Biosecure Act Threatens U.S. Biotech Ties with Chinese CROs and CDMOs

The Biosecure Act, recently passed by the U.S. House of Representatives, may force U.S. biotech and pharma companies to sever ties with major Chinese CROs and CDMOs, such as WuXi AppTec and Complete Genomics.

Several U.S. biotech’s, including Nuvalent and Sage Therapeutics, anticipate disruptions in their supply chains and clinical trials, whereas other companies, including Iteos Therapeutics, have already begun transitioning to alternative manufacturers. Despite the uncertainty, biotech’s such as Sound Pharmaceuticals, remain skeptical about the bill’s future in the Senate.

The following article originally appeared in PharmaVoice.

Some of the most widely used CROs and CDMOs among U.S. pharma and biotech companies are based in China. But the industry may soon be forced to cut ties with these partners if the Biosecure Act, which was passed in the House last week, is ultimately signed into law.

The act would effectively prohibit U.S. companies from doing business with five Chinese firms — including WuXi AppTec, Complete Genomics and MGI Tech — and, in the House version, companies are given eight years to sever ties. The bill also allows Congress to add more companies to its list as it weighs perceived connections between the Chinese government and biopharma industry, as well as cybersecurity and intellectual property concerns.

Despite strong support, the bill’s passage was not smooth sailing, garnering more “nay” votes than expected, with a final house count of 306-81 in favor of the legislation. The downturn in support could signal similar sentiments in the Senate, which has its own version of the act.

“It did not pass as overwhelmingly as it had passed out of committee,” said Nielsen Hobbs, an analyst with Citeline. “It’s both an indication of some softness of support, as well as an invitation for folks [who] want to make modifications to try and do so.”

It’s unclear if the Senate intends to vote on the issue or if there’s enough time left in the year for either version of the bill to make its way into law. And a lame duck Congress is unlikely to push through such a substantial change this fall.

“This is probably not going to pass before the election,” Hobbs predicted.

Even with a murky future, U.S. biotechs are preparing for a potential disentanglement from some of their largest Chinese contractors.

U.S. biotech exposure

China is a linchpin in pharma’s global supply chain, making up about 13% of API manufacturers. Two companies named in the Biosecure Act — WuXi Apptec and WuXi Biologics — are particularly well known as U.S. biotech partners. And if U.S. companies are forced to end their relationships with WuXi, the fallout could be severe.

How exposed are U.S. biotechs to supply interruptions?

Nuvalent, Viridian Therapeutics and Cabaletta Bio are among the biotechs that have said they could see disruptions as a result of the Biosecure Act because they partner with one or more of the named Chinese companies.

Iteos Therapeutics stated in an SEC filing it has “begun the process of transitioning from WuXi to other manufacturers.” However, the biotech noted the process “may take longer than expected” due to difficulties with technology transfer.

Sage Therapeutics, which gained an FDA approval for its postpartum depression med with Biogen last year, said the Biosecure Act could potentially disrupt its research activities and clinical trial partners.

To some biotechs, any contract with a Chinese firm could be a risk. Liver and cardiometabolic-focused biotech 89bio, which struck a deal with Chinese CDMO BiBo Biopharma Engineering to build a plant to produce the active ingredient for its MASH candidate earlier this year, has stated it’s “exposed to the possibility of product supply disruption and increased costs” as a result of the Biosecure Act or other potential policy shifts in U.S.-China diplomacy. BiBo Biopharma is not named in the bill.

Amid this uncertainty, biotechs are preparing for changes.

“Everyone is wisely anticipating it will pass and that they’re going to have less time than they might hope to make this kind of transition,” Hobbs said. “It’s always difficult to create business plans in this climate of uncertainty, but it’s unlikely there’s going to be a sense in the industry that they can keep doing business as usual and not have a contingency plan for addressing how things might shake out.”

Big Pharmas are also at risk. Eli Lilly has tapped WuXi Apptec to produce some of the ingredients in its blockbuster GLP-1 obesity medications, while GSK solidified a licensing deal potentially worth nearly $1.5 billion with WuXi Biologics last year for up to four bi- and multi-specific TCE antibodies developed on WuXi’s platform.

GSK and Lilly did not respond to a request for comment from PharmaVoice.

The industry’s largest association, PhRMA, stated it will work with Congress to avoid drug supply disruptions.

For more, please find the original story source here.