Envafolimab is under clinical development by Alphamab Oncology and currently in Phase II for Cutaneous Squamous Cell Carcinoma (cSCC). According to GlobalData, Phase II drugs for Cutaneous Squamous Cell Carcinoma (cSCC) have a 42% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Envafolimab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Envafolimab overview

Envafolimab (Enweida) is a recombinant humanized single domain antibody against programmed death ligand 1 (“PD-L1”) fused with human Fc. It is formulated as solution for subcutaneous route of administration. Enweida is indicated for the treatment of adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high (MSI-H) phenotype/mismatch-repair deficiency (“dMMR”), including those patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan, as well as other patients with advanced solid tumors who have experienced disease progression after previous therapy and no satisfactory treatment alternatives.

Envafolimab (KN-035) is under development for the treatment of sepsis and septic shock, advanced or metastatic undifferentiated pleomorphic sarcoma, myxofibrosarcoma, metastatic melanoma, metastatic prostate cancer, metastatic breast cancer, non-small cell lung cancer, liver cancer, hepatocellular carcinoma, small-cell lung cancer, soft tissue sarcoma, head and neck cancer, vulvar cancer, neuroendocrine tumors, salivary gland cancer, thyroid papillary or follicular cancer, skin squamous cell carcinoma, skin malignant melanoma , Merkel cell tumor, head and neck squamous cell carcinoma, bladder cancer, cervical cancer, gastrointestinal tract cancer, gastro-esophageal junction adenocarcinoma, metastatic gallbladder cancer, renal cell carcinoma, metastatic cholangiocarcinoma, metastatic pancreatic cancer, metastatic ovarian cancer, MSS endometrial cancer, colon cancer, leiomyosarcoma, urothelial carcinoma, metastatic solid tumors, gastric cancer, hepatitis B and human immunodeficiency virus (HIV) infections (AIDS). It is administered through subcutaneous injection. It was also under development for the treatment of hepatocellular carcinoma.

Alphamab Oncology overview

Alphamab Oncology (Alphamab) is a clinical-stage biopharmaceutical company that discovers, develops, manufactures and commercializes therapeutics for the treatment of cancer. The company’s pipeline products include KN035; an injectable PD-L1 inhibitor for the treatment of dMMR and MSI-H solid tumors, KN046; a BsAb immune checkpoint inhibitor, KN026; an anti-HER2 bispecific antibody. It also comprises KN019; a CTLA-4-based immunosuppressant fusion protein drug candidate used for treating indications such as autoimmune diseases and induced immune disorders. Alphamab offers JSKN-003, JSKN-001, JSKN-002, JSKN-004, JSKN-005, JSKN-006 and JSKN-008. The company appears its proprietary CRIB and CRAM platforms for bispecific and protein engineering and antibody screening to best-in-class medicines in oncology. Alphamab is headquartered in Suzhou, Jiangsu, China.

For a complete picture of Envafolimab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

Data Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.