High-throughput Screening Platform
Single B Cell Screening Platform
ADC Platform
Bispecific Platform
PEGylation Platform
Clinical Trials
Papers
9MW2821 is a novel anti-Nectin-4 ADC drug candidate developed by ADC platform and automated high-throughput antibody discovery platform of Mabwell. It boasts the advantages of homogenous structure, high purity and being easy production. It has also demonstrated favorable druggability properties in binding affinity, endocytosis, preliminary in vivo and in vitro pharmacodynamic activities, drug metabolism properties and preliminary safety.
9MW2921 is a next generation Antibody-Drug Conjugate (ADC) developed by Mabwell based on IDDC™ (Interchain-Disulfide Drug Conjugate) plateform for the treatment of solid tumors. It is an innovative antibody molecule linked to a novel payload (TOP1i) by a novel linker with fully autonomous intellectual property right. When 9MW2921 enters into the body, it can specifically bind to antigens on the cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug and induce the apoptosis of tumor cells.
9MW2921 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs of the same class under development at home and abroad, 9MW2921 is significantly improved and optimized in endocytic activity, plasma stability, drug release characteristics, bystander killing effect, etc. In vivo pharmacodynamic studies demonstrated that 9MW2921 had a better tumor killing activity. In animal safety evaluation models including cynomolgus monkeys and rats, the on-target and off-target toxicities of 9MW2921 were effectively controlled, indicating that 9MW2921 has good drug safety and pharmacokinetic properties.
(XGEVA® Biosimilar)
9MW0321 is a recombinant human anti RANKL monoclonal antibody injection. It can inhibit the activation of OPG/RANKL/RANK signal transduction pathway by binding with RANKL, so as to inhibit tumor growth and reduce bone damage.
8MW0511 is recombinant (Yeast-secreted) Human Serum Albumin-human Granulocyte Colony-stimulating Factor Fusion Protein for Injection. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is engineered by human serum albumin fusion technology to increase the half-life of rhG-CSF in human and prolong the dosing cycle, and to slow release of rhG-CSF and continue to promote the development and release of neutrophils, thereby reducing the incidence, duration, and severity of chemotherapy-associated neutropenia.
6MW3211, developed based on Mabwell's Bispecific Platform, is designed to selectively bind to CD47 and PD-L1 on tumor cells to attenuate CD47-SIRPα signal and block the PD-1/PD-L1 checkpoint inhibition, thereby triggering stronger tumor cell phagocytosis and enhancing T cell activation. The IgG-like structure with a common light chain is the strategy to overcome pairing problem and simplify the production process.
9MW1111 is an innovative recombinant humanized anti-PD-1 monoclonal antibody targeting PD-1 independently developed by Mabwell. By binding to PD-1 on the surface of T cells, 9MW1111 blocks the binding of PD-1 to the ligands PD-L1 and PD-L2, thus eliminating the immunosuppression of PD-1 signal transduction pathway and restoring the immune function of T cells to attack tumor cells.
8MW2311 for injection is a polyethylene glycol coupled human interleukin-2 immunoagonist for the treatment of advanced malignant tumors. After 8MW2311 is injected into the body, it can stimulate the phosphorylation of downstream transcription factor STAT5 and effectively stimulate the proliferation of killer T lymphocyte CD8+T cells, so as to exert its efficacy.
9MW3811 is an innovative humanized monoclonal antibody against IL-11, which can bind IL-11 through high affinity and effectively block the activation of IL-11 downstream signal pathway being developed for fibrosis and oncology.
6MW3511 is a bifunctional group drug protein independently constructed by Mabwell using humanized anti-PD-L1 nanobodies to link to TGF-β RII mutants. The mutant design facilitates the maintenance of whole-molecule stability and reduces degradation of the natural TGF-β group during the manufacture process and in vivo. By blocking PD-1/PD-L1 and TGF-β/TGF-β-R dual pathways simultaneously, and with the excellent local tumor penetrability resulting from the concise structure, 6MW3511 is expected to further address the difficult problem of immunosuppression in the tumor microenvironment. The results of preclinical studies showed that 6MW3511 injection had good in vivo anti-tumor efficacy and good tolerability in animals. It is intended to be used clinically for the treatment of a variety of advanced solid tumors.
9MW3911 is a non-IL-2 blocking CD25 monoclonal antibody with independent intellectual property rights developed by a highly effective Single B Cell Screening Platform. This product selectively removes CD25-overexpressing regulatory T cells (Treg) mainly through antibody-dependent cell-mediated cytotoxicity (ADCC) without blocking IL-2 signaling pathway, thus modulates tumor microenvironment and enhances tumor immunity. Pre-clinical studies showed that 9MW3911 had good in vivo anti-tumor efficacy and good tolerability in animals.
(Humira® Biosimliar)
JUNMAIKANG® is a recombinant humanized anti-TNF-α monoclonal antibody injection jointly developed by Mabwell and Junshi Biosciences. The mechanism is that the antibody binds to TNF-α and reduces the TNF-α-activated immune response, thereby inhibiting the inflammatory response.
9MW1911 is an innovative humanized monoclonal antibody drug independently developed by Mabwell, a domestic pharmaceutical company in China. The drug’s antibody molecule is derived based on the B-lymphocyte screening platform, and the product is characterized by higher binding affinity and potent biological activity. Nonclinical studies have shown that the in vivo mechanism of action of this product in animals was definite and clear. After binding specifically to the target ST2, it blocks the activation of ST2-mediated signaling pathway induced by cytokine IL-33, hence inhibiting the inflammatory reactions and achieving therapeutic effects in multiple auto-immune diseases.
9MW3811 is an innovative humanized monoclonal antibody against IL-11, which can bind IL-11 through high affinity and effectively block the activation of IL-11 downstream signal pathway being developed for fibrosis and oncology.
(Prolia® Blosimilar)
9MW0311 is an independently developed recombinant fully humanized anti-RANKL monoclonal antibody injection. The mechanism of action is that after the combination of RANKL, it can prevent the activation of RANK, inhibit the formation, activation and survival of osteoclasts, and reduce bone resorption, so as to eliminate the symptoms of systemic osteoporosis or local osteolysis.
9MW3011 is monoclonal antibody with an innovative target. It is independently developed by Innovation R&D Center of Mabwell in San Diego, U.S., belonging to Category 1 Therapeutic Biological Products. With its target mainly expressed on the surfaces of liver cell membranes, 9MW3011 can upregulate the level of hepcidin expressed by hepatocytes through specific binding, inhibit the absorption and release of iron, and lower the serum iron level, thus regulating the iron homeostasis in vivo. The proposed indications of 9MW3011 include a variety of diseases classified as rare in different regions of the world, such as β-thalassemia, polycythemia vera and other diseases related to iron homeostasis. There are no mature and effective macromolecular drugs for the relevant indications so far. 9MW3011 is expected to be designated as an orphan drug in the future and become the first-in-class macromolecular drug to regulate iron homeostasis in vivo.
(Eylea® Biosimilar)
9MW0813 is an independently developed recombinant human VEGF receptor-antibody fusion protein. 9MW0813 is a fusion protein formed by recombining the extracellular region binding domains of VEGFR-1 and VEGFR-2 with the Fc segment of human immunoglobulin, which can bind to VEGF-A and PlGF, and has wide applications scope. It is expected to be complementary in the treatment of ocular diseases related to neovascularization.
9MW0211 is a recombinant anti-VEGF humanized monoclonal antibody obtained based on rabbit monoclonal antibody and humanization modification technology. It can specifically bind to VEGF-A, the most active protein in VEGF family, and block its binding to receptors on the surface of endothelial cells, reducing vascular permeability and blocking the generation and development of neovascularization, and reducing leakage caused by neovascularization, thus achieving the treatment of neovascularization-related eye diseases such as neovascular (wet) age-related macular degeneration.
Mabwell has built an automatic high-throughput hybridoma antibody new molecular discovery platform, which is equipped with international advanced equipment, has an independently integrated workstation system, and is combined with a variety of animal immune technologies, efficient and stable hybridoma electrofusion technology, serum-free hybridoma suspension culture technology, real-world flow screening technology and many other underlying technologies. Meanwhile, in the antibody engineering transformation optimization system composed of computer-aided design and various display technologies, the platform adds physical and chemical stability indicators such as antibody expression characteristics, molecular binding epitope and hydrophobicity to ensure that the obtained innovative molecules meet the needs of industrialization. In addition, the platform also has a unique affinity mature transformation technology. On the basis of maintaining the activity of antibody molecules, it can greatly improve the binding affinity of antibody molecules, effectively improving the probability of druggability of innovative molecules.
Advantages： 1) The target development scope is wider and the immune success rate is improved from the source.
2) Highly efficient, stable and reproducible hybridoma electrofusion technique, increasing the hybridoma screening abundance, and being conducive to obtaining candidate antibody molecules.
3) Workflow integrating manipulator and high-throughput antibody sorting equipment.
4) Serum free hybridoma suspension culture significantly accelerated the cloning and screening and reduce the incidence of false positive.
5) Antibody multi property evaluation system for cell stereoepitope level.
Mabwell’s high efficiency B lymphocyte screening platform is based on the direct separation of antigen-specific B lymphocytes from the spleen of immunized animals and human peripheral blood, and the antigen-specific B lymphocytes were enriched and the primary B lymphocytes were cloned and expanded by using the proprietary technology of efficient panning and clonal amplification. The use of efficient panning technology has achieved the screening of one hundred thousand B lymphocytes that can specifically bind to antigen from one hundred million B lymphocytes, the positive rate of secreted antibody binding to antigen is more than 90%, which significantly improves the discovery rate of high affinity antibody molecules, reduces the loss of positive B lymphocytes and improves the abundance of candidate antibodies in the process of panning. The high affinity antibody gene that is difficult to obtain by conventional cell fusion can be obtained by using the high-efficiency B lymphocyte screening technology, thus, better candidate antibody molecules are obtained, which enriches the technical means of new antibody molecule discovery.
Advantages： 1) The positive rate of antigen-specific B lymphocytes was significantly increased.
2) Naturally stable antibody sequences can be obtained by screening.
3) The antibody molecular screening process has high fidelity, and the operating samples can be frozen for a long time.
4) Antibody molecular screening has strong pertinence and low research cost.
5) The technique is highly versatile and can achieve cross-species adaptation.
Mabwell’s ADC Platform is established based on two third-generation antibody coupled drug technologies, namely bridged fixed-point coupling technology and dispersed fixed-point coupling technology. Two different coupling technologies have submitted patent applications for connexon. The coupling process is reliable and the coupling product is more uniform and better than the ADC developed by other bridging fixed-point technologies. Compared with other types of antibody-drug conjugates, it has better pharmacokinetics, pharmacological and toxicological characteristics.
Advantages： 1) Two different coupling technologies can develop ADC drugs for different types of high activity small molecule drugs.
2) The two different coupling techniques are applicable to the common antibody IgG1, and the natural antibody sequence can be used directly.
3) The conjugates have excellent uniformity, simplified process, easy quality control, and can significantly expand the therapeutic window in the process of use.
Mabwell's Bispecific Platform has three mature design schemes of Fc fusion protein like double antibodies in the form of common light chain, heterodimer structure and head tail structure, which can be optimized according to the characteristics of different double antibodies/proteins, The key common problems of engineering cell line screening, production process and quality control were solved, which laid a foundation for the comprehensive expansion of double antibody technology.
Advantages： 1) Differential design based on the molecular characteristics and functional requirements of the antibody reduces the difficulty of process development and quality control in the development stage and even the commercial production stage.
2) Take design as the source to solve the difficulties in process development, improve the stability of antibody molecules, improve the expression in the culture process.
3) Significantly reduce the production cost of bispecific/bifunctional antibodies, make the products more clinically accessible after commercialization.
This technology platform adopts the latest reversible release modification technology in vivo to couple PEG with recombinant protein drugs through degradable connexon to obtain protein drugs with new structure and physicochemical properties. This modification technology is developed based on the first generation technology of random multi-point modification and the second generation technology of fixed-point modification, forming a unique production process and quality control proprietary technology, which has been verified by product development.
Advantages： 1) Inactive prodrug design to reduce toxicity.
2) Conditionally dependent release increases efficacy
3) Prolonged dosing interval and increased compliance
4) Strict quality control to meet the most stringent commercial needs
