From The Editor | April 5, 2024

From Ally To Adversary: BIO's Swift Rebuke Of WuXi


By Louis Garguilo, Chief Editor, Outsourced Pharma


The CEO of the Biotechnology Innovation Organization (BIO) spearheading expulsion of WuXi Apptec relied on WuXi Biologics as CEO of the biotech he founded.

To this day, Amicus Therapeutics utilizes the CDMO to produce FDA-approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) for adults living with late-onset Pompe disease (LOPD) with certain conditions.

In a January 2020 press release, John F. Crowley, then Executive Chairman and CEO of Amicus (and now BIO chief), stated, “Our team’s efforts to bring AT-GAA to all patients living with Pompe around the world continues at a momentous pace and with great passion.”

Further into that same release we read:

“Process performance qualification (PPQ) runs have been initiated with the Company’s key strategic partner, WuXi Biologics. The PPQ runs will serve as the foundation for the Chemistry, Manufacturing, and Control (CMC) module for a BLA submission …

WuXi Biologics will enable and support Amicus with its dual sourcing strategy and manufacture at two sites across their network, including its new facility in Ireland, which remains on-track.” (italics mine)

Now a few months after leaving Amicus and joining BIO, Crowley seems to suggest other U.S. biotechs shouldn’t do the same.

On March 13th, Crowley put out a statement in support of the U.S. Congress’ BIOSECURE Act  calling WuXi AppTec an enemy of the state. (see earlier editorial here)

BIO announced its intent to work with policymakers to ensure “we have the biomanufacturing and distribution capacity and capabilities so that no patient ever goes without the medicines they need. Biomanufacturing resiliency is a strategic imperative that is essential for long-term U.S. leadership and security.”

Oh, and by the way, this at the very end of the release:

“WuXi AppTec proactively ended its membership in BIO.”

“Proactive” as in leave or get kicked out.

Breaking News

As one reader asks:

“Does BIO know something the rest of us don’t?

On March 28th, Reuters ran an “exclusive” that tells us something we did not know:

U.S. intelligence officials in late February told senators working on a biotech security bill that Chinese pharmaceutical firm WuXi AppTec (603259.SS) had transferred U.S. intellectual property to Beijing without consent, according to two sources.”

“The classified briefing to about a dozen senators was led by the FBI, the State Department and the Office of the Director of National Intelligence. Those officials said that WuXi AppTec and other Chinese entities had engaged in activity in the U.S. contrary to U.S. national security interests, the sources said on condition of anonymity.”

A WuXi AppTec spokesperson is quoted:

"We are not aware of any unauthorized transfers by WuXi AppTec of any U.S. client's data or intellectual property to China, and the CDMO "respects and fully complies" with the requirements of U.S. federal and state authorities.”

WuXi Apptec has also responded positively to me for an interview request; that is being arranged at this writing.

I met briefly on March 20th in Manhattan with WuXi Biologics executives (more below). They wanted it made clear WuXi Biologics is not a subsidiary of WuXi Apptec, as gets reported.

Unfortunately, as we’ll consider below, that may become a distinction with little difference.

Industry On Edge

Readers have responded. One wrote:

“Wuxi is manufacturing for Amicus, which is Crowly's company. I’m very puzzled by all this.”

Another with firsthand knowldege of the Amicus-WuXi Biologics relationship told me “WuXi was critical in that effort to get FDA approval for their pompei therapeutics – and they also give Amicus a nice discount.”

No good deed goes unpunished, as they say.

When Amicus received EU regulatory approval in 2023, WuXi shared in the excitement via a press release:

“WuXi Biologics … congratulates its strategic partner Amicus Therapeutics on receiving European Commission's approval for Pombiliti™ (cipaglucosidase alfa) … Pombiliti™ was started at WuXi Biologics in 2012 with just an initial concept and now realizes commercialization …”

Added Chris Chen, CEO, "The joint efforts between Amicus and WuXi Biologics over the past 11 years are just for this moment! We're honored to enable Amicus to … bring this new therapy to the patients with Pompe disease."

Ironically, many in our industry are now concerned the actions above will impair the delivery of new medicines from U.S.-based drug sponsors to patients.

Allegations And Awards

We’ll need to learn what “U.S. intellectual property” was transferred to Beijing without consent” means, and who the two sources are precipitating WuXi’s mention in the BIOSECURE Act.

These allegations are serious. For the sake of our drug development and manufacturing outsourcing industy, they need to be substantiated and clarified.

The Chinese government has a mile-long record of stealing IP. And they have a national directive to become the leader in biotechnology.

In the meantime, readers are on edge.

“There are hundreds of US BioPharma companies dependent on Wuxi,” is one response I received.

This decision is going to put a spanner in getting new medicines discovered, developed and manufactured for US based patients which will in turn harm Americans only.”

That’s exactly opposite of our intentions.

Another reader says that if BIO doesn’t know something the rest of us don’t, this feels like “a reactionary decision that may not have been well thought out.”

I have contacted Crowley and BIO, but received no response.

“Drug supply to patients will undoubtedly be impacted” if sponsors in this country are pressured to stop working with Wuxi or any CDMO from China, this reader went on.

Yet another reader – reading my mind and assuredly that of others – comments that “although BIOSECURE may call out a few companies today, no one should be surprised if a wider ban on Chinese CDMOs came tomorrow.

“I’m a patriot through and through, but the fact is our past leaders failed us when the major push to outsource in the name of globalization closed so many of our plants and capabilities with them.” 

I’m certain many agree in full.

Crowley cites his experience as a naval intelligence officer and member of the U.S. intelligence community” as a key factor in swiftly executing the departure of WuXi Apptec from his organization.

Finally, as alluded to above, as the master of ceremony at the 2024 CDMO Leadership Awards in Manhattan on March 20th – awards based on responses from actual customers of CDMOs – I presented awards in five core categories: capabilities, compatibility, expertise, quality, reliability, and service.

In quite a notable accomplishment, WuXi Biologics won an award in all six categories.

Another CDMO that did that?

WuXi AppTech.