First Chinese-manufactured biologic dosed in an EU clinical trial

By Melissa Fassbender

- Last updated on GMT

The event marks two firsts. (Image: iStock)
The event marks two firsts. (Image: iStock)

Related tags Clinical trial

WuXi Biologics and Prima BioMed have announced that the first dose of a Chinese-manufactured biologic has been dosed in a clinical trial in the European Union.

The companies made the announcement earlier this week that Prima's immuno-oncology product candidate IMP321 (LAG-3 Ig fusion protein), manufactured at WuXi's facility in China, has now been dosed in a Phase IIb clinical trial in Belgium.

"We congratulate our partner Prima BioMed on their exciting progress​," said Dr. Ge Li, Chairman and CEO of WuXi AppTec.

"This milestone shows that WuXi's strong investment in an integrated discovery, development and manufacturing platform in biologics continues to enable entrepreneurs around the world to realize their dreams of bringing potentially life-saving medicines to patients faster​."

According to Prima BioMed’s release, the event marks the first time a biologic manufactured in China has been released for use in a clinical trial within countries in the EU. Additionally, it is the first patient to be dosed as part of the company’s ph IIb metastatic breast cancer clinical trial, AIPAC (Active Immunotherapy PAClitaxel).

"We are very pleased to work with such a distinguished team at Prima BioMed​," said Dr. Chris Chen, CEO of WuXi Biologics.

"With the start of this exciting clinical trial for IMP321, in addition to recent CTA filings and approvals for other product candidates of WuXi partners, WuXi Biologics is rapidly becoming a significant contributor to the expedited development of innovative biologics in the EU​."

The Clinical Trial Application (CTA) for IMP321 was approved by Belgium’s Federal Agency for Medicines and Health Products on October 25, 2015 and is currently pending is other EU countries.

WuXi is supplying IMP321 to Prima's AIPAC trial as well as to its TACTI-Mel Phase I melanoma trial currently recruiting in Australia.

"We have benefited greatly from the considerable expertise of the scientists and staff at WuXi in producing the material we need for our AIPAC clinical trial,” ​added Mr. Marc Voigt, CEO of Prima BioMed.

“The quality of the product WuXi produced and their high operating standards have been most impressive, and we are honored to be the first company to conduct a clinical trial in Europe with material produced in China​."

Related topics Bio Developments

Related news

Show more