BIOSECURE Act Gets Update, Gives US Drugmakers Until 2032 to Sever Ties with Chinese Biotechs

US-China tensions

Pictured: U.S. and Chinese flags in concrete, broken in the middle/iStock, ffikretow

Lawmakers on Friday introduced a new draft of the BIOSECURE Act, which sets a 2032 deadline for U.S. drug manufacturers to cut their ties with WuXi AppTec, WuXi Biologics and other Chinese biotech companies.

The bipartisan bill, introduced by Reps. Brad Wenstrup (R-Ohio) and Raja Krishnamoorthi (D-Ill.), prohibits drugmakers from purchasing equipment or contracting services from a “biotechnology company of concern.”

The draft also bans entities from entering into new agreements—or extending or renewing existing contracts—with these Chinese companies or to farm out these contracts to other potential partners.

However, the bill includes a grandfather clause that would allow existing contracts with the China-based companies until January 1, 2032.

“U.S. supply chains must break free from our dependency on foreign adversaries—American patients cannot be a position where we rely on China for genomic testing or basic pharmaceutical ingredients,” Wenstrup said in a statement, adding that the BIOSECURE Act is the “first step” in the Congress’ “multi-faceted approach” to protect the U.S. national health security.

Friday’s latest draft of the BIOSECURE Act comes as the growing geopolitical tension between the U.S. and China has creeped into the biopharma industry.

In January 2024, Krishnamoorthi and Rep. Mike Gallagher (R-Wis.), introduced the BIOSECURE Act in a bid to ensure that “foreign adversary biotech companies” do not have access to taxpayer dollars. The initial bill named four companies of concern: WuXi AppTec, Beijing Genomics Institute, Complete Genomics and MGI. Friday’s draft has been amended to explicitly identify WuXi Biologics.

The BIOSECURE Act is expected to have far-reaching implications across the industry. In March 2024 trade group Biotechnology Industry Organization (BIO) and WuXi AppTec went their separate ways after Gallagher applied growing pressure on the lobby group by contacting U.S. Attorney General Merrick Garland.

BIO has since reiterated its commitment to uphold national security and cooperate with lawmakers. “Our adversaries abroad have stated that they intend to become the biotechnology center of excellence in the world. America and our allies cannot let this happen,” CEO John Crowley said.

Still, WuXi AppTec is deeply embedded in the biopharma industry and services several prominent players, including Merck, Iovance Biotherapeutics and Kyverna Therapeutics. The potential fallout could have negative impacts on the supply chains of several drugmakers.

In a February 2024 SEC filing, Merck noted that it has “significant research and manufacturing operations in China, including work with Chinese entities such as WuXi AppTec.” If geopolitical tensions end up affecting this work, “such disruption could result in a material adverse effect on the company’s product development, sales, business, cash flow, results of operations financial condition and prospects.”

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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