The Biotech That Walked Right Into a Geopolitical Minefield

Akari also has a second program, AKTX-102, targeting a protein called CEACAM5 across pancreatic, colon, lung, and stomach cancers. That one's still earlier stage.

Why WuXi?

This is where it gets interesting. WuXi XDC isn't just any contract manufacturer. It's one of the biggest ADC specialists on the planet, holding roughly 22% of the global bioconjugate manufacturing market. The company operates as a joint venture between WuXi Biologics and WuXi STA, with GMP facilities that can handle everything from antibody production (up to 2,000-liter bioreactors) to conjugation, fill-and-finish, and quality control. It won "Best CDMO" at the World ADC Awards three years running.

For a small biotech like Akari, that kind of infrastructure is like renting a Formula 1 pit crew instead of trying to change your own tires. You get world-class manufacturing without building your own factory. WuXi XDC's CEO Jimmy Li highlighted the company's ADC expertise, while Akari's CEO Abizer Gaslightwala called the partnership a "major milestone" validating the PH1 technology.

No financial terms were disclosed, which is standard for these kinds of CDMO deals.

The Elephant in the Room

But there's a reason this partnership raised eyebrows. The BIOSECURE Act, signed into law as part of the FY2026 National Defense Authorization Act, was designed to limit U.S. government contractors and federal funding recipients from working with designated "biotechnology companies of concern" (BCCs). The original drafts of the bill explicitly named WuXi AppTec and WuXi Biologics.

The final version, however, removed specific company names. Instead, it created a process: the Office of Management and Budget has until roughly December 2026 to publish a formal BCC list. Companies already on the Department of Defense's "Section 1260H" list of Chinese military companies (which currently includes BGI Group and MGI, but not WuXi entities) face immediate restrictions. Others designated through the OMB process would get a five-year wind-down period for existing contracts.

So as of right now, WuXi is not officially designated as a company of concern. But the risk isn't zero. The DoD updates its 1260H list periodically, and OMB's designation process is still playing out. If WuXi lands on either list, Akari could find itself scrambling to relocate its entire manufacturing relationship.

The Industry's Quiet Calculation

Akari isn't alone in making this bet. Across the industry, biotech companies are doing the geopolitical math and arriving at different answers. Some smaller biotechs have publicly announced supply chain shifts away from China, using it as a selling point for investors. Larger firms have been more ambiguous, "reoptimizing" their chains without fully divesting.

The core tension is simple: the ADC market is booming, with projections ranging from $14 to $18 billion in 2026 and forecasts reaching as high as $39 billion by 2035. Six ADC products crossed the billion-dollar sales mark in 2025. There are over 530 ADC candidates in development globally, with 21 already approved. And WuXi XDC is one of the best in the world at making them.

For a company like Akari, which is pre-clinical and racing to file an IND, speed matters enormously. Finding an alternative manufacturer with comparable ADC expertise would take time, and time is the one thing small biotechs never have enough of.

The Calculated Gamble

There's a reasonable case for this deal. WuXi isn't currently designated. The OMB list isn't out yet. The BIOSECURE Act primarily targets companies with federal contracts or funding, and Akari (as a small, commercially pre-revenue biotech) may not be directly affected even if WuXi does end up on the list. The five-year wind-down provision for newly designated BCCs also provides a buffer.

But "reasonable" and "risk-free" aren't the same thing. If the political winds shift, or if WuXi gets added to the 1260H list before Akari's IND filing, this partnership could become a liability overnight. Investors watching this space should pay close attention to the OMB's timeline and the next DoD list update.

Akari's pivot from complement inhibition to cancer ADCs was already an audacious move. Partnering with WuXi in the current climate doubles down on that audacity. The preclinical data for AKTX-101 looks promising, and WuXi XDC's manufacturing chops are genuinely hard to match. But in biotech, the science is only half the battle. Sometimes the biggest risks aren't in the lab; they're in the headlines.

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