2024年5月27日，金瑞基业宣布，其针对JRF101（注射用和厚朴酚脂质体）的新药临床研究申请（IND 161353）已获得美国食品药品监督管理局（FDA）的审查批准，允许公司继续进行该药物的I期临床研究，并对该公司在中国开展的I期临床数据表示认可。
该研究旨在评估JRF101在晚期恶性实体瘤患者中的临床安全性、耐受性和药代动力学。和厚朴酚是一种具有潜在抗肿瘤活性的植物化学成分，金瑞基业致力于将其开发为创新的肿瘤治疗药物。
在FDA的审查过程中，金瑞基业展现了其研究方案的科学性和合理性。FDA特别强调了进行剂量随机研究的重要性，以支持未来大型试验的剂量选择，并建议金瑞基业在临床协议中包含药代动力学数据分析计划。
金瑞基业表示获得FDA的临床批准将加速其全球化战略部署，并承诺将严格遵守FDA的指导原则，确保研究的质量和安全性，为全球患者提供更多治疗选项。公司未来将与国际临床研究机构紧密合作，同时，公司也将与FDA保持密切沟通，确保研究的顺利进行。
关于JRF101
JRF101（注射用和厚朴酚脂质体）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 54 项，已授权专利29项，已授权的发明专利 12项，获十二五、十三五国家重大新药创制立项支持。
关于金瑞基业医药科技
金瑞基业医药科技是一家致力于生物医药研发的高科技企业，专注于开发创新药物，以满足未被满足的医疗需求，改善患者的生活质量。
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.
