Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 118 |
| INN | Disitamab vedotin |
| Status | Approved |
| Drug code(s) | RC48-ADC, Vedicitumumab |
| Brand name | Aidixi |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine-Citrulline, Cleavable linker |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | Melanoma, Biliary Tract Cancer, Non-Small Cell Lung Cancer, Urothelial Carcinoma, HER2-overexpressing solid tumors (gastric, urothelial), breast cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2015 |
| Start of Phase 2 | December 28, 2017 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2021 |
| Date of first US approval | |
| INN, US product name | Disitamab vedotin |
| US or EU approved indications | None |
| Company | RemeGen |
| Licensee/Partner | Seagen Inc. |
| Comments about company or candidate | August 09, 2021: Seagen Inc. and RemeGen Co., Ltd. (9995.HK), a leading innovative biopharmaceutical company in China, announced that the two companies have entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC. June 9, 2021: Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept). The ADC was approved for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least 2 types of systemic chemotherapy. http://www.remegen.cn/Invest2.aspx?ID=342 NCT04714190 Phase 3 in gastric cancer due to start in Jan 2021 not yet recruiting when first posted on Jan 19, 2021. Aug 2020: Based on the results of trial, we submitted our NDA to the NMPA for conditional approval of disitamab vedotin for GC, which was accepted and granted priority review by the NMPA in August 2020. September 25, 2020 I RemeGen Co., Ltd. ("RemeGen") today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for disitamab vedotin (RC48), a novel humanized anti-HER2 antibody drug conjugate (ADC), for the second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer (UC) who have also previously received platinum-containing chemotherapy treatment. April 29, 2020: RemeGen announced that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase II clinical trial of RC48 NCT04329429 Phase 2 study in Biliary Tract Cancer started in March 2020 (recruiting when first posted on April 1, 2020) Phase 2 studies in gastric cancer and UC are considered pivotal. NCT04073602 Phase 2 in urothelial carcinoma started in Aug 2019. NCT04311034 Phase 1/2 in NSCLC started in Sep 2018. Jan 2019: 4 Phase 2 studies listed on clinicaltrials.gov as recruiting (NCT03809013, NCT03507166, NCT03556345, NCT03500380). RemeGenhas developed the new ADC drug RC48 which has been approved by CFDA for clinical study in September 2015. RC48 is the first ADC new drug in China that has been approved by CFDA for clinical trial. RC48 is mainly used for the treatment of Her2 over-expression gastric cancer, lung cancer, breast cancer, ovarian cancer, and bladder cancer. In 2008, RemeGen, Ltd. was jointly established by Rongchang Pharma and Professor Fang Jianmin. |
| Full address of company | 58 Beijing Middle Road, Yantai Shandong, China Asia China https://www.remegen.com/index.php?v=listing&cid=131 |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |