# Envafolimab

Source: https://onco.cc/drugs/envafolimab/  
OnCo record `envafolimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: china
- 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: China 2021: Previously treated MSI-H or dMMR advanced solid tumours

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Envafolimab
- Alphamab Oncology: https://www.alphamabonc.com/en/
- NMPA (National Medical Products Administration): https://www.nmpa.gov.cn

## Connected records

- cancers: [Cancer of unknown primary (CUP)](https://onco.cc/cancers/cancer-of-unknown-primary/), [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [PD-L1](https://onco.cc/targets/pdl1/)
- companies: [3D Medicines](https://onco.cc/companies/3d-medicines/), [Alphamab Oncology](https://onco.cc/companies/alphamab/), [Tracon Pharmaceuticals](https://onco.cc/companies/tracon/)
- pathways: [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- terms: [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/)
- trials: [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 Col](https://onco.cc/trials/nct06959693/), [A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.](https://onco.cc/trials/nct07729033/), [ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct04891198/), [Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07003815/), [Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies](https://onco.cc/trials/nct07599995/), [Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07636798/), [KN035 for dMMR/MSI-H Advanced Solid Tumors](https://onco.cc/trials/nct03667170/), [Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers](https://onco.cc/trials/nct04910386/), [Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer](https://onco.cc/trials/nct05969847/), [Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors](https://onco.cc/trials/nct05024214/), [Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC](https://onco.cc/trials/nct06123754/), [Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma](https://onco.cc/trials/nct05752136/), [Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC](https://onco.cc/trials/nct03478488/), [Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer](https://onco.cc/trials/nct05112991/)

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