For most of the past three decades, U.S.-listed biotech companies were fair proxies for homemade American science. But now, that assumption is fraying. By one estimate from investment bank Jefferies, roughly a third of the industry’s licensing spending in 2025 went toward drugs and candidates that originated in China, where lower costs and faster regulators have turned its labs into a firehose of ready-to-license molecules and programs.
In antibody-drug conjugates (ADCs) — an increasingly sophisticated class of targeted therapies — Chinese biotechs now supply close to 90% of global licensing activity. The question is, when you buy a U.S. biotech stock whose most promising programs were invented elsewhere, by another company, what are you actually holding?
In some cases, the answer to that question might contain an unpleasant surprise for investors, which is why this trend of importing innovation is also an emerging risk worth understanding.
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It’s dangerous to bet that American biotechs will replicate foreign results
Summit Therapeutics (SMMT +0.75%) is a biotech with an investment thesis that’s almost entirely dependent on the success of ivonescimab, an antibody therapy for various cancers that it licensed from China’s Akeso in 2022, paying $500 million up front and low-double-digit royalties on sales. Summit didn’t discover the molecule; it bought the right to sell it in the U.S., Europe, and Japan.
In May 2025, according to the first peek, investors were given data from ivonescimab’s global phase 3 trial for patients with previously treated, EGFR-mutated non-small cell lung cancer (NSCLC). Treatment with ivonescimab plus chemotherapy led to an impressive 48% gain in progression-free survival (PFS). But the data for overall survival (how long patients lived) did not pass the threshold for statistical significance.
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After the full trial data were presented later in the year, there was another, even larger issue: The cohorts of patients from Western countries saw only a 33% reduction in the risk of progression or death, versus a 45% reduction in Chinese patients, with the Western group’s benefit not being statistically significant. And that’s precisely the kind of discrepancy that regulators at the U.S. Food and Drug Administration (FDA) are likely to take issue with before they decide whether to approve ivonescimab, slated for mid-November of this year.
Similarly, shortly before that readout, an FDA panel ruled that a largely Asian data set supporting another cancer drug was inapplicable to U.S. patients, a precedent that now shadows every China-heavy trial and, by extension, nearly all trials of candidates licensed from China. Summit filed with the FDA for a narrower second-line use indication in early 2026, giving up some of its grander ambitions for ivonescimab.
Investors who bet that Akeso’s data would be easy for Summit to replicate, leading to a low-risk, easy approval process for ivonescimab in the U.S., have not fared well. The biotech’s stock is down 35% in the last 12 months. This emerging risk contributed to that decline, alongside a broadly weak biotech market and ivonescimab’s survival shortfall.
Big pharma is vulnerable, too
This risk applies to major pharma companies and stocks as well.
For instance, Merck (MRK 1.19%) has leaned hard on Chinese innovation, including with a seven-drug deal with Kelun-Biotech worth $175 million up front and up to $9.3 billion in milestones. It hasn’t experienced any of the same problems as Summit did, at least not yet.
Still, this problem is not a passing phase; China’s latest five-year plan, approved in 2026, names biotechnology a “frontier” priority. The supply of licensable assets will only grow from here. Many of the U.S. biopharmas that rely on those assets will satisfy the FDA that their candidates are safe and effective. Others will hit the same wall Summit did: Global populations and the way clinical trial sites operate from one country to the next vary enough that some mismatches are inevitable.
The best way for investors to protect themselves is to ask where a company’s value comes from before buying any shares. A business that discovers, develops, and manufactures its own drugs deserves a richer valuation than a stack of licensed-in bets because the licensee carries extra risks related to royalties going to the originator and whether foreign data clears the FDA.
That doesn’t make Summit or its peers uninvestable, but it does mean that many clinical-stage stocks will look cheap because someone else has built most of their underlying value, which can be problematic.
