WuXi Biologics appears to be making some progress in Europe in recent days, after securing a new biotech partner and EMA certifications for its manufacturing sites in China.
On Thursday, the German biotech Medigene said it had signed a multi-year agreement with WuXi Bio to design a type of T cell engager for cancer. Medigene’s public announcement is a rarity ever since the Biosecure Act started gaining momentum in February this year.
Biopharma companies instead have spelled out potential risks to their supply chains in working with Chinese partners, and have been reviewing their options even if the bill has not yet passed.
“To our knowledge, WuXi Biologics has not, does not and will not pose any national security risk to the US or any other country,” a Medigene spokesperson told Endpoints News in an email. WuXi Biologics has hit back against allegations of having military ties and said the acquisition was misleading.
Concerns raised by the bill appear to have less of an impact in Europe. Last month, WuXi Biologics’ sister company WuXi AppTec reported its revenues increased in Europe and China despite a decline in the US. That said, most of WuXi AppTec’s business is still in the US (62% of revenues) compared with Europe (13%) and China (20%). WuXi Bio is set to report its second-quarter earnings on August 21.
On August 1, WuXi Bio touted that the EMA has reviewed and certified four manufacturing sites and a biosafety testing center in China.
The new certifications mean that the EMA has approved eight new biologics to be produced at these WuXi Bio sites for commercial and New Drug Application manufacturing. The four sites are all located in the city of Wuxi, which is west of Shanghai.
A testing center in Suzhou was also certified to review 10 therapies, including the eight biologics to be made at the WuXi Bio sites. The four sites and the testing center have all been previously approved by the EMA.
Nonetheless, Chinese manufacturers, notably ones with sites in the US and Europe, are likely to still struggle to gain business due to the Biosecure Act, AGC Biologic’ chief business officer Christoph Winterhalter said during Endpoints’ recent virtual Manufacturing Day event.
“[They] are not necessarily a safe bet because of the data integrity that the Biosecure Act is looking for,” Winterhalter said. “It’s all about ‘Where is my data going? Where is my clinical data going?’ So, it’s more a protective act,” he added. In May, AGC Biologics announced it partnered with BioConnection to offer an alternative to WuXi customers for clinical-stage gene therapy manufacturing.
WuXi Bio and Medigene’s new partnership will run for at least three years and will focus on designing and researching T cell receptor-guided T cell engagers (TCR-TCE) for solid tumors. Medigene is working on immuno-oncology therapies.
“This new strategic partnership marks a milestone in the execution of our corporate strategy to apply Medigene’s TCRs into new modalities, such as TCR-TCEs, to create additional value beyond TCR-T therapies for both patients and our shareholders,” the Medigene spokesperson added.
Editor’s note: This article was updated to add a comment from a Medigene spokesperson, clarify a quote from Winterhalter and add further context.