By Fineline Cube 
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced on September 1 that the National Medical Products Administration (NMPA) has accepted its Phase II clinical trial application for the humanized monoclonal antibody 9MW3811 in the treatment of pathological scar disease.
About 9MW3811
- Target – Human interleukin‑11 (IL‑11).
- Mechanism – High‑affinity binding to IL‑11 blocks the IL‑11/IL‑11Rα axis, a key driver of fibrosis and scar formation.
- Classification – Class 1 therapeutic biologic with proprietary intellectual property rights.
Preclinical data demonstrate robust efficacy in multiple fibrosis models, including pulmonary fibrosis, and suggest potential benefit in other IL‑11‑mediated conditions such as scar hyperplasia and abnormal uterine bleeding.
Significance for Mabwell
- Regulatory Milestone – NMPA approval of the Phase II protocol validates Mabwell’s clinical strategy and accelerates the drug’s development timeline.
- Strategic Focus – The move underscores the company’s commitment to addressing unmet needs in fibrosis‑related diseases, a growing therapeutic niche.
- Commercial Potential – Success in Phase II could position 9MW3811 as a first‑in‑class therapy for pathological scar, opening a substantial market in both domestic and international territories.
Next Steps
Mabwell plans to initiate patient enrollment early in 2026, with a target enrollment of 150 participants across multiple centers in China. The company will also explore collaboration opportunities with leading dermatology and plastic‑surgery centers to broaden the trial’s reach.-Fineline Info & Tech