First Patient Dosed in Phase II Trial of AnkeBio’s HK010 Bispecific Antibody

January 15, 2026-Anhui Anke Biotechnology (Group) Co., Ltd. (AnkeBio) today announced that the first patient has been enrolled and dosed in the Phase II clinical trial of its independently developed bispecific antibody, HK010 injection, at the First Affiliated Hospital of the University of Science and Technology of China. This milestone marks the official transition of the HK010 program from Phase I safety evaluation into the Phase II preliminary efficacy assessment stage.

HK010 injection is a human PD-L1×4-1BB bispecific antibody of the IgG4 subclass, representing one of AnkeBio’s key innovative assets in cancer immunotherapy. Preclinical studies have demonstrated robust tumor suppression across multiple tumor models, along with favorable preliminary safety and tolerability, highlighting its therapeutic potential.

Mechanistically, HK010 not only blocks the PD-1/PD-L1 interaction to relieve immune checkpoint inhibition, but also selectively activates 4-1BB signaling on T cells via PD-L1-mediated molecular crosslinking, thereby enhancing antitumor immune responses and enabling potent tumor cell killing. Notably, HK010 lacks both ADCC and CDC activities, does not rely on Fc receptor-mediated crosslinking for T-cell activation, and avoids binding to other members of the PD-L1 and 4-1BB families, thereby minimizing the risk of non-specific activation.

Supported by robust preclinical data and the safety and preliminary efficacy results from the Phase I study, the Phase II trial of HK010 is now underway at multiple clinical sites across China. This stage will focus on evaluating the safety and efficacy of HK010 in patients with advanced solid tumors, generating evidence to inform subsequent Phase III studies.