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本文将概述肽类治疗药物、递送平台和疫苗的当前市场和临床试验进展。通过文献分析，探讨肽类药物开发的关键研究领域，并着重介绍肽类药物的结构修饰原则，以及筛选、设计和递送技术的最新进展。新型肽类治疗药物，包括肽 - 药物复合物、新型肽类疫苗和创新的肽类诊断试剂的加速发展，有望推动疾病治疗方案迈向精准定制的新时代。 一、肽类药物的发展历程与市场现状 自 1922 年胰岛素用于治疗糖尿病，肽类药物正式登上医学舞台。发展至今，全球已有近 100 种肽类药物获批，广泛应用于糖尿病、肥胖症、心血管疾病等诸多领域。从市场数据来看（图 8a展示了部分 GLP-1 激动剂的销售情况），肽类药物市场呈现出持续增长的趋势。以司美格鲁肽为例，其不同剂型在 2024 年的销售额相当可观，这充分反映出市场对肽类治疗药物的强劲需求。通过对 2005 - 2024 年文献的分析（图 3），可以发现该领域的研究热度不断攀升，美国和中国在肽类药物研究方面成果突出。其中，癌症研究逐渐成为肽类药物开发的关键领域（图 3b），这也为攻克癌症难题带来了新的希望。 二、肽类药物的特性与优势 肽类药物具有诸多独特优势。它的特异性极高，能够精准地作用于目标，极大地减少了对正常细胞的不良影响；免疫原性低，引发人体免疫反应的概率较低；生产成本相对较低，在大规模生产上具有一定的经济优势。然而，肽类药物也存在一些局限性，比如在体内稳定性差，容易被快速降解，导致生物利用度较低，这使得许多肽类药物目前只能通过皮下注射给药，给患者带来了不便。三、肽类药物的递送平台创新 为了解决肽类药物的局限性，科研人员在递送平台方面进行了大量创新研究。1.肽 - 药物偶联物（PDCs） PDCs 是一种极具潜力的递送平台，它由细胞靶向肽、连接子和细胞毒性有效载荷组成。形象地说，细胞靶向肽就像是 “导航仪”，能引导药物精准地找到肿瘤细胞；连接子起着连接和控制药物释放的作用；细胞毒性有效载荷则是 “战斗武器”，负责对肿瘤细胞进行攻击。目前，已有一些 PDCs 进入临床试验阶段（表 5展示了处于临床试验阶段的多种 PDCs），例如 Lutathera 用于治疗神经内分泌肿瘤，Pepaxto 用于治疗多发性骨髓瘤，不过 Pepaxto 因疗效问题退出了美国市场。此外，像 SNG1005 和 AEZS - 108 等在研的 PDCs，分别在治疗脑转移癌和前列腺癌方面展现出了良好的前景。 2.CPPs - 工程化纳米载体 CPPs（细胞穿透肽）可以帮助药物顺利穿过细胞膜，进入细胞内部发挥作用。虽然目前相关产品尚未获批上市，但科研人员通过将其与靶向肽结合等方式，不断提高药物递送的精准性。在针对心脏疾病和跨越血脑屏障的药物递送研究方面，已经取得了一些令人欣喜的进展。四、肽类药物在各治疗领域的应用进展1.糖尿病治疗 在糖尿病治疗领域，肽类药物不断推陈出新。从最初的胰岛素，到如今的 GLP - 1 受体激动剂，治疗效果得到了显著提升。例如司美格鲁肽，经过结构修饰后，不仅实现了口服给药，而且只需每周服用一次，大大提高了患者的用药依从性。还有替尔泊肽，作为双靶点激动剂，在控制血糖和体重方面表现优异（图 8b对部分 GLP - 1 激动剂的相关信息进行了展示 ）。2.癌症治疗 肽类药物在癌症治疗中发挥着重要作用。抗癌肽（ACPs）可以直接杀死肿瘤细胞，还能作为疫苗激活人体的抗肿瘤免疫反应。像天然抗癌肽 Apicidin，能够抑制肿瘤血管生成；合成或修饰的抗癌肽，如 Octreotide、Bortezomib 和 Motixafortide 等，已获批用于癌症治疗，并在临床实践中取得了一定的成效。此外，肽类在肿瘤诊断方面也有重要应用，例如\([^{68}Ga]Ga - DOTA - TOC\)和 Illuccix® 等放射性药物，能够帮助医生更精准地定位和诊断肿瘤。3.心血管疾病治疗 在心血管疾病治疗方面，肽类药物作用于多个靶点。例如作用于 G 蛋白偶联受体的 GLP - 1 受体激动剂，不仅能有效控制血糖，还对心血管疾病具有一定的预防作用；作用于利钠肽受体的 Nesiritide 和 Carperitide 等药物，可用于治疗心力衰竭；作用于血管紧张素转化酶（ACE）的抑制肽，则有助于降低血压。4.抗感染治疗 由于抗生素耐药问题日益严峻，抗菌肽（AMPs）成为了研究热点。AMPs 具有抗菌活性高、抗菌谱广、不易产生耐药性等优点。像 Daptomycin、Dalbavancin 和 Rezafungin 等，都是已获批用于治疗细菌感染的抗菌肽药物，还有一些处于研究阶段的药物，也展现出了巨大的潜力。5.抗新冠病毒治疗 针对新冠病毒，肽类药物的研发也在积极推进。例如 Paxlovid®，它由 3CL 蛋白酶抑制剂和低剂量 Ritonavir 组成，能够有效降低患者的住院和死亡风险。此外，还有一些针对新冠病毒 S 蛋白和 3CL 蛋白酶的肽类抑制剂正在研究中，有望成为抗击新冠病毒的新利器。6.其他领域治疗 肽类药物在消化系统疾病、阿尔茨海默病、罕见病、骨科代谢疾病和偏头痛等领域也有应用和研究进展。比如在消化系统疾病中，部分肽类药物可用于控制胃肠道出血和治疗肠道疾病；在阿尔茨海默病治疗中，科研人员尝试利用肽类干预 β - 淀粉样蛋白的聚集；在罕见病治疗方面，Trofinetide 用于治疗 Rett 综合征，Zilucoplan 用于治疗重症肌无力，Teduglutide 用于治疗短肠综合征，为患者带来了新的希望；在骨科代谢疾病中，一些肽类药物有助于促进骨形成，治疗骨质疏松；在偏头痛治疗中，针对降钙素基因相关肽（CGRP）的药物，如 Ubrogepant 和 Rimegepant 等，能够有效缓解症状。五、肽类疫苗的研究进展 在疫苗领域，肽类疫苗具有独特的优势。与传统疫苗相比，它安全性更高，质量更易于控制，还能根据实际需求进行定制。虽然目前尚无肽类疫苗获批上市，但在肿瘤免疫治疗方面的研究进展迅速，许多针对肿瘤特异性抗原的肽类疫苗正在进行临床试验（表 7展示了相关临床试验信息） 。 六、推动肽类药物发展的关键技术1.展示文库技术 展示文库技术是发现新肽类药物的重要手段，包括噬菌体展示技术、细菌展示技术、酵母展示技术、哺乳动物细胞展示技术和无细胞展示技术等。这些技术各自具有优缺点，相互补充，能够快速筛选出与特定靶点结合的肽，为肽类药物的研发提供了有力支持。2.深度学习 深度学习在肽类药物研发中也发挥着重要作用。通过对大量数据的分析，它能够辅助设计和优化肽类药物，显著提高研发效率，加速新型肽类药物的发现。七、口服肽类药物的挑战与突破 口服肽类药物一直是研究的难点，因为肽类药物在胃肠道中容易被降解，且吸收效果不佳。不过，科研人员通过结构修饰，如采用 D - 氨基酸取代、脂质化、PEG 化和环化等方法，以及改进制药配方，如使用渗透增强剂、开发新型载体等，在口服肽类药物的研究上取得了一定的突破（表 8列举了部分已获批的口服肽类药物及其递送策略）。 八、肽类药物面临的挑战与未来展望 尽管肽类药物发展前景广阔，但目前仍面临一些挑战，如药物的稳定性、生物利用度、免疫原性等问题有待进一步解决，生产成本也需要降低。不过，随着技术的不断进步，多学科的深度交叉融合，我坚信肽类药物在未来将会取得更大的发展，为更多患者带来更安全、更有效的治疗方案。 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

The increasing global prevalence of cancer is fueling the demand for peptide-drug conjugates as targeted therapies, providing improved effectiveness and lower systemic toxicity than conventional treatments. Additionally, the expanding use of peptide-based therapeutics, driven by their enhanced treatment outcomes, biocompatibility, and precise tumor-targeting capabilities, is further propelling market growth. LAS VEGAS , Feb. 4, 2025 /PRNewswire/ -- DelveInsight's Peptide-drug Conjugate Market Insights report provides the current and forecast market analysis, individual leading peptide-drug conjugate companies' market shares, challenges, peptide-drug conjugate market drivers, barriers, trends, and key market peptide-drug conjugate companies in the market. Key Takeaways from the Peptide-drug Conjugate Market Report As per DelveInsight estimates, North America is anticipated to dominate the global peptide-drug conjugate market during the forecast period. The LUTATHERA (lutetium Lu 177 dotatate) category in the peptide drug conjugates market dominated with a market share of 37% in 2024. Notable peptide-drug conjugate companies such as Novartis AG, Oncopeptides AB, Cybrexa Therapeutics, Avacta Therapeutics, ProteinQure, Theratechnologies Inc., CBP, Soricimed Biopharma, NMS Group S.p.A., Mainline Scientific LLC., Bicycle Therapeutics, and several others, are currently operating in the peptide-drug conjugate market. In April 2024, PeptiDream Inc. announced the expansion of its peptide discovery collaboration with Novartis Pharma AG. Using its proprietary Peptide Discovery Platform System (PDPS®), PeptiDream identified and optimized macrocyclic peptides for conjugation with radionuclides for therapeutic and diagnostic applications. In March 2023, Ono Pharmaceutical Co., Ltd. announced that it entered into a drug discovery collaboration agreement with PeptiDream Inc., to discover and develop novel macrocyclic constrained peptide drugs against multiple targets of Ono's interest. To read more about the latest highlights related to the PDC market, get a snapshot of the key highlights entailed in the Global Peptide-drug Conjugate Market Report Peptide-drug Conjugate Overview Peptide-drug conjugates (PDCs) are an emerging class of targeted therapeutics that combine the specificity of peptides with the potent efficacy of cytotoxic drugs. These conjugates leverage peptides as targeting ligands to deliver drugs selectively to diseased cells, such as cancerous or infected tissues, thereby minimizing off-target toxicity. The design of PDCs involves three key components: a targeting peptide, a linker, and a payload (therapeutic drug). The peptide is typically selected based on its ability to recognize and bind to overexpressed receptors on diseased cells, ensuring precise drug delivery. The linker plays a crucial role in controlling drug release, which can be triggered by specific conditions like enzymatic cleavage or pH changes in the tumor microenvironment. Compared to antibody-drug conjugates (ADCs), PDCs offer advantages such as smaller size, better tissue penetration, and lower immunogenicity. They are particularly promising for targeting intracellular pathways, where antibodies may struggle to enter. Advances in peptide engineering, including modifications to enhance stability and binding affinity, have further improved the efficacy of PDCs in preclinical and clinical settings. PDCs are being explored in various therapeutic areas, including oncology, infectious diseases, and metabolic disorders. As research progresses, optimizing peptide selection, linker chemistry, and payload potency will be critical in developing next-generation PDCs with superior safety and efficacy profiles. Peptide-drug Conjugate Market Insights North America dominated the global peptide drug conjugates market in 2024, accounting for the largest share of 56.70%. The market is expected to grow at a CAGR of 28.47% from 2025 to 2032, primarily driven by the increasing incidence of cancer in the U.S. Additionally, the region's market growth is fueled by rising collaborations among key industry players for PDC development and increasing investments in this sector. Furthermore, major companies in North America are emphasizing research and development to create innovative peptide-drug conjugates. For instance, in February 2021, Theratechnologies Inc. announced that the U.S. FDA granted fast-track designation to TH1902, a docetaxel-based peptide-drug conjugate, for treating patients with sortilin-positive recurrent advanced solid tumors that are resistant to standard therapies. In addition, in April 2024, Novartis, which already has two FDA-approved PDC drugs, expanded its collaboration with PeptiDream to further develop peptide-drug conjugates in a deal exceeding USD 2.8 billion. These factors collectively contribute to the anticipated growth of the peptide drug conjugates market in the region. To know more about why North America is leading the market growth in the PDC market, get a snapshot of the Peptide-drug Conjugate Market Outlook Peptide-drug Conjugate Market Dynamics The peptide-drug conjugate market is witnessing significant growth, driven by advancements in targeted therapies and the increasing prevalence of cancer and other chronic diseases. PDCs combine the specificity of peptides with the potency of cytotoxic drugs, offering an improved therapeutic index compared to traditional chemotherapy. With growing interest in precision medicine, pharmaceutical companies are heavily investing in PDC research and development, leading to an expanding pipeline of clinical candidates. One of the key market drivers is the rising demand for novel drug delivery systems that enhance efficacy while minimizing off-target effects. Peptides, due to their high specificity and low immunogenicity, serve as excellent carriers for cytotoxic payloads. Additionally, advancements in peptide synthesis and linker technologies have improved the stability and half-life of PDCs, making them more viable for clinical applications. Companies such as Bicycle Therapeutics and PeptiDream are leading the innovation in this space. Despite the promising outlook, the PDC market faces challenges such as manufacturing complexities, high development costs, and regulatory hurdles. Peptide synthesis and conjugation processes require stringent quality control, and scalability remains a concern. Furthermore, competition from other targeted therapies, such as ADCs and small-molecule inhibitors, poses a challenge for widespread adoption. Looking ahead, growth opportunities exist in expanding indications beyond oncology, such as antimicrobial, autoimmune, and neurodegenerative diseases. Strategic collaborations between biotech firms and large pharmaceutical companies are accelerating clinical development, while advancements in artificial intelligence and computational modeling are further refining peptide design and optimization. With ongoing innovations and increasing investments, the PDC market is poised for substantial expansion in the coming years. Get a sneak peek at the PDC market dynamics @ Peptide-drug Conjugate Market Dynamics Analysis Peptide-drug Conjugate Market Assessment Peptide-drug Conjugate Market Segmentation Peptide-drug Conjugate Market Segmentation By Product: LUTATHERA (lutetium Lu 177 dotatate), PEPAXTI (Melphalan flufenamide), and PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) Peptide-drug Conjugate Market Segmentation By Cancer Type: Prostate Cancer, Gastrointestinal Cancer, Multiple Myeloma Peptide-drug Conjugate Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the PDC market are set to emerge as the trendsetter explore @ Peptide-drug Conjugate Companies Table of Contents Interested in knowing the PDC market by 2032? Click to get a snapshot of the Peptide-drug Conjugate Market Trends Related Reports Antibody-drug Conjugates in Oncology Competitive Landscape Antibody-drug Conjugates in Oncology Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ADC in oncology companies, including Jiangsu Hengrui Medicine Co., Bio-Thera Solutions, MediLink Therapeutics, Byondis, AbbVie, Oxford BioTherapeutics, Iksuda Therapeutics, Novelty Nobility, LegoChem Biosciences, DualityBio, Lepu Biopharma, Ambrx, CSPC ZhongQi Pharmaceutical Technology, MacroGenics, ADC Therapeutics, Genor Biopharma, CStone Pharmaceuticals, AstraZeneca, Alteogen, Biocity Biopharmaceutics, among others. Antibody-drug Conjugates Competitive Landscape Antibody-drug Conjugates Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ADC companies, including Sorrento Therapeutics, Ambrx, MacroGenics, SOTIO Biotech, Klus Pharma, BioAtla, BiOneCure Therapeutics, Shanghai Miracogen, ProfoundBio, ImmunoGen, Arcus Biosciences, CytomX Therapeutics, RemeGen, Bliss Biopharmaceutical, Aivita Biomedical, CoImmune, Zenith Epigenetics, Sutro Biopharma, Ambrx, Mythic Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Byondis, MediLink Therapeutics (Suzhou), Oncomatryx Biopharma, MacroGenics, Shanghai Miracogen, Mirati Therapeutics, Ambrx, Orum Therapeutics, Silverback Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Aivita Biomedical, Northwest Biotherapeutics, Daiichi Sankyo, Merck, Pfizer, GSK, AstraZeneca, Eisai, FOSUN PHARMA, LaNova, Mabwell Therapeutics, MBRACE THERAPEUTICS, MINGHUSI PHARMACEUTICALS, BioNTech , Bio-Thera, Corbus Pharmaceuticals, AbbVie, Multitude Therapeutics, Innovent, OnCusp Therapeutics, Simcere, Ymmunobio, Jiangsu Hengrui Medicine, among others. Antibody-drug Conjugates Market Antibody Drug Conjugates Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ADC companies, including Sorrento Therapeutics, Ambrx, MacroGenics, SOTIO Biotech, Klus Pharma, BioAtla, BiOneCure Therapeutics, Shanghai Miracogen, ProfoundBio, ImmunoGen, Arcus Biosciences, CytomX Therapeutics, RemeGen, Bliss Biopharmaceutical, Aivita Biomedical, CoImmune, Zenith Epigenetics, Sutro Biopharma, Ambrx, Mythic Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Byondis, MediLink Therapeutics (Suzhou), Oncomatryx Biopharma, MacroGenics, Shanghai Miracogen, Mirati Therapeutics, Ambrx, Orum Therapeutics, Silverback Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Aivita Biomedical, Northwest Biotherapeutics, Daiichi Sankyo, Merck, Pfizer, GSK, AstraZeneca, Eisai, FOSUN PHARMA, LaNova, Mabwell Therapeutics, MBRACE THERAPEUTICS, MINGHUSI PHARMACEUTICALS, BioNTech , Bio-Thera, Corbus Pharmaceuticals, AbbVie, Multitude Therapeutics, Innovent, OnCusp Therapeutics, Simcere, Ymmunobio, Jiangsu Hengrui Medicine, among others. Bispecific Antibody Competitive Landscape Bispecific Antibody Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key bispecific antibodies companies, including Janssen, Amgen, Akeso, Zymeworks, Roche, IGM Biosciences, MacroGenics, Provention Bio, Jiangsu Alphamab Biopharmaceuticals, Sichuan Baili Pharmaceutical, Regeneron Pharmaceuticals, Boehringer Ingelheim, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED