Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 82 |
| INN | Camrelizumab |
| Status | Approved |
| Drug code(s) | INCSHR1210, SHR-1210 |
| Brand name | AiRuiKa |
| 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 | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Esophageal Carcinoma, Hepatocellular Carcinoma, non-small cell lung cancer, melanoma, Advanced solid tumors, Nasopharyngeal Carcinoma, Hodgkin lymphoma, breast cancer, incl. triple-negative |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | May 15, 2017 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2019 |
| Date of first US approval | |
| INN, US product name | Camrelizumab |
| US or EU approved indications | None |
| Company | Jiangsu HengRui Medicine Co. Ltd |
| Licensee/Partner | Incyte, Atridia |
| Comments about company or candidate | Oct 2024: Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) accepted the resubmission of a new drug application (NDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2025. May 2024: FDA issues Complete Response Letter regarding its hepatocellular carcinoma (HCC) combination treatment candidate of rivoceranib and camrelizumab. 출처 : KBR(https://www.koreabiomed.com); https://static.sse.com.cn/disclosure/listedinfo/announcement/c/new/2024-05-18/600276_20240518_01L3.pdf July 17, 2023 – Elevar Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 16, 2024. May 17, 2023 – Elevar Therapeutics, Inc. announced it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma. Oct 2022: Elevar Therapeutics, Inc. (formerly LSK BioPharma) announced a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib in combination with camrelizumab as a treatment option for hepatocellular carcinoma (HCC), the most common type of liver cancer and cause of more than 830,000 annual deaths worldwide. The meeting reaffirmed Elevar’s plans to file an NDA for the combination of rivoceranib plus camrelizumab as early as is feasible in 2023. May 2022: Jiangsu Hengrui Medicine said a global phase 3 trial of its PD-1 inhibitor camrelizumab and VEGFR inhibitor apatinib, also known as rivoceranib, have hit its goals in newly diagnosed patients of liver cancer. The company plans to submit a BLA for the drug combination. NCT04335006 Phase 3 in breast cancer not yet recruiting when posted on April 6, 2020. Conditional approval granted in China in May (?) 2019 for the treatment of relapsed or refractory classical Hodgkin lymphoma (https://endpts.com/fast-moving-chinese-regulators-wave-third-homegrown-pd-1-to-market/). April 8, 2019: LSK BioPharma (or "LSKB"), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or "Hengrui"), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced that the Companies have received FDA clearance to initiate a clinical trial in the United States in first-line patients with advanced hepatocellular carcinoma (HCC), evaluating the safety and efficacy of LSKB's rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, in combination with Hengrui's camrelizumab (SHR-1210), a humanized anti-PD-1 monoclonal antibody currently under NDA review in China for classic Hodgkin's Lymphoma (cHL).NCT03707509 Phase 3 study in Nasopharyngeal carcinoma and Esophageal cancer, NCT03645876 Phase 2 in colorectal cancer recruiting as of Nov 2018. NCT03691090 Phase 3 study started in Dec 2018. Jan 17 2019. NCT03605706 Phase 3 study in hepatocellular carcinoma recruiting as of July 1, 2018. A marketing application for camrelizumab for relapsed/refractory classic Hodgkin’s Lymphoma was submitted by Hengrui to China NMPA, which was accepted in April 2018, and is currently under review. Phase 3 NCT03099382 in Esophageal Carcinoma recruiting as of May 10, 2017. NCT03134872 Phase 3 study in NSCLC recruiting as of May 25, 2017. NCT02989922 Phase 2/3 study in HCC recruiting as of Nov 2016. NCT02721589 Phase 1 sponsored by Jiangsu HenRui Medicine Co. recruiting as of Oct 2016. NCT02492789 Phase 1 is solid tumors recruiting as of Nov 23 2015. Atridia located in New South Wales, Australia, but does not have web site; start-up as of June 2015. Company may be affiliated with, or licensed this anti-PD-1 mAb from, Jiangsu Hengrui Medicine Co. Ltd. On Sep 2 2015, Incyte Corporation (Nasdaq: INCY) announced a global license and collaboration agreement with Jiangsu Hengrui Medicine Co., Ltd. for the development and commercialization of SHR-1210, an investigational anti-PD-1 monoclonal antibody. Under the agreement, Incyte will have the exclusive development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan |
| Full address of company | No.7 Kunlunshan Road, Lianyungang Eco & Tech Development Zone, Jiangsu, 222000 Asia China https://www.globaldata.com/company-profile/jiangsu-hengrui-medicine-co-ltd/#:~:text=Jiangsu%20Hengrui%20is%20headquartered%20in%20Lianyungang%2C%20Jiangsu%20Province%2C%20China. |
Immune checkpoint inhibitor. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
| Anticipated events | Regulatory review US- March 20, 2025 PDUFA date |
| Factor(s) contributing to discontinuation | None |