China's Hengrui Pharma has secured conditional approval for SHR2554, the country's first EZH2 inhibitor for relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) after at least one prior systemic therapy. The oral therapy demonstrated significant improvement over historical controls in Phase II trials (n=67), meeting prespecified efficacy thresholds for accelerated approval. Hengrui licensed ex-China rights to Treeline Biosciences in February 2023 following breakthrough therapy designation (BTD) from China's National Medical Products Administration (NMPA) in January 2023.

SHR2554 potently inhibits both wild-type and mutant EZH2 enzymatic activity, addressing unmet needs in aggressive T-cell malignancies where treatment options remain limited. The approval marks Hengrui's fourth novel drug launch in 2025, reinforcing its leadership in oncology innovation. Detailed Phase II results will support full regulatory approval following confirmatory trials in this rare haematologic malignancy.

According to PharmCube's NextBiopharm® database, SHR2554 is one of only four EZH2 inhibitors approved globally, among a total of 41 active projects. Click here to request a free trial for NextBiopharm®.