Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that its novel anti‑IL‑11 monoclonal antibody 9MW3811 has received approval from the China National Medical Products Administration (NMPA) to initiate a Phase II clinical trial for pathological scarring. 9MW3811 becomes the world’s first IL‑11‑targeting therapeutic to enter clinical stage for this indication.

Interleukin‑11 (IL‑11) is a cytokine that plays a critical role in chronic inflammation and fibrosis across multiple organs, including the lungs, skin, kidneys, and liver. 9MW3811 is a proprietary IL-11-targeting humanized monoclonal antibody developed by Mabwell, classified as a Category 1 therapeutic biologic with independent intellectual property rights. It is designed to bind IL‑11 with high affinity and effectively inhibit abnormal activation of the IL‑11/IL‑11Rα signaling pathway. This intervention helps block the pathological progression of fibrosis‑related diseases.

Key advantages of 9MW3811 include:

1)     Higher target affinity and stronger signaling blockade capability

2)     A long half‑life exceeding one month, making it suitable for chronic diseases requiring long‑term treatment

Preclinical studies have shown that 9MW3811 demonstrated significant efficacy in multiple models such as pulmonary fibrosis, and showed potential application value in fibrosis‑related diseases such as hypertrophic scar and abnormal endometrial bleeding. Especially in human‑derived keloid animal models, 9MW3811 can effectively alleviate the process of skin fibrosis and reduce the volume of existing scars. 9MW3811 has been approved to initiate clinical studies in China, US and Australia for indications including advanced malignant tumors and idiopathic pulmonary fibrosis (IPF), 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. The Phase II clinical trial of 9MW3811 for pathological scarring is planned to start at the end of 2025.

IL‑11 is also closely related to the occurrence of aging‑related diseases (Nature, 2024). Mabwell has reached an exclusive license agreement with CALICO Life Sciences, a company under Alphabet focusing on innovative anti‑aging therapies, for 9MW3811. In addition to having broad application prospects in multi-organ fibrotic diseases including IPF, thyroid eye disease, skin fibrosis, renal fibrosis, hepatic fibrosis and cardiac fibrosis, 9MW3811 also has potential application prospectsin aging-related diseases such as chronic conditions caused by cellular senescence, age-related frailty, and longevity.

About Pathological scarring

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. 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.