The First Batch of Phase I Clinical Trial Subjects for GBB’s Class 1 new Drug Has Been Enrolled

Created on:2020-06-05 08:41

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June  5th,2020 Press Release

 

The First Batch of Phase I Clinical Trial Subjects for GBB’s Class 1 new Drug Has Been Enrolled

 

[2020/6/5, Dongguan] On June 4th, the first batch of phase I clinical trial subjects of the recombinant human erythropoietin (Fc) fusion protein injection (rhEPO-Fc project) has been enrolled in Guangdong Provincial People's Hospital.

RhEPO-Fc is a Class 1 therapeutic biologics independently developed by Dongguan Taili Biotech Co., Ltd., a subsidiary of Great Bay Bio. Boji Medical provides CRO services for its Phase I clinical trials.

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The subjects are all healthy volunteers. After enrollment, they will be injected with the clinical drugs and stay in hospital for the 72-hour observation. After that, the 29-day follow-up will be conducted. The clinical trial will focus on subjects’ safety and tolerability after the medication, and observe their pharmacokinetics and pharmacodynamics characteristics.

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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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