Zhitong Financial App News, Corning Jerry Pharmaceutical-B (09966) announced that anitumab (trade name: Enitumab®, R&D code: KN026) co-developed with Shanghai Jinmante Biotechnology Co., Ltd. (Jinmante Biology), a subsidiary of Shiyao Group Co., Ltd. (01093), is used in combination with docetaxel (albumin binding type) (HB1801) for first-line unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive (HER2+) adult breast cancer has been obtained as a national drug The Drug Evaluation Center (CDE) of the Supervisory Authority granted breakthrough therapy certification (BTD). Previously, antitumab had been granted BTD by CDE for the treatment of HER2+ gastric cancer (including gastroesophageal junction adenocarcinoma) that failed first-line standard treatment. The awarding of BTD further confirms the excellent clinical value of anituzumab and its broad application potential in the field of HER2+ solid tumors.
The phase III clinical study (KN026-003) of anitumab combined with HB1801 for first-line treatment of advanced HER2+ breast cancer was evaluated by the Independent Data Monitoring Committee (IDMC) in June 2026 and successfully reached the main research endpoint PFS. Research results showed that the PFS of anitumab and HB1801 combination therapy is significantly superior to the current standard THP treatment regimen. The efficacy has significant statistical significance and clear clinical benefits, and the overall safety is good. Detailed data from the study will be presented at an international academic conference in the near future, and the company plans to submit a new drug marketing application (NDA) for this indication in the near future.
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. The BTD award for antizumab will help further accelerate its development process and review and approval speed in advanced HER2+ breast cancer, and is expected to change the first-line treatment pattern for advanced HER2+ breast cancer.