中文
Products
Pipeline
Innovative Platforms

  • ADC Platform

  • TCE BsAb and TsAb 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
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 monotherapy / combo with PD-1) 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.

Program
Target
Pre-Clinical
IND Enabling
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 monotherapy (2L+)

UC combination with toripalimab (1L)

UC perioperative combination with toripalimab

China status

TNBC monotherapy (resistance to TOPi based ADC2) (CN/US1)

TNBC combination with toripalimab (1L)

CC monotherapy (2L/3L)

CC combination with other anti-tumor treatments (1L)

EC monotherapy (2L+)

EC combination with other anti-tumor treatments (1L)

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
B7-H3 ADC

SCLC monotherapy (2L+)

China status

Advanced solid tumor (CN/US3)

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.
7MW4911
- CDH17 ADC
CDH17 ADC

Advanced solid tumor (CN,US)

7MW4911
7MW4911 is an ADC that specifically targets CDH17, a cell adhesion protein that has been identified through comprehensive pan-tumor multi-omics analysis as a promising target for cancer therapy. CDH17 is expressed at low levels in normal tissues, where it is localized to the basolateral membrane of intestinal epithelial cells. However, it is significantly overexpressed in various gastrointestinal cancers, including colorectal, gastric, and pancreatic cancers, where its high expression correlates with tumor progression, metastasis, and poor clinical outcomes, making it an ideal target for therapeutic intervention. We have independent intellectual property rights and have filed patent applications for the molecular structure of 7MW4911.
8MW0511
- HSA-mhG-CSF
HSA-mhG-CSF

Febrile neutropenia 4

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.
MAIWEIJIAN（迈卫健®）
- RANKL
RANKL
Approved in China

Giant cell tomor of bone*

Solid tumor bone metastases and multiple myeloma5

MAIWEIJIAN（迈卫健®）
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).
JUNMAIKANG（君迈康®）
- TNF-α
TNF-α
Approved in China

8 indications (Rheumatoid arthritis, etc. )*

JUNMAIKANG（君迈康®）
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

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 fibrosis6

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（迈利舒®）
- RANKL
RANKL
Approved in China

Treatment of postmenopausal women with osteoporosis at high risk for fracture7

MAILISHU（迈利舒®）
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

polycythemia vera

Iron overload disorders including β-thalassemia

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.
*Please refer to product insert or clinical trial registration information for a complete list of indications
Note: Pipeline info from proposed HKEX prospectus, excluding 9MW2921 (Trop-2 ADC, Phase I/II), 9MW1411 (α-toxin, Phase II), and 6MW3211 (CD47/PD-L1, Phase II).
1. The FDA issued a study may proceed letter for the Phase I clinical trial of 9MW2821 for Nectin-4 positive metastatic solid tumors in July 2022, and we communicated with the FDA on the protocol amendment for 9MW2821 as a monotherapy for the treatment of TNBC in patients with resistance to topoisomerase inhibitors based ADC in December 2024. The FDA granted the Fast Track Designation for 9MW2821 for the treatment of locally advanced or metastatic Nectin-4 positive TNBC in July 2024.
2. We will continue to explore 9MW2821 as a monotherapy for the second or later line treatment of TNBC.
3. The FDA issued a study may proceed letter for the Phase I/II clinical trial of 7MW3711for advanced solid tumors in February 2024.
4. The proposed indication for 8MW0511 is to be used in adult patients with non-myeloid malignant neoplasms to reduce the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer drugs prone to causing febrile neutropenia.
5. We plan to file supplementary application for Maiweijian（迈卫健®） for the treatment of solid tumor bone metastases and multiple myeloma with the NMPA, and the indication extrapolation is exempt from clinical trial.
6. The FDA approved the IND application of 9MW3811 for idiopathic pulmonary fibrosis in June 2023.
7. We will continue to explore Mailishu（迈利舒®）in other types of osteoporosis.
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

TCE BsAb and TsAb platform

Our TCE bispecific and trispecific antibody platform is specifically designed to enable the generation of a diverse range of bispecific and tri-specific antibodies, each optimized for targeted therapeutic applications. At the core of this platform is a set of engineered CD3 targeting antibodies with varying binding profiles and activation properties, alongside agonistic antibodies targeting secondary activation signals for T cell engagement. These antibodies are engineered to cross-react with cynomolgus monkey CD3, which facilitates the evaluation of TCE-mediated cytotoxicity in non-human primate models, a crucial step for preclinical validation. The platform supports a broad array of bispecific and tri-specific formats, allowing for precise targeting of tumor antigens across different expression levels, ensuring both specificity and efficacy in target engagement. A distinctive feature of this platform is its differentiated design strategy, which tailors antibody development to the unique structural and functional requirements of each candidate. This approach significantly streamlines the process development and quality control phases throughout the antibody lifecycle, from preclinical studies through to commercial-scale production. By leveraging this design-driven methodology, the platform effectively addresses key challenges, such as improving antibody stability, optimizing expression yields, and simplifying the overall manufacturing process.

Advantages

    01Purpose-built structures: Based on target abundance and specificity, select CD3 molecules and formats that demonstrate both high potency and superior safety.

    02Increased Therapeutic Window: Low CD3 affinity minimizes T cell binding, reducing CRS risk. No T cell activation without tumor presence.

    03Enhanced Functionality: Integrates a second signal to enhance T cell proliferation, prevent exhaustion, and provide a more durable response.

ADC Platform

TCE BsAb and TsAb platform

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

TCE BsAb and TsAb platform

Our TCE bispecific and trispecific antibody platform is specifically designed to enable the generation of a diverse range of bispecific and tri-specific antibodies, each optimized for targeted therapeutic applications. At the core of this platform is a set of engineered CD3 targeting antibodies with varying binding profiles and activation properties, alongside agonistic antibodies targeting secondary activation signals for T cell engagement. These antibodies are engineered to cross-react with cynomolgus monkey CD3, which facilitates the evaluation of TCE-mediated cytotoxicity in non-human primate models, a crucial step for preclinical validation. The platform supports a broad array of bispecific and tri-specific formats, allowing for precise targeting of tumor antigens across different expression levels, ensuring both specificity and efficacy in target engagement. A distinctive feature of this platform is its differentiated design strategy, which tailors antibody development to the unique structural and functional requirements of each candidate. This approach significantly streamlines the process development and quality control phases throughout the antibody lifecycle, from preclinical studies through to commercial-scale production. By leveraging this design-driven methodology, the platform effectively addresses key challenges, such as improving antibody stability, optimizing expression yields, and simplifying the overall manufacturing process.

Advantages

    01Purpose-built structures: Based on target abundance and specificity, select CD3 molecules and formats that demonstrate both high potency and superior safety.

    02Increased Therapeutic Window: Low CD3 affinity minimizes T cell binding, reducing CRS risk. No T cell activation without tumor presence.

    03Enhanced Functionality: Integrates a second signal to enhance T cell proliferation, prevent exhaustion, and provide a more durable response.

R&D Progress
Clinical Trials
➞News
2025-01-13
Mabwell's Nectin-4 Targeted ADC 9MW2821 Combination Therapy Demonstrates 87.5% ORR and Granted CDE Breakthrough Therapy Designation
➞
2024-11-13
Mabwell's Novel Nectin-4 Targeting ADC 9MW2821 Approved for 2 Clinical Trials by CDE of NMPA
➞
2024-08-25
Mabwell Announces CDE Approval to Initiate Phase III Clinical Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor
➞
2024-08-22
Mabwell Announces the CDE Approval of Novel Nectin-4 Targeting ADC to Initiate Phase III Clinical Trial for the Treatment of Cervical Cancer
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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
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2024-05-12
Mabwell Announces Clinical Trial Progress of 9MW2821 in Triple-Negative Breast Cancer
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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
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2024-02-18
Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711
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2023-12-07
Mabwell Announces the CDE Approval of Novel Nectin-4 Targeting ADC for Phase III Clinical Trial
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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
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2023-09-05
Mabwell Announces the First Patient Dosed in the Clinical Studies of 2 Novel ADCs
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2023-07-17
Mabwell Announces the NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND
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2023-07-14
Mabwell Announces the NMPA Approval of Novel Trop-2 ADC (9MW2921) for IND
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2023-06-15
Mabwell Announces the U.S. FDA approval of 9MW3811 for IND
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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
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2023-03-03
Mabwell's Clinical Trial Application for 9MW3911 Injection - An Innovative Drug, Accepted by NMPA
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2023-02-27
First in Class, Mabwell Announces the TGA Approval of 9MW3811 for IND
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2023-02-05
Accelerating Development of Mabwell's ADC Plateform: Clinical Trial Application for an Innovative Drug (9MW2921) Accepted by NMPA
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2023-01-03
Mabwell Announces the NMPA approval of 9MW3011 (FIC) for IND
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2022-11-21
Mabwell Announces the U.S. FDA approval of 9MW3011 (FIC) for IND
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2022-10-19
First in class! Mabwell's Clinical Trial Application for 9MW3011 Injection - An Innovative Drug Accepted by NMPA
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2022-08-23
Mabwell's Innovative Drug 6MW3511 Injection is Approved for Clinical Trial
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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
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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
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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
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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
➞
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)
➞
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
➞
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.

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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.

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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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