On November 29, 2023, the inaugural center initiation meeting for the Phase I clinical trial of innovative drug ND-003, jointly developed by Shenzhen NewDEL Biotech Co., Ltd. ("NewDEL Biotech") and Shenzhen Small Molecule Drug Innovation Center Co., Ltd. ("Small Molecule Center"), was successfully held at the Sun Yat-sen University Cancer Center ("SYSUCC"). Professor Zhang Li's team, Professor Yang Yunpeng's team from SYSUCC Huangpu Campus, representatives from the sponsor NewDEL Biotech, and other relevant partners, totaling nearly 50 individuals, attended the meeting either in person or online. During the meeting, participants engaged in thorough discussions and analyses of the key points and challenges outlined in the protocol, harmonizing standards and procedures to lay a solid foundation for ensuring the quality of the clinical research.
Throughout the meeting, attendees, particularly the professors from SYSUCC, provided valuable insights and suggestions for the smooth progression of the ND-003 clinical trial. They offered numerous feasible recommendations and measures, particularly focusing on critical issues such as the recruitment and screening of trial participants, aiming for high-quality and swift enrollment to address the clinical needs of patients with relevant indications who lack effective treatments or are awaiting superior therapies. The convening of this initiation meeting marks another significant milestone following the implicit approval of the ND-003 clinical trial by the National Medical Products Administration, signaling the formal commencement of the ND-003 clinical trial.