[Edaily Reporter KIM SUNG-JIN ] Yuhan(000100) With royalty revenue from the new lung cancer drug “Lecraza” (generic name: lazertinib) falling short of initial expectations, attention is turning to the future competitive landscape as rival drugs continue to show promising results. This is because, amid Lecraza’s sluggish growth, competition for market leadership could intensify significantly if a new combination therapy for AstraZeneca’s Tagrisso—a competing candidate—is approved.

Royalty Growth Falls Short of Expectations Despite Rising Sales

According to industry sources on the 29th, Yuhan Corporation announced during its third-quarter earnings conference call held the previous day that royalty revenue from Lecraza sales totaled 7.5 billion won. This represents an increase of approximately 9% compared to the previous quarter (6.9 billion won), and considering that Lecraza royalty revenue was 5.4 billion won in the first quarter of this year, it indicates a continued quarterly upward trend.

Lecraza is a non-small cell lung cancer treatment developed by Yuhan Corporation and licensed to the global pharmaceutical company Johnson & Johnson (J&J). It received marketing approval from the Ministry of Food and Drug Safety in South Korea as early as 2021, and following approval by the U.S. Food and Drug Administration (FDA) in August 2024, it has been marketed under the name “Razcluz” in combination with J&J’s bispecific antibody anticancer drug “Libravant” (active ingredient: amivantamab). The combination therapy of these two drugs is used as first-line treatment for patients with advanced non-small cell lung cancer harboring EGFR gene mutations.

Sales figures continue to rise. According to J&J’s third-quarter earnings report released on the 13th, combined sales of Libravant and Razcluz reached $320 million (approximately 450 billion won), a 62.3% increase from $198 million during the same period last year. Lecraza is currently sold not only in the U.S. but also in Japan, China, and Europe.

The issue is that while Leqraza’s revenue continues to rise, its growth rate falls short of market expectations. A source familiar with Yuhan Corporation’s situation cited exchange rates as one reason for the slow growth. The source explained, “Since we receive royalties in dollars, the impact of the falling exchange rate is reflected in the figures.”

Indeed, looking at exchange rate trends, the average won-dollar exchange rate fell by 5.59% (83.92 won), from 1,501.68 won in the second quarter to 1,417.76 won in the third quarter. This is a factor likely to have a significant impact on royalty revenue.

However, industry observers believe that even after accounting for this exchange rate effect, Lecraza’s market penetration rate remains lower than expected. Kim Seung-min, an analyst at MIRAE ASSET SECURITIES, stated, “Growth excluding the impact of the exchange rate decline is estimated at 24%, which falls short of the previous growth forecast of 65%.”

Tagrisso Secures a New Competitive Edge in First-Line Treatment in China

In this context, AstraZeneca’s new combination therapy is drawing attention. On the 26th, at the European Society for Medical Oncology (ESMO 2026) conference, AstraZeneca unveiled the results of the SANOVO Phase 3 clinical trial, which evaluated the combination of the lung cancer treatment “Tagrisso” (active ingredient: osimertinib) and the MET inhibitor savolitinib. This clinical trial was conducted in China on 326 patients with non-small cell lung cancer who were found to have both EGFR mutations and MET protein overexpression. The study compared the efficacy of co-administering Tagrisso and savolitinib to previously untreated patients with that of Tagrisso monotherapy.

According to data released by HutchMed, a Chinese global pharmaceutical company developing savolitinib in collaboration with AstraZeneca, the median progression-free survival (PFS) in the combination therapy group was 24.9 months. This is 11.1 months longer than the 13.8 months observed in the Tagrisso monotherapy group. The risk of disease progression or death was reduced by 44%, and the median overall survival (OS) in the combination therapy group was 44.5 months—9.6 months longer than the 34.9 months observed in the monotherapy group. Based on these results, HutchMed plans to submit a regulatory application in China to expand the indication for first-line treatment.

China is a market where Lecraz has already been launched, and market competition is expected to intensify if AstraZeneca’s “Tagrisso and Savolitinib” combination therapy is approved. J&J received marketing approval for “Libravant + Lecraza” in July 2025 and began administering the treatment to local patients in October of the same year. At that time, Yuhan Corporation received a milestone payment of $45 million (approximately 60 billion won) related to the drug’s commercialization in China. This signals the emergence of a strong market competitor roughly one year after Lecraza’s launch.

Consequently, competition in China is expected to serve as a litmus test for the future direction of the EGFR-mutated non-small cell lung cancer treatment market. While Lecraza and Librivant have so far touted clinical results showing improved survival compared to Tagrisso monotherapy as their competitive edge, the competitive landscape is expected to shift as AstraZeneca also enhances treatment efficacy through new combination therapies.

Of course, the target patient populations for the two combination therapies do not fully overlap. Lecraza and Libravant are intended for patients with EGFR exon 19 deletion or the L858R mutation. Tagrisso and Savolitinib, on the other hand, are being developed for patients among this group who have confirmed MET protein overexpression; while there is some overlap in the patient population, their competitive scope within the overall market is not identical.

Looking at Lecraza in isolation, the emergence of these competing drugs could act as a factor limiting its future growth potential. Given that its growth is already considered slower than expected, it cannot be ruled out that intensifying market competition could act as a burden on future global sales expansion and royalty growth.

Beyond First-Line Treatment to Subsequent Therapies… Tagrisso Expands Its Scope

AstraZeneca is also accelerating the development of follow-on therapies. In a Phase 3 clinical trial presented at this year’s ESMO conference—which enrolled patients whose disease had progressed after Tagrisso treatment—the median overall survival for the Tagrisso/savolitinib combination therapy was 17.8 months, 4.9 months longer than the 12.9 months observed in the chemotherapy group. The risk of death was reduced by 32%. While SANOVO targeted treatment-naïve patients, SAFFRON is a clinical trial aimed at patients who have developed MET-related resistance following prior EGFR-targeted therapy.

Although Lecraza is approved in South Korea for both first- and second-line treatment, in the global market it is primarily marketed as a first-line combination therapy with Libravant. J&J also studied combination therapies including Lecraza in the setting of subsequent treatment, but the only combination that actually led to U.S. approval was the Libravant and chemotherapy regimen, which did not include Lecraza.

Of course, Lecraza still has growth potential. J&J has secured a subcutaneous injection formulation of Libravant that reduces the burden of administration compared to the existing intravenous injection, and in the U.S., it has even received approval for a once-monthly dosing regimen. Since Lecraza was developed as an oral medication, the burden of administration is low to begin with; however, if the burden of hospital visits and administration associated with Libravant—which is used in combination therapy—is reduced, a synergistic effect is expected to result.

An official from a company developing treatments for non-small cell lung cancer (NSCLC) stated, “The market for first-line treatment of EGFR-mutated NSCLC is highly competitive,” adding, “Since the side effects of the Tagrisso and savolitinib combination therapy are somewhat higher than those of monotherapy, the key will be how to manage them.”