Roche's FGF21 analogue pegozafermin has received Breakthrough Therapy Designation (BTD) from China's Centre for Drug Evaluation (CDE) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The candidate, acquired through Roche's USD 3.5 billion takeover of 89bio in September 2025, is noted for its dual anti-fibrotic and anti-inflammatory mechanisms. This designation is expected to accelerate its regulatory pathway in China.

The decision is supported by Phase II ENLIVEN trial data, which demonstrated significant efficacy in patients with stage 2 or 3 fibrosis. In the trial, 27% of patients receiving the 44 mg dose achieved at least a one-stage improvement in fibrosis without worsening of MASH, compared to just 7% in the placebo group.

According to PharmCube's NextBiopharm® database, pegozafermin is one of three FGF21-targeted assets currently in Phase III development globally, alongside candidates from GSK and Novo Nordisk. Click here to request a free trial for NextBiopharm®.