Fibrin Sealant (Baxter)

据Business Wire（商业资讯） 在 2026年1月8日发布。新闻稿指出： 处于临床阶段的生物技术公司INTENT Biologics今天宣布，美国食品和药物管理局(FDA)已根据IND 019567授予PEP Biologic™治疗糖尿病足溃疡(DFU)的快速通道认证。 INTENT Biologics 的首席执行官 Suneet Varma（原辉瑞高管）在新闻稿中提到，如果获批，这将是 近30年来首个 用于糖尿病足溃疡的创新生物药，也将是 全球首个获批的外泌体疗法。 公司介绍 INTENT Biologics 是在 2025年9月 由外泌体领军企业 RION 正式剥离成立的独立公司，专门负责炎症与免疫（I&I）领域外泌体药物的商业化。其核心技术 PEP™ (Purified Exosome Product) 源自梅奥医学中心（Mayo Clinic）超过 20 年的转化医学研究，核心成分是高度纯化的血小板衍生外泌体，具有极强的组织修复和抗炎能力。 历史临床进展状态 根据 ClinicalTrials.gov（美国临床试验数据库）及公司官网（intent.bio）的公开信息： III期临床启动： 公司确认已在 2026 年启动针对 DFU 的关键性 III期临床试验。此前公布的 II 期数据显示，接受 PEP 治疗 12 周后的患者愈合率达 54%，显著优于标准治疗组25%。 管线拓展： 除去 DFU，该药物在 2026 年的计划还包括启动针对压力性溃疡（褥疮）、手术创口和静脉性腿部溃疡（VLU）的 III 期试验。 一项 Ⅱ 期多中心、前瞻性、随机对照研究，旨在评估局部应用 PEP-TISSEEL 在糖尿病足溃疡 (DFU) 受试者中的安全性和有效性 PEP 药物产品是冻干粉末，装在 10R 玻璃瓶中。PEP 药物产品是一种冻干粉末，提取自血浆中的无细胞血小板。每瓶粉饼重约 75 毫克。本方案将评估 2 瓶 PEP 药物产品在 10 mL TISSEEL 纤维蛋白密封剂（15mg/mL PEP-TISSEEL）中的给药情况，为期 12 周。 TISSEEL 是一种纤维蛋白密封剂，可作为标准外科技术（如缝合和结扎）的辅助手段，防止临时结肠造口翻转后结肠吻合处发生渗漏。 入组受试者将按 1:1 的比例随机分配，其中 20 名受试者将接受 2 瓶 PEP（以 10 mL TISSEEL 和 SOC 的形式输送），另外 20 名受试者只接受 SOC。 给药形式 缓释系统（PEP-TISSEEL） 在治疗糖尿病足（DFU）时，复溶后的外泌体会与 TISSEEL（纤维蛋白封闭剂） 混合。这种纤维蛋白胶作为“支架”，能将外泌体固定在伤口处并实现长达 2 周 的持续释放，而不是一次性流失。 剂型特点冻干技术（常温稳定化的关键） 这是 PEP 区别于其他外泌体药品的显著特点： 脱水干燥： 纯化后的外泌体被加工成冻干粉末（Lyophilized Powder）。 稳定性： 这种形式使得 PEP 在室温下可保存 24 个月。而大多数其他公司的外泌体药物通常需要 -80 ℃或 -20℃冷冻保存，极大地限制了临床使用的便利性。 深度合作伙伴 Lonza（龙沙）合作公告： 2025 年 9 月 23 日，全球领先的 CDMO 巨头 Lonza 宣布与 RION 达成战略合作。公告中提到，Lonza 将利用其在休斯顿的工厂，结合 RION 的专有工艺，实现 PEP™ 药物成分的 cAMP 级别规模化生产。这证实了该平台具备从“实验室隔离”向“工业化放量”转化的成熟性。 行业影响解决生物药“最后一公里”的物流难题 长期以来，细胞疗法（如 CAR-T）和早期的外泌体研究受限于  -80 ℃或 -20℃的超低温冷链。 启示： PEP 实现常温稳定（24个月保质期）证明了冻干技术与复杂膜结构外泌体结合的可行性。 行业影响： 这意味着生物药可以像抗生素一样在普通药房储存，极大降低了医院的准入门槛和物流成本，使外泌体具备了大规模商业化（Off-the-shelf）的基础。 制造工艺（CMC）是竞争的真正护城河 过去外泌体被认为是“实验室产物”，难以标准化。 启示： RION 与 CDMO 巨头 Lonza 的深度绑定，说明外泌体行业的竞争已从“发现新功能”转向“大规模稳定生产”。 行业影响： 医药企业意识到，谁先解决 TFF（切向流过滤）、层析纯化以及效价测定（Potency Assay）的标准化，谁就能掌握行业的话语权。这也催生了专门针对外泌体外包生产的供应链繁荣。 相关专利技术文章可联系小编获取，信息会在外泌体资讯群中分享 链接数据平台，挖掘市场，链接价值，共同成长。 关注linkdate.ltd网站，注册即可免费下载热门行业研究报告

RION's Phase 2A clinical trial focuses on evaluating the safety and efficacy of Platelet Exosome Product™ (PEP™) combined with TISSEEL fibrin sealant for treating Diabetic Foot Ulcers (DFU). Diabetic Foot Ulcers, affecting 18.6 million people worldwide each year, significantly impact quality of life and impose substantial economic burdens on healthcare systems. The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU. ROCHESTER, Minn.--(BUSINESS WIRE)-- RION, a clinical-stage regenerative medicine company, at the forefront of the exosome therapeutic revolution, has officially commenced a Phase 2A study aimed at assessing the efficacy and safety of its exclusive exosome regenerative therapeutic, known as Purified Exosome Product™ (PEP™), for the management of Diabetic Foot Ulcers (DFU). This press release features multimedia. View the full release here: RION, located in Rochester, MN, is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived exosomes. (Photo: Business Wire) Diabetic Foot Ulcers affect approximately 18.6 million people worldwide each year1 and are associated with increasing rates of amputation and death​​. The economic burden of DFUs is substantial, imposing $13 billion in cost on the US public and private healthcare systems.2 The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU. Building on the success of the Phase 1B study conducted at Mayo Clinic, RION's Phase 2A trial represents a significant step forward in the development of a regenerative biologic for Diabetic Foot Ulcers. This prospective, randomized, multi-center study will involve 40 patients across the United States. Patients will be divided into two cohorts: one receiving standard care and the other treated with PEP™ exosomes, enabling a thorough comparison of outcomes. A positive outcome in the Phase 2A trial has the potential to pave the way for a pivotal study followed by the submission of a Biologics License Application (BLA). PEP™ addresses a significant unmet medical need in the realm of diabetic wound care. Dr. Atta Behfar, Co-founder of RION, said, “The progress we've made in advancing PEP™, reflects our deep commitment to developing powerful exosome therapies that unleash the body’s ability to heal from within. Not only will this study address a critical unmet need in chronic wound care, but it’s a pivotal moment for RION. We are disrupting the boundaries of exosome technology, to develop a new generation of therapies endowed with the potential to truly transform the way we treat complex and incurable diseases.” In the United States, the treatment of DFUs remains a significant challenge in the medical community, with no new biologics approved by the US FDA for diabetic wounds since the late 1990s3. RION is committed to bringing exosome-based therapies to patients as quickly and safely as possible to transform the management and outcomes of this devastating condition​​​​. About RION RION was born out of the Mayo Clinic after two decades of research and innovation at that institution. RION is located in Rochester, MN and is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™. RION is rewriting the regenerative medicine playbook. Our cutting-edge proprietary biomanufacturing platform crafts the future of regenerative therapy, unlocking the potent secrets within these tiny cellular messengers. RION’s regenerative PEP™ technology will be integral to the therapeutic exosome revolution. About PEP™ RION's Purified Exosome Product™ (PEP™) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. PEP™ is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. RION and its scientific collaborators have performed extensive research showing the potential of PEP™ to heal a wide array of damaged tissue. The company is currently evaluating PEP™ in preclinical and clinical studies for several indications. While our focus remains on wound healing, multiple IND-enabling efforts in musculoskeletal, cardiovascular disease, pulmonary disease and women’s health disorders are creating new solutions where current standards of care cannot address unmet clinical needs. About Diabetic Foot Ulcers (DFU) Diabetic foot ulcers (DFUs) are not just wounds. These slow-healing sores on the feet are a brutal consequence of diabetes, inflicting a triple threat: excruciating pain, crippling mobility, and the specter of amputation. The numbers paint a grim picture. Up to 25% of people with diabetes will face a DFU in their lifetime4, and for almost a quarter of them also limb amputation5. In fact, every three and a half minutes in the US, a DFU becomes an amputation6. This isn't just a statistic, it's a story of lives shattered, livelihoods lost, and families forever changed. Many patients endure the agony of recurrences, their lives trapped in a cycle of healing and reopening wounds. And sadly, the shadow of mortality looms large. 40% of DFU sufferers will succumb to the condition7, making it a pervasive silent killer of diabetic communities. The economic cost is equally staggering. DFUs drain healthcare systems, piling on direct treatment expenses and crippling indirect costs from lost productivity and long-term disability. RION's journey is paved with unwavering determination. We seek to break the cycle of pain, loss, and economic burden through application of our next-generation regenerative exosome technology. We will remain undeterred in our pursuit to have PEP™ become the first biologic to be approved for the treatment of DFU in over 25 years. References 1. Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578. PMID: 37395769; PMCID: PMC10723802. 2. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660. PMID: 24186882. 3. Fang RC, Galiano RD. A review of becaplermin gel in the treatment of diabetic neuropathic foot ulcers. Biologics. 2008 Mar;2(1):1-12. doi: 10.2147/btt.s1338. PMID: 19707423; PMCID: PMC2727777. 4. Yazdanpanah L, Shahbazian H, Nazari I, Arti HR, Ahmadi F, Mohammadianinejad SE, Cheraghian B, Hesam S. Incidence and Risk Factors of Diabetic Foot Ulcer: A Population-Based Diabetic Foot Cohort (ADFC Study)-Two-Year Follow-Up Study. Int J Endocrinol. 2018 Mar 15;2018:7631659. doi: 10.1155/2018/7631659. PMID: 29736169; PMCID: PMC5875034. 5. Liao X, Li SH, El Akkawi MM, Fu XB, Liu HW, Huang YS. Surgical amputation for patients with diabetic foot ulcers: A Chinese expert panel consensus treatment guide. Front Surg. 2022 Nov 8;9:1003339. doi: 10.3389/fsurg.2022.1003339. PMID: 36425891; PMCID: PMC9679004. 6. Amputation Prevention Alliance. (n.d.). Amputation prevention alliance. Amputation Prevention Alliance | ADA. 7. Jeyaraman K, Berhane T, Hamilton M, Chandra AP, Falhammar H. Mortality in patients with diabetic foot ulcer: a retrospective study of 513 cases from a single Centre in the Northern Territory of Australia. BMC Endocr Disord. 2019 Jan 3;19(1):1. doi: 10.1186/s12902-018-0327-2. PMID: 30606164; PMCID: PMC6318899.