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 scar hyperplasia and abnormal uterine bleeding. Especially in human‑derived keloid animal models, 9MW3811 can effectively alleviate the process of skin fibrosis and reduce the volume of existing scars. Previously, 9MW3811 has been approved globally to carry out clinical studies for advanced malignant tumors and idiopathic pulmonary fibrosis, and has completed Phase I healthy volunteer trials in Australia and China. The results showed good safety and a half‑life of more than one month, with research progress in a globally leading position among drugs targeting the same pathway. 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 anti‑aging innovative therapies, for 9MW3811. In the future, in addition to having broad application prospects in multi‑organ fibrosis diseases including idiopathic pulmonary fibrosis, thyroid eye disease, skin fibrosis, kidney fibrosis, liver fibrosis, and cardiac fibrosis, 9MW3811 also has potential application prospects in aging‑related diseases such as chronic diseases caused by cellular senescence, frailty caused by aging, 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.