Drugs / Sugemalimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | non-small cell lung carcinoma | 2020-11-23 | “China’s National Medical Products Administration has accepted for review CStone’s New Drug Application (NDA) for sugemalimab (CS1001)” ligand.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Cejemly | — | 2024-07-24 | europa.eu ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04421352 | Jan 2021 → Dec 2023 | small cell lung carcinoma | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04472858 | Oct 2020 → Dec 2023 | neoplasm | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT03744403 | Dec 2018 → Oct 2020 | cancer | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03312842 | Oct 2017 → Aug 2021 | cancer of unknown primary site | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07190027 | Nov 2025 overdue | non-small cell lung carcinoma | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04194801 | Dec 2019 → Oct 2021 | hepatocellular carcinoma | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT04200404 | Dec 2019 → May 2021 | refractory malignant neoplasm | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07711470 | Jul 2026 → Dec 2028 expected | esophageal squamous cell carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06987734 | Jun 2025 → Dec 2027 expected | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT05940532 | Jun 2023 → Jan 2025 overdue | non-small cell lung carcinoma | Hunan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04770207 | Nov 2020 → Nov 2029 expected | hepatocellular carcinoma | Second Affiliated Hospital of Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT03595657 | Jun 2018 → Mar 2023 | mature T-cell and NK-cell non-Hodgkin lymphoma | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03505996 | May 2018 → Feb 2020 | classic Hodgkin lymphoma | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05623267 | Jul 2023 → Dec 2025 overdue | small cell lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 36 trials · 4 met primary | ||||||
| Phase 3 | NCT05700448 | Jun 2027 → Dec 2029 expected | extranodal nasal NK/T cell lymphoma | CStone Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06031597 | Sep 2023 → Dec 2025 | non-small cell lung carcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04187352 | Dec 2019 → Oct 2022 | esophageal squamous cell carcinoma | CStone Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03802591 | Mar 2019 → Jul 2023 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | CStone Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03789604 | Dec 2018 → May 2023 overdue | non-small cell lung carcinoma | CStone Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT03728556 | Oct 2018 → Apr 2023 | non-small cell lung carcinoma | CStone Pharmaceuticals | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07247227 | Oct 2023 → May 2027 expected | non-small cell lung carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05131438 | — | extranodal nasal NK/T cell lymphoma | EQRx International, Inc. | No longer available | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 0 | NCT06097962 Background | Jul 2023 → Jul 2027 expected | non-small cell lung carcinoma | Base Therapeutics (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06217757 Background | Apr 2024 → Oct 2027 expected | small cell lung carcinoma | Sichuan University | Recruiting | No outcome recorded |
| Phase 3 | NCT06617416 Comparator | Nov 2024 → Oct 2026 expected | non-small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | CStone Pharmaceuticals | Results 舒格利单抗定量药理学研究成果获国际期刊与欧洲监管认可，彰显基石药业全球开发综合实力 cstonepharma.com ↗
2026年2月，公司团队在《CPT: Pharmacometrics & Systems Pharmacology》发表研究，系统阐述了舒格利单抗如何通过群体药代动力学（PopPK）模型、暴露-反应分析及模拟，支持欧洲患者给药方案的确定。 |
| 2020-11-23 | Ligand Pharmaceuticals | Regulatory Ligand Announces Clinical and Regulatory Progress by Multiple Partners with OmniAb® Antibodies ligand.com ↗
This marks the first regulatory submission by CStone for sugemalimab. |
| 2020-08-07 | Ligand Pharmaceuticals | Results CStone Announces That OmniAb-derived CS1001 (Anti-PD-L1) Phase 3 Trial Met the Primary Endpoint as First-Line Treatment in Stage IV Squamous and Non-squamous Non-Small Cell Lung Cancer and Announces Plans to Submit a New Drug Application ligand.com ↗
In the overall population containing both squamous and non-squamous NSCLC patients, investigator-assessed progression free survival (PFS) HR (95% CI) was 0.50 (0.39, 0.64), p<0.0001. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | CStone Pharmaceuticals | 舒格利单抗定量药理学研究成果获国际期刊与欧洲监管认可，彰显基石药业全球开发综合实力 cstonepharma.com ↗ |
| 2021-12-22 | Ligand Pharmaceuticals | Ligand’s Partner CStone Pharmaceuticals Receives Approval in China for Sugemalimab (Cejemly®) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer in Combination with Chemotherapy ligand.com ↗ |
| 2020-11-23 | Ligand Pharmaceuticals | Ligand Announces Clinical and Regulatory Progress by Multiple Partners with OmniAb® Antibodies ligand.com ↗ |
| 2020-08-07 | Ligand Pharmaceuticals | CStone Announces That OmniAb-derived CS1001 (Anti-PD-L1) Phase 3 Trial Met the Primary Endpoint as First-Line Treatment in Stage IV Squamous and Non-squamous Non-Small Cell Lung Cancer and Announces Plans to Submit a New Drug Application ligand.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sugemalimab | “Fixed Delay Arm Delayed PD-1 + Chemo PD-1 inhibitor (e.g., Sintilimab/Keytruda/Tislelizumab/Camrelizumab/Toripalimab/Nivolumab/Atezolizumab/Sugemalimab) Immune checkpoint...” NCT07190027 ↗17“We randomly assigned patients (2:1, using an interactive voice-web response system) to receive sugemalimab 1200 mg or matching placebo, intravenously every 3 weeks for up to 24 months.” PMID 35038429 ↗ Jan 2022 “This phase II study evaluated the efficacy and safety of sugemalimab, an anti-PD-L1 monoclonal antibody, in R/R ENKTL.” PMID 36996373 ↗ Mar 2023 “with sugemalimab, a PD-L1 inhibitor, plus chemotherapy versus placebo plus chemotherapy.” PMID 40523368 ↗ Jun 2025 “receive either sugemalimab (an anti-PD-L1 antibody; 1,200 mg) or placebo every 3 weeks” PMID 38302715 ↗ Feb 2024 “Sugemalimab” NCT06031597 ↗ |
| Known as | Cejemly | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594535 ↗ |
| Known as | CS1001 | “Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W).” NCT04194801 ↗ |
| Known as | WBP-315 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594535 ↗ |
| Action | Inhibit | “anti-PD-L1 monoclonal antibody” NCT03312842 ↗ |
| Modality | Monoclonal antibody | “sugemalimab, a full-length, fully human anti-PD-L1 monoclonal antibody” PMID 34984540 ↗ Jan 2022 |
| Route | Intravenous | “Participants will receive CS1001 1200 mg by intravenous infusion every three weeks” NCT03505996 ↗ |
| Target | CD274 | “Programmed cell death 1 ligand 1 binding agent” CHEMBL4594535 ↗ |