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Wednesday, April 24, 2024

BMS-Cellares CAR-T Pact Highlights U.S.-China Biopharma Tensions

 This week’s $380 million collaboration between Bristol Myers Squibb and contract drug manufacturing organization Cellares is ostensibly about securing capacity for producing CAR T cell therapies, but it also has strong geopolitical overtones.

BMS likely connected with Cellares to diversify its supply chain rather than take more drastic steps to distance itself from China, said Scott Moore, a political scientist and director of China programs and strategic initiatives for the University of Pennsylvania.

“Supply chain diversification is the obvious initial way to deal with that [tension], but they may have to grapple with it in many other ways as well,” Moore said. “Decoupling [from Chinese companies] would obviously mean unwinding investments, obviously forgoing additional partnerships and joint ventures," he told BioSpace

Under the new agreement, South San Francisco, Calif.–based Cellares will dedicate its manufacturing platform, called Cell Shuttle, to facilities in the U.S., Japan and the European Union for exclusive use by BMS.

Moore said the mention of the U.S., Europe and Japan was an obvious clue. “It wouldn’t really make much sense to specifically reference the location of those manufacturing facilities without a China context."

Hovering over the current climate is the BIOSECURE Act, proposed legislation intended to distance U.S. biomedical R&D from Chinese companies that may pose a national security risk. The very public separation between the Biotechnology Industry Organization (BIO) and China-based WuXi AppTec has also exacerbated tensions. “That’s a real earthquake in the industry,” Moore said.

Cellares did not explicitly reference China but did talk about the BIOSECURE Act. “The BIOSECURE Act is a tremendous tailwind for Cellares in general,” CEO Fabian Gerlinghaus told BioSpace in an email. “The fact that we’re a U.S.-based, American company is a real strength in this geopolitical climate.”

However, Gerlinghaus said that the primary focus of the arrangement is to provide BMS with additional CAR-T manufacturing capacity. BMS already is an investor in Cellares and the two been involved in proof-of-concept tests of technology transfer for CAR-T manufacturing since last year.

“I think there are probably multiple reasons, but all driven by the same context, which is essentially geopolitical risks that didn't really exist seven or eight years ago, and really probably wouldn't have influenced major business decisions prior to two years ago,” Moore said.

A BMS spokesperson declined to comment for this story.

Tensions Have Been Building

Biopharma tensions between the U.S. and China have been building for some time. Moore was a health and science policy advisor on U.S.-China environmental initiatives in the U.S. Department of State when U.S. foreign policy started framing China as more of an adversary during the latter part of the Obama administration. Then the Trump administration instituted a formal national security strategy that made the adversarial relationship more explicit.

“That set the stage for this third phase, where biotech is really a focus,” starting about 2-3 years ago, Moore said.

“Absolutely, geopolitics are complicating biotech in a way in which they never previously used to, and companies really have to have to grapple with that.”

But biopharma is not taking overt steps to distance itself from China yet. Large firms continue to out license assets from China, though Novartis CFO Harry Kirsch reportedly said this week that the company is currently examining relationships with Chinese contract research organizations in case the BIOSECURE Act becomes law.

https://www.biospace.com/article/bms-cellares-car-t-pact-highlights-u-s-china-biopharma-tensions/

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