编者按：近年来，多肽疗法正迅速崛起为全球新药研发的重要方向。从GLP-1类代谢疾病疗法持续取得突破，到肿瘤、神经系统疾病及免疫疾病等领域不断涌现的新型多肽分子，多肽药物的研发版图正在不断拓展。在这一背景下，药明康德旗下WuXi TIDES平台围绕多肽、寡核苷酸及其相关化学偶联药物构建了一体化解决方案，覆盖定制合成、共价连接、工艺开发以及CMC等关键环节，助力创新项目更高效地推进至临床阶段。与此同时，药明康德生物分析部（BAS）依托成熟的技术平台，建立了覆盖药代动力学（PK）分析、抗药抗体（ADA）及中和抗体（NAb）评价的一体化生物分析解决方案，为复杂修饰多肽及偶联多肽药物的临床研究提供有力支持。而药明康德DMPK团队能够从机制层面解析多肽药物的ADME行为，并结合蛋白结合、渗透性及代谢产物鉴定研究，支持结构优化与递送策略设计。本文将盘点2026年第二季度全球多肽疗法在监管审批、临床研究以及产业合作等方面的重要进展，带您了解这一快速发展领域的最新动态与趋势。
监管进展
2026年第二季度，多肽疗法在多个疾病领域迎来重要监管进展。其中，吉利德科学（Gilead Sciences）旗下Hepcludex（bulevirtide）注射液获得美国FDA加速批准，用于治疗无肝硬化或代偿性肝硬化成人患者的慢性丁型肝炎病毒（HDV）感染。根据FDA新闻稿，Hepcludex是首款获得FDA批准用于治疗慢性HDV感染的疗法，也为这一长期缺乏获批疗法的病毒性肝炎领域带来新的治疗选择。该批准主要基于3期MYR301研究，结果显示，接受Hepcludex治疗的患者在第48周实现联合病毒学与生化应答的比例为48%，而延迟治疗组为2%。
在肥胖相关适应症方面，Rhythm Pharmaceuticals旗下Imcivree（setmelanotide）获得欧盟委员会批准，用于治疗因下丘脑损伤或功能障碍导致的获得性下丘脑性肥胖（HO）成人和4岁及以上儿童患者。此次欧盟批准主要基于3期TRANSCEND研究，Imcivree组患者在52周时身体质量指数（BMI）较基线平均下降16.5%，安慰剂组则上升3.3%，安慰剂校正后BMI降幅为19.8%。
胰高血糖素样肽-1（GLP-1）类疗法也继续推进给药方式创新。诺和诺德（Novo Nordisk）宣布，Wegovy片剂（每日一次口服司美格鲁肽25 mg）获得欧洲药品管理局（EMA）人用药品委员会（CHMP）推荐批准，用于减轻过多体重并维持长期减重效果。根据新闻稿，这是首个获得CHMP推荐用于体重管理的口服GLP-1疗法。在OASIS 4试验中，对于患有肥胖或伴有一种或多种合并症的超重成人受试者，在坚持治疗的情况下，每日一次口服司美格鲁肽25 mg显示出16.6%的平均体重减轻幅度。Wegovy片剂实现的减重效果与注射剂型Wegovy（2.4 mg）相似。
此外，艾伯维（AbbVie）与Ironwood Pharmaceuticals联合开发的Linzess（linaclotide）也在本季度获美国FDA批准扩展适应症，用于2岁及以上功能性便秘（FC）儿童患者。Linzess是一款鸟苷酸环化酶-C（GC-C）激动剂，此次批准基于一项在2至5岁FC儿童患者中开展的12周3期研究，结果显示每日一次linaclotide（72 μg）相较安慰剂可改善自发排便频率。
临床进展
在临床研究方面，肥胖与代谢疾病依然是第二季度多肽疗法活跃的方向。辉瑞（Pfizer）旗下超长效GLP-1受体激动剂berobenatide（曾用名MET-097i）在2b期VESPER-3研究中展现积极结果。部分患者从每周给药切换至每月给药后，至第28周仍实现最高12.3%的安慰剂校正后体重下降。
围绕GLP-1与其他肽类激素的联合机制，多家公司也取得临床进展。礼来（Eli Lilly and Company）公布其潜在“first-in-class”三重激素受体激动剂retatrutide的3期TRIUMPH-1研究结果。Retatrutide可同时靶向GIP、GLP-1和胰高血糖素受体。研究显示，在肥胖或伴有至少一种体重相关合并症的超重成人患者中，retatrutide 9 mg和12 mg组治疗80周后平均体重分别降低25.9%和28.3%，安慰剂组为2.2%；在104周延长期分析中，12 mg递增至最大耐受剂量组体重下降达到30.3%。
勃林格殷格翰（Boehringer Ingelheim）与Zealand Pharma合作开发的新型胰高血糖素/GLP-1双受体激动剂survodutide也公布了多项3期数据。SYNCHRONIZE-1研究显示，在不合并2型糖尿病的超重或肥胖成人患者中，survodutide治疗76周后平均体重最多下降16.6%。在该研究的亚组分析中，survodutide使内脏脂肪降低最高达34.0%，肝脏脂肪减少最高达63.1%，且瘦体重流失占比不超过10.8%。在代谢相关脂肪性肝病（MASLD）方面，SYNCHRONIZE-MASLD研究也达到共同主要终点。与基线相比，在接受survodutide治疗48周后，约60%同时患有MASLD且超重或肥胖的受试者实现了肝脏脂肪正常化。
罗氏（Roche）与Carmot Therapeutics开发的acmopatide（CT-868）是一款每日一次GLP-1/GIP双受体激动剂，在1型糖尿病合并超重或肥胖成人患者2期研究中，4.1 mg剂量组治疗16周后糖化血色蛋白（HbA1c）下降0.34个百分点，56%的患者HbA1c低于7%，体重下降呈剂量依赖性，最高约7%，胰岛素使用量最多减少15%。
与此同时，胰淀素靶向疗法也持续推进。诺和诺德旗下CagriSema（长效胰淀素类似物cagrilintide和司美格鲁肽组成的固定剂量联合疗法）在REIMAGINE系列3期研究中显示，该固定剂量联合疗法在2型糖尿病患者中可改善血糖控制并支持体重下降；其中REIMAGINE 3研究中，在接受基础胰岛素治疗且血糖控制不佳的2型糖尿病成人患者中，CagriSema使患者的HbA1c由8.8%降至6.5%，体重降低最高达12%，且未出现严重低血糖事件。而该公司开发的zenagamtide则是一款每周一次皮下注射的GLP-1与胰淀素受体肽类激动剂，在2型糖尿病成人患者2期研究中，40 mg剂量组在36周时HbA1c较基线下降1.71个百分点，体重下降最高达14.6%。
Zealand Pharma公布ZUPREME-1研究新数据，其与罗氏联合开发的每周一次胰淀素类似物petrelintide在42周时使超重或肥胖成人患者体重平均较基线最多降低10.7%，安慰剂组为1.7%，且总体胃肠道不良事件发生率与安慰剂接近。
除代谢疾病外，多肽疗法在肿瘤、神经损伤及内分泌疾病领域也不断拓展。在肿瘤领域，Sapience Therapeutics两款稳定化多肽疗法均公布临床数据。其C/EBPβ多肽拮抗剂lucicebtide联合标准治疗用于新确诊胶质母细胞瘤患者的2期研究显示，截至2026年4月，9名可评估患者的预计中位无进展生存期为28.4个月，而历史数据为4.0至6.9个月；ST316作为潜在“first-in-class”的β-catenin拮抗剂，在二线转移性结直肠癌患者2期扩展研究中与FOLFIRI加贝伐珠单抗联合使用，15名患者中确认客观缓解率为47%，疾病控制率为93%。此外，Oxford Vacmedix宣布其基于重组重叠肽（ROP）平台开发的癌症疫苗疗法OVM-200完成1期研究，并达到安全性主要终点及免疫应答、剂量选择等次要终点。试验还报告了早期的临床活性迹象，包括在非小细胞肺癌（NSCLC）患者中观察到的疾病稳定，以及在前列腺癌患者中观察到的前列腺特异性抗原（PSA）应答。
NervGen Pharma也宣布，已就其神经修复肽NVG-291的RESTORE临床3期注册研究设计与美国FDA达成一致，计划在慢性四肢瘫患者中开展一项纳入约150名受试者的随机、双盲、安慰剂对照研究。
在内分泌疾病方面，MBX Biosciences公布每周一次甲状旁腺激素（PTH）替代疗法canvuparatide治疗慢性甲状旁腺功能减退症患者的2期研究及开放标签延长期一年数据。结果显示，治疗一年时57%的可评估患者达到应答标准，血钙维持在正常范围，24小时尿钙下降并保持在正常范围内，肾功能指标估算肾小球滤过率（eGFR）较基线改善并维持至一年；公司表示3期关键性研究计划于2026年第三季度启动。
研发合作与融资进展
第二季度，多肽疗法相关公司在资本市场和战略合作方面同样活跃。Parabilis Medicines与再生元（Regeneron Pharmaceuticals）达成战略研发合作，双方将基于Parabilis的Helicon多肽平台开发多种候选疗法，重点探索抗体-Helicon偶联物（AHC）。根据协议，Parabilis将获得1.25亿美元，包括5000万美元首付款和7500万美元股权投资承诺，并有资格获得最高约22亿美元潜在里程碑付款等款项。同一季度，Parabilis完成扩大规模的首次公开募股（IPO），募集资金总额为6.70亿美元。与此同时，Kailera Therapeutics也在本季度完成IPO，募集资金总额约为6.25亿美元。这两家公司在本季度完成大额IPO，显示产业界对于多肽疗法在各治疗领域应用的持续信心。
融资方面，ReAlta Life Sciences完成超额认购的4000万美元融资，用于推进主打疗法pegtarazimod治疗新生儿缺氧缺血性脑病（HIE）的2期STAR研究及后续监管里程碑。Pegtarazimod是一种由15个氨基酸组成的潜在“first-in-class”多肽疗法，可同时靶向补体激活和中性粒细胞相关炎症通路。MultiValent Biotherapies则完成2742.5万美元A轮融资，所获资金将支持其主打疗法MVB-101的临床开发。MVB-101是一种前列腺特异性膜抗原（PSMA）和叶酸受体α（FRα）双靶向多肽偶联药物，携带单甲基奥瑞他汀E（MMAE）载荷，分子大小约为传统抗体偶联药物（ADC）的1/50。
总体来看，2026年第二季度多肽疗法行业延续了第一季度的高活跃度。一方面，HDV、获得性下丘脑性肥胖、儿童功能性便秘等适应症迎来监管突破；另一方面，肥胖和代谢疾病仍是创新最密集的领域，双重与三重受体激动剂、超长效GLP-1和胰淀素类似物不断拓展疗效上限，并提高给药便利性。与此同时，稳定化多肽、肽类药物偶联物和肽类疫苗正在将多肽疗法的边界推向肿瘤、神经修复和罕见内分泌疾病。随着更多后期临床研究和大型合作落地，多肽疗法正在从代谢疾病核心阵地，逐步走向更广泛的疾病治疗场景。
在多肽药物不断迈向复杂结构与精准调控的新阶段，如何高效、准确地识别其体内代谢产物，已成为影响分子优化与临床转化的重要环节。由于多肽易发生蛋白水解酶介导的逐步降解，并产生大量结构高度相似的代谢片段，传统分析策略往往难以实现全面解析。围绕这一挑战，药明康德DMPK团队构建了面向多肽药物的系统化代谢产物鉴定（MetID）平台，通过高分辨液相色谱-质谱（LC-HRMS）技术与数据分析工具的深度结合，实现多肽代谢产物的精准发现与结构解析。研究显示，多肽代谢产物鉴定不仅能够在非临床阶段识别代谢软点，指导分子结构优化，还可在后期研究中支持安全性评估与临床代谢研究决策，是贯穿药物开发全周期的关键研究内容。
依托自主开发的TidesID及相关数据解析工具，药明康德DMPK能够对复杂质谱数据进行高效解读，通过靶向与非靶向分析相结合的策略，系统识别体外与体内样品中的未知代谢物，并解析其降解路径与转化机制。该平台结合多维数据处理技术，如背景扣除、质量亏损过滤及特征离子提取，实现软件算法与专家经验协同分析，从而显著提升代谢产物发现的完整性与准确性。与此同时，团队可在多种生物基质与研究体系中开展代谢研究，建立从代谢路径解析到结构优化反馈的闭环研究流程，为研发团队提供具有机制深度的数据支持。
通过将先进分析技术、专用算法工具与丰富的多肽DMPK经验相结合，药明康德DMPK团队能够系统揭示多肽在体内的降解规律与关键代谢特征，帮助研发人员更早识别影响稳定性与暴露水平的关键因素，从而加速候选分子的优化与开发推进，为下一代多肽药物研发提供坚实的科学支持。
Semaglutide Recommended for Approval in the EU; New Chronic HDV Therapy Receives FDA Accelerated Approval…
Editor’s Note: In recent years, peptide therapeutics have rapidly emerged as an important area of global drug discovery. From continued breakthroughs in GLP-1-based therapies for metabolic diseases to the emergence of novel peptide molecules in oncology, neurological disorders, immunology, and other therapeutic areas, the development landscape for peptide medicines continues to expand. Against this backdrop, WuXi AppTec’s WuXi TIDES platform has built an integrated solution for peptides, oligonucleotides, and related chemically conjugated molecules, covering key areas such as custom synthesis, covalent conjugation, process development, and CMC, helping innovative programs advance more efficiently toward the clinic. At the same time, WuXi AppTec’s Bioanalytical Services (BAS) team has established an integrated bioanalytical solution supported by a mature technology platform, covering pharmacokinetic (PK) analysis, anti-drug antibody assessment, and neutralizing antibody evaluation, providing strong support for clinical studies of complex modified peptides and peptide conjugates. WuXi AppTec’s DMPK team can also analyze the ADME behavior of peptide drugs at the mechanistic level and support structural optimization and delivery strategy design through protein binding, permeability, and metabolite identification studies. This article reviews key global advances in peptide therapeutics in the second quarter of 2026 across regulatory approvals, clinical research, and industry collaborations to provide an update on the latest dynamics and trends in this rapidly evolving field.
Regulatory Progress
In the second quarter of 2026, peptide therapeutics achieved important regulatory progress across multiple disease areas. Notably, Gilead Sciences’ Hepcludex (bulevirtide) injection received accelerated approval from the U.S. FDA for the treatment of chronic hepatitis D virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. According to the FDA press release, Hepcludex is the first FDA-approved therapy for chronic HDV infection, bringing a new treatment option to a viral hepatitis field that has long lacked approved therapies. The approval was primarily based on the Phase 3 MYR301 study, which showed that 48% of patients receiving Hepcludex achieved a combined virologic and biochemical response at Week 48, compared with 2% in the delayed-treatment group.
In obesity-related indications, Rhythm Pharmaceuticals’ Imcivree (setmelanotide) received European Commission (EC) approval for the treatment of adults and children aged 4 years and older with acquired hypothalamic obesity (HO) caused by hypothalamic injury or dysfunction. The EU approval was primarily based on the Phase 3 TRANSCEND study, in which patients treated with Imcivree achieved a mean body mass index (BMI) reduction of 16.5% from baseline at Week 52, while the placebo group showed a 3.3% increase, representing a placebo-adjusted BMI reduction of 19.8%.
Glucagon-like peptide-1 (GLP-1) therapies also continued to advance innovation in dosing routes. Novo Nordisk announced that the Wegovy pill, once-daily oral semaglutide 25 mg, was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for reducing excess body weight and maintaining long-term weight reduction. According to the company, this is the first oral GLP-1 therapy to receive a CHMP recommendation for weight management. In the OASIS 4 trial, once-daily oral semaglutide 25 mg demonstrated an average body weight reduction of 16.6% among adults with obesity or overweight with one or more comorbidities who adhered to treatment. The weight loss achieved with the Wegovy pill was similar to that observed with the injectable formulation of Wegovy (2.4 mg).
In addition, Linzess (linaclotide), jointly developed by AbbVie and Ironwood Pharmaceuticals, received FDA approval in the second quarter for an expanded indication in pediatric patients aged 2 years and older with functional constipation (FC). Linzess is a guanylate cyclase-C (GC-C) agonist. The approval was based on a 12-week Phase 3 study in pediatric patients aged 2 to 5 years with FC, which showed that once-daily linaclotide 72 μg improved the frequency of spontaneous bowel movements compared with placebo.
Clinical Progress
In clinical research, obesity and metabolic diseases remained active areas for peptide therapeutics in the second quarter. Pfizer’s ultra-long-acting GLP-1 receptor agonist berobenatide, formerly known as MET-097i, showed positive results in the Phase 2b VESPER-3 study. After some patients switched from once-weekly to once-monthly dosing, the therapy still achieved a placebo-adjusted body weight reduction of up to 12.3% at Week 28.
Multiple companies also reported clinical progress around mechanisms combining GLP-1 with other peptide hormones. Eli Lilly and Company announced Phase 3 TRIUMPH-1 results for retatrutide, its potential first-in-class triple hormone receptor agonist. Retatrutide simultaneously targets GIP, GLP-1, and glucagon receptors. The study showed that among adults with obesity or overweight with at least one weight-related comorbidity, patients treated with retatrutide 9 mg and 12 mg achieved average body weight reductions of 25.9% and 28.3%, respectively, after 80 weeks of treatment, compared with 2.2% in the placebo group. In an extension analysis through 104 weeks, the group escalated from 12 mg to the maximum tolerated dose achieved a body weight reduction of 30.3%.
Survodutide, a novel glucagon/GLP-1 dual receptor agonist jointly developed by Boehringer Ingelheim and Zealand Pharma, also reported multiple Phase 3 datasets. The SYNCHRONIZE-1 study showed that among adults with overweight or obesity without type 2 diabetes, treatment with survodutide for 76 weeks led to an average body weight reduction of up to 16.6%. In a subgroup analysis of the study, survodutide reduced visceral fat by up to 34.0% and liver fat by up to 63.1%, while lean mass loss accounted for no more than 10.8%. In metabolic dysfunction-associated steatotic liver disease (MASLD), the SYNCHRONIZE-MASLD study also met its co-primary endpoints. Compared with baseline, approximately 60% of participants with MASLD and overweight or obesity achieved liver fat normalization after 48 weeks of survodutide treatment.
Acmopatide (CT-868), developed by Roche and Carmot Therapeutics, is a once-daily GLP-1/GIP dual receptor agonist. In a Phase 2 study of adults with type 1 diabetes and overweight or obesity, the 4.1 mg dose group achieved a 0.34% reduction in HbA1c after 16 weeks of treatment; 56% of patients achieved HbA1c below 7%, body weight decreased in a dose-dependent manner, by up to approximately 7%, and insulin use was reduced by up to 15%.
At the same time, amylin-targeted therapies continued to advance. Novo Nordisk’s CagriSema, a fixed-dose combination therapy consisting of the long-acting amylin analog cagrilintide and semaglutide, showed in the Phase 3 REIMAGINE program that the combination could improve glycemic control and support body weight reduction in patients with type 2 diabetes. In the REIMAGINE 3 study, among adults with type 2 diabetes inadequately controlled on basal insulin, CagriSema reduced HbA1c from 8.8% to 6.5%, achieved body weight reduction of up to 12%, and was not associated with severe hypoglycemia. Zenagamtide, also developed by Novo Nordisk, is a once-weekly subcutaneous GLP-1 and amylin receptor peptide agonist. In a Phase 2 study in adults with type 2 diabetes, the 40 mg dose group achieved a 1.71% reduction in HbA1c from baseline at Week 36 and body weight reduction of up to 14.6%.
Petrelintide, Zealand Pharma’s once-weekly amylin analog co-developed with Roche, reduced body weight by up to 10.7% at Week 42 in adults with overweight or obesity, compared with 1.7% in the placebo group, while the overall incidence of gastrointestinal adverse events was similar to that observed with placebo.
Beyond metabolic diseases, peptide therapeutics are also expanding into oncology, neural repair, and endocrine disorders. In oncology, Sapience Therapeutics reported clinical data for two stabilized peptide therapies. Its C/EBPβ peptide antagonist lucicebtide, in combination with standard of care for newly diagnosed glioblastoma, showed in a Phase 2 study that, as of April 2026, the estimated median progression-free survival among nine evaluable patients was 28.4 months, compared with historical data of 4.0 to 6.9 months. ST316, a potential first-in-class β-catenin antagonist, was evaluated in combination with FOLFIRI plus bevacizumab in a Phase 2 expansion study in second-line metastatic colorectal cancer. Among 15 patients, the confirmed objective response rate was 47%, and the disease control rate was 93%. In addition, Oxford Vacmedix announced that OVM-200, a cancer vaccine therapy developed based on its recombinant overlapping peptide (ROP) platform, completed a Phase 1 study and met its primary safety endpoint as well as secondary endpoints related to immune response and dose selection. The trial also reported early signs of clinical activity, including stable disease observed in patients with non-small cell lung cancer (NSCLC) and prostate-specific antigen (PSA) responses observed in patients with prostate cancer.
NervGen Pharma also announced that its neural repair peptide NVG-291 had reached alignment with the FDA on the design of RESTORE, a Phase 3 registrational study. The company plans to conduct a randomized, double-blind, placebo-controlled study in approximately 150 patients with chronic tetraplegia.
In endocrine disorders, MBX Biosciences announced one-year data from a Phase 2 study and open-label extension of canvuparatide, its once-weekly parathyroid hormone (PTH) replacement therapy, in patients with chronic hypoparathyroidism. The results showed that 57% of evaluable patients met the response criteria at one year, serum calcium levels were maintained within the normal range, 24-hour urinary calcium decreased and remained within the normal range, and estimated glomerular filtration rate (eGFR), a marker of kidney function, improved from baseline and was maintained through one year. The company stated that a pivotal Phase 3 study is planned to start in the third quarter of 2026.
Partnerships and Financing
In the second quarter, companies developing peptide therapeutics were also active in capital markets and strategic collaborations. Parabilis Medicines entered into a strategic R&D collaboration with Regeneron Pharmaceuticals. The two companies will develop multiple therapeutic candidates based on Parabilis’ Helicon peptide platform, with a focus on exploring Antibody-Helicon Conjugates (AHCs). Under the agreement, Parabilis will receive $125 million, including a $50 million upfront payment and a $75 million equity investment commitment, and will be eligible to receive up to approximately $2.2 billion in potential milestone payments and other consideration. In the same quarter, Parabilis completed an upsized initial public offering (IPO), raising gross proceeds of $670 million. Meanwhile, Kailera Therapeutics also completed its IPO in the second quarter, raising gross proceeds of approximately $625 million. The successful IPOs of these two companies highlight continued industry confidence in the potential application of peptide therapeutics across multiple therapeutic areas.
Meanwhile, ReAlta Life Sciences closed an oversubscribed $40 million financing round to advance the Phase 2 STAR study of its lead candidate pegtarazimod for hypoxic ischemic encephalopathy (HIE), as well as subsequent regulatory milestones. Pegtarazimod is a potential first-in-class peptide therapy composed of 15 amino acids and is designed to target both complement activation and neutrophil-associated inflammatory pathways. MultiValent Biotherapies also completed a $27.425 million Series A financing round, with proceeds supporting the clinical development of its lead candidate MVB-101. MVB-101 is a prostate-specific membrane antigen (PSMA) and folate receptor alpha (FRα) dual-targeting peptide-drug conjugate carrying a monomethyl auristatin E (MMAE) payload, with a molecular size approximately one-fiftieth that of a conventional antibody-drug conjugate (ADC).
Overall, the peptide therapeutics industry sustained strong momentum in the second quarter of 2026. On the one hand, indications such as HDV infection, acquired hypothalamic obesity, and pediatric functional constipation achieved important regulatory breakthroughs. On the other hand, obesity and metabolic diseases remained among the most innovation-intensive areas, with dual and triple receptor agonists, ultra-long-acting GLP-1 therapies, and amylin analogs continuing to expand the boundaries of efficacy and dosing convenience. Meanwhile, stabilized peptides, peptide-drug conjugates, and peptide vaccines are pushing the boundaries of peptide therapeutics into oncology, neural repair, and rare endocrine diseases. As more late-stage clinical studies and major collaborations move forward, peptide therapeutics are expanding from their core position in metabolic diseases into a broader range of therapeutic settings.
As peptide therapeutics continue to gain momentum across metabolic diseases, oncology, and rare disorders, comprehensive characterization of their drug metabolism and pharmacokinetics (DMPK) properties has become essential for successful development. Unlike traditional small molecules, peptide drugs are highly susceptible to enzymatic degradation, often exhibit tissue-specific metabolism, and may demonstrate rapid clearance or complex exposure–response relationships. Addressing these modality-specific challenges requires specialized experimental design and integrated analytical capabilities. WuXi AppTec DMPK team has established a dedicated platform for peptide drug characterization that combines mechanistic understanding with scalable testing infrastructure, enabling systematic evaluation of peptide ADME properties from early discovery through IND-enabling stages.
At the core of this capability is a comprehensive in vitro metabolic stability assessment framework designed to evaluate peptide degradation across biologically relevant matrices. The platform supports studies in multiple tissues and enzyme systems to model how peptides behave under physiologically relevant conditions, helping researchers identify dominant metabolic pathways and understand how sequence design, chemical modification, or formulation strategies influence stability and exposure. These studies generate actionable insights that guide molecular optimization and candidate selection while reducing downstream development risk. Complementary in vivo pharmacokinetic studies further characterize distribution, clearance mechanisms, and systemic exposure profiles, allowing teams to establish a translational PK understanding early in development.
WuXi AppTec integrates advanced bioanalytical technologies with cross-disciplinary expertise spanning peptide chemistry, metabolism science, and quantitative pharmacokinetics. WuXi AppTec DMPK team supports metabolite identification, tissue distribution analysis, and exposure–efficacy interpretation, enabling a holistic understanding of peptide disposition. Automated workflows and standardized methodologies ensure data consistency while maintaining flexibility to address diverse peptide modalities, including modified peptides, long-acting analogs, and conjugated formats.
By connecting mechanistic ADME insights with development decision-making, WuXi AppTec’s peptide DMPK platform helps partners address common challenges such as short half-life, proteolytic instability, and variability across species models. The result is a plug-and-play capability that can seamlessly support multiple development programs, providing reliable data to inform design optimization, safety assessment, and clinical translation strategies. Through integrated scientific expertise and global operational scale, WuXi AppTec DMPK team enables peptide innovators to move more confidently from molecular concept to development-ready candidate, accelerating the advancement of next-generation peptide therapeutics.
参考资料：
[1] 各家公司新闻稿
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