Hengrui Pharmaceuticals has received breakthrough therapy designation (BTD) from its China homeland's Centre for Drug Evaluation (CDE) for HRS-5346, an inhibitor of lipoprotein(a), or Lp(a). The candidate, developed by Hengrui's subsidiary TuoJie Biotech, is intended for the treatment of elevated Lp(a) levels. In March 2025, MSD entered into an agreement to secure exclusive global rights to HRS-5346 outside of Greater China in a deal worth up to USD 1.97 billion.

Elevated Lp(a) is an independent risk factor for atherosclerotic cardiovascular disease (ASCVD), a leading cause of death globally, affecting an estimated 1.4 billion people worldwide. Currently, there are no approved Lp(a)-lowering therapies on the market. HRS-5346 has completed a Phase II study in a high cardiovascular risk population with elevated Lp(a), though the results have not yet been disclosed.

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