The Clinical Launch Meeting of RhEPO-Fc Innovative Drug Project Was Successfully Held in Guangdong Provincial People's Hospital

Created on:2020-05-21 19:50

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May 19th,2020 Press Release

 

 

The Clinical Launch Meeting of RhEPO-Fc Innovative Drug Project Was Successfully Held in Guangdong Provincial People's Hospital

 

[2020/5/21, Dongguan] On May 19th, 2020, the launch meeting of Phase I clinical trial study of recombinant human erythropoietin (Fc) fusion protein injection (the rhEPO-Fc project) was held in Guangdong Provincial People's Hospital, marking the official launch of the rhEPO-Fc project.

The rhEPO-Fc is an innovative Class 1 therapeutic biological product developed independently by Dongguan Taili Biotach Co., Ltd., a subsidiary of Great Bay Bio. Boji Medical provides CRO services during the whole Phase I clinical trials.

用1_副本_副本

Participants of this meeting include Yang Min, Director of Medical Research Department of Guangdong Provincial People's Hospital, Director of Phase I Research and rhEPO-Fc Project PI, Guo Lan Director of Cardiac Rehabilitation Area and Phase I Ward Director, Lan Wanjun, Director of CMC Platform of Dongguan Taili Biotach Co., Ltd., Bai Hucheng, the Deputy Director of the Phase I clinical department of Boji Medical and other heads of relevant units.

用3_副本_副本

During the meeting, Bai Hucheng explained the overall project plan to other participants. Yang Min made the summary and all the participants reached a consensus. At the end, Yang Min said that the meeting was substantial and profound with details well explained. She believes that with the joint efforts of medical institutions, sponsors, CROs, biological sample analyzing units, data management and statistical units, the trail would be finished successfully.

用2_副本

Dr. Chen Liang, CEO and co-founder of Great Bay Bio said: "We would like to extend gratitude to the Guangdong Provincial People's Hospital for overcoming all difficulties during the epidemic outbreak and promoting the rhEPO-Fc project out of our expectation, which also fully demonstrates the efficient execution of Guangdong Provincial People’s Hospital and Boji Medical. The successful implementation of this project will definitely benefit kidney patients.”

用4_副本_副本

The half-life of ordinary EPO preparations is only 6-8 hours in human serum circulation. The long-term and frequent medication would not only increase treating costs, but also seriously reduce the patient's medication compliance and life quality.

Recombinant human erythropoietin (Fc) fusion protein (rhEPO-Fc) is an innovative class 1 therapeutic biological product independently developed by Dongguan Taili Biotech Co., Ltd. It is a long-acting EPO drug and a fusion protein made by connecting erythropoietin and the constant region Fc fragment of immunoglobulin IgG. It can prolong the half-life of rhEPO in human body and reduce the medication frequency and even the dosage.

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About Great Bay Bio 

 

Headquartered in Hong Kong, Great Bay Bio (GBB) is a high-tech enterprise developing biologics with AI technologies. Since its foundation, it has been committed to biotech and biologics development. It has founded Dongguan Taili Biotech Co., Ltd. and Guangzhou Taili Biomedical Technology Co., Ltd. Investing more than RMB 300 million, the company has successfully established the independent and integrated technology platform for drug R&D and large-scale preparation. Through customized CMC packaging services, it has successfully helped several products reach NDA stage, some of which are national class I new drugs.

GBB positions itself as a Contract Development and Manufacturing Organization (CDMO), applying AI technology to CMC (Chemistry, Manufacturing, Control) platform for drug development, which targets the drawbacks of drug development including long timeline and high costs, and solves them with the AI+CMC model. Based on massive datum obtained from conventional biologics development, CMC platform can build models and conduct AI analyses. Integrating AI and biotechnology, it can overcome hurdles in biologics development and greatly reduce the time and costs so as to provide much cheaper, efficient and high-quality drug development service for the clients, and also bring much economical drug to the society.

GBB has been recognized as the Patent Incubation Company, Patent Pilot Company, National High-tech Company, Dongguan New Research Institution, Guangdong Top Ten Foreign R&D Center, Guangdong R&D Center of Genetic Engineering Medicine and Engineering, and Guangdong Doctoral Workstation. Since 2006, it has undertaken a number of government projects. More than RMB 20 million has been received from the government to support its provincial and national projects, such as Guangdong-Hong Kong Key Breakthrough Project and National Major New Drug Projects.

The CMC platform has an area of over 3100 m2 and a whole set of advanced biopharmaceutical R&D equipment. The key equipment has been purchased from world-renowned manufacturers such as Sartorius, Bio-Rad, GE Healthcare, and Waters. The pilot workshop is designed strictly in accordance with cGMP requirements, mainly at the C level and some even at the A level.

 

 

For more details, please visit:www.greatbay-bio.com

Contact for business:js.chen@greatbay-bio.com

Contact for media and investment: public@greatbay-bio.com

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