HLX43是一款潛在同類最優(yōu)及疾病領(lǐng)域最優(yōu)的廣譜抗腫瘤ADC，兼具免疫檢查點(diǎn)阻斷與載荷細(xì)胞毒性的雙重作用機(jī)制。臨床前研究顯示，HLX43在PD-1/PD-L1單抗耐藥的非小細(xì)胞肺癌、宮頸癌、食管鱗癌等多個(gè)瘤種中展現(xiàn)出治療潛力，且耐受性良好。其I期臨床數(shù)據(jù)于2025美國(guó)臨床腫瘤學(xué)會(huì)(ASCO)年會(huì)及2025世界肺癌大會(huì)(WCLC)上先后發(fā)布，在NSCLC等實(shí)體瘤中展現(xiàn)出“高效、低毒”的顯著療效，尤其在NSCLC的治療上，HLX43展現(xiàn)了全人群覆蓋的潛力。

　　在即將召開的2025ESMO Asia上，HLX43將披露在更廣泛實(shí)體瘤中的臨床數(shù)據(jù)，其用于晚期宮頸癌等婦科惡性腫瘤治療的II期臨床結(jié)果將在大會(huì)上以優(yōu)選論文口頭報(bào)告形式首發(fā)亮相。根據(jù)ESMO Asia最新口頭報(bào)告披露，HLX43在晚期宮頸癌中展現(xiàn)了優(yōu)異的初步臨床療效，且安全性可控。在30例可評(píng)估療效的患者中，研究者評(píng)估的客觀緩解率(ORR)為41.4%，疾病控制率(DCR)為82.8%；其中，3mg/kg劑量組的ORR和DCR分別達(dá)到70.0%和100%。

　　中文場(chǎng)次

　　英文場(chǎng)次

　　 HLX43is a potential best-in-class as well best-in-disease broad-spectrum anti-tumor ADC candidate targeting PD-L1,which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity.Preclinical data have shown that,HLX43has good anti-tumor effects and a favorable tolerability profile in non-small cell lung cancer(NSCLC),cervical cancer(CC),esophageal squamous cell carcinoma(ESCC),and other tumor types that were PD-1/L1mAb-resistant.The results from the Phase1clinical trial of HLX43were first released at the2025ASCO Annual Meeting and2025WCLC,demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC.

　　 HLX43will be featured at the upcoming2025ESMO Asia Congress,with its Phase2clinical data on recurrent/metastatic cervical cancer making a debut as a Proffered Paper Oral Presentation.This announcement represents a significant step in validating the drug's broad-spectrum potential across various solid tumors.According to the ESMO Asia Proffered Paper release,HLX43has demonstrated promising preliminary efficacy with a manageable safety profile in advanced cervical cancer.Among the30response evaluable patients,investigator-assessed ORR was41.4%and disease control rate(DCR)was82.8%.ORR,and DCR for the3mg/kg dose group was70.0%,and100%,respectively.