# Sugemalimab

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

## TL;DR

Sugemalimab is CStone's PD-L1 antibody, approved in China for first-line lung cancer with chemotherapy and after chemoradiotherapy in stage III disease, and the first China-developed PD-L1 antibody to win European approval.

## Summary

GEMSTONE-302 (479 patients, squamous and non-squamous metastatic NSCLC) gave a progression-free survival hazard ratio of 0.50 versus placebo plus platinum chemotherapy, the basis of the NMPA approval in December 2021. GEMSTONE-301 added unresectable stage III NSCLC after concurrent or sequential chemoradiotherapy in 2022, and relapsed or refractory extranodal NK/T-cell lymphoma followed. The European Commission approved sugemalimab with platinum chemotherapy for first-line metastatic NSCLC without EGFR, ALK, ROS1 or RET alterations in July 2024, making it the first anti-PD-L1 antibody from a Chinese company approved in the EU.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: china
- Brand: Cejemly
- Code: CS1001
- Modality: Monoclonal antibody (anti-PD-L1, fully human IgG4)
- Mechanism: Fully human anti-PD-L1 IgG4 antibody generated in the OmniRat platform; blocks PD-L1 binding to PD-1 and B7-1.
- Approvals: China 2021: First-line metastatic squamous and non-squamous NSCLC with platinum chemotherapy (GEMSTONE-302); China 2022: Unresectable stage III NSCLC without progression after chemoradiotherapy (GEMSTONE-301); EU 2024: First-line metastatic NSCLC with platinum chemotherapy, no sensitising EGFR, ALK, ROS1 or RET alterations

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Sugemalimab
- CStone Pharmaceuticals: https://www.cstonepharma.com/en/
- GEMSTONE-302 (Lancet Oncol 2022): https://doi.org/10.1016/S1470-2045(21)00650-1
- EMA: Cejemly: https://www.ema.europa.eu/en/medicines/human/EPAR/cejemly

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)](https://onco.cc/cancers/peripheral-t-cell-lymphoma/), [Unresectable stage III non-small-cell lung cancer](https://onco.cc/cancers/stage-iii-unresectable-nsclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [CD80 (B7-1)](https://onco.cc/targets/cd80/), [PD-L1](https://onco.cc/targets/pdl1/)
- companies: [CStone Pharmaceuticals](https://onco.cc/companies/cstone/)
- pathways: [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- trials: [A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC](https://onco.cc/trials/nct06617416/), [GEMSTONE-301](https://onco.cc/trials/gemstone-301/), [GEMSTONE-302](https://onco.cc/trials/gemstone-302/), [Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT](https://onco.cc/trials/nct05623267/)

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