{"entity":{"id":"envafolimab","kind":"drug","name":"Envafolimab","aka":[],"tldr":"Envafolimab is the first PD-L1 antibody given as a quick injection under the skin rather than an infusion, approved in China for advanced tumours with mismatch-repair deficiency.","summary":"Approved by the NMPA in November 2021 for previously treated MSI-H or dMMR advanced solid tumours, on a single-arm study across colorectal and other cancers, the first subcutaneous PD-(L)1 antibody approved anywhere. Developed by Alphamab Oncology with 3D Medicines in China; TRACON Pharmaceuticals held North American rights for a sarcoma programme that did not succeed. Its convenience rather than potency is the point: a 30-second injection in a country where infusion chairs are scarce outside big cities.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Envafolimab","links":[{"label":"Alphamab Oncology","url":"https://www.alphamabonc.com/en/"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["colorectal","cancer-of-unknown-primary"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":["pdl1"],"drugs":[],"companies":["alphamab","3d-medicines","tracon"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":["msi"],"trials":["nct05112991","nct05024214","nct04891198","nct03478488","nct03667170","nct06123754"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Enweida","code":"KN035","modality":"Single-domain antibody (anti-PD-L1, subcutaneous)","mechanism":"Camelid-derived humanised single-domain anti-PD-L1 antibody fused to an IgG1 Fc, small enough for a rapid subcutaneous injection.","approvals":[{"region":"China","year":2021,"indication":"Previously treated MSI-H or dMMR advanced solid tumours"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/envafolimab/","neighbours":{"cancer":[{"id":"cancer-of-unknown-primary","kind":"cancer","name":"Cancer of unknown primary (CUP)","route":"/cancers/cancer-of-unknown-primary/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"company":[{"id":"3d-medicines","kind":"company","name":"3D Medicines","route":"/companies/3d-medicines/"},{"id":"alphamab","kind":"company","name":"Alphamab Oncology","route":"/companies/alphamab/"},{"id":"tracon","kind":"company","name":"Tracon Pharmaceuticals","route":"/companies/tracon/"}],"pathway":[{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"}],"term":[{"id":"msi","kind":"term","name":"Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)","route":"/terms/msi/"}],"trial":[{"id":"nct06959693","kind":"trial","name":"A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic 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Cancer","route":"/trials/nct07636798/"},{"id":"nct03667170","kind":"trial","name":"KN035 for dMMR/MSI-H Advanced Solid Tumors","route":"/trials/nct03667170/"},{"id":"nct04910386","kind":"trial","name":"Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers","route":"/trials/nct04910386/"},{"id":"nct05969847","kind":"trial","name":"Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer","route":"/trials/nct05969847/"},{"id":"nct05024214","kind":"trial","name":"Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors","route":"/trials/nct05024214/"},{"id":"nct06123754","kind":"trial","name":"Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC","route":"/trials/nct06123754/"},{"id":"nct05752136","kind":"trial","name":"Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma","route":"/trials/nct05752136/"},{"id":"nct03478488","kind":"trial","name":"Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC","route":"/trials/nct03478488/"},{"id":"nct05112991","kind":"trial","name":"Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer","route":"/trials/nct05112991/"}]}}