Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 174 |
| INN | None |
| Status | No development reported |
| Drug code(s) | 9MW0211, MW02, TMAB001 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rabbit B cell derived |
| Target(s) | VEGF |
| Indications of clinical studies | Macular degeneration |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | No development reported |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2011 |
| Start of Phase 2 | |
| Start of Phase 3 | May 07, 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 | Mabwell (Shanghai) Bioscience Co. Ltd. |
| Licensee/Partner | Apexigen |
| Comments about company or candidate | Nov 2024: No new information found. Aug 2022: Out-licensed Programs: Apexigen’s APXiMAB™ discovery platform has enabled the discovery of multiple protein therapeutic product candidates against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. In addition to the product candidates that the company wholly owns, several product candidates discovered through the use of the APXiMAB platform are in clinical development by the company’s licensees. The most advanced of these programs is Novartis’ Beovu® (brolucizumab-dbll) product, which received FDA approval in 2019 and is marketed in over 70 countries. Two of the company’s licensees are developing other programs in later-stage development: Simcere’s BD0801 is in Phase 3 clinical development in ovarian cancer and Mabwell’s 9MW0211 is in an adaptive, pivotal Phase 2/3 clinical trial in wet age-related macular degeneration. April 8, 2022: Apexigen filing with SEC: In May 2008, Jiangsu T-Mab Biotechnology Ltd., Co. (“T-Mab”) entered into a license, co-development and contract manufacture agreement (the “T-Mab Agreement”) with Epitomics for the development and commercialization of therapeutic candidates in two therapeutic programs, each directed to a specified target for specified fields, including VEGF for the treatment of ocular diseases, in China. Epitomics assigned the T-Mab Agreement to us in connection with our spin-out from Epitomics. Mabwell (Shanghai) Bioscience Co., Ltd. (“Mabwell”) acquired T-Mab in 2015. Mabwell is responsible for conducting the development and commercialization of the therapeutic candidates in China. We may, at our discretion, develop and commercialize such therapeutic candidates outside of China, however, we must pay Mabwell a royalty on sales of such therapeutic candidates made outside of China if we do so. Under the agreement, we granted Mabwell an exclusive, royalty-bearing, perpetual license (without the right to sublicense) to our rights in certain intellectual property that we licensed from Epitomics to develop and commercialize such therapeutic candidates. Mabwell is obligated to pay us a mid-single-digit percentage royalty on net sales of such therapeutic candidates in China. If we choose to commercialize such therapeutic candidates outside of China, we would be obligated to pay Mabwell a mid-single-digit percentage royalty on net sales of such therapeutic candidates outside of China that we sell directly to end users and a mid-single-digit percentage of revenue we receive as sublicense fees, milestone payments and royalties related to the sale of such therapeutic candidate. Each party’s obligations to pay royalties to the other party continue until a mid-teen number of years after first commercial sale of licensed product in each party’s respective territory. Mabwell is currently in Phase 3 development of 9MW0211, an anti-VEGF antibody licensed under the T-Mab Agreement. (https://www.sec.gov/Archives/edgar/data/1814140/000119312522100592/d323670ds4.htm) NCT05297292 / CTR20202561 A multicenter, randomized, double-blind study evaluating the efficacy and safety of recombinant anti-VEGF humanized monoclonal antibody injection (code MW02) in the treatment of subjects with neovascular (wet) age-related macular degeneration (nAMD) , Phase II/III clinical research with seamless design of positive control started in May 2021. Start of first Phase 1 estimated; similar / same as Suvemcitug? |
| Full address of company | BLDG 3, No 576, Libing Rd, Pudong New District, Shanghai, PRC Asia China https://www.mabwell.com/en/about.html?ab=l#mwView |
9MW0211 is an anti-VEGF antibody https://mabwell.com/en/rd.html
| Anticipated events | Termination |
| Factor(s) contributing to discontinuation | None |