TOT BIOPHARM (Stock code: 1875.HK) announced that the CDMO service for commercial scale-up and manufacture of COVID-19 specific neutralizing antibody injection (JMB2002) for its partner Jemincare has completed in mid-August, one and a half months ahead of the expected delivery time. Meanwhile, TOT BIOPHARM expressed congratulations to JMB2002 for completing the Phase I clinical trial.

TOT BIOPHARM provided commercial scale-up and manufacture services with a size of 2,000 L for the Project JMB2002. Leveraging its one-stop innovative drug development and manufacture platform, TOT BIOPHARM completed the milestone delivery one and a half months earlier than expected, fully empowering the Project JMB2002 to conduct clinical studies in China, US and Europe as well as the later commercial manufacture, contributing to the fight against COVID-19 across the world.
Relying on the world-class commercial manufacture platform, mature QC/QA quality system and standardized CDMO project management system, TOT BIOPHARM is able to provide one-stop, end-to-end CDMO services with high quality from R&D to commercial manufacture at the same site. Based on the process advantages and years of experiences, TOT BIOPHARM completed the 2,000 L commercial scaling up and manufacture for JMB2002 disposably, and completed the delivery with both quality and quantity guaranteed.

Xueping Wang, General Manager of Innovative Drug R&D Center of Jemincare Research Institute，said，

“ Jemincare expressed heartfelt thanks to TOT BIOPHARM for its outstanding achievement in the Project JMB2002. TOT BIOPHARM has rich practical experience and successful cases in the development and manufacture of large molecules, and both parties will continue to diversify our cooperation. We will also continue to steadily advance the development of neutralizing antibodies, thus contributing to the global fight against COVID-19.”

Dr. Jun Liu, CEO of TOT BIOPHARM said,

“TOT BIOPHARM expressed warm congratulations to Jemincare on the completion of the Phase I clinical trial of JMB2002, and we look forward to the early approval of JMB2002, which will provide a new option for the global response to COVID-19. By giving full play to our R&D and manufacturing strengths, TOT BIOPHARM will meet the cost and speed challenges through our existing core competencies to assist our partners in R&D and manufacturing, and promote safe and effective drugs to serve patients as soon as possible.”