The Two-in-One Cancer Drug China Can't Stop Approving

The Data Behind the Hype

The approval rests on the HARMONi-6 trial, and while full detailed results haven't been published yet, Akeso reported that the study hit both of its big goals: better PFS and better OS compared to a PD-1 inhibitor plus chemo.

We can also look at HARMONi-2, an earlier trial that tested ivonescimab as monotherapy against pembrolizumab in first-line PD-L1-positive NSCLC. In the squamous subgroup, ivonescimab nearly doubled median PFS: 9.7 months versus 5.8 months for Keytruda. The hazard ratio was 0.48, which essentially means patients on ivonescimab had roughly half the risk of their disease progressing at any given time.

Across the broader trial population, the story was similar, with median PFS of 11.1 months versus 5.8 months and a hazard ratio of 0.51. Those are the kinds of numbers that make oncologists sit up straight.

The one caveat: overall survival data from HARMONi-2 were still immature at the time of the main readout. OS takes longer to measure because, thankfully, patients live longer. That data gap has given skeptics room to question whether the PFS advantage will translate into a true survival benefit.

China as a Launchpad, Not Just a Market

Ivonescimab's approval trajectory in China reads like a speedrun. The NMPA first approved it in May 2024 for EGFR-mutated NSCLC patients who had already failed targeted therapy. Then came the April 2025 approval for first-line PD-L1-positive NSCLC as monotherapy.

Each new label widens the pool of eligible patients. And in China, where lung cancer is the most common cancer diagnosis, that pool is enormous. Squamous NSCLC is a major subset of lung cancer cases, and these patients have fewer targeted therapy options than their non-squamous counterparts. The unmet need is real: outcomes remain poor, responses often don't last, and patients with low or no PD-L1 expression get less benefit from existing immunotherapies.

But the bigger story is what happens outside China. Summit Therapeutics holds the rights to develop and sell ivonescimab in the U.S., Canada, Europe, and Japan. Summit submitted a BLA (essentially an application for FDA approval) in late 2025 for ivonescimab in EGFR-mutated NSCLC, and the FDA accepted it for review with a PDUFA target date of November 14, 2026. That decision is now just three months away.

Summit has also been building partnerships. A clinical collaboration with GSK is testing ivonescimab alongside GSK's B7-H3 asset, with dosing underway as of mid-2026. Another collaboration with RevMed started enrolling patients in early 2026. The message is clear: ivonescimab's backers are betting it can compete on the global stage, not just in China.

Can It Actually Dethrone Keytruda?

This is the billion-dollar question, and Wall Street is split. Truist analysts have been constructive, expressing confidence that the final overall survival data will hold up. BMO, on the other hand, has been notably cautious, essentially saying: "King Keytruda still reigns."

The skeptics have a point. Almost all of ivonescimab's clinical data comes from trials conducted in China. Regulatory agencies and oncologists in the U.S. and Europe tend to want confirmatory data from diverse, multiregional populations before fully embracing a new standard of care. Mature OS data will be critical; PFS improvements don't always translate into patients living longer.

The bulls also have a point. Ivonescimab is the first approved PD-1/VEGF bispecific antibody, which gives it a genuine first-mover advantage. Its cooperative binding mechanism is scientifically differentiated, not just a marketing story. And its China approvals show that the drug works across multiple NSCLC settings, building a body of evidence that's hard to ignore.

The Bottom Line

Ivonescimab's growing list of China approvals cements it as one of the most important oncology assets to emerge from a Chinese biotech company. It's no longer a promising molecule with Phase III data; it's a commercial product with a growing label and a clear path toward global markets.

The next few months are pivotal. The November FDA decision on the EGFR-mutated NSCLC indication will tell us whether U.S. regulators see what Chinese regulators have seen. If that goes well, the squamous NSCLC indication won't be far behind.

For now, Keytruda's throne is still intact. But for the first time, there's a credible challenger warming up in the wings, and it only needs one infusion to do what used to take two.