Chinese biopharmaceutical company Mabwell Shanghai Bioscience Co Ltd (SHA: 688062) said on Tuesday that its novel anti-IL-11 monoclonal antibody, 9MW3811, has been approved by the China National Medical Products Administration to begin a Phase II clinical trial for pathological scarring, making this the first IL-11-targeting drug to reach clinical development for this indication globally.

9MW3811 is a proprietary humanised monoclonal antibody designed to inhibit the IL-11/IL-11Rα signalling pathway, which drives chronic inflammation and fibrosis across organs such as the lungs, skin, kidneys, and liver. The biologic, classified as a Category 1 therapeutic, has a half-life exceeding one month, making it suitable for long-term treatment.

Preclinical studies demonstrated significant efficacy in models of pulmonary fibrosis, hypertrophic scars, and keloids, with the drug reducing scar volume in human-derived keloid animal models. Clinical trials for 9MW3811 have already been approved in China, the United States, and Australia for multiple indications, including idiopathic pulmonary fibrosis and advanced tumours. Phase I studies in healthy volunteers confirmed favourable safety and pharmacokinetic results.

The Phase II trial for pathological scarring is expected to commence by the end of 2025.

Concurrently, Mabwell has signed an exclusive licence agreement with CALICO Life Sciences, a subsidiary of Alphabet (NASDAQ: GOOGL), to explore 9MW3811's potential in anti-ageing therapies.