Phase III clinical trial scheme discussion of recombinant human erythropoietin -Fc fusion protein for injection was successfully held
Recently, the Phase III clinical trial scheme discussion of recombinant human erythropoietin -Fc fusion protein for injection (hereinafter referred to as "rhEPO-Fc fusion protein") jointly conducted by Beijing New Leading Zhengzhou Deep Blue Sea and Shandong Danhong Pharmaceutical (a wholly-owned subsidiary of Buchang Pharmaceutical) was successfully held in the form of offline main venue (Beijing)+online video conference.
rhEPO-Fc fusion protein is a long-acting EPO (erythropoietin) variety, and its indication is anemia caused by chronic renal failure or tumor chemotherapy. At present, the long-acting EPO products listed in the world mainly include high glycosylation long-acting EPO AraNESP (and nesp) from Amgen (and Concord Kirin) and pegylated long-acting EPO Mircera from Roche. However, the domestic EPO market is still dominated by short-acting EPO, including Yibiao, Jimaixin, Huanerbo and so on.
▲ Professor Zuo Li, Director of Department of Nephrology, Peking University People's Hospital
The rhEPO-Fc fusion protein is the first class 1 new drug of rhEPO-Fc with completely independent intellectual property rights in China, and it is the first to enter the phase III clinical stage. Phase III clinical trial was led by Professor Zuo Li, director of Department of Nephrology, Peking University People's Hospital, and nearly 40 centers in China participated in the study.
▲ Zhang Ronghuo, new leading vice president of Beijing and general manager of Zhengzhou Deep Blue Sea
Professor Zuo Li, director of the Department of Nephrology, Peking University People's Hospital, and more than 70 major researchers and institutional leaders from nearly 40 centers in China, as well as Dr. The meeting was chaired by Vice President Zhang Ronghuo. eneral manager of Beijing Buchang New Drug Research and Development Co., Ltd., Zhang Ronghuo, new leading vice president of contract research organization in Beijing and general manager of Zhengzhou Shenlanhai, Lu Xinghong, deputy general manager of clinical division, and relevant personnel of the project attended the meeting.
▲ Dr. Yang Chun, General Manager of Beijing Buchang New Drug Research and Development Co., Ltd
At the beginning of the meeting, Dr. Yang Chun, General Manager of Beijing Buchang New Drug R&D Co., Ltd., the project sponsor, first introduced the background information of the project and the preparatory work in the early stage.
Subsequently, Dr. Zhu Haobin, Director of Beijing New Leading Zhengzhou Deep Blue Sea Medical Department, elaborated on the research scheme in detail and had a heated discussion with all the participants. Professor Zuo Li and the project team answered the questions one by one, which greatly improved the confidence of the participants.
In this seminar, all the participants showed a strong sense of responsibility, high professionalism and scientific and rigorous work style. I believe that in the upcoming Phase III clinical trial, Beijing New Leading Zhengzhou Deep Blue Sea will work together with researchers from more than 40 centers across the country to complete this research with high quality, high efficiency and intimacy in strict accordance with the latest regulations, which will add a lot of color to the research and development of new drugs in the field of long-acting EPO in China.
EPO project introduction
Erythropoietin, EPO) is a cytokine that promotes the proliferation and differentiation of bone marrow erythroid progenitor cells. The first generation of genetically engineered recombinant human erythropoietin (rhEPO) drugs generally have the weakness of short half-life (4 ~ 8 hours), which requires 2-3 times or more per week to obtain curative effect, which brings inconvenience to its clinical application. al failure, tumor after radiotherapy and chemotherapy, multiple myeloma, myelodysplastic syndrome and anemia caused by AIDS.
In view of this, the research aimed at prolonging the plasma half-life and/or improving the biological activity of EPO at home and abroad has never stopped. Another way to prolong the serum half-life of EPO is to prepare the fusion protein of EPO and human IgG Fc (rhEPO-Fc). The mechanism of prolonging the half-life of this method is as follows: (1) the introduction of 1)Fc increases the molecular weight of EPO, reduces the glomerular filtration rate and prolongs the half-life; (2) After the introduction of Fc, EPO enters the endoplasmic body by endocytosis, and then combines with the intracellular FC recycling receptor to be released out of the cell, EPO can be reused, thus prolonging the half-life of EPO.
About Beijing New Leading Zhengzhou Deep Blue Sea:
Deep Blue Sea (Zhengzhou) Biomedicine is a well-known brand created by Beijing New Leading in the field of clinical CRO. The company has more than 300 highly professional clinical service teams and has set up resident offices in more than 20 central cities such as Shijiazhuang, Wuhan, Changsha, Hangzhou, Zhengzhou, Shenyang, Dalian and Guangzhou. The company consists of medical department, clinical operation department, data department, quality control committee, pharmacovigilance department, registration department and human genetic resources management committee. Through innovative service mode and multi-dimensional information technology, it can promote the development of clinical research and change the outsourcing service mode of clinical research, and provide customers with diversified R&D support and services, including Phase I ~ IV clinical trials of innovative drugs and generic drugs, bioequivalence (BE) trials of generic drugs, PK/PD clinical studies, in-vivo and in-vitro correlation studies (IVIVR), medical device clinical studies and third-party audits, etc., covering large and small molecular drugs in an all-round way to meet different needs.
At present, the company has established cooperation with more than 400 GCP hospitals in 28 provinces and cities in China, and has cooperated with more than 80 hospitals for more than 5 years, such as Peking University First Hospital, Beijing anzhen hospital, Beijing Fuwai Cardiovascular Hospital, Shanghai Changhai Hospital, Zhongshan Hospital affiliated to Fudan University, jiangsu province hospital, Sino-Japanese Friendship Hospital of Jilin University, First Affiliated Hospital of Harbin Medical University, Guangdong Traditional Chinese Medicine Hospital and First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine.