sugemalimab

Home
Ligands
sugemalimab

GtoPdb Ligand ID: 12342

Synonyms: Cejemly® (China) | CS-1001 | CS1001 | WBP-3155 | WBP3155

sugemalimab is an approved drug (China (2021), EMA (2024))

Comment: Sugemalimab is a fully human, high-affinity anti-programmed death ligand 1 (PD-L1) IgG4 monoclonal antibody. It is a checkpoint inhibitor class immuno therapeutic. In vitro, it competitively blocks the binding of human PD-L1 to PD-1 and CD80, and it induces T lymphocyte proliferation and enhances antitumour immunity [2].

No information available.

No information available.

Summary of Clinical Use
Sugemalimab was issued its first clinical approval in China (December 2021) [1]. It is indicated as first-line treatment for EGFR gene mutation and anaplastic lymphoma kinase (ALK) negative metastatic non-small cell lung cancer (NSCLC). First-in-human safety, pharmacokinetics, preliminary efficacy for sugemalimab were reported in 2022 [2]. Full authorisation in the EU was issued in July 2024, where it is indicated as a first line treatment for metastatic NSCLC without sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.

Summary of Clinical Use

Sugemalimab was issued its first clinical approval in China (December 2021) [1]. It is indicated as first-line treatment for EGFR gene mutation and anaplastic lymphoma kinase (ALK) negative metastatic non-small cell lung cancer (NSCLC). First-in-human safety, pharmacokinetics, preliminary efficacy for sugemalimab were reported in 2022 [2]. Full authorisation in the EU was issued in July 2024, where it is indicated as a first line treatment for metastatic NSCLC without sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT03312842	A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors	Phase 1 Interventional	CStone Pharmaceuticals		2
NCT03728556	A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung Cancer	Phase 3 Interventional	CStone Pharmaceuticals	The GEMSTONE-301 study	3