美國(guó)時(shí)間 2024年11月18日 ，金瑞基業(yè)生物科技有限公司研發(fā)的全球首創(chuàng)藥—JRF101（注射用和厚樸酚脂質(zhì)體）獲得美國(guó)食品藥品監(jiān)督管理局（FDA）授予的罕見(jiàn)病藥物資格（Orphan Drug Designation, ODD）。這一認(rèn)定是繼JRF101今年初獲得FDA臨床試驗(yàn)批準(zhǔn)（IND Clearance）后的又一重大里程碑。

          JRF101是一款針對(duì)腦部腫瘤的新型治療藥物，旨在滿足這一罕見(jiàn)且高危疾病領(lǐng)域的未被滿足的醫(yī)療需求。此次獲得ODD，表明FDA認(rèn)可了JRF101在治療腦部腫瘤方面的潛力。根據(jù)FDA的相關(guān)政策，JRF101將享受一系列激勵(lì)措施，包括7年的市場(chǎng)獨(dú)占權(quán)、臨床研發(fā)稅收減免以及FDA申請(qǐng)費(fèi)用的豁免。

          金瑞基業(yè)生物科技有限公司董事長(zhǎng)和創(chuàng)始人賴新天博士表示：“我們非常榮幸JRF101能夠獲得FDA的罕見(jiàn)病藥物資格。這是對(duì)我們團(tuán)隊(duì)在創(chuàng)新藥物研發(fā)領(lǐng)域努力的高度認(rèn)可，也激勵(lì)我們加快推進(jìn)JRF101的臨床開(kāi)發(fā)，為腦部腫瘤患者提供全新的治療希望。”

          此次罕見(jiàn)病藥物資格的授予，不僅為JRF101的全球開(kāi)發(fā)和商業(yè)化奠定了堅(jiān)實(shí)基礎(chǔ)，也進(jìn)一步鞏固了金瑞基業(yè)在創(chuàng)新腫瘤藥物研發(fā)領(lǐng)域的領(lǐng)先地位。

關(guān)于JRF101
         JRF101是首個(gè)用脂質(zhì)體包裹天然小分子的全球首創(chuàng)藥；從中藥厚樸中提取分離獲得的高純度單體“和厚樸酚”，采用新型載體脂質(zhì)體包裹，制備成能靶向腫瘤組織的“和厚樸酚脂質(zhì)體凍干粉”，具有顯著抗腫瘤活性且能克服化療和靶向藥耐藥。JRF101為具有自主知識(shí)產(chǎn)權(quán)的1類創(chuàng)新藥，已申請(qǐng)國(guó)內(nèi)外專利 67 項(xiàng)，其中34項(xiàng)已獲得授權(quán)，獲十二五、十三五國(guó)家重大新藥創(chuàng)制立項(xiàng)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.

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.