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  • Automatic High-throughput Hybridoma Antibody Molecular Discovery Platform

  • Single B Cell Screening Platform

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  • Bispecific Antibody Platform

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JUNMAIKANG Adalimumab biosimilar
MAILISHU Denosumab biosimilar
Pipeline
R&D code
Target
Pre-Clinical Pre-
Clinical
IND
Phase I
Phase II
Phase III
NDA/BLA NDA/
BLA
Launched
Therapeutic Areas: 9MW2821
- Nectin-4 ADC

Nectin-4 ADC
9MW2821

UC - Phase III clinical trial (Ranked 1st of clinical development in China and second globally)

CC & other - Phase II clinical trial (Ranked 1st of clinical development in the world)

World's first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC.

9MW2821 is a novel Nectin-4 targeting 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.


Clinical Data: 

UC:

As of Dec. 5, 2023, 9MW2821 has shown an ORR and DCR of 62.2% and 91.9%, respectively, in a Phase II clinical study at a dose of 1.25 mg/kg in patients with advanced UC who have received monotherapy. The median progression-free survival (PFS) was 6.7 months. 

EC:

As of Feb. 20, 2024, 9MW2821 has shown an ORR and DCR of 30% and 73.3%, respectively, in a Phase II clinical study at a dose of 1.25 mg/kg in 30 patients with advanced EC who have received monotherapy and completed at least one tumor assessment.

Therapeutic Areas: 9MW2921
- Trop-2 ADC

Trop-2 ADC
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.


Therapeutic Areas: 7MW3711
- B7-H3 ADC

B7-H3 ADC
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.


Therapeutic Areas: 9MW0321
- RANKL

RANKL
9MW0321

Denosumab is a fully human IgG2 monoclonal antibody. NMPA has accepted the listing application of 9MW0321 as a denosumab biosimilar to. Denosumab is indicated to treat giant cell tumor of the bone and prevent skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors by acting as a RANKL (receptor activator of Nf-kB ligand) inhibitor to prevent osteoclastic-medicated bone resorption.

Therapeutic Areas: 8MW0511
- HSA-G-CSF

HSA-G-CSF
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. 

Therapeutic Areas: 6MW3211
- CD47/PD-L1

CD47/PD-L1
6MW3211

6MW3211, developed based on Mabwell's Bispecific Antibody 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.

Therapeutic Areas: 9MW3811
- IL-11

IL-11
9MW3811

First in China & top tier of global 

MW3811 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. 

Therapeutic field: JUNMAIKANG
- TNF-α

TNF-α
JUNMAIKANG

JUNMAIKANG(Adalimumab 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.

Therapeutic field: 9MW1911
- ST2

ST2
9MW1911

First in China 

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.

Therapeutic field: 9MW3811
- IL-11

IL-11
9MW3811

First in China & top tier of global 

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.

High-tech Platforms
Automatic High-throughput Hybridoma Antibody Molecular Discovery Platform

Mabwell has built an automatic high-throughput hybridoma antibody 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. 

High-tech Platforms
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:

    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. 

High-tech Platforms
ADC Platform

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.
IDDC™ is a next generation ADC site-specific conjugate 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.

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.

High-tech Platforms
Bispecific Antibody 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:

    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.

R&D Progress
Clinical Trials
Feb 25, 2024
FDA Grants Fast Track Designation to 9MW2821
Feb 18, 2024
FDA Grants Orphan Drug Designation to 9MW3011
Feb 18, 2024
Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711
Dec 07, 2023
Mabwell Announces the CDE Approval of Novel Nectin-4 Targeting ADC for Phase III Clinical Trial
Sep 27, 2023
Mabwell Announces First Patient Dosed in Phase Ib/II Trial of its Novel Nectin-4 Targeting ADC in Combination with PD-1 Inhibitor
Sep 05, 2023
Mabwell Announces the First Patient Dosed in the Clinical Studies of 2 Novel ADCs
Jul 17, 2023
Mabwell Announces the NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND
Jul 14, 2023
Mabwell Announces the NMPA Approval of Novel Trop-2 ADC (9MW2921) for IND
Jun 15, 2023
Mabwell Announces the U.S. FDA approval of 9MW3811 for IND
Mar 16, 2023
Mabwell's Clinical Trial Application for 9MW3811 Accepted by NMPA
May 18, 2023
Clinical Trial Application for 7MW3711 - an Innovative Drug Developed by Mabwell's ADC Platform, Accepted by NMPA
Mar 13, 2023
Mabwell Launched First in human Clinical Trial of Its Iron Homeostasis Regulating Macromolecular Drug 9MW3011
Mar 03, 2023
Mabwell's Clinical Trial Application for 9MW3911 Injection - An Innovative Drug, Accepted by NMPA
Feb 27, 2023
First in Class, Mabwell Announces the TGA Approval of 9MW3811 for IND
Feb 05, 2023
Accelerating Development of Mabwell's ADC Plateform: Clinical Trial Application for an Innovative Drug (9MW2921) Accepted by NMPA
Jan 03, 2023
Mabwell Announces the NMPA approval of 9MW3011 (FIC) for IND
Nov 21, 2022
Mabwell Announces the U.S. FDA approval of 9MW3011 (FIC) for IND
Oct 19, 2022
First in class! Mabwell's Clinical Trial Application for 9MW3011 Injection - An Innovative Drug Accepted by NMPA
Aug 23, 2022
Mabwell's Innovative Drug 6MW3511 Injection is Approved for Clinical Trial
Jul 29, 2022
Mabwell’s anti-Nectin-4 ADC drug received FDA’s IND Approval
Jun 17, 2022
The IND Application for 6MW3511 Injection - An Innovative Drug from Mabwell is Accepted by NMPA
Feb 17, 2022
The IND Application of Mabwell Innovative Drug 8MW2311 for Injection was Accepted by NMPA
Dec 30, 2021
Mabwell Announced the First Person Dosed in the Phase I Study of First Anti-ST2 Antibody in China
Dec 22, 2021
The New Drug Application of Mabwell's Denosumab Injection Biosimilars 9MW0311 Was Accepted
Dec 22, 2021
The New Drug Application of Mabwell's Denosumab Injection Biosimilars 9MW0321 Was Accepted
Sep 27, 2021
Mabwell Announced the First Patient Dosed in the Phase I Study of CD47/PD-L1 Bispecific Antibody
Oct 19, 2021
China's First Anti-Nectin-4 ADC Drug Receives IND Approval
Aug 20, 2021
Mabwell Receives IND Clearance from FDA for Initiating Clinical Trials for its Anti-CD47/PD-L1 Bispecific Antibody
Aug 10, 2021
NMPA Accepted IND Application of China's First Anti-Nectin-4 ADC Drug
Jul 21, 2021
Mabwell's Anti-CD47/PD-L1 Bispecific Antibody 6MW3211 Receives IND Approval in China
May 08, 2021
First China-made Anti-ST2 Antibody Developed by Mabwell Approved for Clinical Study
Feb 19, 2021
Mabwell's first domestic anti-ST2 antibody clinical application was accepted
Oct 12, 2018
IA001 Injection Received Clinical Trial Approval
Feb 12, 2018
Innovative Cytokine 8MW0511 Obtained Clinical Approval
R&D Progress
Papers
Efficacy, Safety, and Population Pharmacokinetics ofMW032 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
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.
Blockade of dual immune checkpoint inhibitory signals with a CD47/PD-L1 bispecific antibody for cancer treatment
Theranostics 2023; 13(1):148-160.
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)
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
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
Characterization of neutralizing antibody with prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus monkeys
NATURE COMMUNICATIONS , (2020) 11:5752
Identification of a monoclonal antibody that targets PD-1 in a manner requiring PD-1 Asn58 glycosylation
COMMUNICATIONS BIOLOGY , (2019) 2:392
Preclinical pharmacokinetics of a recombinant humanized rabbit anti-VEGF monoclonal antibody in rabbits and monkeys
Toxicology Letters , Volume 292 , August 2018, Pages 73-77
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
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
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)
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

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.