Core Viewpoint - Anke Biotech (300009) has received the Clinical Trial Approval Notification from the National Medical Products Administration for its innovative biological product, AK2024 injection, aimed at treating HER2-positive advanced solid tumors [1] Group 1: Product Information - AK2024 injection is classified as a Class 1 therapeutic biological product and is designed for clinical trials as a monotherapy in HER2-positive advanced solid tumors [1] - The product is developed using a functional detection method based on Trastuzumab, identifying anti-HER2 antibodies that exhibit synergistic anti-tumor activity with Trastuzumab [1] - AK2024 selectively targets the extracellular domain of the human epidermal growth factor receptor 2 (HER2), with a different antigen recognition epitope compared to Trastuzumab or Pertuzumab [1] Group 2: Preclinical Research Findings - Preclinical studies indicate that AK2024 can inhibit the proliferation of HER2-positive tumor cells and demonstrates a synergistic effect with Trastuzumab [1] - The efficacy of AK2024 is reported to be superior to Pertuzumab in enhancing the anti-tumor synergistic effect of Trastuzumab [1]
7月1日午间公告一览:安科生物AK2024注射液获药物临床试验批准