2024年5月27日，金瑞基業(yè)宣布，其針對JRF101（注射用和厚樸酚脂質(zhì)體）的新藥臨床研究申請（IND 161353）已獲得美國食品藥品監(jiān)督管理局（FDA）的審查批準(zhǔn)，允許公司繼續(xù)進行該藥物的I期臨床研究，并對該公司在中國開展的I期臨床數(shù)據(jù)表示認可。
該研究旨在評估JRF101在晚期惡性實體瘤患者中的臨床安全性、耐受性和藥代動力學(xué)。和厚樸酚是一種具有潛在抗腫瘤活性的植物化學(xué)成分，金瑞基業(yè)致力于將其開發(fā)為創(chuàng)新的腫瘤治療藥物。
在FDA的審查過程中，金瑞基業(yè)展現(xiàn)了其研究方案的科學(xué)性和合理性。FDA特別強調(diào)了進行劑量隨機研究的重要性，以支持未來大型試驗的劑量選擇，并建議金瑞基業(yè)在臨床協(xié)議中包含藥代動力學(xué)數(shù)據(jù)分析計劃。
金瑞基業(yè)表示獲得FDA的臨床批準(zhǔn)將加速其全球化戰(zhàn)略部署，并承諾將嚴格遵守FDA的指導(dǎo)原則，確保研究的質(zhì)量和安全性，為全球患者提供更多治療選項。公司未來將與國際臨床研究機構(gòu)緊密合作，同時，公司也將與FDA保持密切溝通，確保研究的順利進行。
關(guān)于JRF101
JRF101（注射用和厚樸酚脂質(zhì)體）是首個用脂質(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為具有自主知識產(chǎn)權(quán)的1類創(chuàng)新藥，已申請國內(nèi)外專利 54 項，已授權(quán)專利29項，已授權(quán)的發(fā)明專利 12項，獲十二五、十三五國家重大新藥創(chuàng)制立項支持。
關(guān)于金瑞基業(yè)醫(yī)藥科技
金瑞基業(yè)醫(yī)藥科技是一家致力于生物醫(yī)藥研發(fā)的高科技企業(yè)，專注于開發(fā)創(chuàng)新藥物，以滿足未被滿足的醫(yī)療需求，改善患者的生活質(zhì)量。
Jinrui Foundation Biotech Co., Ltd. Receives FDA Approval to Conduct Phase I Clinical Study of JRF101 Honokiol Liposome
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.
