口服司美格魯肽在歐盟獲推薦批準(zhǔn)；慢性丁肝新藥獲FDA加速批準(zhǔn)…… | Bilingual

編者按：近年來，多肽療法正迅速崛起為全球新藥研發(fā)的重要方向。從GLP-1類代謝疾病療法持續(xù)取得突破，到腫瘤、神經(jīng)系統(tǒng)疾病及免疫疾病等領(lǐng)域不斷涌現(xiàn)的新型多肽分子，多肽藥物的研發(fā)版圖正在不斷拓展。在這一背景下，藥明康德旗下WuXi TIDES平臺圍繞多肽、寡核苷酸及其相關(guān)化學(xué)偶聯(lián)藥物構(gòu)建了一體化解決方案，覆蓋定制合成、共價(jià)連接、工藝開發(fā)以及CMC等關(guān)鍵環(huán)節(jié)，助力創(chuàng)新項(xiàng)目更高效地推進(jìn)至臨床階段。與此同時(shí)，藥明康德生物分析部（BAS）依托成熟的技術(shù)平臺，建立了覆蓋藥代動(dòng)力學(xué)（PK）分析、抗藥抗體（ADA）及中和抗體（NAb）評價(jià)的一體化生物分析解決方案，為復(fù)雜修飾多肽及偶聯(lián)多肽藥物的臨床研究提供有力支持。而藥明康德DMPK團(tuán)隊(duì)能夠從機(jī)制層面解析多肽藥物的ADME行為，并結(jié)合蛋白結(jié)合、滲透性及代謝產(chǎn)物鑒定研究，支持結(jié)構(gòu)優(yōu)化與遞送策略設(shè)計(jì)。本文將盤點(diǎn)2026年第二季度全球多肽療法在監(jiān)管審批、臨床研究以及產(chǎn)業(yè)合作等方面的重要進(jìn)展，帶您了解這一快速發(fā)展領(lǐng)域的最新動(dòng)態(tài)與趨勢。

監(jiān)管進(jìn)展

2026年第二季度，多肽療法在多個(gè)疾病領(lǐng)域迎來重要監(jiān)管進(jìn)展。其中，吉利德科學(xué)（Gilead Sciences）旗下Hepcludex（bulevirtide）注射液獲得美國FDA加速批準(zhǔn)，用于治療無肝硬化或代償性肝硬化成人患者的慢性丁型肝炎病毒（HDV）感染。根據(jù)FDA新聞稿，Hepcludex是首款獲得FDA批準(zhǔn)用于治療慢性HDV感染的療法，也為這一長期缺乏獲批療法的病毒性肝炎領(lǐng)域帶來新的治療選擇。該批準(zhǔn)主要基于3期MYR301研究，結(jié)果顯示，接受Hepcludex治療的患者在第48周實(shí)現(xiàn)聯(lián)合病毒學(xué)與生化應(yīng)答的比例為48%，而延遲治療組為2%。

在肥胖相關(guān)適應(yīng)癥方面，Rhythm Pharmaceuticals旗下Imcivree（setmelanotide）獲得歐盟委員會(huì)批準(zhǔn)，用于治療因下丘腦損傷或功能障礙導(dǎo)致的獲得性下丘腦性肥胖（HO）成人和4歲及以上兒童患者。此次歐盟批準(zhǔn)主要基于3期TRANSCEND研究，Imcivree組患者在52周時(shí)身體質(zhì)量指數(shù)（BMI）較基線平均下降16.5%，安慰劑組則上升3.3%，安慰劑校正后BMI降幅為19.8%。

胰高血糖素樣肽-1（GLP-1）類療法也繼續(xù)推進(jìn)給藥方式創(chuàng)新。諾和諾德（Novo Nordisk）宣布，Wegovy片劑（每日一次口服司美格魯肽25 mg）獲得歐洲藥品管理局（EMA）人用藥品委員會(huì)（CHMP）推薦批準(zhǔn)，用于減輕過多體重并維持長期減重效果。根據(jù)新聞稿，這是首個(gè)獲得CHMP推薦用于體重管理的口服GLP-1療法。在OASIS 4試驗(yàn)中，對于患有肥胖或伴有一種或多種合并癥的超重成人受試者，在堅(jiān)持治療的情況下，每日一次口服司美格魯肽25 mg顯示出16.6%的平均體重減輕幅度。Wegovy片劑實(shí)現(xiàn)的減重效果與注射劑型Wegovy（2.4 mg）相似。

此外，艾伯維（AbbVie）與Ironwood Pharmaceuticals聯(lián)合開發(fā)的Linzess（linaclotide）也在本季度獲美國FDA批準(zhǔn)擴(kuò)展適應(yīng)癥，用于2歲及以上功能性便秘（FC）兒童患者。Linzess是一款鳥苷酸環(huán)化酶-C（GC-C）激動(dòng)劑，此次批準(zhǔn)基于一項(xiàng)在2至5歲FC兒童患者中開展的12周3期研究，結(jié)果顯示每日一次linaclotide（72 μg）相較安慰劑可改善自發(fā)排便頻率。

臨床進(jìn)展

在臨床研究方面，肥胖與代謝疾病依然是第二季度多肽療法活躍的方向。輝瑞（Pfizer）旗下超長效GLP-1受體激動(dòng)劑berobenatide（曾用名MET-097i）在2b期VESPER-3研究中展現(xiàn)積極結(jié)果。部分患者從每周給藥切換至每月給藥后，至第28周仍實(shí)現(xiàn)最高12.3%的安慰劑校正后體重下降。

圍繞GLP-1與其他肽類激素的聯(lián)合機(jī)制，多家公司也取得臨床進(jìn)展。禮來（Eli Lilly and Company）公布其潛在“first-in-class”三重激素受體激動(dòng)劑retatrutide的3期TRIUMPH-1研究結(jié)果。Retatrutide可同時(shí)靶向GIP、GLP-1和胰高血糖素受體。研究顯示，在肥胖或伴有至少一種體重相關(guān)合并癥的超重成人患者中，retatrutide 9 mg和12 mg組治療80周后平均體重分別降低25.9%和28.3%，安慰劑組為2.2%；在104周延長期分析中，12 mg遞增至最大耐受劑量組體重下降達(dá)到30.3%。

勃林格殷格翰（Boehringer Ingelheim）與Zealand Pharma合作開發(fā)的新型胰高血糖素/GLP-1雙受體激動(dòng)劑survodutide也公布了多項(xiàng)3期數(shù)據(jù)。SYNCHRONIZE-1研究顯示，在不合并2型糖尿病的超重或肥胖成人患者中，survodutide治療76周后平均體重最多下降16.6%。在該研究的亞組分析中，survodutide使內(nèi)臟脂肪降低最高達(dá)34.0%，肝臟脂肪減少最高達(dá)63.1%，且瘦體重流失占比不超過10.8%。在代謝相關(guān)脂肪性肝病（MASLD）方面，SYNCHRONIZE-MASLD研究也達(dá)到共同主要終點(diǎn)。與基線相比，在接受survodutide治療48周后，約60%同時(shí)患有MASLD且超重或肥胖的受試者實(shí)現(xiàn)了肝臟脂肪正常化。

羅氏（Roche）與Carmot Therapeutics開發(fā)的acmopatide（CT-868）是一款每日一次GLP-1/GIP雙受體激動(dòng)劑，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劑量組治療16周后糖化血色蛋白（HbA1c）下降0.34個(gè)百分點(diǎn)，56%的患者HbA1c低于7%，體重下降呈劑量依賴性，最高約7%，胰島素使用量最多減少15%。

與此同時(shí)，胰淀素靶向療法也持續(xù)推進(jìn)。諾和諾德旗下CagriSema（長效胰淀素類似物cagrilintide和司美格魯肽組成的固定劑量聯(lián)合療法）在REIMAGINE系列3期研究中顯示，該固定劑量聯(lián)合療法在2型糖尿病患者中可改善血糖控制并支持體重下降；其中REIMAGINE 3研究中，在接受基礎(chǔ)胰島素治療且血糖控制不佳的2型糖尿病成人患者中，CagriSema使患者的HbA1c由8.8%降至6.5%，體重降低最高達(dá)12%，且未出現(xiàn)嚴(yán)重低血糖事件。而該公司開發(fā)的zenagamtide則是一款每周一次皮下注射的GLP-1與胰淀素受體肽類激動(dòng)劑，在2型糖尿病成人患者2期研究中，40 mg劑量組在36周時(shí)HbA1c較基線下降1.71個(gè)百分點(diǎn)，體重下降最高達(dá)14.6%。

Zealand Pharma公布ZUPREME-1研究新數(shù)據(jù)，其與羅氏聯(lián)合開發(fā)的每周一次胰淀素類似物petrelintide在42周時(shí)使超重或肥胖成人患者體重平均較基線最多降低10.7%，安慰劑組為1.7%，且總體胃腸道不良事件發(fā)生率與安慰劑接近。

除代謝疾病外，多肽療法在腫瘤、神經(jīng)損傷及內(nèi)分泌疾病領(lǐng)域也不斷拓展。在腫瘤領(lǐng)域，Sapience Therapeutics兩款穩(wěn)定化多肽療法均公布臨床數(shù)據(jù)。其C/EBPβ多肽拮抗劑lucicebtide聯(lián)合標(biāo)準(zhǔn)治療用于新確診膠質(zhì)母細(xì)胞瘤患者的2期研究顯示，截至2026年4月，9名可評估患者的預(yù)計(jì)中位無進(jìn)展生存期為28.4個(gè)月，而歷史數(shù)據(jù)為4.0至6.9個(gè)月；ST316作為潛在“first-in-class”的β-catenin拮抗劑，在二線轉(zhuǎn)移性結(jié)直腸癌患者2期擴(kuò)展研究中與FOLFIRI加貝伐珠單抗聯(lián)合使用，15名患者中確認(rèn)客觀緩解率為47%，疾病控制率為93%。此外，Oxford Vacmedix宣布其基于重組重疊肽（ROP）平臺開發(fā)的癌癥疫苗療法OVM-200完成1期研究，并達(dá)到安全性主要終點(diǎn)及免疫應(yīng)答、劑量選擇等次要終點(diǎn)。試驗(yàn)還報(bào)告了早期的臨床活性跡象，包括在非小細(xì)胞肺癌（NSCLC）患者中觀察到的疾病穩(wěn)定，以及在前列腺癌患者中觀察到的前列腺特異性抗原（PSA）應(yīng)答。

NervGen Pharma也宣布，已就其神經(jīng)修復(fù)肽NVG-291的RESTORE臨床3期注冊研究設(shè)計(jì)與美國FDA達(dá)成一致，計(jì)劃在慢性四肢癱患者中開展一項(xiàng)納入約150名受試者的隨機(jī)、雙盲、安慰劑對照研究。

在內(nèi)分泌疾病方面，MBX Biosciences公布每周一次甲狀旁腺激素（PTH）替代療法canvuparatide治療慢性甲狀旁腺功能減退癥患者的2期研究及開放標(biāo)簽延長期一年數(shù)據(jù)。結(jié)果顯示，治療一年時(shí)57%的可評估患者達(dá)到應(yīng)答標(biāo)準(zhǔn)，血鈣維持在正常范圍，24小時(shí)尿鈣下降并保持在正常范圍內(nèi)，腎功能指標(biāo)估算腎小球?yàn)V過率（eGFR）較基線改善并維持至一年；公司表示3期關(guān)鍵性研究計(jì)劃于2026年第三季度啟動(dòng)。

研發(fā)合作與融資進(jìn)展

第二季度，多肽療法相關(guān)公司在資本市場和戰(zhàn)略合作方面同樣活躍。Parabilis Medicines與再生元（Regeneron Pharmaceuticals）達(dá)成戰(zhàn)略研發(fā)合作，雙方將基于Parabilis的Helicon多肽平臺開發(fā)多種候選療法，重點(diǎn)探索抗體-Helicon偶聯(lián)物（AHC）。根據(jù)協(xié)議，Parabilis將獲得1.25億美元，包括5000萬美元首付款和7500萬美元股權(quán)投資承諾，并有資格獲得最高約22億美元潛在里程碑付款等款項(xiàng)。同一季度，Parabilis完成擴(kuò)大規(guī)模的首次公開募股（IPO），募集資金總額為6.70億美元。與此同時(shí)，Kailera Therapeutics也在本季度完成IPO，募集資金總額約為6.25億美元。這兩家公司在本季度完成大額IPO，顯示產(chǎn)業(yè)界對于多肽療法在各治療領(lǐng)域應(yīng)用的持續(xù)信心。

融資方面，ReAlta Life Sciences完成超額認(rèn)購的4000萬美元融資，用于推進(jìn)主打療法pegtarazimod治療新生兒缺氧缺血性腦病（HIE）的2期STAR研究及后續(xù)監(jiān)管里程碑。Pegtarazimod是一種由15個(gè)氨基酸組成的潛在“first-in-class”多肽療法，可同時(shí)靶向補(bǔ)體激活和中性粒細(xì)胞相關(guān)炎癥通路。MultiValent Biotherapies則完成2742.5萬美元A輪融資，所獲資金將支持其主打療法MVB-101的臨床開發(fā)。MVB-101是一種前列腺特異性膜抗原（PSMA）和葉酸受體α（FRα）雙靶向多肽偶聯(lián)藥物，攜帶單甲基奧瑞他汀E（MMAE）載荷，分子大小約為傳統(tǒng)抗體偶聯(lián)藥物（ADC）的1/50。

總體來看，2026年第二季度多肽療法行業(yè)延續(xù)了第一季度的高活躍度。一方面，HDV、獲得性下丘腦性肥胖、兒童功能性便秘等適應(yīng)癥迎來監(jiān)管突破；另一方面，肥胖和代謝疾病仍是創(chuàng)新最密集的領(lǐng)域，雙重與三重受體激動(dòng)劑、超長效GLP-1和胰淀素類似物不斷拓展療效上限，并提高給藥便利性。與此同時(shí)，穩(wěn)定化多肽、肽類藥物偶聯(lián)物和肽類疫苗正在將多肽療法的邊界推向腫瘤、神經(jīng)修復(fù)和罕見內(nèi)分泌疾病。隨著更多后期臨床研究和大型合作落地，多肽療法正在從代謝疾病核心陣地，逐步走向更廣泛的疾病治療場景。

在多肽藥物不斷邁向復(fù)雜結(jié)構(gòu)與精準(zhǔn)調(diào)控的新階段，如何高效、準(zhǔn)確地識別其體內(nèi)代謝產(chǎn)物，已成為影響分子優(yōu)化與臨床轉(zhuǎn)化的重要環(huán)節(jié)。由于多肽易發(fā)生蛋白水解酶介導(dǎo)的逐步降解，并產(chǎn)生大量結(jié)構(gòu)高度相似的代謝片段，傳統(tǒng)分析策略往往難以實(shí)現(xiàn)全面解析。圍繞這一挑戰(zhàn)，藥明康德DMPK團(tuán)隊(duì)構(gòu)建了面向多肽藥物的系統(tǒng)化代謝產(chǎn)物鑒定（MetID）平臺，通過高分辨液相色譜-質(zhì)譜（LC-HRMS）技術(shù)與數(shù)據(jù)分析工具的深度結(jié)合，實(shí)現(xiàn)多肽代謝產(chǎn)物的精準(zhǔn)發(fā)現(xiàn)與結(jié)構(gòu)解析。研究顯示，多肽代謝產(chǎn)物鑒定不僅能夠在非臨床階段識別代謝軟點(diǎn)，指導(dǎo)分子結(jié)構(gòu)優(yōu)化，還可在后期研究中支持安全性評估與臨床代謝研究決策，是貫穿藥物開發(fā)全周期的關(guān)鍵研究內(nèi)容。

依托自主開發(fā)的TidesID及相關(guān)數(shù)據(jù)解析工具，藥明康德DMPK能夠?qū)?fù)雜質(zhì)譜數(shù)據(jù)進(jìn)行高效解讀，通過靶向與非靶向分析相結(jié)合的策略，系統(tǒng)識別體外與體內(nèi)樣品中的未知代謝物，并解析其降解路徑與轉(zhuǎn)化機(jī)制。該平臺結(jié)合多維數(shù)據(jù)處理技術(shù)，如背景扣除、質(zhì)量虧損過濾及特征離子提取，實(shí)現(xiàn)軟件算法與專家經(jīng)驗(yàn)協(xié)同分析，從而顯著提升代謝產(chǎn)物發(fā)現(xiàn)的完整性與準(zhǔn)確性。與此同時(shí)，團(tuán)隊(duì)可在多種生物基質(zhì)與研究體系中開展代謝研究，建立從代謝路徑解析到結(jié)構(gòu)優(yōu)化反饋的閉環(huán)研究流程，為研發(fā)團(tuán)隊(duì)提供具有機(jī)制深度的數(shù)據(jù)支持。

通過將先進(jìn)分析技術(shù)、專用算法工具與豐富的多肽DMPK經(jīng)驗(yàn)相結(jié)合，藥明康德DMPK團(tuán)隊(duì)能夠系統(tǒng)揭示多肽在體內(nèi)的降解規(guī)律與關(guān)鍵代謝特征，幫助研發(fā)人員更早識別影響穩(wěn)定性與暴露水平的關(guān)鍵因素，從而加速候選分子的優(yōu)化與開發(fā)推進(jìn)，為下一代多肽藥物研發(fā)提供堅(jiān)實(shí)的科學(xué)支持。

Semaglutide Recommended for Approval in the EU; New Chronic HDV Therapy Receives FDA AcceleratedApproval…

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.

參考資料：

[1] 各家公司新聞稿

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