Lawmakers request intelligence briefing on CDMO GenScript, Legend Biotech's ties to China

For several months, a U.S. security crackdown on biopharma firms suspected to be linked to the Chinese Communist Party (CCP) has continued to gain steam. Now, several new names could be feeling the heat.

In a new letter (PDF) to FBI director Christopher Wray and Director of National Intelligence Avril Haines, two House lawmakers are requesting an intelligence briefing on the CDMO GenScript and three of its business segments, including the cell therapy specialist Legend Biotech.

The lawmakers—John Moolenaar, R-Michigan, and Raja Krishnamoorthi, D-Illinois—say that public reporting "reveals tight links between GenScript and the CCP."

The lawmakers are the chairman and ranking member, respectively, of the House Select Committee on Strategic Competition Between the United States and the Chinese Communist Party.

In citing GenScript's corporate materials, an executive's interviews with the media, plus information from universities and the U.S. government, the House representatives paint a picture of a company working toward the CCP's strategy of "achieving self-reliance in critical technologies and leveraging these advancements to boost the [Peoples Republic of China]'s global competitiveness and influence."

"While these aspirations do not necessarily equate to illicit behavior, they do underscore the need for vigilance in safeguarding U.S. competitiveness and preventing the transfer of sensitive technologies and capabilities to PRC state-influenced entities," the lawmakers wrote.

The U.S. representatives are requesting a briefing from Wray and Haines "on available intelligence and law enforcement information regarding GenScript Biotech Corporation and its U.S.-based subsidiaries to determine the extent of CCP influence and control over their operations, the potential risks they pose to U.S. national security, and the implications of their efforts to displace U.S. leadership in the biotechnology sector."

In a statement to The Wall Street Journal, a GenScript spokesperson said the letter "does not allege any illicit behavior on the company’s part. The company is not under the control of any government.” 

A Legend spokesperson told Fierce Pharma the company is "a US-based global organization that has made significant advancements in the field of cell therapy for cancer patients, having treated 3,000 multiple myeloma patients to date." The company remains "focused on our goal of bringing hope and opportunity to cancer patients and their families," the spokesperson added.

This development comes amid a multi-month U.S. biopharma security crackdown that so far has centered around WuXi AppTec and several Chinese genomics players. More recently, WuXi Biologics became implicated in a potential future ban from receiving U.S. government contracts, or working with companies that receive federal funding. 

Such a ban would effectively cut the named Chinese service providers from the U.S. market. The threat of this decoupling has left many of their U.S. partners scrambling to establish supply chain continuity, should the threat come to pass.

As it stands, the BIOSECURE Act is awaiting votes in the House and Senate.

Editor's note: This story was updated with a statement from Legend Biotech.