HiFiBiO Therapeutics

HiFiBiO has advanced eight clinical candidates since its founding in 2017. As of mid-2025, three programs are in Phase 1 trials targeting TNFR2 agonist (HFB200301), BTLA antagonist (HFB200603), and a second-generation OX40 agonist (HFB301001). Four Phase I dose escalation trials have been completed. The company leverages its DIS® platform to enhance the probability of success for immunotherapies by enabling deep understanding of immune modulation at the single-cell level. Two additional assets were handed over to FibroGen; two more INDs were planned for filing in 2024. The pipeline is primarily focused on oncology and autoimmune indications with a strong emphasis on first-in-class or best-in-class biologic drugs.