HiFiBiO Therapeutics Receives Approval from Chinese NMPA for IND Application for HFB200301, an Innovative Anti-Tumor Monoclonal Antibody

CAMBRIDGE, MA – October 9, 2023 – HiFiBiO Therapeutics, a clinical stage global biotech company focusing on improving patient lives with single cell precision, announced today that the Chinese National Medical Products Administration (NMPA) has approved the company’s Investigational New Drug (IND) application for HFB200301, a pioneering, first-in-class anti-TNFR2 agonistic monoclonal antibody.

HFB200301 is currently undergoing Phase I clinical trial (NCT05238883) evaluation in the treatment of advanced solid tumors in the United States and Europe, both as a monotherapy and in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor. This trial is guided by HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform, which utilizes patient data to optimize dosages, dosing regimens, indication selection, and biomarker strategies.

Liang Schweizer, PhD, Founder, Chairperson, and CEO of HiFiBiO Therapeutics, commented on this significant development, saying, “The approval of our HFB200301 IND by the NMPA represents yet another pivotal milestone for the program, confirming our strong commitment to developing safe and effective treatments for cancer patients globally.”

“Incorporating Chinese patients into our study will provide invaluable insights into the therapeutic potential of HFB200301 across a diverse patient population, ultimately guiding our efforts to develop novel immuno-oncology treatments to patients with significant unmet medical needs,” emphasized Robert Andtbacka, MD, CM, CMO of HiFiBiO Therapeutics.

Under the terms of the previously announced clinical supply agreement, Novartis will supply tislelizumab for use in combination with HFB200301, and HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights.



HFB200301 is a first-in-class anti-TNFR2 agonistic monoclonal antibody that binds potently and selectively to TNFR2, and induces the activation of CD4 T cells, CD8 T cells, and NK cells. HFB200301 demonstrates potent antitumor activity as a monotherapy and in combination with anti-PD-1 in animal tumor models. HiFiBiO is implementing a biomarker strategy, leveraging its DIS® platform, to identify indications that may benefit the most from HFB200301 as a monotherapy or as a combination therapy.


Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody, is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. Pre-clinical studies have shown that binding to Fcγ receptors on macrophages can compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.


About HiFiBiO Therapeutics

HiFiBiO Therapeutics is a global clinical-stage biotechnology company pioneering a unique high-resolution translational platform called DIS® (Drug Intelligence Science). DIS® combines unique single cell capabilities with AI/ML approaches using patient samples to discover novel targets, effective antibody drugs, and predictive biomarkers. With DIS®, HiFiBiO gains an unprecedented understanding of immune modulation in human diseases, driving a robust clinical pipeline of transformative immunotherapies. HiFiBiO has also partnered with major multinational pharmaceutical and biotech companies to apply its innovative DIS® approach and has been recognized as one of 2023’s Fierce 15 biotech companies. For additional information, please visit


HiFiBiO® and DIS® are trademarks of HiFiBiO and its affiliates.