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——FSH-CTP project II/III phase drug clinical trial team leader unit kick-off meeting
On September 4, 2020, the “Phase II/III clinical trial of recombinant human follicle stimulating hormone-CTP fusion protein injection in assisted reproductive technology (ART) patients” led by Professor Cao Yunxia, President of Anhui Medical University The team leader unit kick-off meeting was held in the section conference room. Professor Chen Feihu, Director of the Science and Technology Department of Anhui Medical University, Professor Fei Guanghe, Deputy Dean of the First Affiliated Hospital of Anhui Medical University, Wang Xianai, Director of the Institutional Office of the First Affiliated Hospital of Anhui Medical University, Hu Wei, Director of the Institutional Office of the Second Affiliated Hospital of Anhui Medical University Dr. Liu Yanjun, chairman of the board of directors of Suzhou Shengji Pharmaceutical Co., Ltd., and Ms. Wang Zheng, general manager of the bidder, attended and gave speeches. The opening ceremony of the kick-off meeting was presided over by Wei Zhaolian, director of the Obstetrics and Gynecology Department of the First Affiliated Hospital of Anhui Medical University.
The First Affiliated Hospital of Anhui Medical University is the drug clinical trial institution with the earliest clinical trial qualification accreditation, the most certified professional points, the number of clinical trial projects undertaken and the largest project funding in Anhui Province. This drug clinical trial is led by the First Affiliated Hospital of Anhui Medical University and jointly carried out by 10 other well-known medical institutions in the United Nations. Each center is promoting the implementation of the project according to the plan. The First Affiliated Hospital of Anhui Medical University is also the leader of the trial. The first center to be launched, this project is also the first phase II/III clinical trial of drugs with the First Affiliated Hospital of Anhui Medical University as the team leader unit.
Before the kick-off meeting, the chairperson Wei Zhaolian introduced us to the people of the meeting and the meeting agenda.
Professor Cao Yunxia first introduced the general situation of the project and put forward strict requirements for the development of the project. The key support direction of the company is positioned as the development of new drugs and the construction of a high-level technology platform. The recombinant human follicle stimulating hormone-CTP fusion protein injection currently undertaken is independently researched by the sponsor and independently funded. It is a gonadotropin used for human super-ovulation stimulation. Preparation, the successful implementation of our clinical validation will surely provide strong support for drug innovation.
Professor Chen Feihu, on behalf of the project supporting unit, introduced the general situation of the clinical drug trial institution and the reproductive center, and pointed out that Professor Cao Yunxia, in conjunction with the First Affiliated Hospital, Second Affiliated Hospital and Institute of Clinical Pharmacology of Anhui Medical College, won the 2020 National New Drug Innovation Major Special Project-the first in China. The construction of a technical platform for clinical evaluation of new reproductive system drugs is of great significance for establishing an effective, proprietary and standardized clinical evaluation platform for reproductive prevention and treatment drugs in drug clinical trial institutions, and systematically evaluating the clinical safety and effectiveness of such drugs. .
Professor Fei Guanghe, deputy dean and director of the First Affiliated Hospital of Ann Medical University, proposed this project as the first phase II/III drug clinical trial project of the First Affiliated Hospital of Ann Medical University as the team leader unit. It has a demonstrative effect and will fully cooperate and create conditions. Ensure the smooth start and implementation of the project. At the same time, it said that it will use the project as the main line to carry out systematic key technology construction and improve the construction of hospital drug clinical trial institutions, so as to provide professional technical support for clinical research on reproductive drugs.
Dr. Liu Yanjun, Chairman of Suzhou Shengji Pharmaceutical Co., Ltd., the sponsor of the sponsor, first thanked Professor Cao Yunxia and other experts and professors of the First Affiliated Hospital of Anhui Medical University for their strong support to the clinical trials of the FSH-CTP project, and then introduced the company's development history and research drug-related information in detail , Said that the launching of the Phase II/III clinical trial team leader unit’s kick-off meeting was a new milestone, marking Suzhou Shengji’s introduction of long-acting FSH products to the market and another treatment option for assisted reproductive patients. Furthermore, it shows Suzhou Shengji's determination to study first-class biological drugs related to assisted reproduction and benefit more assisted reproduction patients.
Dr. Yao Wenqi from Beijing Stamsel Technology Co., Ltd. and Wang Xianai, director of the Institutional Office of the First Affiliated Hospital of Ann Medical University, who participated in the design of the project research plan, respectively conducted clinical research programs and new GCP training for participants in clinical drug trials. The research team is required to continuously promote the progress of the trial under the premise of protecting the subjects in strict accordance with the clinical protocol and ethical requirements to ensure the smooth progress of the trial process. After the training, the participating experts and researchers conducted in-depth and detailed discussions on the design of the research plan, various work processes and key issues in the implementation of the research, which laid a good foundation for ensuring the implementation of the scientific norms of the clinical research.
Finally, Professor Yunxia Cao announced that the "Phase II/III clinical trial of recombinant human follicle stimulating hormone-CTP fusion protein injection in assisted reproductive technology (ART) patients" was officially launched.
The kick-off meeting was highly praised by the researchers and research nurses who participated in the training. Participants expressed that they have gained a lot and improved the level of clinical drug trials, especially in the field of reproductive medicine. They have a deeper understanding and understanding of clinical drug trials. It will seriously participate in this clinical drug trial, accelerate the completion of clinical research and promote the listing of research drugs, and contribute to the research and development of innovative drugs for assisted reproduction, so that more patients will benefit as soon as possible.