Capabilities

R&D

Comprehensive Strength Mabwell has established an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation. The international standard drug discovery platforms and skillful & efficient development platforms enable us to develop innovative biologics efficiently and submit IND rapidly. We focus on oncology and aging-related disease including immunology, bone disorders, ophthalmology, hematology, cardiovascular disease, etc. Our robust pipeline currently comprises 15 high-priority candidates spanning preclinical, clinical, and commercial stages, including 11 novel drug candidates and 4 biosimilars. Of these, 4 products have been approved and commercialized, 1 candidate filed for pre-NDA meeting, 2 candidates are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects.

Innovative Platforms Pipeline R&D Progress

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Innovative Platforms

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.

Manufacturing

International Standard of Intelligent Manufacturing

Compliant with GMP requirements in China, U.S., and EU
Integrated production capacity of monoclonal antibodies, fusion proteins, ADCs and other drug molecules to support clinical research and commercial manufacturing
Transparent factory, penetrating supervision, permeable management, flexible production

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Taizhou, Jiangsu Pilot & Commercial Manufacturing Site EU QP Audited

Capacity

8,000L, antibody production; 4,000L, recombinant protein production 2 drug product filling lines for pre-filling syringes & vials

Production

Undertaking production of MAILISHU & MAIWEIJIAN

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Taizhou, Jiangsu Large Scale ADC Commercial Manufacturing Site

Area

~53,400 ㎡

ADC production

Capable of providing drug samples for pre-clinical & early phase clinical use Scaling up production in the kilogram can meet the needs of pivotal trials to commercialization QA & QC (under construction) Ready for trial production

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Shanghai Large Scale Commercial Manufacturing Site EU QP Audited

Capacity

Designed capacity of 1,000kg per year

Digitalization

Distributed Control System greatly improves the automation of liquid preparation process Full-automatic 3D warehouse to meet smart inventory management The integration of automation and informatization to achieve digitalization

Commercialization

Market led, Medical-driven, Access first

Deeply engaged in academic promotion in autoimmune diseases, osteoporosis and oncology, we have built mature and professional marketing network in China, bringing world-class novel therapeutic options to more domestic patients. Our marketing management team is led by professionals with over 20 years of experience in average.

Improve Global Health

We are expanding to Euramerican market and emerging markets to meet the clinical needs of patients worldwide, and have entered into strategic partnerships with more than a dozen countries overseas.

License out / NewCo

2025.9 - Mabwell and Aditum Bio announced the launch of Kalexo Bio, a new company formed in conjunction with an exclusive global license agreement to develop 2MW7141, a novel dual-target siRNA candidate2025.6 - Entered into an agreement with Qilu Pharmaceutical about Albipagrastim alfa for Injection (8MW0511)2025.6 - Entered into an agreement with Calico Life Sciences LLC about 9MW38112023.1 - Entered into an agreement with DISC MEDICINE (NASDAQ: IRON) about 9MW3011 (R&D code in the US: MWTX-001, MWTX-002 & MWTX-003)

Partnership in emerging market

Get in touch with our BD team: ib@welcomei.net

2025.7 - Established partnership with UNILAB (ranks number 1 in the ASEAN pharmaceutical industry) to market denosumab products in the Philippines

2024.11 - Established partnership with TABUK to market 2 products in MENA region

2024.11 - Established a licensing and commercialization agreement of denosumab products in Peru

2024.8 - Established a licensing and commercialization agreement of denosumab products with CRISTÁLIA in Brazil

2024.1 - Established a licensing and commercialization agreement to market of denosumab products in Indonesia

2023.11 - Established partnership with Innobic (wholly owned subsidiary of PTT Public Company Ltd, the state-owned enterprise and the largest company by market capitalization on Thailand Stock Exchange) to market products in Thailand

2023.10 - Established partnership with UPL to market 9MW0113 in Argentina

2023.9 - Established partnership with Legrand to market 9MW0311 & 9MW0321 in Colombia and Ecuador

2023.8 - Established partnership with UNILAB (ranks number 1 in the ASEAN pharmaceutical industry) to market 9MW0113 in the Philippines

2023.7 - Established partnership with Sothema (the biggest pharmaceutical company in Morocco) to market 9MW0113 in Morocco

2023.7 - Established partnership with Searle (one of the top pharmaceutical companies in Pakistan) to market 9MW0311 & 9MW0321 in Pakistan

2023.6 - Established a licensing and commercialization agreement of 9MW0311 & 9MW0321 for Egypt market