Mabwell Biosciences Licenses Preclinical Dual-Target siRNA Drug 2MW7141 to NewCo Kalexo Bio in $1B Deal

On September 17, Mabwell issued an announcement stating that it had entered into an Exclusive License Agreement and a Preferred Stock Purchase Agreement with Kalexo regarding the 2MW7141 program. Pursuant to these agreements, Mabwell grants Kalexo the exclusive global rights to develop, manufacture, and commercialize, as well as to further develop through other means, the licensed products associated with the 2MW7141 program.

Mabwell will receive upfront and milestone payments of up to $1 billion (approximately RMB 7.1 billion) from Kalexo, as well as low-single-digit royalties. As part of the consideration, this includes a one-time, non-refundable upfront and near-term cash payment of $12 million. Subject to agreed conditions, Mabwell will also receive a total double-digit percentage of Kalexo’s Series A preferred shares.

Kalexo, the partner in this collaboration, is an innovative pharmaceutical company established by Aditum Bio. Focusing on the translational medicine stage of drug development, Aditum Bio was co-founded in 2019 by former Novartis executives Joe Jimenez and Mark Fishman. The firm aims to accelerate the progression of new drugs from early-stage research and development to clinical trials by leveraging capital and specialized resources. This model has created a flexible startup platform, operated by a dedicated management team composed of R&D experts from within Aditum Bio.

Clearly, Kalexo is a typical start-up NewCo. This also marks Mabwell’s first collaboration involving the NewCo model, in which it establishes a new company in partnership with external capital to advance the development of specific pipelines.

The 2MW7141 pipeline involved in this collaboration is a dual-target small nucleic acid drug independently developed by Mabwell, currently in the preclinical stage. It is primarily indicated for lipid regulation in patients with dyslipidemia and for the prevention of high-risk cardiovascular events.2MW7141 demonstrates a well-defined synergistic regulatory effect, exhibiting potent and durable inhibition of target genes in preclinical studies with a low risk of off-target effects. As a promising first-in-class dual-target siRNA therapeutic utilizing a non-LNP delivery system, 2MW7141 has the potential to provide more efficient and convenient treatment options for patients with dyslipidemia and those at high risk for atherosclerotic cardiovascular disease.

Currently, the 2MW7141 project is progressing smoothly. Preliminary trials have initially validated the effectiveness of Mabwell’s independently developed small nucleic acid drug R&D platform for dual/multi-target therapies. By deeply integrating artificial intelligence with high-throughput automated screening systems, the platform reduced the timeline from project initiation to candidate compound selection to just a few months, significantly enhancing R&D efficiency. Leveraging the highly reproducible and modular advantages of small nucleic acid drug development, this platform is poised to expand into additional therapeutic areas, further strengthening Mabwell’s strategic layout in age-related diseases.

Although this marks Mabwell’s first collaboration via the NewCo model, it is the company’s third business development (BD) partnership this year.On the evening of June 26, Mabwell issued two consecutive announcements, revealing partnerships with Qilu Pharmaceutical and CALICO, respectively.

The product that has reached a cooperation agreement with Qilu Pharmaceutical is Mabwell's marketed drug Agalsidase Alfa for Injection (brand name: Mailisheng, product code: 8MW0511).Under the agreement, Mabwell grants Qilu Pharmaceutical an exclusive license to develop, manufacture, improve, utilize, and commercialize the licensed products within China. Taikang Bio, a wholly-owned subsidiary of Mabwell, is eligible to receive upfront and sales milestone payments totaling up to RMB 500 million, as well as royalties at a high single-digit to low double-digit percentage of the net sales of the licensed products. Qilu Pharmaceutical will pay Taikang Bio a one-time, non-refundable upfront payment of RMB 380 million.

The pipeline that has reached a cooperation agreement with CALICO is 9MW3811, a humanized monoclonal antibody targeting human interleukin-11, independently developed by Mabwell.Under the agreement, Mabwell grants CALICO an exclusive license to develop, manufacture, and commercialize 9MW3811 in all territories outside of China. CALICO will pay Mabwell a one-time, non-refundable upfront payment of $25 million. In addition, Mabwell is eligible to receive up to $571 million in aggregate milestone payments for preclinical, development, regulatory, and commercial achievements, as well as tiered royalties based on net sales of the licensed products.

Including the RMB 7.1 billion from this NewCo deal, Mabwell’s total partnership value reached RMB 11.8 billion year-to-date, with upfront payments totaling approximately RMB 643 million. Behind these successive business development (BD) deals lies Mabwell’s urgent need for capital.Although Mabwell currently has commercialized products such as the denosumab biosimilar, the adalimumab biosimilar, and the innovative drug agalsidase alfa for injection, the company has not yet achieved profitability. Its net profit excluding non-recurring items was RMB 574 million in the first half of this year, compared to a loss of RMB 461 million in the same period of 2024. As of the end of the first half of this year, Mabwell’s asset-liability ratio stood at 77.54%, up from 52.73% in the same period of 2024. Among these figures, short-term borrowings and monetary funds were RMB 1.01 billion and RMB 1.39 billion, respectively.

When the path to “self-sustaining revenue generation” proves unviable, “BD-driven cash flow” will become another survival route for biotech companies. Mabwell has indeed alleviated its financial pressure in the short term through business development (BD) deals. Furthermore, Mabwell is actively seeking “capital infusion,” having resubmitted its prospectus to the Hong Kong Stock Exchange in late August.

In summary, Mabwell’s transaction with Kalexo represents a strategic choice made in light of its current capabilities, market conditions, and risk appetite. The endorsement from overseas business development (BD) can rapidly elevate valuation and deliver substantial upfront payments, thereby alleviating cash flow pressures. On the other hand, it also significantly reduces Mabwell’s heavy financial burden associated with late-stage clinical trials and commercial promotion. However, the inherent high risks of new drug development, the intense competition in overseas markets, and the uncertainties intrinsic to the NewCo model all mean that the global expansion path for 2MW7141 remains fraught with both opportunities and challenges. Mabwell’s ultimate success will still depend on the continuous output of its overall R&D pipeline, the successful commercialization of multiple projects, and its comprehensive ability to navigate the complexities of the global market.