> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/envafolimab-067ce798-3523-4c36-9d89-3452238113d3
> Record changed: 2026-10-13

# Envafolimab

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298006)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298006)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298006)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298006)

**Drug name**

Envafolimab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298006)

### Other names (24)

- anti pd l1 monoclonal antibody kn035
- ANTI-PD-L1 MONOCLONAL ANTIBODY KN035
- asc 22
- ASC-22
- asc22
- Asc22
- ASC22
- envafolimab
- Envafolimab
- envafolimab \[INN\]
- Envafolimab \[WHO-DD\]
- Envafolimab Injection
- envafolimab inn
- envafolimab who dd
- immunoglobulin g anti human programmed death ligand 1 human camelidae monoclonal kn 035 gamma chain variable region fragment fusion protein with immunoglobulin g1 human monoclonal kn 035 gamma 1 chain fc fragment dimer
- IMMUNOGLOBULIN G, ANTI-(HUMAN PROGRAMMED DEATH LIGAND 1) (HUMAN-CAMELIDAE MONOCLONAL KN-035 .GAMMA.-CHAIN VARIABLE REGION FRAGMENT) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (HUMAN MONOCLONAL KN-035 .GAMMA.1-CHAIN FC FRAGMENT), DIMER
- immunoglobulin vh h ch2 ch3 gamma1 chain dimer anti homo sapiens cd274 programmed death ligand 1 pdl1 pd l1 b7 homolog 1 b7h1 monoclonal antibodygamma1 heavy chain vh h ch2 ch3 1 360 vh vicugna pacos ighv3 3 01 80 6 ighd ighj5 01 92 3 homo sapiens ighv3 64 04 78 4 ighd ighj1 01 92 3 8 8 21 1 128 homo sapiens ighg1 01 g1m1 hinge 1 15 c5 s 133 129 143 ch2 144 253 d27 a 178 p116 g 244 ch3 d12 269 l14 271 254 358 chs 359 360 129 360 dimer 139 139 142 142 bisdisulfide
- IMMUNOGLOBULIN VH-H-CH2-CH3 GAMMA1 CHAIN DIMER, ANTI-(HOMO SAPIENS CD274 (PROGRAMMED DEATH LIGAND 1, PDL1, PD-L1, B7 HOMOLOG 1, B7H1)), MONOCLONAL ANTIBODYGAMMA1 HEAVY CHAIN VH-H-CH2-CH3 (1-360) (VH (VICUGNA PACOS IGHV3-3\*01 (80.6%)-(IGHD)-IGHJ5\*01 (92.3%)/HOMO SAPIENS IGHV3-64\*04 (78.4%)-(IGHD)-IGHJ1\*01 (92.3%)) (8.8.21) (1-128)-HOMO SAPIENS IGHG1\*01 G1M1 (HINGE 1-15, C5>S (133) (129-143), CH2 (144-253) D27>A (178), P116>G (244), CH3 D12 (269) L14 (271) (254-358), CHS (359-360)) (129-360))DIMER (139-139'':142-142'')-BISDISULFIDE
- kn 035
- Kn 035
- KN-035
- kn035
- Kn035
- KN035

## Identifiers

**CAS registry numbers**

- 2102192-68-5

**ChEMBL ID**

CHEMBL4298006

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298006)

**FDA ingredient codes (UNII)**

- ES1M06M6QH

## Regulatory information

### Other regulatory facts

**Patents**

0

**Designations**

2

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

## Pharmacology

### Drug classification

**Pharmacology name**

envafolimab

**Type**

Antibody

**Drug name stem**

\-mab

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action (2)

- **Mechanism**  
Programmed cell death 1 ligand 1 binding agent

**Action type**  
BINDING\_AGENT

**Target**  
Programmed cell death 1 ligand 1

**Protein identifier**  
Q9NZQ7
- **Action**  
Binding

**Action type**  
Binding

**Target**  
programmed cell death 1 ligand 1

**Gene symbol**  
programmed cell death 1 ligand 1

**Median affinity**

8.52

**Affinity units**  
pKd

**Primary target**  
Yes

### Open Targets mechanisms

- **Mechanism**  
Programmed cell death 1 ligand 1 binding agent

**Action type**  
BINDING AGENT

**Target**  
Programmed cell death 1 ligand 1

### Investigated indications (30)

- **Condition**  
HIV Infections

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000180

**Subject identifier**  
D015658
- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000503

**Subject identifier**  
D013274
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000691

**Subject identifier**  
D012509
- **Condition**  
HIV Infections

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000764

**Subject identifier**  
D015658
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Biliary Tract Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003891

**Subject identifier**  
D001661
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004142

**Subject identifier**  
D015179
- **Condition**  
Hepatitis B, Chronic

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004239

**Subject identifier**  
D019694
- **Condition**  
Nasopharyngeal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004252

**Subject identifier**  
D009303
- **Condition**  
Colonic Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004288

**Subject identifier**  
D003110
- **Condition**  
Esophageal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005922

**Subject identifier**  
D004938
- **Condition**  
Pancreatic Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000359

**Subject identifier**  
D010190
- **Condition**  
Rectal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1000657

**Subject identifier**  
D012004
- **Condition**  
Meningeal Carcinomatosis

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1001012

**Subject identifier**  
D055756
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1001968

**Subject identifier**  
D012509
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002974

**Subject identifier**  
D002583
- **Condition**  
Biliary Tract Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0003060

**Subject identifier**  
D001661
- **Condition**  
Adenocarcinoma

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0003219

**Subject identifier**  
D000230
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Gallbladder Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005411

**Subject identifier**  
D005706
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005575

**Subject identifier**  
D015179
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Esophageal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007576

**Subject identifier**  
D004938

And 5 more, listed on the interactive page.

### Open Targets indications (55)

- **Condition identifier**  
EFO\_0000180

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000182

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000616

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000764

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001075
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0004142

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0004239

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000657

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1001012

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001961
- **Condition identifier**  
EFO\_1001968

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000544

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0001056

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002142

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002158
- **Condition identifier**  
MONDO\_0002169

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002974

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0003060

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0003210
- **Condition identifier**  
MONDO\_0003219

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005005

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005008

**Highest recorded phase**  
2

And 30 more, listed on the interactive page.

### Reported adverse events (25)

- **Event**  
alanine aminotransferase increased

**Reports**  
2

**Reporting signal score**

6.13248
- **Event**  
anaemia

**Reports**  
5

**Reporting signal score**

16.9242
- **Event**  
aspartate aminotransferase increased

**Reports**  
2

**Reporting signal score**

6.37947
- **Event**  
biliary tract disorder

**Reports**  
1

**Reporting signal score**

6.40325
- **Event**  
decreased appetite

**Reports**  
3

**Reporting signal score**

8.99762
- **Event**  
endocrine disorder

**Reports**  
1

**Reporting signal score**

6.78159
- **Event**  
fatigue

**Reports**  
5

**Reporting signal score**

12.3454
- **Event**  
gastrointestinal disorder

**Reports**  
2

**Reporting signal score**

6.98039
- **Event**  
hyperbilirubinaemia

**Reports**  
3

**Reporting signal score**

16.3299
- **Event**  
hypertension

**Reports**  
4

**Reporting signal score**

12.7799
- **Event**  
hyperthyroidism

**Reports**  
2

**Reporting signal score**

9.57268
- **Event**  
hypoalbuminaemia

**Reports**  
4

**Reporting signal score**

24.8646
- **Event**  
hypokalaemia

**Reports**  
2

**Reporting signal score**

6.99414
- **Event**  
hypothyroidism

**Reports**  
3

**Reporting signal score**

14.1504
- **Event**  
immune effector cell-associated neurotoxicity syndrome

**Reports**  
1

**Reporting signal score**

6.30152
- **Event**  
leukopenia

**Reports**  
3

**Reporting signal score**

11.4774
- **Event**  
myocardial necrosis marker increased

**Reports**  
1

**Reporting signal score**

6.50483
- **Event**  
neutropenia

**Reports**  
4

**Reporting signal score**

13.2694
- **Event**  
palmar-plantar erythrodysaesthesia syndrome

**Reports**  
3

**Reporting signal score**

14.0171
- **Event**  
pneumonitis

**Reports**  
3

**Reporting signal score**

14.0255
- **Event**  
post embolisation syndrome

**Reports**  
1

**Reporting signal score**

8.67634
- **Event**  
rash

**Reports**  
5

**Reporting signal score**

14.2373
- **Event**  
thrombocytopenia

**Reports**  
5

**Reporting signal score**

18.9049
- **Event**  
transaminases increased

**Reports**  
2

**Reporting signal score**

7.89095
- **Event**  
vomiting

**Reports**  
4

**Reporting signal score**

9.64434

### Trial references (54)

- NCT02827968  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02827968)
- NCT03101488  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03101488)
- NCT03248843  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03248843)
- NCT03667170  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03667170)
- NCT04182789  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04182789)
- NCT04891198  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04891198)
- NCT06301828  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06301828)
- NCT06470971  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06470971)
- NCT04034823  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04034823)
- NCT04465890  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04465890)
- NCT04910386  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04910386)
- NCT05055167  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05055167)
- NCT05068427  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05068427)
- NCT05243355  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05243355)
- NCT05360979  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05360979)
- NCT05414630  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05414630)
- NCT05465733  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05465733)
- NCT05529355  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05529355)
- NCT05534113  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05534113)
- NCT05910034  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910034)
- NCT06108726  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108726)
- NCT05112991  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05112991)
- NCT05129189  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129189)
- NCT05203276  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203276)
- NCT05904015  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05904015)

And 29 more, listed on the interactive page.

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

## Related records

### Trials (84)

- 89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors
- A Clinical Study of Immunotherapy Combined With Chemotherapy and Anti-angiogenic Therapy in Operable NSCLC
- 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 Colorectal Cancer (mCRC)
- A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread
- A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients
- A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients
- A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer
- A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma
- A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer
- A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer
- A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors
- Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
- ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection
- Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
- Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
- Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer
- Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment
- D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
- Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer
- Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma

### In development for (28)

- [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) Phase 2
- [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Phase 2
- [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) Phase 2
- [Colonic neoplasm](https://trialight.com/data/condition/colonic-neoplasm-be61bc3a-c82f-5b84-a20f-3f9931cfcc77.md) Phase 2
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2
- [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) Phase 2
- [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) Phase 2
- [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) Phase 2
- [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) Phase 2
- Gallbladder cancer Phase 2
- [Gastric adenocarcinoma](https://trialight.com/data/condition/gastric-adenocarcinoma-6bb74a55-7ba6-53e3-a113-22296a84d6ae.md) Phase 2
- [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) Phase 2
- [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 2
- [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 2
- [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) Phase 2
- Malignant colon neoplasm Phase 2
- [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md) Phase 2

### Other linked conditions (3)

- Intrahepatic cholangiocarcinoma
- Malignant epithelial tumor of ovary
- Ovarian carcinoma

### Targets (1)

- [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) Programmed cell death 1 ligand 1 binding agent

---

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