Maxwell Biosciences, Inc.

2026年类器官技术前沿进展 在2026年2月这一生物技术发展的关键节点，类器官（Organoids）领域正经历从“形态模拟”向“功能整合”的质变，随着类器官在科学界、社会及监管机构中获得前所未有的支持，类器官技术已不再仅仅是实验室中的三维细胞培养物，而是进化为具备脉管系统、免疫能力以及初步生物计算功能的复杂生命系统。类器官技术在2026年最显著的突破并非仅局限于生物学层面，而在于其深度介入了全球监管体系与临床前评价范式。这一转变标志着制药行业从依赖动物模型向人类相关（Human-relevant）模型的系统性迁移。1. 神经类器官与“类器官智能”（OI）的崛起 神经科学领域在2026年见证了类器官从静态解剖模型向具备计算能力和环境交互能力的“生物计算机”演进。类器官的定向目标学习实验 2026年2月19日，研究人员在《Cell Reports》上发表了一项突破性研究，证明实验室培养的脑类器官可以通过强化学习算法完成定向任务——解决经典的“倒立摆（Cart-pole）”控制问题。通过将类器官放置在Maxwell Biosciences开发的专业电生理芯片上，研究人员利用电信号向神经元发送和接收信息。在经过软件“教练”的闭环训练后，这些微小的神经回路在任务中的“胜率”从随机水平的4.5%提升至46%。这标志着学术界首次严谨地证明了脑类器官具备目标导向的学习能力，为“类器官智能（Organoid Intelligence, OI）”奠定了基础。2. 内分泌与代谢类器官的功能成熟化 2026年，类器官在内分泌系统（尤其是胰腺和肝脏）的成熟度方面取得了决定性进展，使其在再生医学中的应用前景更加清晰。电子植入物诱导胰腺类器官成熟 胰腺类器官长期面临体外发育不成熟、无法对血糖变化做出精准激素反馈的难题。宾夕法尼亚大学与哈佛大学在2026年2月合作研发了一种“赛博格类器官”系统，通过在培养中的胰腺组织内嵌入超薄导电网，模拟人体的24小时昼夜节律电活动。研究发现，这种节律性的电刺激能够诱导胰岛细胞像协同工作的团队一样同步放电，从而在受热或糖分刺激时正确分泌胰岛素。这一方法不仅为糖尿病治疗提供了新的细胞源，还通过AI实时监控胰岛细胞的健康状态，为未来工程化的人造器官移植铺平了道路。肝脏类器官的代谢带化（Zonation） 肝脏作为一个高度复杂的代谢器官，其不同区域执行不同的代谢功能，即“代谢带化”。2025年底至2026年初的研究通过中胚层与内胚层的共分化策略，成功重建了包含所有三个代谢区带以及器官特异性脉管系统的肝脏类器官。这些新型模型在模拟非酒精性脂肪性肝病（MASLD）和非酒精性脂肪性肝炎（MASH）时，表现出了与人体极高的病理一致性，尤其在评价Thyromimetic药物（如Resmetirom）的炎症副作用时，准确预测了临床试验中观察到的反常免疫信号。3. 肿瘤微环境建模与免疫治疗的量产革命 肿瘤类器官（PDO）已从简单的上皮细胞团进化为包含基质细胞、免疫细胞和脉管系统的全组分肿瘤微环境模型。免疫类器官：从单一干细胞到千万级NK细胞 中国科学院在2026年2月20日宣布了一项重大突破：利用工程化造血干细胞（CD34⁺ HSPCs）在人工造血类器官系统中大规模生产自然杀伤细胞（NK细胞）。研究人员通过三步法扩张和分化工艺，实现了从单个干细胞生成多达1400万个诱导NK（iNK）细胞或760万个配备CAR的iNK细胞。这种基于类器官的免疫细胞生产范式，理论上仅需一份脐带血的五分之一即可产生数以万计的治疗剂量，有望彻底打破CAR-T/NK疗法价格昂贵的僵局。肿瘤脉管化与转移研究 2026年的肿瘤类器官研究愈发关注“转移龛（Metastatic Niche）”的构建。通过器官芯片（OoC）技术将肝、肺、骨髓类器官连接，研究人员得以便捷地观察肿瘤细胞如何通过微流控模拟的循环系统侵入远端器官。特别是针对索拉非尼（Sorafenib）耐药机制的研究，脉管化类器官模型揭示了内皮细胞与肿瘤细胞间的互作（Crosstalk）是导致耐药的关键因素，这一发现在传统2D培养中完全无法观测到。4. 组织工程中的先进损伤模拟与修复 类器官技术在2026年已成为测试再生药物的“金标准”，特别是在难以通过动物模型模拟的人类特异性损伤领域。脊髓损伤模型与“跳舞分子”疗法 美国西北大学Samuel Stupp教授团队在2026年2月展示了目前最先进的人类脊髓类器官损伤模型。该研究的里程碑意义在于首次将小胶质细胞引入脊髓类器官，从而能够真实模拟创伤后的炎症反应和胶质瘢痕形成。研究利用该模型测试了获得FDA孤儿药认定的一种名为“跳舞分子（Dancing Molecules）”的再生疗法。这些分子通过调整分子运动性来增强与不断移动的细胞受体的结合能力。实验结果显示，受损类器官在接受治疗后，神经突起（Neurites）显著再生，且胶质瘢痕相关组织明显减少。这为临床前测试提供了一个比动物模型更快速、更具成本效益的人类组织平台。5. 市场景观、标准化与全球产业布局全球市场预测与竞争格局 2026年，全球人类类器官市场规模预计将达到14.4亿美元，并以18.8%的年复合增长率持续扩张至2034年的57.1亿美元。制药与生物技术公司占据了约48.4%的市场份额，这得益于其对缩短临床前研发周期的迫切需求。 美国依然占据全球市场的领先地位（约38.2%），这得益于其深厚的一流学术积淀和早期监管接受度。亚太地区，尤其是中国（约10.1%份额）和日本（约7.1%份额），正通过大规模投入生物芯片和全自动化类器官工厂，迅速缩小与欧美国家的技术差距。6. 未来展望：数字孪生与生物计算 站在2026年的视角，类器官技术的终极目标是构建患者的“生物数字孪生”。通过整合单细胞多组学数据、器官芯片实时监测数据以及机器学习预测模型，科学家正在尝试构建能够预演患者用药反应的闭环系统。 此外，类器官与人工智能的结合已进入双向互动阶段：一方面AI优化了类器官的设计与分析，另一方面，具备逻辑处理能力的生物神经环路正在启发新一代的“神经形态计算”。结论 2026年2月的类器官领域正处于突破性的窗口期。监管机构的政策红利、脉管化与免疫化模型的成熟、以及光遗传学与AI质控技术的引入，共同推动了这一技术从“实验室玩具”向“临床基础设施”的转变。尽管在血管网络完全重建和长效标准化方面仍存挑战，但类器官技术无疑已成为通往精准医疗与再生医学未来的核心桥梁。对于生命科学从业者而言，拥抱这一“无界化”时代，将是把握未来十年制药与医学发展脉搏的关键。 参考文献 Robbins A, Schweiger HE, Hernandez S, Spaeth A, Voitiuk K, Parks DF, van der Molen T, Geng J, Cline I, Kosik KS, Salama SR, Sharf T, Mostajo-Radji MA, Haussler D, Teodorescu M. Goal-directed learning in cortical organoids. Cell Rep. 2026 Feb 19:116984. Li Q, Liu R, Lin Z, Zhang X, Wang W, Galicia-Silva IM, Liu M, Gao Z, Pollock SD, Alvarez-Dominguez JR, Liu J. Implanted flexible electronics reveal principles of human islet cell electrical maturation. Science. 2026 Feb 19;391(6787):eaeb3295. Hu F, Li J, Wang Y, Lin Y, Zhang J, Xu J, Zheng X, Weng Q, Liu X, Geng Y, Wu H, Liu L, Peng H, Wu B, Huang D, Xia C, Wang T, Du X, Zeng H, Dong F, Zhang Y, Zhu X, Zhang M, Wang J. Large-scale generation of iNK and CAR-iNK cells from CD34⁺ haematopoietic stem and progenitor cells for adoptive immunotherapy. Nat Biomed Eng. 2025 Oct 7. Takata N, Li Z, Metlushko A, Chen F, Sather NA, Lin X, Schipma MJ, Carballo-Molina OA, Jamroz C, Strong ME, Smith CS, Yang Y, Wai CM, Joshi N, Kolberg-Edelbrock J, Gray KJ, Wang S, Palmer LC, Stupp SI. Injury and therapy in a human spinal cord organoid. Nat Biomed Eng. 2026 Feb 11. 欢迎各位咨询——科途官方客服： 关于科途医学 科途医学是一家专注于类器官培养全流程产品、类器官建模服务、类器官疾病模型库建设、临床前药物发现、转化医学CRO服务的高科技公司，可提供类器官一站式解决方案。基于分泌蛋白质组学筛选技术，公司已经建立了40多种组织的类器官培养方法。产品包括EHSgel 基质胶、多种类器官培养基、类器官相关细胞因子、组织消化酶解液、类器官分离回收液、类器官冻存液等。我们致力于提供高质量、更可靠的类器官产品，助力客户科学研究的进展，欢迎您来电咨询。 使用科途医学类器官产品或模型发表的科研文献列表(部分) 订购及业务咨询：info@K2Oncology.com 技术服务咨询：TechSupport@k2oncology.com 联系电话：010-67889128，13371633638（微信同步），17778038351 网址：www.K2Oncology.com 地址： ●北京市北京经济技术开发区经海六路5号院东尚·E园10号楼1层109 ●浙江省湖州市红丰路1366号6幢10楼1001室   ●河北省廊坊市固安县新兴园肽谷生物医药加速器产业园1号楼A1-1-4室

This partnership will establish a new research and production facility in Andhra Pradesh, driving India’s transition toward pharmaceutical leadership and creating high-tech jobs Research and development of novel pharma IP could be a key component for a stronger pharma workforce in India. AUSTIN, TX, December 18, 2025—Maxwell Biosciences subsidiary, Havih Envirosciences, an Indian citizen-owned and operated life sciences company, announced a strategic partnership with the Government of Andhra Pradesh to establish advanced pharmaceutical research and production capabilities in the state. The collaboration was formalized through an agreement with the Andhra Pradesh Centre for Advanced Research on Livestock Limited (APCARL) on November 21, 2025. Under the agreement, APCARL will provide Havih access to advanced R&D laboratories and underground Biosafety Level 4 (BSL-4) biocontainment facilities at its Pulivendula campus in YSR Kadapa district. Havih will develop and supply next-generation anti-infective medicines for early use within Andhra Pradesh, with manufacturing and export centered in India. “India’s growth trajectory and Prime Minister Modi’s Viksit Bharat @ 2047 vision make this exactly the right moment to pair world-class innovation platforms with sovereign, India-based execution. Maxwell was built to translate frontier immune-inspired science into durable, real-world solutions, and Andhra Pradesh offers the scientific ambition, infrastructure and policy alignment to do that efficiently and at a global scale with India as the launchpad. Through Havih and APCARL, we are anchoring advanced biocontainment research, first-in-class drug development and globally relevant intellectual property in India—while building a high-skill workforce capable of sustaining long-term wage growth and export leadership. This partnership reflects how global technology platforms and India-first innovation can work together to strengthen both public health and economic resilience,” said Scotch McClure, Founder, CEO & Chairman of Maxwell Biosciences. About Havih Envirosciences Havih Envirosciences Pvt. Ltd. is an Indian citizen-owned and operated life sciences and environmental health company focused on India-first innovation in advanced anti-infective medicines, biosafety solutions and environmental resilience technologies. Established to build indigenous scientific capability and high-value intellectual property, Havih serves as a platform for translating cutting-edge research into globally competitive products developed and manufactured in India. Havih’s mission is to strengthen India’s leadership in branded pharmaceutical research and development by enabling high-margin innovation, advanced containment research and workforce upskilling aligned with national priorities such as Viksit Bharat @ 2047, Make in India and Atmanirbhar Bharat. The company emphasizes biosafety, biodefense and public-health preparedness while supporting international export markets from an India-based innovation core. Through strategic collaborations with government research institutions and global technology partners, Havih is building a next-generation R&D and production ecosystem designed to deliver durable economic value, globally relevant IP and higher-skilled, higher-wage scientific employment for India’s growing workforce. About Maxwell Biosciences Maxwell Biosciences is a global health technology company pioneering a new category of immune-inspired small molecules called Claromers®. Designed to mimic and enhance the body’s natural defenses, Claromers® destroy pathogenic bacteria, viruses, fungi and biofilms—without harming healthy cells or the microbiome. Originally developed for critical infectious diseases, Maxwell’s technology is now entering commercial deployment across cosmetics, personal care, medical coatings and biodefense. Claromers® require no refrigeration, are safe for the commensal microbiome and are highly stable in even the harshest environments. Backed by a decade of research, a robust patent portfolio and leadership with deep expertise in science, military, AI and global health, Maxwell has active collaborative agreements with the US military and governments worldwide. FDA clinical trials are planned for 2026. Non-pharmaceutical commercialization is underway, with pilot access for select partners. Maxwell’s AI-first platform enables rapid innovation against the rising threat of resistant pathogens, offering scalable, shelf-stable and microbiome-resilient solutions for a healthier planet. To learn more about Maxwell Biosciences, visit MaxwellBiosciences.com, or follow us on X and LinkedIn. Contacts Media press@maxwellbiosciences.com Investors investor.relations@maxwellbiosciences.com

Dr. Brad Wenstrup has broad experience in government, military and civilian medicine and expertise in managing bacterial, fungal and viral infections, key to Maxwell’s vision to create health for the world. Retired Colonel Brad Wenstrup, DPM AUSTIN, TX, November 20, 2025—Maxwell Biosciences (“Maxwell"), a preclinical drug platform company developing a synthetic immune system that may serve as a key biodefense asset, today announced the appointment of Dr. Brad Wenstrup to its Board of Directors. This appointment adds a key national biodefense expert to Maxwell’s board. “Brad has spent over 20 years battling for better healthcare for our warriors, our citizens and putting America first,” said Maxwell Biosciences CEO, Founder & Chairman Scotch McClure. “I am looking forward to working with him to help Congress and our executive branch understand the incredible global security impact of Maxwell’s anti-infective therapeutics platform.” “Brad has spent over 20 years battling for better healthcare for our warriors, our citizens and putting America first,” said Maxwell Biosciences CEO, Founder & Chairman Scotch McClure. “I am looking forward to working with him to help Congress and our executive branch understand the incredible global security impact of Maxwell’s anti-infective therapeutics platform.” Dr. Brad Wenstrup is a retired Army Colonel with a distinguished record of government, military and medical service, for more than 27 years in private practice and 25 years in military medicine and surgery—with expertise in managing bacterial, fungal and viral infections. He served as the Chief of Surgery with the 344th Combat Support Hospital in Iraq and held positions at Walter Reed National Military Medical Center and as Medical Policy Advisor to the Chief of the Army Reserve. Dr. Wenstrup has worked collaboratively with agencies such as DARPA, DTRA, BARDA, NCMI, HHS, NIH, FDA, NIAID, CMS, VA, and Military Health and was a member of the Cincinnati Board of Health from 2010-2012. From 2013 to 2025, Dr. Wenstrup represented Ohio’s 2nd District in the U.S. House of Representatives and served on several key committees, including Armed Services, Veterans Affairs, Ways and Means, and the Permanent Select Committee on Intelligence, where he held multiple Chairmanships. As a leader on the Intelligence Committee, Dr. Wenstrup played a pivotal role in biodefense, he was selected as Chairman of the Select Subcommittee on the Coronavirus Pandemic and he currently serves on the President's Intelligence Advisory Board. “I am thrilled on every professional level, especially after the pandemic, to be on the Maxwell Biosciences team. This opportunity represents a tremendous chance to enhance the health of all Americans and people worldwide,” said newly-appointed Maxwell Biosciences Board Director Dr. Brad Wenstrup. “I am thrilled on every professional level, especially after the pandemic, to be on the Maxwell Biosciences team. This opportunity represents a tremendous chance to enhance the health of all Americans and people worldwide,” said newly-appointed Maxwell Biosciences Board Director Dr. Brad Wenstrup. About Maxwell Biosciences Maxwell Biosciences is a global health technology company pioneering a new category of immune-inspired small molecules called Claromers®. Designed to mimic and enhance the body’s natural defenses, Claromers® destroy pathogenic bacteria, viruses, fungi and biofilms—without harming healthy cells or the microbiome. Originally developed for critical infectious diseases, Maxwell’s technology is now entering commercial deployment across cosmetics, personal care, medical coatings and biodefense. Claromers® require no refrigeration and are highly stable in even the harshest environments. Backed by a decade of research, a robust patent portfolio and leadership with deep expertise in science, military, AI and global health, Maxwell has active collaborative agreements with the US military and governments worldwide. FDA clinical trials are planned for 2026. Non-pharmaceutical commercialization is underway, with pilot access for select partners. Maxwell’s AI-first platform enables rapid innovation against the rising threat of resistant pathogens, offering scalable, shelf-stable and microbiome-resilient solutions for a healthier planet. To learn more about Maxwell Biosciences, visit MaxwellBiosciences.com, or follow us on X and LinkedIn. Contacts Media press@maxwellbiosciences.com Investors investor.relations@maxwellbiosciences.com