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Products
Pipeline
Innovative Platforms
  • Automatic High-throughput Hybridoma Antibody Molecular Discovery Platform

  • Single B Cell Screening Platform

  • ADC Platform

  • Bispecifics Platform

R&D Progress
  • Clinical Trials

  • Papers

Products

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MAIWEIJIAN Denosumab biosimilar
MAILISHU Denosumab biosimilar
JUNMAIKANG Adalimumab biosimilar
Pipeline
Key Novel Drug Candidates
9MW2821
9MW1911
9MW3011
9MW3811
1MW5011
9MW2821
9MW1911
9MW3011
9MW3811
1MW5011
? ?
9MW2821
Target: Nectin-4 ADC
Ongoing Phase III trials: urothelium carcinoma (UC) monotherapy/combination therapy (2nd globally, 1st in Chinese company), cervical cancer (CC) monotherapy (1st globally)
First Nectin-4-targeting drug candidate to reveal clinical efficacy data of CC, esophageal cancer (EC) and triple-negative breast cancer (TNBC)
Granted?Fast Track Designation (CC, ESCC, TNBC)/Orphan Drug Designation (EC)?by US FDA, and Breakthrough Therapy Designation (UC) by China NMPA
Advantages

Based on the IDDC? platform of Mabwell, 9MW2821 reveals the advantages of homogenous structure, high purity, with simple production process. 9MW2821 has achieved positive clinical outcomes in multiple tumor indications.

9MW1911
Target: ST2
First anti-ST2 antibody developed by Chinese company to enter clinical trial & second tier globally in terms of development progress
Great potential in the field of chronic obstructive pulmonary disease (COPD)
Phase Ib/IIa study ongoing
No antibodies targeting ST2 or its ligand IL-33 has been launched worldwide
Mechanism of Action

By specifically binding to the target ST2, 9MW1911 blocks the activation of the ST2-mediated signaling pathway induced by cytokine IL-33, inhibiting inflammatory reactions and achieving therapeutic effects in multiple auto-immune diseases.

9MW3011
Target: TMPRSS6
First anti-TMPRSS6 antibody in China & top tier globally(R&D code in the US: MWTX-003/DISC-3405)
Proposed indications include β-thalassemia and polycythemia vera
Granted Fast Track Designation/Orphan Drug Designation by US FDA
Advantages

Compared to small molecules, peptides, and gene therapy drugs or drug candidates, 9MW3011 reveals the advantages of a long half-life, great safety profile, and reduced treatment costs. The scarcity of effective therapies for related indications can position itself as a promising macromolecular drug candidate for regulating iron homeostasis globally.

9MW3811
Target: IL-11
First anti-IL-11 antibody to enter clinical trial in China & top tier globally
Great potential in the field of idiopathic pulmonary fibrosis (IPF)
Approved to initiate clinical study in China, Australia & US; Phase I study is ongoing in China & Australia
Mechanism of Action

9MW3811 effectively blocks the activation of IL-11 downstream signal pathway being developed for fibrosis and oncology. Preclinical study result has been published on AACR.

1MW5011
Target: Small molecule drug
First in class potential in treating osteoarthritis
Oral administration, more portable and better tolerated for long-term treatment
No structural damage inhibitors for osteoarthritis is available yet
Mechanism of Action

After oral intake into the human body, 1MW5011 can be rapidly converted into N-butyrylglucosamine in the body and enriched in the joint cavity, which improves cartilage destruction in osteoarthritis patients by increasing the anabolic metabolism and decreasing the catabolic metabolism of articular cartilage, and indirectly improves the bioavailability of N-butyryl glucosamine, and thus exerts a therapeutic effect on osteoarthritis.

Product
Target
Pre-Clinical
IND
Phase I Phase I
Phase II Phase II
Phase III Phase III
NDA/BLA NDA/BLA
Launched
9MW2821
- Nectin-4 ADC
Nectin-4 ADC

UC combination (1L)

UC monotherapy (2L+)

CC monotherapy (2L/3L)

ESCC

TNBC combination (1L)

TNBC monotherapy

Other solid tumors

9MW2821
Phase III clinical trial in urothelium carcinoma (UC) is ongoing (Global ranking: 2nd, China: 1st)

First Nectin-4-targeting drug candidate to reveal clinical efficacy data of cervical cancer (CC), esophageal cancer (EC) and triple-negative breast cancer (TNBC)

Granted Fast Track Designation (FTD) & Orphan Drug Designation (ODD) by U.S. FDA,Breakthrough Therapy Designation (BTD) by CDE of NMPA

9MW2821 is a novel Nectin-4 targeting ADC 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.

Clinical Study results (updated by June 5, 2024):

UC (37 patients evaluable for efficacy assessment):

ORR: 62.2%, DCR: 91.9%, mPFS: 8.8 months, mOS: 14.2 months.

CC (53 patients evaluable for efficacy assessment):

ORR: 35.8%, DCR: 81.1%, mPFS: 3.9 months, mOS not yet reached.

Nectin-4 tumor cell staining intensity 3+ (39 patients): ORR 43.6%.

EC (39 patients evaluable for efficacy assessment):

ORR: 23.1%, DCR: 69.2%, mPFS: 3.9 months, mOS: 8.2 months.

TNBC (20 patients with locally advanced or metastatic triple-negative breast cancer evaluable for efficacy assessment))

ORR: 50%, DCR: 80.0%, mPFS: 5.9 months, mOS not yet reached.
7MW3711
- B7-H3 ADC
B7-H3 ADC

Advanced solid tumor

7MW3711
7MW3711 is a novel B7-H3 targeting ADC developed by Mabwell's IDDC? platform for the treatment of advanced malignant solid tumors. It is composed of innovative antibody molecule, novel linker, and novel payload (TOP1i). When 7MW3711 enters human body, it specifically binds to antigens on the tumor cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug, and induce the apoptosis of tumor cells.

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs in the same class at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. In the safety evaluation model of animals including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 are effectively controlled, showing its good safety profile and pharmacokinetic properties. The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development.
9MW2921
- Trop-2 ADC
Trop-2 ADC

Advanced solid tumor

9MW2921
9MW2921 is a novel trop-2 targeting ADC developed by Mabwell's IDDC? platform for the treatment of advanced solid tumors. It is composed of innovative antibody molecule, novel linker and novel payload (TOP1i) . When 9MW2921 enters the body, it specifically binds 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 safety profile and pharmacokinetic properties.
MAIWEIJIAN
- RANKL
RANKL
Approved in China

Giant cell tomor of bone*

MAIWEIJIAN
MAIWEIJIAN is the first Xgeva? biosimilar approved in China for the treatment of giant cell tumor of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development (defined as having at least one mature long bone and a weight of ≥ 45kg).
8MW0511
- HSA-G-CSF
HSA-G-CSF

Febrile neutropenia caused by anti-cancer drugs*

8MW0511
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.

New drug application of 8MW0511 has been accepted by NMPA for use in adult patients with non-myeloid malignant neoplasms to reduce the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer drugs that are susceptible to febrile neutropenia.
6MW3211
- CD47/PD-L1
CD47/PD-L1

Malignant advanced tumor

6MW3211
6MW3211, developed based on Mabwell's Bispecifics 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.
9MW3811
- IL-11
IL-11

Malignant advanced tumor

9MW3811
First anti-IL-11 antibody to enter clinical trial in China & top tier globally

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.

Preclinical study showed that 9MW3811 bound to IL-11 with high affinity, effectively blocked the activation of IL-11 signaling pathway, specifically regulated the interaction of tumor cells with T cells, macrophages, and tumor-associated fibroblasts, and thus enhanced the release of inflammatory cytokines in the tumor microenvironment, and increased the infiltration of T cells. Combination anti-tumor efficacy with anti-PD1 antibodies has been observed in a variety of solid tumor models.
JUNMAIKANG
- TNF-α
TNF-α
Approved in China

8 indications (Rheumatoid arthritis, etc. )*

JUNMAIKANG
JUNMAIKANG (Humira? biosimliar) 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. JUNMAIKANG has been approved by NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis, crohn's disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and pediatric Crohn's disease.
9MW1911
- ST2
ST2

COPD, asthma & atopic dermatitis

9MW1911
First anti-ST2 antibody developed by Chinese company to enter clinical trial & second tier globally in terms of development progress

9MW1911 is an innovative humanized monoclonal antibody 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
- IL-11
IL-11

Idiopathic pulmonary fibrosis

9MW3811
First anti-IL-11 antibody to enter clinical trial in China & top tier globally

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.

In preclinical studies of fibrotic diseases, 9MW3811 significantly reduced the area of pulmonary fibrosis, reduced the content of lung collagen and improved lung function in mice with fibrosis, making it a promising therapeutic agent for idiopathic pulmonary fibrosis and other diseases.
MAILISHU
- RANKL
RANKL
Approved in China

Treatment of postmenopausal women with osteoporosis at high risk for fracture

MAILISHU
MAILISHU (9MW0311) is the second approved Prolia? biosimilar. It is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures by acting as a RANKL (receptor activator of Nf-kB ligand) inhibitor to prevent osteoclastic-medicated bone resorption.
1MW5011
- -
-

Osteoarthritis

1MW5011
1MW0511 (RP901) is poised to revolutionize osteoarthritis treatment, administered orally to accumulate in the joint cavity where it can mitigate cartilage destruction. By promoting anabolism and curbing catabolism of joint cartilage, RP901 has demonstrated potent bone protection and therapeutic effects in osteoarthritis patients. Preclinical studies have underscored its high oral bioavailability in rats and monkeys, and isotopically labeled studies have demonstrated that it is well-distributed within the bone joint, while safety profiles from preclinical and Phase I clinical trials have been reassuring.
9MW0813
- VEGF-Trap
VEGF-Trap

Diabetic macular edema, neovascular (wet) age-related macular degeneration

9MW0813
9MW0813 (Eylea? biosimilar) 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
- VEGF
VEGF

Neovascular (wet) age-related macular degeneration

9MW0211
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.
9MW3011
- TMPRSS6
TMPRSS6

Iron overload disorders including β-thalassemia, polycythemia vera

9MW3011
First anti-TMPRSS6 antibody in China & top tier globally

9MW3011 (R&D code in the US: MWTX-003/DISC-3405) is an anti-TMPRSS6 antibody developed by Innovation R&D Center of Mabwell in San Diego, U.S. 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 β-thalassemia and polycythemia vera. At present, there are no mature and effective macromolecular drug for relevant indications. FDA has granted Fast Track Designation (FTD) & Orphan Drug Designation (ODD) to 9MW3011.

Mabwell has granted DISC Medicine, INC. (NASDAQ:IRON) exclusive rights to develop and commercialize 9MW3011 in the United States, Europe, and other territories excluding Great China and Southeast Asia.
9MW1411
- α-toxin
α-toxin

Staphylococcus aureus infection

9MW1411
9MW1411 is developed based on the technology of automated high-throughput hybridoma antibody molecule discovery platform. The mechanism of action of 9MW1411 is that the drug binds to α-toxin protein monomer, thus blocking the binding of α-toxin monomer to the receptor ADAM10 on the surface of cell membrane, inhibiting the toxicity of α-toxin to human cells, protecting the barrier of epithelial tissue from damage, and alleviating inflammatory reactions, therefore reducing the detrimental effect of Staphylococcus aureus infection to patients.
*Please refer to product insert or clinical trial registration information for a complete list of indications
Innovative Platforms
Automatic High-throughput Hybridoma Antibody Molecular Discovery Platform

Mabwell's automatic high-throughput hybridoma antibody molecular discovery platform, 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

    01The target development scope is wider and the immune success rate is improved from the source.

    02Highly efficient, stable and reproducible hybridoma electrofusion technique, increasing the hybridoma screening abundance, and being conducive to obtaining candidate antibody molecules.

    03Workflow integrating manipulator and high-throughput antibody sorting equipment.

    04Serum free hybridoma suspension culture significantly accelerated the cloning and screening and reduce the incidence of false positive.

    05Antibody multi property evaluation system for cell stereoepitope level.

Single B Cell Screening Platform

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

    01The positive rate of antigen-specific B lymphocytes was significantly increased.

    02Naturally stable antibody sequences can be obtained by screening.

    03The antibody molecular screening process has high fidelity, and the operating samples can be frozen for a long time.

    04Antibody molecular screening has strong pertinence and low research cost.

    05The technique is highly versatile and can achieve cross-species adaptation.

ADC Platform

Mabwell's ADC Platform is established based on two 3rd-generation antibody conjugation technologies. Both technologies have submitted patent applications. 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

    01Two different coupling technologies can develop ADC drugs for different types of high activity small molecule drugs.

    02The two different coupling techniques are applicable to the common antibody IgG1, and the natural antibody sequence can be used directly.

    03The conjugates have excellent uniformity, simplified process, easy quality control, and can significantly expand the therapeutic window in the process of use.

Interchain-Disulfide Drug Conjugate (IDDC?) platform

IDDC? is a next generation ADC site-specific conjugation technology platform independently developed by Mabwell. It is composed of multiple systematized core patent technologies including site-specific conjugate process DARfinity?, special designed linker IDconnect?, novel payload Mtoxin?, and conditional release structure LysOnly?, which improves structural homogeneity, quality stability, pharmacodynamics and tolerability of the ADC products.

Patent Technologies
    01 DARfinity?

    Site-specific conjugation technology

    Increasing structural homogeneity of drug

    02 IDconnect?

    Stable interchain disulfide bonds

    Enhancing the stability of ADC during metabolism

    03 LysOnly?

    Efficient and stable release structure

    Showing great stability / Stable in the bloodstream

    Dependent on specific enzymes for degradation

    Reducing off-target toxicity

    04 Mtoxin? Payload

    Novel topoisomerase inhibitors

Bispecifics Platform

Mabwell's Bispecific Antibody 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

    01Differential 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.

    02Take design as the source to solve the difficulties in process development, improve the stability of antibody molecules, improve the expression in the culture process.

    03Significantly reduce the production cost of bispecific/bifunctional antibodies, make the products more clinically accessible after commercialization.

Automatic High-throughput Hybridoma Antibody Molecular Discovery Platform

Single B Cell Screening Platform

ADC Platform

Bispecifics Platform

Automatic High-throughput Hybridoma Antibody Molecular Discovery Platform

Mabwell's automatic high-throughput hybridoma antibody molecular discovery platform, 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

    01The target development scope is wider and the immune success rate is improved from the source.

    02Highly efficient, stable and reproducible hybridoma electrofusion technique, increasing the hybridoma screening abundance, and being conducive to obtaining candidate antibody molecules.

    03Workflow integrating manipulator and high-throughput antibody sorting equipment.

    04Serum free hybridoma suspension culture significantly accelerated the cloning and screening and reduce the incidence of false positive.

    05Antibody multi property evaluation system for cell stereoepitope level.

Single B Cell Screening Platform

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

    01The positive rate of antigen-specific B lymphocytes was significantly increased.

    02Naturally stable antibody sequences can be obtained by screening.

    03The antibody molecular screening process has high fidelity, and the operating samples can be frozen for a long time.

    04Antibody molecular screening has strong pertinence and low research cost.

    05The technique is highly versatile and can achieve cross-species adaptation.

ADC Platform

Mabwell's ADC Platform is established based on two 3rd-generation antibody conjugation technologies. Both technologies have submitted patent applications. 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

    01Two different coupling technologies can develop ADC drugs for different types of high activity small molecule drugs.

    02The two different coupling techniques are applicable to the common antibody IgG1, and the natural antibody sequence can be used directly.

    03The conjugates have excellent uniformity, simplified process, easy quality control, and can significantly expand the therapeutic window in the process of use.

Interchain-Disulfide Drug Conjugate (IDDC?) platform

IDDC? is a next generation ADC site-specific conjugation technology platform independently developed by Mabwell. It is composed of multiple systematized core patent technologies including site-specific conjugate process DARfinity?, special designed linker IDconnect?, novel payload Mtoxin?, and conditional release structure LysOnly?, which improves structural homogeneity, quality stability, pharmacodynamics and tolerability of the ADC products.

Patent Technologies
    01 DARfinity?

    Site-specific conjugation technology

    Increasing structural homogeneity of drug

    02 IDconnect?

    Stable interchain disulfide bonds

    Enhancing the stability of ADC during metabolism

    03 LysOnly?

    Efficient and stable release structure

    Showing great stability / Stable in the bloodstream

    Dependent on specific enzymes for degradation

    Reducing off-target toxicity

    04 Mtoxin? Payload

    Novel topoisomerase inhibitors

Bispecifics Platform

Mabwell's Bispecific Antibody 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

    01Differential 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.

    02Take design as the source to solve the difficulties in process development, improve the stability of antibody molecules, improve the expression in the culture process.

    03Significantly reduce the production cost of bispecific/bifunctional antibodies, make the products more clinically accessible after commercialization.

R&D Progress
Clinical Trials
2024-08-14
Mabwell's Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by CDE of NMPA
?
2024-07-16
FDA Grants Orphan Drug Designation to 7MW3711
?
2024-07-15
Mabwell Receives NMPA Approval for Clinical Trial of Novel Nectin-4 Targeting ADC in TNBC
?
2024-07-12
FDA Grants Fast Track Designation to 9MW2821 for the Treatment of Patients with Locally Advanced or Metastatic Nectin-4 Positive TNBC
?
2024-05-24
Mabwell Announces 9MW2821 Clinical Data and Latest Progress to be presented at 2024 ASCO Annual Meeting
?
2024-05-14
FDA Grants Fast Track Designation to 9MW2821 for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer
?
2024-05-12
Mabwell Announces Clinical Trial Progress of 9MW2821 in Triple-Negative Breast Cancer
?
2024-05-06
FDA Grants Orphan Drug Designation to 9MW2821
?
2024-03-18
SGO 2024 | The First Published Clinical Data of Nectin-4-Targeting ADC Developed by Mabwell in Cervical Cancer Demonstrates Its Outstanding Therapeutic Potential
?
2024-02-25
FDA Grants Fast Track Designation to 9MW2821
?
2024-02-18
FDA Grants Orphan Drug Designation to 9MW3011
?
2024-02-18
Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711
?
2023-12-07
Mabwell Announces the CDE Approval of Novel Nectin-4 Targeting ADC for Phase III Clinical Trial
?
2023-09-27
Mabwell Announces First Patient Dosed in Phase Ib/II Trial of its Novel Nectin-4 Targeting ADC in Combination with PD-1 Inhibitor
?
2023-09-05
Mabwell Announces the First Patient Dosed in the Clinical Studies of 2 Novel ADCs
?
2023-07-17
Mabwell Announces the NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND
?
2023-07-14
Mabwell Announces the NMPA Approval of Novel Trop-2 ADC (9MW2921) for IND
?
2023-06-15
Mabwell Announces the U.S. FDA approval of 9MW3811 for IND
?
2023-03-16
Mabwell's Clinical Trial Application for 9MW3811 Accepted by NMPA
?
2023-05-18
Clinical Trial Application for 7MW3711 - an Innovative Drug Developed by Mabwell's ADC Platform, Accepted by NMPA
?
2023-03-13
Mabwell Launched First in human Clinical Trial of Its Iron Homeostasis Regulating Macromolecular Drug 9MW3011
?
2023-03-03
Mabwell's Clinical Trial Application for 9MW3911 Injection - An Innovative Drug, Accepted by NMPA
?
2023-02-27
First in Class, Mabwell Announces the TGA Approval of 9MW3811 for IND
?
2023-02-05
Accelerating Development of Mabwell's ADC Plateform: Clinical Trial Application for an Innovative Drug (9MW2921) Accepted by NMPA
?
2023-01-03
Mabwell Announces the NMPA approval of 9MW3011 (FIC) for IND
?
2022-11-21
Mabwell Announces the U.S. FDA approval of 9MW3011 (FIC) for IND
?
2022-10-19
First in class! Mabwell's Clinical Trial Application for 9MW3011 Injection - An Innovative Drug Accepted by NMPA
?
2022-08-23
Mabwell's Innovative Drug 6MW3511 Injection is Approved for Clinical Trial
?
2022-07-29
Mabwell’s anti-Nectin-4 ADC drug received FDA’s IND Approval
?
2022-06-17
The IND Application for 6MW3511 Injection - An Innovative Drug from Mabwell is Accepted by NMPA
?
2022-02-17
The IND Application of Mabwell Innovative Drug 8MW2311 for Injection was Accepted by NMPA
?
2021-12-30
Mabwell Announced the First Person Dosed in the Phase I Study of First Anti-ST2 Antibody in China
?
2021-12-22
The New Drug Application of Mabwell's Denosumab Injection Biosimilars 9MW0311 Was Accepted
?
2021-12-22
The New Drug Application of Mabwell's Denosumab Injection Biosimilars 9MW0321 Was Accepted
?
2021-09-27
Mabwell Announced the First Patient Dosed in the Phase I Study of CD47/PD-L1 Bispecific Antibody
?
2021-10-19
China's First Anti-Nectin-4 ADC Drug Receives IND Approval
?
2021-08-20
Mabwell Receives IND Clearance from FDA for Initiating Clinical Trials for its Anti-CD47/PD-L1 Bispecific Antibody
?
2021-08-10
NMPA Accepted IND Application of China's First Anti-Nectin-4 ADC Drug
?
2021-07-21
Mabwell's Anti-CD47/PD-L1 Bispecific Antibody 6MW3211 Receives IND Approval in China
?
2021-05-08
First China-made Anti-ST2 Antibody Developed by Mabwell Approved for Clinical Study
?
2021-02-19
Mabwell's first domestic anti-ST2 antibody clinical application was accepted
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2018-10-12
IA001 Injection Received Clinical Trial Approval
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2018-02-12
Innovative Cytokine 8MW0511 Obtained Clinical Approval
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R&D Progress
Papers
Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor–Related Bone Metastases A Randomized, Double-Blind, Phase 3 Equivalence Trial
JAMA Oncology , doi:10.1001/jamaoncol.2023.6520
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Preclinical Evaluation of 9MW2821, a Site-Specific Monomethyl Auristatin E-based Antibody-Drug Conjugate for treatment of Nectin-4-expressing Cancers
Molecular Cancer Therapeutics MCT-22-0743.
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Blockade of dual immune checkpoint inhibitory signals with a CD47/PD-L1 bispecific antibody for cancer treatment
Theranostics 2023; 13(1):148-160.
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Antibody-dependent enhancement (ADE) of SARS-CoV-2 pseudoviral infection requires FcγRIIB and virus-antibody complex with bivalent interaction
Communications Biology , volume 5, Article number: 262 (2022)
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Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: A Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody
Emerging Microbes & Infections , 2021, VOL.10, NO.1, 1638-1648
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Characterization of MW06, a human monoclonal antibody with cross-neutralization activity against both SARS-CoV-2 and SARS-CoV
MABS , 2021, VOL. 13, NO. 1
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Characterization of neutralizing antibody with prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus monkeys
NATURE COMMUNICATIONS , (2020) 11:5752
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Identification of a monoclonal antibody that targets PD-1 in a manner requiring PD-1 Asn58 glycosylation
COMMUNICATIONS BIOLOGY , (2019) 2:392
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Preclinical pharmacokinetics of a recombinant humanized rabbit anti-VEGF monoclonal antibody in rabbits and monkeys
Toxicology Letters , Volume 292 , August 2018, Pages 73-77
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Recombinant humanized anti-vascular endothelial growth factor monoclonal antibody efficiently suppresses laser-induced choroidal neovascularization in rhesus monkeys
Eur J Pharm Sci. , 2017 Nov 15;109:624-630
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A human glucagon-like peptide-1-albumin recombinant protein with prolonged hypoglycemic effect provides efficient and beneficial control of glucose metabolism in diabetic mice
Biol Pharm Bull. , 2017 Sep 1;40(9):1399-1408
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Effects of GW002, a novel recombinant human glucagon-like peptide-1 (GLP-1) analog fusion protein, on CHO recombinant cells and BKS-db mice
Acta Diabetologica , volume 54 , 685–693 (2017)
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患者招募
MAIWEIJIAN Denosumab biosimilar

Indications: treatment of adults and skeletally mature adolescents (defined as at least 1 mature long bone and weighing ≥ 45 kg) with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

MAILISHU Denosumab biosimilar

Indications: treatment of postmenopausal women with osteoporosis at high risk for fracture. In postmenopausal women with osteoporosis, MAILISHU reduces the incidence of vertebral, nonvertebral, and hip fractures.

JUNMAIKANG Adalimumab biosimilar

Indications: rheumatoid arthritis, ankylosing spondylitis (AS), psoriasis, crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis (pJIA), pediatric plaque psoriasis, pediatric crohn’s disease

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