Cetuximab

DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading global science and technology company, today announced that the European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026. Erbitux is now indicated in combination with encorafenib for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) — both in first-line treatment in combination with FOLFOX (BREAKWATER regimen) and for patients who have received prior systemic therapy (BEACON regimen). The first-line approval is based on results from the Phase 3 BREAKWATER trial, which showed that the cetuximab–encorafenib–FOLFOX combination delivered statistically significant and clinically meaningful improvements in the dual primary endpoints of objective response rate (ORR) and PFS, as well as a significant overall survival benefit — reducing the risk of death by 51% versus chemotherapy with or without bevacizumab. ”The approval of Erbitux in combination with encorafenib and FOLFOX marks an important milestone for patients with BRAF V600E-mutant mCRC who can now benefit from a first targeted treatment option in the first-line setting,” said Matthias Wernicke, Head of Global Therapeutic Area Specialty Care, in the healthcare business sector of Merck. “BRAF V600E-mutant mCRC is associated with a historically poor prognosis and limited effective options. This approval reinforces Erbitux as the backbone of anti-EGFR therapy in colorectal cancer — and reflects our ongoing commitment to addressing unmet needs for patients across the full treatment continuum.” BREAKWATER (NCT04607421) is a Phase 3, randomized, active-controlled, open-label, multicenter trial evaluating encorafenib in combination with cetuximab and FOLFOX in participants with previously untreated BRAF V600E-mutant mCRC. The trial was conducted by Pfizer, in collaboration with Merck, and Ono Pharmaceutical. The combination of cetuximab, encorafenib and FOLFOX received accelerated FDA approval in December 2024 for treatment-naïve patients based on ORR data, and full FDA approval in February 2026 based on PFS and OS data — with the indication expanded to include fluorouracil-based chemotherapy (FOLFOX or FOLFIRI). The BREAKWATER regimen demonstrated statistically significant and clinically meaningful improvements across all key endpoints versus standard-of-care chemotherapy (FOLFOX/FOLFOXIRI/CAPOX with or without bevacizumab).1,2 Median PFS was 12.8 months versus 7.1 months (HR 0.53; 95% CI: 0.41–0.68; P<0.001), representing a 47% reduction in the risk of progression or death. Overall survival was likewise significantly improved, with a median OS of 30.3 months versus 15.1 months (HR 0.49; 95% CI: 0.38–0.63; P<0.001) — a 51% reduction in the risk of death, more than doubling median overall survival compared to standard care. Confirmed ORR was 65.7% (95% CI: 59.4–71.4) in the BREAKWATER arm versus 37.4% (95% CI: 31.6–43.7) in the control arm. Safety profiles were consistent with those previously established for each individual agent; serious adverse events occurred in 46.1% versus 38.9% in the standard-care arm. The cetuximab–encorafenib–FOLFOX regimen has been endorsed as first-line standard of care by the April 2026 ESMO Clinical Practice Guidelines (Recommendation Grade I, A) for patients with metastatic colorectal cancer harboring the BRAF V600E mutation.3 While the BREAKWATER regimen redefines first-line therapy, the Phase 3 BEACON CRC trial confirmed Erbitux as a standard of care in second-line and beyond. The combination of Erbitux and encorafenib — also approved by the EC on June 26, 2026 for patients with BRAF V600E-mutant mCRC who have received prior systemic therapy — significantly improved OS versus the irinotecan-based control (median 9.3 vs. 5.9 months; HR 0.61; 95% CI: 0.48–0.77; p<0.0001), reducing the risk of death by 39%.4,5 This regimen maintains quality of life with no increase in Grade ≥3 adverse events versus standard chemotherapy. Erbitux is the first and only anti-EGFR therapy approved for both RAS wild-type and BRAF V600E-mutant mCRC patients — supporting patients throughout their treatment journey and across multiple lines of therapy. Colorectal cancer remains a major global health challenge. It is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related deaths, with 1.92 million new cases and approximately 900,000 deaths recorded in 2022 alone.6 Projections indicate cases will increase by more than 85% and mortality will double in coming decades. Of patients presenting with metastatic disease — approximately 20% at diagnosis — 5-year survival remains at only 16.2%. BRAF V600E mutations occur in approximately 8–12% of patients with mCRC and are associated with a particularly poor prognosis, with mortality risk more than double that of patients without the mutation. Extending the indication of Erbitux to this patient population represents a meaningful step toward more personalized and effective treatment — addressing a significant and clinically important unmet need. With this dual approval — first-line (BREAKWATER) and second-line (BEACON) — Erbitux is now established as the pioneering anti-EGFR backbone across the mCRC treatment continuum. This milestone underscores Merck’s commitment to driving innovation in oncology and improving outcomes for patients with difficult-to-treat cancers. Local HCP Declaration Pierre Fabre, which holds the commercialization rights for BRAFTOVI (encorafenib) in Europe, submitted the BREAKWATER data to European Medical Agency (EMA) and received EC approval on June 22,2026. The BEACON regimen was already approved under BRAFTOVI since June 2020. About BREAKWATER Study BREAKWATER is a Phase 3, randomized, open-label, multicenter trial, whose findings support a targeted, first-line approach for patients with BRAF V600E-mutant mCRC.2 The combination of ERBITUX, encorafenib, and the FOLFOX regimen significantly improved outcomes versus standard of care, with a 47% reduction in the risk of progression or death (HR 0.53) and a 51% reduction in the risk of death (HR 0.49). The data also show a meaningful increase in the ORR and a median OS of over 30 months in the experimental arm, underscoring the value of combined inhibition of BRAF and EGFR pathways in this poor-prognosis population and suggesting this treatment strategy as a new first-line standard of care. About BEACON Study BEACON CRC is a randomised, open-label, global Phase 3 trial evaluating the efficacy and safety of ERBITUX in combination with encorafenib ± binimetinib in patients with BRAF V600E-mutant mCRC whose disease has progressed after one or two prior regimens. BEACON CRC is the first Phase 3 trial designed to test a BRAF combination targeted therapy in BRAF V600E-mutant mCRC. The data showed that ERBITUX in combination with encorafenib significantly improved OS in patients with BRAF V600E-mutant mCRC (median 9.3 months vs 5.9 months; HR: 0.61; 95% CI: 0.48–0.77; p<0.0001) and reduced the risk of death by 39%, compared with the ERBITUX plus irinotecan-containing regimen (control) arm. Data also showed that, besides improving OS, ERBITUX-encorafenib resulted in no worsening in quality of life or increase in grade 3 AEs versus irinotecan-based chemotherapy–cetuximab.4,5 About Cetuximab (ERBITUX®) Cetuximab is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Cetuximab is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, Cetuximab also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]). Cetuximab has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX (Cetuximab), a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998. About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2025, Merck generated sales of € 21.1 billion in 65 countries. Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. 1 Elez E, et al. Encorafenib, cetuximab, and mFOLFOX6 in BRAF-mutated colorectal cancer. N Engl J Med. 2025;392:2425–37. 2 Kopetz S, et al. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. Nat Med. 2025;31:901–908. 3 Cremolini C, et al. on behalf of the ESMO Guidelines Committee. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2026. doi: https://doi.org/10.1016/j.annonc.2026.03.005. 4 Kopetz S, et al. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019. PMID: 31566309. 5 Tabernero J, et al. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E–Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021;39(4):273–284. 6 World Health Organization. Colorectal cancer: Key facts. Accessed 14 July 2026. https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer.

【系列导读】这是菲常医讯"类器官在制药中的潜在应用"系列专题的第二篇。 上一篇我们解析了类器官为何值得关注——以低成本、短周期、高通量、高临床相关性的组合优势，提供了传统模型无法兼顾的平衡点。本篇聚焦实战：MNC如何布局？哪些新药已凭类器官数据拿到IND？技术瓶颈又将在多大程度上制约规模化应用？ 01 MNC的类器官"军备竞赛" 2018年5月，阿斯利康率先出手——与类器官芯片公司Emulate达成合作，将后者的人体器官芯片技术整合进阿斯利康IMED药物安全实验室，着手开发全新的筛药平台。彼时，这一举动在业界尚属孤例，鲜有人意识到它拉开了什么序幕。 此后七年，一场围绕类器官技术的产业布局在跨国药企（MNC）中悄然展开。从合作开发到收购整合，从单一环节到全链条覆盖，节奏持续加快。下表梳理了公开可查的主要布局事件： 此外，诺和诺德、武田、第一三共等MNC也都有自主开发类器官平台的动作。 纵观这份时间线，一个清晰的趋势浮现：MNC对类器官的布局正从"试探性合作"走向"战略性整合"。早期以合作开发为主——阿斯利康与Emulate的联手是典型代表；而近两年，收购整合的比重明显上升，默克收购HUB Organoids、罗氏收购Herophilus、GSK收购Cellphenomics，一系列动作表明MNC已不再满足于"借用"类器官公司的服务，而是试图将这一能力内化为自身研发体系的核心组件。 DOI：10.1186/S12958-020-00621-Z 02 产业格局全景 从产业链角度看，类器官行业可以粗略划分为三层：上游是类器官芯片等原料供应商，中游是提供类器官服务的CRO，下游则是药企、医院和高校。 但这条看似清晰的链条，正在被MNC的深度介入所重塑。不少MNC通过合作开发、收购等方式，与中游和上游展开更加密切的合作，甚至将类器官芯片平台直接整合到自身业务中，由此模糊了传统的上下游边界。 目光转向国内，公开的合作信息相对较少。2021年，百济神州与创芯国际达成合作，共同建立类器官新药研发技术平台，将新药研发与类器官技术相结合，联合开拓类器官智能化药物评价系统，是国内较早的公开案例。 💡 总体来看，药企与CRO合作仍是当前主流模式。国外类器官服务更加普及，MNC与CRO合作、布局类器官芯片的案例较为常见；国内药企的类器官应用尚处于早期阶段，但已有头部企业率先试水。 03 5个IND案例深度拆解 以下5个案例是公开可查的、基于类器官（芯片）数据获批IND的代表性药物。需要说明的是，制药公司通常不会特别注明IND申请是否使用了类器官数据，因此实际使用类器官芯片的新药远不止这些。但这5个案例已足够展现类器官在不同药物类型和适应症中的应用实况。 案例一：SAR445088丨全球首个完全基于类器官芯片数据获批IND 技术路径：Hesperos使用iPSC分化形成的运动神经元和人类施万细胞，在微电极阵列（MEA）上培养以使轴突生长到电极上，构建类器官芯片。然后添加抗GM1（神经节苷酯1）抗体和补体，并使用来自MMN和CIDP患者的血清处理类器官芯片，建立了两种脱髓鞘神经疾病模型。最后使用TNT005，验证抗补体C1S疗法的效果。类器官芯片可以反映动作电位的生成和传导速度。 临床数据：SAR445088的类器官芯片疗效数据结合此前的安全性数据，成功获得FDA临床许可。Phase 2临床结果积极，目前正在进行Phase 3临床实验。 💡 案例启示：这是类器官芯片在罕见病领域的标杆案例。当动物模型完全缺位时，类器官芯片不是"补充"，而是"唯一选项"——FDA接受了完全基于类器官芯片数据的IND申请，这本身就是对该技术可信度的权威背书。 案例二：HRS-1893丨国内首个基于类器官芯片数据获批IND 技术路径：该类器官芯片由人工血管组和心肌细胞微球组组成，可以实现药物和营养物质经血管吸收，具有血液流通和血管过滤功能，可模拟药物经血管内皮吸收、过滤后作用于心肌细胞的过程。血管可以收缩、舒张，以评估药物影响。 筛选过程：在早期筛选阶段，双方经过6轮基于类器官芯片的化合物筛选，最终获得了EC50低的分子，并通过了多批次和长时间的稳定性测试，最终选定HRS-1893。 商业价值：恒瑞报道HRS-1893临床Ⅱ期研究已达预期目标，并开展Ⅲ期研究。2025年9月13日，HRS-1893海外授权给Braveheart Bio，获得7500万美元的首付款和近期里程碑款，以及最高10.13亿美元的里程碑款。 💡 案例启示：这是中国药企利用类器官芯片进行药物开发的标杆案例。6轮芯片筛选精准选定分子、海外授权斩获超10亿美元里程碑——类器官不仅支撑了IND申报，更直接创造了可量化的商业价值。 案例三：IM83丨基于类器官芯片数据获批IND的CAR-T 技术路径与数据：大橡科技提供了IM83在肝癌类器官芯片的疗效数据和安全性数据。将IM83和"非铠装"CAR-T与骨肉瘤类器官共培养，IM83诱导了较高的肿瘤细胞死亡率（62.27%）。机制研究证实，与"非铠装"CAR-T细胞相比，IM83与GPC3-CD40+肿瘤细胞共培养时诱导更高水平的肿瘤细胞凋亡。 💡 案例启示：该研究开辟了国内肿瘤类器官数据应用的先例。CAR-T作为新兴细胞疗法，其药效评价对模型要求极高——类器官芯片提供了更接近人体肿瘤微环境的评价体系，为细胞疗法的临床前评价提供了新路径。 案例四：MCLA-158丨完全采用类器官模型进行药物筛选的双特异性抗体 技术路径：MCLA-158在药物筛选和安全性评估中完全使用了类器官。在药物发现阶段，HUB使用CRC PDOs（结直肠癌患者来源类器官）建立了类器官库并进行外显子测序，利用高内涵成像技术，对500多个抗体分子进行筛选。最初使用P14和P18初筛，得到28个候选抗体，随后使用22个肿瘤类器官和1个正常黏膜类器官验证活性，最终获得MCLA-158。 关键数据： 在P18中，对比MCLA-158与西妥昔单抗的活性，MCLA-158表现出更好的生长抑制活性 在多数肿瘤类器官中，MCLA-158都表现出更优的抑制活性，在KRAS突变的类器官中更为明显 安全性评估中，MCLA-158在正常细胞和肿瘤细胞之间的杀伤效果差异明显，而西妥昔单抗没有显著性差异——说明类器官可用于安全性评估 临床进展：MCLA-158已进入临床Ⅲ期。其Ⅱ期临床结果积极，治疗82名二线或三线晚期HNSCC患者，ORR为36%，mPFS为4.9个月，mOS为11.4个月。 💡 案例启示：这是类器官在药物发现阶段（而非仅临床前评价）发挥核心作用的典型案例。从500+抗体筛选到最终候选分子选定，全程基于类器官——类器官不仅是"评价工具"，更是"发现引擎"。 案例五：QLF3108丨基于类器官芯片数据获批IND的双特异性抗体 技术路径：大橡科技利用IBAC O2芯片，构建肿瘤类器官免疫共培养模型，高度还原人体肿瘤免疫微环境，为IND申报提供了关键性数据。 💡 案例启示：虽然该药物在2024年8月主动暂停（暂停原因未公开），但其IND获批本身证明了类器官芯片免疫共培养模型在双抗药效评价中的监管认可度。与案例三（IM83）一样，均由大橡科技提供类器官芯片数据，体现了该公司在肿瘤免疫共培养模型方面的技术积累。 04 案例带给我们的三个关键发现 将5个案例横向对比，可以提炼出三个关键发现。 1.适应症选择：优先用于缺乏动物模型的领域。  SAR445088所针对的CIDP和MMN，HRS-1893所针对的肥厚型心肌病，都面临"动物模型难以评估疗效"的困境。类器官芯片首先在传统模型失灵的领域建立了不可替代的价值——当没有其他选择时，类器官不是"锦上添花"，而是"雪中送炭"。在肿瘤领域，类器官则更多与动物模型配合使用，提供补充数据。值得注意的是，类器官还可以建立罕见肿瘤、耐药性肿瘤或缺少现有模型的肿瘤类器官，通过杀伤活性筛选药物——这些同样是传统模型难以覆盖的领域。 2.药物类型：不限于特定类型。  5个案例覆盖了小分子（HRS-1893，6轮芯片筛选选定分子）、抗体（SAR445088、MCLA-158、QLF3108，涵盖单抗和双抗）以及CAR-T细胞疗法（IM83，类器官也是细胞疗法应用较多的领域）。类器官的适用性远比想象中宽泛，无论是小分子的毒性筛选、抗体的活性验证，还是细胞疗法的杀伤效果评价，都能提供有价值的数据。 3.临床进展：多数结果积极。  5个案例中，4个已进入或即将进入更高阶段临床实验（SAR445088 Phase 3、HRS-1893 Phase 3、MCLA-158 Phase 3、IM83 Phase 1），仅QLF3108主动暂停。这一积极信号验证了基于类器官筛选的药物在人体中的有效性——类器官不是"纸面技术"，其筛选结果具有真实的临床转化价值。 05 当前的类器官技术仍面临四大技术瓶颈——离规模化应用还有多远？ 5个IND案例展示了类器官的实战能力，但规模化应用仍面临四个核心瓶颈。这些问题短期内难以根本解决，是制约类器官从"候选方法"走向"主流方法"的关键障碍。瓶颈一：培养可重复性低 DOI：10.1038/s41563-020-00853-9 类器官发育的基础——干细胞自组织过程难以控制，发育过程具有随机性。不同个体的细胞差异、肿瘤细胞自身的异质性，导致大多数现有类器官培养物普遍缺乏可重复性：同一批次培养的类器官会出现质量不统一、大小不一致等现象。 问题还不止于此。类器官培养缺乏可靠的方案和行业标准，样本采集与处理方式、所使用的细胞外基质、操作人员的手法差异，乃至气泡、微生物感染等因素，都是试验重复性的阻力。目前，在类器官的复杂性（高仿真性）和可重复性之间保持平衡，仍是一大难题。 现有探索已取得一定进展。有研究通过改进类器官生长发育的培养平台，利用微孔水凝胶来标准化类器官的大小和分化率，在肠类器官中取得较好效果。还有研究结合生物打印技术，批量生产高可重复性的肾脏类器官，但暂时还没有实际应用。在产业层面，类器官公司通过建立标准化的培养流程，定期进行形态学观察、DNA测序等方法来保证一致性，但仍无法解决不同患者来源的差异以及不同公司之间的差异。瓶颈二：行业标准化有待实现 作为新兴技术，类器官目前国内外尚无强制性标准，多为团体标准，有一定参考价值但约束力有限。 国内已发布14个类器官相关团体标准，主要针对肿瘤类器官，非肿瘤类器官仅涉及肠道、肝脏、胆囊等消化道类器官。这些团体标准主要由科研机构、医院、政府推动，无法涵盖所有使用中的类器官技术和应用方向。 不过，标准建设正在加速。2024年5月，国内多家三甲医院和研究机构权威专家联合发表了肿瘤类器官药敏性检测共识。2024年10月，由东南大学、艾玮得生物首席科学家顾忠泽教授团队牵头完成的我国首个器官芯片领域国家标准GB/T 44831-2024《皮肤芯片通用技术要求》正式发布。欧盟于2024年10月正式颁布了《关于类器官和类器官操作技术的相关指南》。FDA也在与多个企业建立类器官标准，但尚未有相关文件正式发布。 标准缺失直接影响的是类器官数据的监管认可度和跨机构可比性。标准的建立，是类器官走向规模化应用的制度前提。瓶颈三：仿真度有待提升 仿真度是类器官和器官芯片存在的主要意义——建立更符合人体生理的体外模型。然而，目前类器官在反映人类特定细胞特征方面，还存在两大关键局限。 一是血管化。目前大多数类器官本身并不具备有功能的血管，这会导致类器官发育不成熟和过早分化。随着类器官体积的增长，受限于氧气缺失以及代谢废物增加，可能导致组织坏死。已有研究将类器官和血管内皮细胞共培养，利用生物打印和微纤维支架，成功在多种器官特异性类器官上实现了血管化；还有研究将脑类器官移植到小鼠脑皮层，观察到血管化和存活率的提高。目前最常用的血管化方法是将人脐静脉内皮细胞与类器官共培养，可生成微血管，但由于缺乏构成微血管壁的其它细胞，微血管并不稳定。 二是免疫化。体外类器官培养体系中的细胞类型相对不足，尤其是缺乏免疫细胞，难以模拟肿瘤和免疫环境的相互作用关系。目前免疫化的方法可分为三种：间接共培养（肿瘤类器官和基质混合培养后加入免疫细胞，通过细胞因子释放影响肿瘤类器官）、悬浮共培养（肿瘤类器官培养后分离出来与免疫细胞共培养，需消化为单细胞，免疫细胞可直接接触并渗透）、以及直接共培养（将免疫细胞与类器官共同包埋于基质胶等三维支架中，可维持类器官结构完整性）。市场上主流的类器官公司都可以做间接共培养模型，但仍存在外部添加的免疫细胞种类有限、状态与原始TME不一致、长期培养稳定性低（如T细胞可能耗竭）和肿瘤组织空间异质性导致样本缺乏TME成分、可重复性低等问题。瓶颈四：长期培养稳定性有待提升 实现稳定的长期培养，对于维持类器官的功能、表型和表观遗传完整性至关重要，以确保它们准确复制患者特异性的肿瘤特征。然而，营养耗尽、缺氧和废物积累等问题会持续损害细胞活力，尤其是在较大的类器官中更为突出。 现有方案主要从培养基质和减少人工两个方向入手。使用合成水凝胶和先进的生物材料，可以减少批间差异性并精确控制基质刚度、孔隙率和生化信号。与微流控技术相结合的动态培养系统，通过实时调节氧气和养分输送，减少缺氧和废物积累，进一步提高稳定性。但更换基质会增加成本和操作复杂性。 06 AI——可能的破局变量 面对上述瓶颈，人工智能（AI）被视为可能同时解决多个问题的"破局变量"。 希格生科的"类器官+AI"模式提供了一个可参考的范式：首先通过基因编辑技术构建肿瘤类器官模型，随后利用AI虚拟设计并筛选出潜在药物分子，最后在类器官模型上进行验证。通过这种方法，最多可以缩短40%的研发周期。希格生科目前布局四条first-in-class药物管线和1个类器官平台，其中核心管线SIGX1094R作为全球首款弥漫性胃癌靶向药，先后在中美开展Phase 1临床，并获得美国FDA孤儿药资格认定（ODD）及快速通道认定（FTD）。 AI的潜力不止于药物筛选。在类器官培养层面，AI驱动的监测系统可以预测营养需求并检测细胞应激的早期迹象，实时调整培养条件。与自动化平台相结合，不仅可以增强稳定性，还可以降低成本，使类器官长期培养可以大规模应用。 💡 AI与类器官的融合，有望同时改善可重复性（标准化培养条件）、长期培养稳定性（实时监测和调节）和筛选效率（虚拟筛选+验证）三个瓶颈。这可能是类器官技术走向规模化的关键加速器。 结语 5个IND案例、3种药物类型、中外药企同步推进——类器官已不再是停留在论文里的概念，而是真金白银地支撑着药物开发决策。从赛诺菲SAR445088的"无动物模型可用"到恒瑞HRS-1893的"10亿美元出海授权"，类器官的实战价值已被验证。 但四大技术瓶颈——可重复性低、标准化缺失、仿真度不足、长期培养稳定性——短期内难以根本解决。这些瓶颈不会阻止类器官的应用推进，但会决定其渗透的速度和深度。 技术瓶颈正在被逐一攻坚，而更大的变量来自政策——中美欧的监管态度分化，正在重塑全球制药的竞争格局。 对于制药企业而言，关键问题已经从"类器官能不能用"变成了"什么时候用、跟谁合作、怎么用得最好"。 下一篇，我们将从政策分水岭切入，全景解析中美欧监管态势分化、未来应用趋势研判，以及6家类器官服务商的选型指南。 免责声明：本文内容仅供信息分享与学术交流，不构成任何投资建议或医疗建议。文中涉及的技术判断和政策解读基于公开资料，具体应用请以最新监管要求为准。 如果您对类器官技术或相关赛道有任何观点或疑问，欢迎在评论区交流分享。 推荐阅读为什么90%的新药走不到终点？类器官正在重塑临床前研发丨非常谈 · 类器官专题01