BAO PHARMA-B (02659.HK): IND for KJ015 injection (anti-HER2 bispecific antibody subcutaneous formulation) approved by US FDA
NewTimeSpace News: On 24 August 2026, Shanghai Bao Pharmaceuticals Co., Ltd. (stock code: 02659) announced that the investigational new drug (IND) application for its self-developed KJ015 injection, an anti-HER2 bispecific antibody subcutaneous formulation, was approved by the U.S. Food and Drug Administration (FDA) on 21 August 2026, permitting clinical trials to be conducted in the United States.
The announcement stated that KJ015 is an innovative bispecific anti-HER2 antibody subcutaneous formulation derived from common light chain technology, designed with two Fab arms carrying a common light chain to form a near-native IgG1 structure. By maintaining 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 heterodimerization of HER2 with EGFR, HER3 and HER4, leading to attenuated downstream signaling such as MAPK and PI3K/Akt. The Company's preclinical studies showed enhanced overall efficacy of KJ015 compared with conventional anti-HER2 monoclonal antibody combinations at the preclinical stage.
The near-native structure of KJ015, together with its deamidation design, confers stable physicochemical properties and high yield in large-scale production, and its stability at high concentrations supports the subcutaneous formulation with the Company's recombinant human hyaluronidase. The subcutaneous administration design can shorten the time to onset, improve patient convenience and lower the risks associated with intravenous administration, providing a safer and more patient-friendly alternative. The Company is developing KJ015 in-house and owns global rights for its development and commercialization. KJ015 received IND approval from the National Medical Products Administration in December 2024, and Phase I clinical trials commenced in China in June 2025, expected to be completed in the second half of 2026.
The Company cautioned that there is no guarantee that KJ015 will ultimately be successfully developed or commercialized, and given the unpredictable factors in clinical trial processes, shareholders and potential investors should exercise caution when dealing in the Company's shares.
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