Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for HK010, a bispecific antibody (BsAb) targeting PD-L1 and 4-1BB, for the treatment of advanced malignant tumors.
Drug Profile
HK010 is designed to block the PD-L1/PD-1 pathway while conditionally activating the 4-1BB co-stimulatory signal, aiming to release immunosuppression and activate the immune system. The BsAb features a differential affinity design between the two antigen-binding ends and weakened Fc function to balance efficacy and toxicity. Preclinical studies in animal tumor models demonstrated potent anti-tumor activity, with a favorable safety profile in monkey toxicology studies.
Market Context
China has multiple PD-L1/4-1BB bispecific antibodies in development, including Biotheus Bio’s PM1003, Elpiscience Bio’s ES101, Qilu Pharma’s QLF31907, Leads Biolabs’ LBL-024, I-Mab’s TJ-L14B/ABL503, and Antengene’s ATG-101, all of which are in clinical stages.-Fineline Info & Tech
