On January 31, 2024, the first center kick-off meeting of the Phase B clinical trial of Hanke Mabharm Hua21 Injection, a subsidiary of Anke Biotech, was successfully held in the First Affiliated Hospital of Anhui Medical University, marking the official entry of the Phase B clinical study of "Evaluation of Recombinant Anti-HER2 Humanized Hua21 Monoclonal Antibody Injection Combined with Trastuzumab Combined with Chemotherapy**HER2-positive Locally Advanced Metastatic Gastric Cancer in Patients With HER2-positive Metastatic Gastric Cancer" officially entered the clinical trial subject enrollment stage.
Project kick-off meeting
The First Affiliated Hospital of Anhui Medical University was the co-leader unit of this study, and the main investigators, Dean Sun Beicheng, Director Du Yingying of the Department of Oncology, Director Li Yongxiang, Director Han Wenxiu, Director Yu Changjun of the Department of Gastrointestinal Surgery, Director Cao Xiandong, Director Zhang Zhen, Director Chen Wei, Director Zhang Mei and Director Liu Pingping of the Department of Oncology, and Director Wang Xianai of the Institutional Office attended the meeting. Cheng Liansheng, General Manager of Hanke Mabo, the sponsor, Lu Chunyan, Vice President of Anke Biotechnology Group, and Zhang Liangbi, Director of Anke Biopharmaceutical Clinical Research Center, attended the kick-off meeting with their teams. The kick-off meeting was presided over by Director Wang Xianai.
At the beginning of the meeting, President Sun Beicheng made an opening speech at the clinical kick-off meeting: The First Affiliated Hospital of Anhui Medical University has rich experience in clinical research. It is hoped that through the strong cooperation with Anke Biotech and Hanke Mabx, Hua21 injection, a potential and promising product, will bring good news to the majority of patients. Subsequently, Ma Qing, deputy director of Anke Biopharmaceutical Clinical Research Center, introduced the research background, protocol design, research population, research process and other aspects of this clinical trial. During the discussion stage, the general manager of Hanke Mab and the leaders of Acro Biotech gave detailed answers to the questions that may be encountered in the trial process by the on-site clinical experts. At the end of the meeting, Vice President Lu Chunyan summarized the kick-off meeting, highly affirmed the quality and importance of the meeting, and the meeting was successfully completed according to the established schedule. The successful conclusion of this conference marks the official entry of the phase B clinical trial of Hua21 injection.
Hua21 injection.
Hua21 Injection (full name: recombinant anti-HER2 humanized Hua21 monoclonal antibody injection) is the first Category 1 innovative drug to enter the clinical trial stage. Hua21 is a humanized monoclonal antibody tumor-targeted drug targeting for HER2, which contains a completely different amino acid sequence from trastuzumab and has completely independent intellectual property rights. HUA21 induces the endocytosis and downregulation of HER2 receptors, interrupts the cancer cell signaling pathway, thereby inhibiting the growth and proliferation of cancer cells, promoting cancer cell apoptosis, anti-tumor angiogenesis, and ultimately inhibiting tumors.