Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 535 |
| INN | Nofazinlimab |
| Status | Clinical |
| Drug code(s) | CS1003 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Hybridoma |
| Target(s) | PD-1 |
| Indications of clinical studies | Hepatocellular carcinoma, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | December 20, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Cstone Pharma |
| Licensee/Partner | EQRx |
| Comments about company or candidate | Dec 2023: The global multi-regional phase III study of CS1003-305 of nofazinlimab in combination with lenvatinib versus placebo in combination with lenvatinib as the first-line treatment for patients with advanced hepatocellular carcinoma (HCC) has completed its prespecified patient enrollment and a topline readout is expected in the first quarter of 2024. May 2023: In March 2022, the global multi-regional phase 3 registrational trial of nofazinlimab in combination with lenvatinib as first-line treatment for patients with advanced hepatocellular carcinoma, CS1003-305, has successfully reached its prespecified enrollment target." also "announced that CStone will regain rights for the development and commercialization of sugemalimab (anti-PD-L1 monoclonal antibody) and nofazinlimab (anti-PD-1 monoclonal antibody) outside of Greater China, upon the termination of the License Agreement for sugemalimab and nofazinlimab between CStone and EQRx. https://www.cstonepharma.com/en/html/news/2915.html NDA filing for 1L HCC in China expected in 2023 (https://www.cstonepharma.com/en/uploads/2022/07/165846866935356.pdf) NCT04194775 in HCC started in Dec 2019 has primary completion date in June 2023. EudraCT Number 2019-003337-41: A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1003 in Combination with Lenvatinib Compared to Placebo in Combination with Lenvatinib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC) sponsored by CStone. EQRx’s PD-1 antibody (formerly known as CS1003) has received Orphan Drug Designation from the FDA for a type of primary liver cancer. October 26, 2020: CStone Pharmaceuticals announced 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. Sep 2019: The CS1003-102 study data presented at Chinese Society of Clinical Oncology Annual Meeting was generated from 19 patients with advanced tumors, who were enrolled during the dose escalation phase of the study. NCT03809767 Phase 1 study started in Oct 2018. Dec. 27, 2017: CStone Pharmaceuticals (Suzhou) Co., Ltd., (CStone) today announced that a formal application for clinical trial approval has been submitted to Human Research Ethics Committees of the Scientia Clinical Research center in Australia for the anti-programmed death-1 (PD-1) monoclonal antibody (mAb) candidate CS1003. The application represents CStone's third novel independently-developed pipeline candidate to reach the clinical development stages, and the second such molecule to be filed for clinical trial approval in Australia. NCT03475251 Phase 1 study started in May 2018. |
| Full address of company | C1 Building, No. 218, Xinghu Street, Suzhou Industrial Park, China Asia China https://www.cstonepharma.com/en/about/contact.html |
Immune checkpoint inhibitor. CS1003 is a humanized IgG4 anti-PD-1 monoclonal antibody developed by CStone's proprietary hybridoma platform and has shown good tolerability and efficacy in in vivo studies.
| Anticipated events | NDA filing in China expected in 2024? |
| Factor(s) contributing to discontinuation | None |