The $6 Billion Pill Just Got a Rival From Shanghai

Dizal already proved the drug works in patients who'd failed chemo. In a Chinese study of 97 evaluable patients, sunvozertinib delivered a confirmed response rate of 61%, which is impressive for this hard-to-treat group. The FDA granted accelerated approval in July 2025 based on a multinational study showing a 46% response rate with responses lasting a median of 11.1 months.

The WU-KONG28 result takes it one step further: proving sunvozertinib works as a first treatment, not just a backup plan.

How This Stacks Up Against J&J

The original headline framed this as Dizal "challenging J&J," which deserves some nuance. J&J's Rybrevant plus lazertinib combination is mostly aimed at common EGFR mutations, not exon 20 insertions. In that broader population, the MARIPOSA trial showed an overall survival benefit over Tagrisso, which is the gold standard of evidence. That's J&J's big swing.

In the exon 20 insertion niche specifically, Rybrevant already has approval, but it requires IV infusion and is often paired with chemotherapy. Sunvozertinib is a pill. You take it at home. No infusion center, no needle, no scheduling hassles.

So the real competitive tension isn't a direct head-to-head slugfest. It's more like two restaurants opening on the same block: one is a sit-down steakhouse (Rybrevant's IV combo), and the other is a high-quality takeout spot (sunvozertinib's oral convenience). Both can thrive, but patients and doctors increasingly prefer options that fit into daily life.

The bigger picture is that a China-originated drug is now posting competitive first-line data in a segment worth billions. That's the part that should make incumbents nervous.

The Geopolitical Elephant in the Room

This clinical win lands at an awkward moment. The BIOSECURE Act is now law in the U.S., restricting federal agencies and federally funded programs from working with designated Chinese biotech companies. The legislation targets supply-chain relationships (think: contract manufacturers, clinical research organizations, and genomics providers), not drug approvals directly. But it's created a chilling effect on cross-border biotech collaboration.

Dizal itself was founded in 2017 in Shanghai's Zhangjiang Hi-Tech Park, with roots tracing back to an AstraZeneca Innovation Center China joint venture. Its investors include Lilly Asia Ventures, HongShan, and the China State Development & Investment Corporation. The company runs global trials across 16 countries and has an FDA-approved drug.

The tension is obvious: U.S. policymakers are building walls in biotech at the exact moment Chinese companies are producing world-class clinical data. Sunvozertinib's first-line win doesn't exist in a political vacuum. It adds fuel to the debate about whether restricting cross-border licensing ultimately helps or hurts American patients who need better treatments.

What Comes Next

Dizal has already filed a supplemental application in China for first-line approval in exon 20 insertion NSCLC, and it was granted priority review. The ASCO presentation will reveal the actual numbers behind the WU-KONG28 headline, including specific PFS figures that will let analysts compare sunvozertinib directly against chemotherapy benchmarks and, indirectly, against Rybrevant's track record.

The company is also developing DZD6008, a fourth-generation EGFR inhibitor designed to overcome resistance that develops after third-generation drugs like Tagrisso. Updated data on that program will also be presented at ASCO 2026.

For the EGFR-NSCLC indication in the seven major markets, forecasters expect the space to grow from roughly $6.6 billion in 2025 to $14.2 billion by 2036. That's a lot of pie to fight over, and new entrants keep arriving: bispecific antibodies, antibody-drug conjugates, and novel combinations are all jockeying for position.

Tagrisso still commands the majority of first-line prescriptions in Western markets, likely north of 60-70% share in classic EGFR mutations. But the walls of the fortress are developing cracks. Regional competitors like aumolertinib and furmonertinib are gaining ground in Asia.

And now, a company that most Western investors couldn't have named last year just proved its pill can beat chemo in first-line lung cancer. The EGFR landscape isn't just competitive anymore; it's a free-for-all. The only question is whether geopolitics will let the science play out.

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