚朴中提取分离获得的高纯度单体“和厚朴酚”，采用新型载体脂质体包裹，制备成能靶向肿瘤组织的“和厚朴酚脂质体冻干粉”，具有显著抗肿瘤活性且能克服化疗和靶向药耐药。JRF101为具有自主知识产权的1类创新药，已申请国内外专利 67 项，其中34项已获得授权，获十二五、十三五国家重大新药创制立项支持。
Jinrui Foundation Biotech Co., Ltd. Announces FDA Grants Orphan Drug Designation to JRF101
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.
