BAO PHARMA-B (02659): The clinical trial application for KJ015 injection (anti-HER2 bispecific antibody subcutaneous formulation) has been approved by the US FDA.

BAO PHARMA-B (02659) announced that on August 21, 2026, the clinical trial application (IND) for KJ015 injection (a subcutaneous formulation of a bispecific antibody targeting HER2, collectively referred to as "KJ015"), independently developed by the company, was approved by the U.S. Food and Drug Administration (FDA), allowing clinical trials to be conducted in the United States. KJ015 is an innovative subcutaneous formulation of a bispecific anti-HER2 antibody derived from universal light chain technology, designed to possess two Fab arms featuring universal light chains, forming a structure close to natural IgG1. With its ability to maintain high affinity for two epitopes simultaneously, KJ015 can target the clinically validated epitopes recognized by Herceptin (trastuzumab) and Perjeta (pertuzumab), inhibiting HER2 homodimerization as well as the heterodimerization of HER2 with EGFR, HER3, and HER4. Compared to existing bispecific anti-HER2 antibodies, KJ015 has a more rational affinity and structural refinement, effectively inhibiting the dimerization of HER2 with ERBB family members and weakening downstream signals such as MAPK and PI3K/Akt; this dual binding promotes antibody-antigen aggregation, facilitating the internalization and recognition of tumor antigens, distinguishing it from the combinations of monoclonal antibodies. The companys preclinical research indicated that KJ015 demonstrated enhanced overall efficacy in the preclinical stage compared to traditional combinations of anti-HER2 monoclonal antibodies. Its near-natural structure, combined with a deamidated design, stabilizes its physicochemical properties and allows for high yields in large-scale production. Its stability at high concentrations is also beneficial for formulating subcutaneous preparations with the company's recombinant human hyaluronidase. The design of KJ015 facilitates subcutaneous administration, which can reduce the onset time of the drug, improve patient convenience, and lower the risks associated with intravenous administration, thus providing a safer and more patient-friendly alternative. The company is developing KJ015 internally and holds global rights for its development and commercialization. In December 2024, KJ015 received IND approval from the National Medical Products Administration of the People's Republic of China (NMPA), and Phase I clinical trials are expected to commence in China in June 2025, with completion anticipated in the second half of 2026.