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

Zhitong Finance App News, Corning Jerry Pharmaceutical-B (09966) issued an announcement to launch a new marketing application for anituzumab (trade name: Enitumab®, R&D code: KN026) in combination with injectable docetaxel (albumin binding) (HB1801) first-line treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive (HER2+) (HER2+) breast cancer for adults NDA) has been accepted by the China National Drug Administration (China Drug Administration) and included in the priority review and approval process. Previously, the combination therapy of anitumab and HB1801 for this indication was granted breakthrough therapy certification by the State Drug Administration.

This NDA is mainly based on a key phase III clinical study (Study ID: kn026-003/Healer). Research results showed that the progression-free survival (PFS) of first-line treatment of advanced HER2+ breast cancer with anitumab and HB1801 was significantly superior to the current standard treatment of trastuzumab combined with pertuzumab and docetaxel (THP scheme). The efficacy had significant statistical significance and clear clinical benefits, and overall safety was good. Detailed data from the study will be presented at an international academic conference in the near future.

In China, about 20% of breast cancer patients are in advanced stages when first diagnosed, and about 10% of early-stage HER2+ breast cancer patients will relapse within 3 years after radical surgery. THP is still the first choice for first-line treatment of advanced HER2+ breast cancer at home and abroad. Although this treatment plan has significantly prolonged PFS in such patients, about 50% of patients still progress within 2 years, and clinical needs need to be met urgently. The kn026-003/healer study is the world's first phase III study to challenge the HER2 double antibody combination therapy head-to-head in advanced HER2+ breast cancer and confirm that the efficacy surpasses the THP scheme. It has achieved a historic breakthrough in the field of first-line treatment of HER2+ advanced breast cancer, and is expected to provide a new treatment option with better efficacy, better safety, and more convenient administration for advanced HER2+ breast cancer patients in China.

Currently, anitumab and HB1801 combination therapy have completed the full clinical layout of the new adjuvant, adjuvant, and advanced first-line treatment of HER2+ breast cancer. Among them, the NDA for the new adjuvant treatment of early-stage or locally advanced HER2+ adult breast cancer with this combination therapy has also been accepted by the National Drug Administration and included in the priority review and approval process.