On 21 August 2026, Shanghai Bao Pharmaceuticals Co., Ltd. (Bao Pharma) received U.S. Food and Drug Administration clearance for an Investigational New Drug application covering KJ015 for Injection (subcutaneous). The approval authorises the commencement of clinical trials in the United States.

KJ015 is a dual-epitope anti-HER2 bispecific antibody generated via common light-chain technology. The molecule simultaneously targets the trastuzumab and pertuzumab binding regions on HER2, inhibiting both HER2 homodimerisation and heterodimerisation with EGFR, HER3 and HER4. Pre-clinical studies cited in the announcement indicate enhanced inhibition of downstream MAPK and PI3K/Akt signalling versus conventional monoclonal-antibody combinations.

The candidate’s near-native IgG1 structure and deamidation design reportedly support stable, high-concentration formulation, enabling subcutaneous administration when co-formulated with recombinant human hyaluronidase. The subcutaneous route is expected to shorten administration time and lower intravenous-related risks. Bao Pharma owns global development and commercialisation rights to KJ015.

Regulatory progress to date includes National Medical Products Administration IND approval in December 2024 and initiation of a Phase I trial in China in June 2025, which is scheduled for completion in 2H 2026.

The company notes that clinical outcomes and regulatory decisions remain uncertain, and advises investors to exercise caution when trading its shares.