Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1269 |
| INN | Retlirafusp alfa |
| Status | Regulatory review |
| Drug code(s) | SHR-1701 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Bispecific, Immunoconjugate |
| Format, general category | Full length Ab fusion |
| Format details | IgG-(TGFbeta-R2-ECD)2 |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | TGFbeta receptor II ECD |
| Discovery method/technology | None |
| Target(s) | PD-L1, TGF beta |
| Indications of clinical studies | Rectal cancer, cervical Cancer, Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer, Small cell lung cancer, Pancreatic cancer, Non-small cell lung cancer, nasopharyngeal carcinoma, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2018 |
| Start of Phase 2 | |
| Start of Phase 3 | June 22, 2021 |
| 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 | Jiangsu HengRui Medicine Co. Ltd. |
| Licensee/Partner | Suzhou Suncadia Biopharmaceuticals Co. Ltd. |
| Comments about company or candidate | On September 19, 2024, the National Medical Products Administration (NMPA) accepted Hengrui Pharmaceutical's marketing authorization application for the Class 1 new drug Retlirafusp-α Injection (SHR-1701). The application seeks approval for its use in combination with Fluorouracil and platinum-based drugs for the first-line treatment of locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma. According to the pipeline on Suzhou Suncadia Biopharmaceuticals website and to clinicaltrials.gov there are 5 phase 2/3 or 3 studies: Phase 3 study for Cervical cancer (NCT05179239 recruiting as of March 29, 2022); Phase 2/3 study for Colorectal cancer (NCT04856787 recruiting as of July 13, 2021); Phase 3 study for Gastric or gastroesophageal junction cancer (NCT04950322 recruiting as of September 7, 2022); Phase 3 study for Non-small cell lung cancer (NCT05132413 not yet recruiting as of November 24, 2021); Phase 2/3 study for Perioperative treatment of resectable gastric or gastroesophageal junction cancer (NCT05149807 is enrolling by invitation as of February 10, 2022) NCT05179239 Phase 3 in cervical cancer started in Feb 2022. NCT04950322 Phase 3 in Gastric or Gastroesophageal Junction Cancer started in Dec 2021. NCT05149807 Phase 2/3 study in Gastric Cancer or Gastroesophageal Junction Cancer sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. started in Jan 2022. NCT04856787 Phase 2/3 study in CRC due to start in May 2021 sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. NCT04650633 A Phase II,Open-label Trial to Investigate the Efficacy and Safety of SHR-1701 in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck due to start in Jan 2021. NCT04580498 is a Phase 2 Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC due to start Oct 15, 2020 NCT04679038 Phase 1/2 due to start in Jan 2021. NCT04624217 Phase 1/2 study in pancreatic cancer started in Nov 2020. NCT04324814 Phase 1 study in solid tumors recruiting as of March 2020. NCT04282070 Phase 1 in Nasopharyngeal Carcinoma not yet recruiting as of Feb 2020. NCT03710265 Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected s due to start in Nov 2018 listed as not yet recruiting as of March 5, 2019 |
| Full address of company | Lianyungang, Jiangsu Province, China. Asia China https://www.hengrui.com/en/about.html |
Immune checkpoint target. S228P F234A L235A K447A mutations SHR-1701 is an investigational bi-functional fusion protein composed of a mAb against PD-L1 fused to the extracellular domain of human TGF-β receptor II, designed to simultaneously block the two immunosuppressive signaling pathways commonly used by cancer cells. http://www.hrs.com.cn/hren/products_pipeline_oncology.html
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |