Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 841 |
| INN | Becotatug |
| Status | Clinical |
| Drug code(s) | JMT101 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | EGFR |
| Indications of clinical studies | Non-Small Cell Lung Cancer, colon cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2 pivotal |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2016 |
| Start of Phase 2 | December 15, 2021 |
| Start of Phase 3 | |
| 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 | CSPC Pharmaceutical Group Limited |
| Licensee/Partner | None |
| Comments about company or candidate | Aug 2024: Launch anticipated in 2027 (https://www.cspc.com.hk/en/ir/presentations/20241H.pdf) NCT06380348 / CTR20241252 Phase 3 in NSCLC due to start in Apr 2024. NCT06319313 / CTR20240822 Phase 2/3 in NSCLC due to start in May 2024 NCT06089330 Phase 2 in colorectal cancer due to start in Jan 2024. CTR20212469 Phase 2 study in NSCLC enrolled first subject in Dec 2021; most recent hospital approval granted April 2022; in progress NCT04448379 is a Phase 1 study in NSCLC started in JUne 2020 has unknown status (last update in Dec 2020). JMT101 is a humanized monoclonal antibody targeting epidermal growth factor receptor (EGFR), with proprietary intellectual property rights. JMT101 received the IND approval from NMPA in May 2016 without supplementary filing demanded. JMT101 showed higher affinity and efficacy, and much lower immunogenicity and side effects than its congeneric products including cetuximab and panitumumab. At present, the phase I clinical trial of JMT101 in PRC has been almost completed for the potential indication of metastatic colon cancer. NCT04689100 started in April 2017. CSPC Pharmaceutical acquired Yong Shun Technology Development. |
| Full address of company | No.226 Huanghe Street, Shijiazhuang, Hebei Province, PRC 050035 Asia China https://www.cspc.com.hk/en/contacts/contactus.php |
JMT101 is an anti-EGFR IgG1 monoclonal antibody developed using cetuximab as a prototype. It shared a similar backbone with cetuximab. Through glycosylation modification, humanization and affinity maturation, JMT101 had reduced immunogenicity, less likelihood of cross-reactivity and a six-fold increase in target affinity in comparison to cetuximab. https://www.nature.com/articles/s41467-023-39139-4 See also https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.e16025
| Anticipated events | Phase 2/3 pending; Marketing application, Launch in NSCLC planned in 2027 |
| Factor(s) contributing to discontinuation | None |