Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that the China National Medical Products Administration (NMPA) has formally accepted its Investigational New Drug (IND) application for 9MW3811, a novel anti-IL-11 monoclonal antibody, to initiate Phase II clinical trials for pathological scarring. The trial is expected to be initiated by late 2025, positioning 9MW3811 as the first IL-11-targeted therapeutic globally to advance into clinical stage for this indication.

Interleukin-11 (IL-11) is a cytokine critically implicated in chronic inflammation and fibrotic disorders across multiple organs (e.g., lungs, skin, kidneys, liver) and is increasingly linked to aging-related diseases (Nature, 2024). Pathological scarring, encompassing hypertrophic scars, keloids, and contracture scars, is notably driven by IL-11-mediated fibroblast-to-myofibroblast transdifferentiation via upregulation of extracellular matrix and α-smooth muscle actin (α-SMA), as demonstrated in the study “CD39 Fibroblasts Enhance Myofibroblast Activation by Promoting IL-11 Secretion in Hypertrophic Scars” in Journal of Investigative Dermatology (2022). Targeting IL-11 signaling effectively reduces α-SMA positive fibroblasts, halting scar progression.

9MW3811 is a proprietary IL-11-targeting humanized mAb developed by Mabwell. It binds IL-11 with high affinity, effectively inhibiting abnormal activation of the IL-11/IL-11Rα signaling pathway and thereby intervening in the pathological progression of fibrosis-related diseases. Its key advantages include:
- Higher target affinity and signaling blockade capability;
- A long half-life period exceeding one month, making it more suitable for chronic diseases requiring long-term treatment.

Preclinical studies demonstrate that 9MW3811 shows significant efficacy in various models including pulmonary fibrosis, and exhibits therapeutic potential in fibrosis-related diseases such as hypertrophic scar  and abnormal endometrial bleeding. Particularly in human patient-derived keloid animal models, 9MW3811 effectively alleviates skin fibrosis progression and reduces existing scar volume. According to Frost & Sullivan data, there are approximately 25 million patients with pathological scars worldwide (about 7.4 million in China), with incidence rates continuing to rise. The number of Chinese patients is expected to exceed 10 million by 2030. Therefore, IL-11-targeted therapy holds significant clinical value and market potential.

9MW3811 has been approved to initiate clinical studies for advanced malignant tumors and idiopathic pulmonary fibrosis (IPF) in China, US and Australia, and has completed Phase I trials in healthy volunteers in Australia and China. The results demonstrate favorable safety and a half-life exceeding one month, placing it at a leading position globally for this target.

Mabwell has entered into an exclusive licensing agreement with CALICO Life Sciences for 9MW3811. CALICO, a subsidiary of Alphabet focused on innovative anti-aging therapies, has strong research capabilities in the field of anti-aging. 9MW3811 not only has broad application prospects in multi-organ fibrotic diseases including IPF, thyroid eye disease, skin fibrosis, renal fibrosis, hepatic fibrosis and cardiac fibrosis, but also holds potential in aging-related diseases such as chronic conditions caused by cellular senescence, age-related frailty, and longevity.