Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 56 |
| INN | Sugemalimab |
| Status | Approved |
| Drug code(s) | CS1001, WBP3155 |
| Brand name | Cejemly® |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic rat (OmniRat, OMT platform) |
| Target(s) | PD-L1 |
| Indications of clinical studies | Head and neck cancer, endometrial cancer, small cell lung cancer, gastric cancer, non-small cell lung cancer, solid tumors, lymphomas |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, China, UKJ |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2016 |
| Start of Phase 2 | |
| Start of Phase 3 | October 26, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2021 |
| Date of first US approval | |
| INN, US product name | Sugemalimab |
| US or EU approved indications | EU: First-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. |
| Company | Cstone Pharmaceuticals |
| Licensee/Partner | Ewopharma, EQRx, Pfizer |
| Comments about company or candidate | NonSmall Cell Lung Cancer is approved for United Kingdom on Oct 30, 2024 with SFL Pharma GmbH. Ewopharma gained the commercial rights for sugemalimab in Switzerland and 18 Central Eastern European countries. July 26, 2024: CStone Pharmaceuticals announced that the European Commission has approved sugemalimab (Brand name: Cejemly®) in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. May 30, 2024: EMA's CHMP adopted a positive opinion for Cejemly (sugemalimab) for the treatment of adults with metastatic non-small-cell lung cancer. Plan submission of BLA for ENKTL in 2023 February 23, 2023 - CStone Pharmaceuticals announced that the Marketing Authorization Application for sugemalimab in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer has been accepted by the European Medicines Agency December 19, 2022- CStone Pharmaceuticals announced that The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application (MAA) submitted by its partner EQRx for sugemalimab in combination with chemotherapy as first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). Sep 2022: CStone Pharmaceuticals announced that NMPA of China has accepted and granted priority review to the supplemental new drug application (sNDA) for sugemalimab in the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). June 6, 2022: CStone Pharmaceuticals and Pfizer Inc. (NYSE: PFE) today announced that the NMPA of China has approved sugemalimab (Cejemly®) for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy. Together with the previous approval of the treatment for first-line stage IV NSCLC patients, sugemalimab is now the only anti- PD-1/PD-L1 monoclonal antibody for both stage III and stage IV NSCLC patients. Dec 2021: Ligand Pharmaceuticals Incorporated announced that its partner CStone Pharmaceuticals has received approval from China’s NMPA for sugemalimab (Cejemly), an OmniAb-derived anti-PD-L1 monoclonal antibody, for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) in combination with chemotherapy. Sep 2, 2021: CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China has accepted the new drug application (NDA) for sugemalimab as a consolidation therapy in patients with unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. CStone has formed a strategic partnership with Pfizer that includes the development and commercialization of sugemalimab in mainland China, and a framework to bring additional oncology assets to the Greater China market. Nov 12, 2020: CStone Pharmaceuticals announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for sugemalimab (CS1001, an anti-PD-L1 monoclonal antibody) combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer (NSCLC) patients. Sugemalimab has received Breakthrough Drug Designation and Orphan Drug Designation from the United States Food and Drug Administration (FDA) for the treatment of certain lymphomas October 26, 2020 I CStone Pharmaceuticals ("CStone", HKEX: 2616) announced today an agreement to out-license ex-Greater China rights for two key late-stage immuno-oncology assets, sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1), to EQRx, a biopharmaceutical company with an innovative business model that will allow these drugs to be competitively positioned in global markets against established treatments for the target indications.July 2020: Phase II Trial Registered For Advanced Metastatic Or Recurrent Head And Neck Squamous Cell Carcinoma (HNSCC) And Endometrial Cancer As Second Line Therapy In The China September 19, 2019 I CStone Pharmaceuticals announced trial data from the esophageal squamous cell carcinoma (ESCC) cohort of a Phase Ib clinical trial of the Company's investigational anti-PD-L1 antibody CS1001 in an oral presentation at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology. April 16, 2019 -- CStone Pharmaceuticals announces that the first patient has been successfully enrolled and dosed in a Phase III clinical trial assessing CS1001, China's first fully human, full-length anti-PD-L1 antibody, in combination with chemotherapy for the treatment of gastric adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma. The multi-center, placebo-controlled clinical trial GEMSTONE-303 will evaluate efficacy and safety of CS1001 plus oxaliplatin and capecitabine (XELOX) chemotherapy as first-line treatment in patients with unresectable, locally advanced, or metastatic gastric adenocarcinoma or GEJ adenocarcinoma. CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerance and produced sustained clinical benefit during the Phase Ia stage of the study. In addition, two pivotal Phase II studies and three Phase III studies have been initiated in China. NCT03728556 Phase 3 study in NSCLC recruiting as of Oct 26, 2018. October 16, 2018 I CStone Pharmaceuticals announced the recent approval of investigational new drug (IND) application from the United States Food and Drug Administration (FDA) for CS1001, a fully human anti-programmed death ligand 1 (PD-L1) monoclonal antibody independently developed by CStone. This marks CStone's first drug to gain IND approval in the United States, and henceforth the company expects to make further IND filings with the FDA for other self-developed pipeline drug candidates. NCT03312842 Phase 1 study. Company is based in both Shanghai and Suzhou China. CFDA has recently accepted the submission of WBP3155's IND (acceptance number CXSL1600075). Wholly owned and independently developed by CStone Pharmaceuticals, WBP3155 is China's first innovative, fully humanized, full length original format IgG (most similar to human's naturally produced IgG) monoclonal antibody drug candidate. WuXi patent (WO2017020291) confirms target and origin (OMT rats) |
| Full address of company | C1 Building, No. 218, Xinghu Street, Suzhou Industrial Park Asia China https://www.cstonepharma.com/en/about/contact.htmll |
Immune checkpoint inhibitor. WBP3155 is China's first innovative, fully humanized, full length original format IgG monoclonal antibody drug candidate; according to Ligand, CS1001 is an OmniAb-derived full-length anti-PDL1 monoclonal antibody.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |