Mabwell Bio sprints towards Hong Kong listing, domestic Nectin-4 ADC frontrunner poised for launch

Mabwell Bio Rushes for Hong Kong IPO as Domestic Nectin-4 ADC Frontrunner Awaits Launch

On April 20, Chinese innovative pharmaceutical company Mabwell (Shanghai) Bioscience Co., Ltd. ("Mabwell Bio") officially launched its Hong Kong share offering. If successfully listed in Hong Kong, the company will form a dual-platform "A+H" structure, further broadening its financing channels and accelerating the global development and commercialization of its innovative drugs.

Mabwell Bio is an innovative biopharmaceutical company with a full industry chain layout, focusing on the independent development of drugs for oncology and age-related diseases, covering oncology, immunology, ophthalmology, and orthopedics. The company was founded in 2017 and listed on the Shanghai Stock Exchange's STAR Market in 2022 (stock code: 688062).

Core Product 9MW2821: Domestic Nectin-4 ADC Frontrunner

Mabwell Bio's core product 9MW2821 (BFv) is a Nectin-4-targeting antibody-drug conjugate (ADC), currently in several key Phase III clinical trials. According to Frost & Sullivan data, 9MW2821 is the most advanced product among all Nectin-4-targeting ADCs developed in China for treating urothelial carcinoma, second globally only to Padcev, which has received FDA approval.

More notably, 9MW2821 is the world's first Nectin-4-targeting ADC to enter key Phase III trials for cervical cancer. The product has received three Fast Track designations and one Orphan Drug designation from the US FDA, as well as two Breakthrough Therapy designations from China's NMPA.

Clinical data shows impressive efficacy for 9MW2821. As of October 2024, in patients with advanced urothelial carcinoma previously treated with platinum-based chemotherapy and PD-(L) 1 inhibitors, 9MW2821 monotherapy achieved an objective response rate (ORR) of 62.2%, a disease control rate (DCR) of 91.9%, a median progression-free survival (PFS) of 7.4 months, and a median overall survival (OS) of 14.6 months. In triple-negative breast cancer patients, the ORR reached 50.0% and DCR was 80.0%. As of April 2025, among 40 evaluable urothelial carcinoma patients receiving 9MW2821 as first-line treatment, the ORR was 87.5%, cORR was 80%, DCR was 92.5%, and median PFS was 12.5 months.

Currently, the company is advancing several Phase III trials in China for 9MW2821 as monotherapy or in combination with toripalimab for urothelial carcinoma, and as monotherapy for cervical cancer, while also conducting a Phase I monotherapy study in the US for triple-negative breast cancer.

Differentiated Pipeline Layout: ADC + Non-ADC Dual Drivers

Beyond its core product, Mabwell Bio has established a rich pipeline portfolio covering oncology, immunology, orthopedics, and ophthalmology, including 4 marketed products and 10 candidate drugs (1 in NDA stage, 8 in clinical stage, 1 in preclinical stage).

In the ADC field, the company has built a diverse set of innovative ADCs. Among them, the B7-H3-targeting 7MW3711 has received Orphan Drug designation from the FDA for small cell lung cancer, with early clinical data showing good safety and tolerability, and a Phase Ib/II trial in combination with JS207 (a PD-1/VEGF bispecific antibody) was initiated in February 2026. The next-generation CDH17-targeting ADC 7MW4911 demonstrated efficient internalization and selective killing properties in preclinical studies. Monotherapy for advanced solid tumors initiated Phase I clinical trials in China in November 2025 and Phase I/II trials in the US in January 2026.

Regarding the non-ADC pipeline, 9MW1911 is China's first self-developed non-Th2 pathway-targeting macromolecular drug for COPD. Phase II data showed a reduction of over 30% in the annualized rate of moderate-to-severe COPD exacerbations compared to the placebo group, ranking second globally in clinical progress for the ST2 target. 9MW3811 is the first IL-11-targeting drug to enter the clinical stage for treating pathological scars. Clinical trials have shown good safety, with a half-life in humans of up to 30 days. Recently, the company announced that China's NMPA has accepted the IND application for the LILRB4/CD3 TCE bispecific antibody 6MW5311. The US clinical trial application for this product is currently in the pre-IND stage, with plans to formally submit the application to the FDA in Q2 2026.

Leveraging the clinical progress advantage of its core pipeline and its differentiated ADC portfolio, Mabwell Bio is accelerating its transformation into a global innovative pharmaceutical company.

Technology Platforms Build Competitive Barriers

Mabwell Bio has established four core proprietary ADC technologies: DARfinity (site-specific conjugation process), IDconnect (linker molecule), Mtoxin (novel toxin molecule), and LysOnly (conditional release structure). These four proprietary technologies form the pillars of the company's site-specific ADC development platform, the Interchain Disulfide Drug Conjugate ("IDDC") platform.

Based on the IDDC platform, 9MW2821 forms a dual-site conjugation via disulfide bonds between the drug-loaded linker and the humanized Nectin-4-targeting monoclonal antibody. Compared to Padcev, 9MW2821 has a stable linker and uniform DAR, making it more stable in blood circulation and thus more effectively delivered to tumor cells, performing significantly better than traditional non-site-specific ADC products.

Furthermore, the company possesses an integrated high-efficiency antibody discovery platform and a TCE bispecific/trispecific antibody development platform, providing technical support for continuous innovation.

Commercialization Capability Emerges, Internationalization Accelerates

As of December 31, 2025, Mabwell Bio had established a distribution network in China covering 327 cities and over 8,000 hospitals, with 127 distributors. In 2025, the company achieved revenue of RMB 659 million, a year-on-year increase of 230%, primarily driven by increased drug sales and out-licensing revenue.

Regarding internationalization, the company has entered into license agreements with several leading domestic and international pharmaceutical companies, including Disc, Calico, and Qilu Pharmaceutical. Among them, an exclusive license agreement with Disc for 9MW3011 involves potential milestone payments of up to USD 410 million; an exclusive license with Calico for 9MW3811 involves potential milestone payments of nearly USD 600 million; an exclusive license with Qilu Pharmaceutical for Mailisheng® involves upfront and milestone payments totaling up to RMB 500 million; and an exclusive license agreement was signed with Kalexo Bio for the development of a novel dual-target siRNA candidate drug.

Although the net loss in 2025 was still RMB 972 million (mainly due to R&D expenses of RMB 977 million), the company's revenue structure continued to optimize, with out-licensing revenue increasing from 27.6% in 2024 to 62.0% in 2025. As of the end of 2025, the company held cash and bank balances of approximately RMB 1.527 billion, with its R&D pipeline advancing steadily.

In terms of commercialization, the company has made substantial progress. Currently, Mabwell Bio has three commercialized biosimilar products, namely Mailishu®, Maiweijian®, and Junmaikang®, which collectively contributed approximately RMB 248 million in sales revenue in 2025. The company will also receive royalty fees of up to a double-digit percentage of the sales of Mailisheng® in the future, with further growth anticipated.

Conclusion

Overall, with its differentiated ADC pipeline, solid technology platforms, increasingly robust commercialization network, and proactive internationalization strategy, Mabwell Bio is accelerating its transition into the global commercial stage. If the H-share listing is successful, the company will gain more ample financial resources and is expected to accelerate its run on the golden track of ADCs.