On March 16, 2022, the First Investigator Meeting for Phase II Clinical Trial of Lizaisi Injection was successfully held at Lize Business District, Fengtai District, Beijing.Professor Zhang Lan, Principal Investigator (PI) of the Phase I trial from Xuanwu Hospital, Capital Medical University, Professor Song Haiqing, PI of the Phase II trial from Xuanwu Hospital, Capital Medical University, Deputy General Manager Liu Chi (Project Lead) and Marketing Director Kang Ting of Vanworld Pharmaceutical (Rugao) Co., Ltd., the team of Quark Pharmaceutical (the contracted CRO), as well as medical representatives from more than a dozen research institutions attended the meeting together.
First of all, Professor Song Haiqing from Xuanwu Hospital, the lead research institution of this project, delivered an opening speech. Professor Song stated that the Phase II research team consists of numerous experienced clinical institutions, forming a robust working group. He expressed confidence that the project would be completed smoothly through joint efforts and collaboration among the sponsor, CRO and all research sites.Neuroprotective therapy for stroke has attracted extensive research attention in recent years. He hoped that more promising drugs like Lizaisi would be launched to maximize clinical benefits for patients. In addition, Professor Song mentioned that the Phase I study was conducted at Xuanwu Hospital, laying a solid foundation for subsequent research. He looked forward to working side by side with all participants to deliver successful outcomes for the Phase II trial.
Subsequently, Professor Zhang Lan reviewed the overall outcomes of the Phase I clinical trial and shared her anticipation and confidence for the advancement of the Phase II project. Professor Zhang noted that the Phase I trial evaluated the overall safety and tolerability of the study drug, generating critical data to support the progression of subsequent clinical research.As a core member of the Phase I team, she expressed great gratification to witness the steady progress of the Lizaisi clinical trial toward the ultimate goal of benefiting patients. In closing, Professor Zhang extended her best wishes and full confidence that the Phase II trial would achieve smooth completion under the leadership of Professor Song Haiqing.
Director Kang Ting from Vanworld Pharmaceutical (Rugao) Co., Ltd. gave a detailed presentation on the company and its product, and put forward core expectations for the trial execution. She urged the team to deliver high-quality trial results while ensuring all clinical trial data remains authentic, accurate, complete, timely and compliant with regulatory requirements.
Afterwards, Dr. Wang Fang, Medical Director of Quark Pharmaceutical, presented and conducted training on the clinical trial protocol. Her presentation covered the trial objectives, general project overview, inclusion and exclusion criteria, and key observation endpoints, with special emphasis on critical precautions across all trial procedures. She also hosted an online discussion with investigators from each research site, addressing and answering all potential challenges that may arise during trial implementation one by one.
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