Corning Jerry Pharmaceutical-B (09966): Anituzumab (KN026) new adjuvant drug marketing application for HER2-positive breast cancer was accepted by the National Drug Administration

Zhitong Financial App News, Corning Jerry Pharmaceutical-B (09966) announced that the new drug marketing application (NDA) for the novel adjuvant treatment of early stage or locally advanced breast cancer (HER2+), developed in cooperation with Shanghai Jinmante Biotechnology Co., Ltd., a subsidiary of Shiyao Group (01093), has been accepted and accepted by the China National Drug Administration for injectable docetaxel (albumin binding) (HB1801) Priority review KN026 Approval process.

This NDA is mainly based on a key phase III clinical trial (study number: kn026-004/neo-healer) to enroll patients with early-stage or locally advanced HER2+ breast cancer. Research results showed that anituzumab combined with HB1801 ± carboplatin in adjuvant treatment of early or locally advanced breast cancer with HER2+ can significantly improve the overall pathologic complete remission rate (tPCR) compared with existing standard treatment (trastuzumab combined with pertuzumab and docetaxel ± carboplatin). TpcR assessed by the Independent Blind Assessment Committee (BIRC) reached 62.4% (95% CI: 56.20 to 68.23), with one-sided P = 0.0036. The efficacy conclusion was established. The efficacy improvement had both statistical and clinical value, and the overall safety was controllable.