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, GBB is a high-tech enterprise dedicated to applying artificial intelligence and other cutting-edge technologies to CMC (Chemistry, Manufacturing, Control) for development of biopharmaceuticals and other blue ocean bio-products (such as cell therapy), ultimately solving numerous pain points of CMC development, including high failure rates, long development timeline and high costs. Since the company’s establishment, it has obtained massive data from conventional biologics development in its 3100 m2 CMC facilities in Dongguan, PRC. With over RMB 300M investment, the facilities bolster advance equipment from world-renowned manufacturers. GBB has also successfully brought a number of biologic products to NDA stage, some of which are classified as national class I innovative drugs. Currently, the company has created the intelligent centralized database, where deep learning is being performed to create next generation AI-enabled CMC platforms. To learn more, please visit http://www.greatbay-bio.com.

 

PR Contact: Miss Liu 

Email: yt.liu@greatbay-bio.com

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