[News] BaoPharma’s KJ015 Injection (Subcutaneous) Receives Clinical Trial Approval from the NMPA

On December 4, 2024, Shanghai BaoPharma Co., Ltd. (“BaoPharma”) received the Drug Clinical Trial Approval Notification from the National Medical Products Administration (NMPA) for KJ015 Injection (Subcutaneous).
KJ015 Injection (Subcutaneous) is classified as a Category 1 therapeutic biologic under drug registration regulations.
The active pharmaceutical ingredient, KJ015, is an anti-HER2 bispecific antibody independently designed by BaoPharma, derived from common light chain technology. By maintaining high affinity for two epitopes simultaneously, KJ015 forms clustering interactions with antigens on the cell membrane surface, resulting in superior efficacy against HER2-positive tumors compared to combination of trastuzumab and pertuzumab.
The lead preclinical indication for KJ015 is gastroesophageal adenocarcinoma, with additional potential applications in cholangiocarcinoma, gallbladder cancer, salivary gland cancer, endometrial cancer, ovarian cancer, colorectal cancer, and other HER2-high and HER2-intermediate expressing malignancies. Notably, even in HER2-positive breast cancer, KJ015 demonstrates competitive pharmacodynamic advantages.
With a symmetric molecular design, KJ015 offers high stability, high expression levels, a simplified manufacturing process, and cost efficiency. When combined with BaoPharma’s proprietary hyaluronidase, it further enhances the safety and convenience of subcutaneous administration, delivering strong market competitiveness.