HJB - Your Trusted Biologics CDMO Partner

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HJB - Your Trusted Biologics CDMO Partner

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Dec, 2018

HJB Announces Milestone by Helping Lepu Biotech Advance Clinical Trials Progress

Recently, HJB delivered monoclonal antibodies to Taizhou Houde Aoke Technology, a subsidiary of Lepu Biotech Co., Ltd. ("Lepu Biotech"), and these antibodies have entered clinical trials and were successfully administered to patients. It is the first product manufactured by HJB under GMP conditions to enter clinical trials since the company started operation in January 2018, which marks an important milestone for HJB’s GMP manufacturing capability and CDMO services.

This project started in mid-April 2018. HJB delivered the first batch of GMP products to the client in one-time manner in October, and the first patient dosing has been conducted in the clinical trials in early December. It is HJB’s high standards of GMP quality management system, manufacturing , operation and service mindset that ensured excellent drug quality and efficient production.

To be able to complete GMP production and dosing of patients in such a short time, Lepu Biotech’s technical team commented: "Currently we are facing extremely fierce competition, but HJB has provided great push to our drug development not only by ensuring product quality and quantity, but also completing the project ahead of schedule. HJB also offered professional and valuable insights for our IND application in China and the US. "

HJB’s Founder and President Dr. Jonathan Zhao said, “Congratulations to Lepu Biotech for on the important milestone. In this project, our team completed the technology transfer in a short time utilizing the company’s outstanding integrated platform of process and manufacturing. This will be the beginning for us to create more values for our partners in the future."

Since completed and operational in January this year, HJB has passed on-site equipment and facilities verification, established quality management system and completed the GMP production and release for the first IND project. HJB is dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners.