Mabwell (688062.SH, 02493.HK), an innovative biopharmaceutical company with a fully integrated industry chain, announced results from a Phase II/III clinical study of its novel anti-VEGF mAb 9MW0211 for neovascular (wet) age-related macular degeneration (nAMD) at the 40th World Ophthalmology Congress, held in Prague, Czech Republic, from June 26 to 29, 2026. The results demonstrated that 9MW0211 (1.5 mg Q4W) was non-inferior to ranibizumab in efficacy and exhibited advantages in retinal fluid resolution.

The study (CTR20202561) aimed to evaluate the efficacy, safety, and immunogenicity of 9MW0211 in treating nAMD and to confirm its non-inferiority to ranibizumab. The trial adopted a seamless Phase II/III integrated design, enrolling a total of 476 participants, with 332 in the 9MW0211 group and 144 in the ranibizumab group. The study findings were upgraded from a poster presentation to an oral podium presentation at the congress. Professor Zhang Ming, Chief Physician of Ophthalmology at West China Hospital, Sichuan University, presented the results on behalf of the study team.

The primary efficacy endpoint was the change in best-corrected visual acuity (BCVA) letter score at Week 52. Results showed that the 9MW0211 1.5mg Q4W group achieved a mean improvement of 14.1 letters from baseline in BCVA at Week 52, demonstrating non-inferiority to the ranibizumab Q4W group. In terms of anatomical outcomes, the 9MW0211 1.5mg Q4W group showed a mean reduction in central retinal thickness (CRT) of 205.6 μm at Week 52, compared to a reduction of 141.0 μm in the ranibizumab group, indicating a superior advantage in fluid resolution. Furthermore, the proportion of patients achieving absence of intraretinal and subretinal fluid was consistently higher in the 9MW0211 Q4W group than in the ranibizumab group at Weeks 12, 24, and 52. Regarding safety, the incidence of treatment-emergent adverse events (TEAEs) was comparable between the overall 9MW0211 dose groups and the ranibizumab group.

Age-related macular degeneration (AMD) is a leading cause of vision loss in the elderly, with neovascular AMD being the primary type responsible for severe vision impairment. The study results highlight the superior therapeutic potential and favorable safety profile of 9MW0211, suggesting it may offer a promising new treatment option for patients with nAMD.