Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that its New Drug Application for 9MW0813 injection has been accepted by the National Medical Products Administration (NMPA) for the treatment of diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).

As a biosimilar to aflibercept (Eylea®), 9MW0813 is a fusion protein formed by recombining the extracellular region binding domains of VEGFR-1 and VEGFR-2 with the Fc segment of human immunoglobulin. It is capable of binding VEGF-A and PlGF.

Developed in accordance with NMPA's "Guideline on Biosimilarity Evaluation and Indication Extrapolation for Biosimilars" (February 2021), 9MW0813 underwent comprehensive comparative analyses. Through multi-batch process optimization, head-to-head quality assessment, structural characterization, functional studies, and stability testing, the product demonstrated manufacturing consistency and quality controllability, exhibiting high pharmaceutical similarity to the reference product. Non-clinical pharmacodynamic, pharmacokinetic and safety comparison studies confirmed identical mechanisms of action, comparable in vivo efficacy, similar pharmacokinetic profiles, and equivalent drug-related toxicity.

Mabwell received IND clearance for 9MW3811 from NMPA in September 2020. Phase I results showed favorable safety profiles in subjects, with no unexpected adverse reactions beyond Eylea's labeling and no detectable anti-drug antibodies. Pharmacokinetic analysis demonstrated comparable blood concentration and key PK parameters between 9MW0813 and the reference product. Therapeutic efficacy was evidenced by visual acuity improvement and retinal structural recovery (CRT reduction and lesion area improvement). Phase III clinical data confirmed similar clinical efficacy, safety profiles, immunogenicity, biomarkers, and pharmacokinetic characteristics between 9MW0813 (2mg, intravitreal injection) and Eylea (2mg, intravitreal injection) in DME patients.

Mabwell previously established a supply and commercialization partnership with an Indian pharmaceutical company, granting exclusive rights for 9MW0813 importation, manufacturing, registration, and commercialization in India, along with non-exclusive rights in ten countries across South Asia and Africa.