Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 314 |
| INN | Suvemcitug |
| Status | Regulatory review |
| Drug code(s) | APX003, BD0801; TK001, Sevacizumab (not WHO assigned INN) |
| Brand name | ENZESHU |
| 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 | Rabbit B cell derived |
| Target(s) | VEGF |
| Indications of clinical studies | Ovarian Cancer, macular degeneration |
| 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) | March 15, 2011 |
| Start of Phase 2 | February 15, 2017 |
| Start of Phase 3 | June 11, 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 Simcere Pharmaceutical Co. Ltd. |
| Licensee/Partner | Apexigen |
| Comments about company or candidate | March 15, 2024, Simcere Zaiming Pharmaceutical Co. Ltd. announced that, the new drug application of Suvemcitug for injection has been accepted by the China National Medical Products Administration (NMPA). It is intended to be used in patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Phase 3 study Ovarian cancer (NCT04908787) is recruiting as of December 29, 2022. Aug 2022: Confirmed as Phase 3 in Simcere's pipeline. Confirmed as Phase 3 in Aug 27, 2021 press release (http://en.simcere.com/news/detail.aspx?mtt=159) NCT04908787 Phase 3 in Platinum-resistant Epithelial Ovarian Cancer due to start in June 2021. Still listed as Phase 2 on Apexigen website accessed Dec 2020. NCT03763123 Phase 1 started in April 2018 recruiting as of last update in Dec 2018. Adverse events and efficacy data from a phase Ib trial in Colorectal cancer presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO-2018; Xu et al. J Clin Oncol 36, 2018 (suppl; abstr e15530)). Conclusions: Preliminary results from this study showed good efficacy of sevacizumab in mCRC patients and the study also provide good insights of dose selection in future clinical development of sevacizumab. Clinical trial information: NCT02453464, completed in 2015. Listed on Apexigen website as Phase 2 as of Feb 2017. NCT03021785 Phase 1 study sponsored by Jiangsu T-Mab Biopharma Co.,Ltd started Oct 2017 still recruiting patients as of March 2018. Partner is Apexigen. Status of NCT01847118 Phase 1 study is unknown as of Dec 2016; last updated in March 2015, started in April 2013, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. In 2008, Simcere acquired rights to APX003 from Epitomics, Inc. Then in July of 2010, Epitomics created Apexigen as an independent therapeutic antibody company, licensed to Apexigen exclusive rights to the use of its antibody technologies for the development and commercialization of antibody therapeutics, and assigned to Apexigen the license and collaboration agreement with Simcere. Apexigen and Simcere collaborated on the IND enabling studies and on the completion of the IND for APX003. Description of development similar to that of 9MW0211. |
| Full address of company | 699-18 Xuanwu Avenue Nanjing China Asia China https://en.simcere.com/ |
Molecule described in https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl128.pdf?sfvrsn=889fe54b_3&download=true
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |