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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

The first Nectin-4 targeting drug candidate to enter Phase III clinical trials for treating cervical cancer globally.

Granted Fast Track Designation (CC, ESCC, TNBC)/Orphan Drug Designation (EC) by US FDA, and Breakthrough Therapy Designation (UC) by CDE of 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.

➞ASCO update

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.

➞2024 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

Oncology

9MW2821

Nectin-4 ADC

UC monotherapy (2L+)

UC combination (1L)

UC perioperative combination

CC monotherapy (2L/3L)

CC combination (1L)

ESCC monotherapy (2L+)

ESCC combination (1L)

TNBC combination (1L)

TNBC monotherapy

Others (monotherapy or combo)

9MW2821

The first Nectin-4-targeting ADC for cervical cancer to enter Phase III clinical trials globally.

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

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

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

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

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

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

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.

Immunology

JUNMAIKANG

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

COPD

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

Idiopathic pulmonary fibrosis

9MW3811

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

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.

Bone Disorders

MAILISHU

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.

Ophthalmology

9MW0813

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

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.

Hematology

9MW3011

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.

Infectious Diseases

9MW1411

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

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

ADC Platform

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.