SK Securities said on the 22nd that sales of Yuhan Corp.'s lung cancer treatment Lazertinib are expected to take off in the United States starting next year, driving earnings growth. It maintained its Buy investment opinion and raised its target price to 160,000 won from 140,000 won. Yuhan Corp.'s closing price in the previous transaction day was 116,400 won.
Researcher Lee Seon-gyeong at SK Securities said, "License revenue is expected to rise as Lazertinib, which was out-licensed to J&J, expands its U.S. market share."
As grounds for Lazertinib's expansion in the U.S. market, the company cited that the National Comprehensive Cancer Network (NCCN) recently listed the combination therapy of Lazertinib and Amivantamab as a "preferred regimen" for first-line treatment of epidermal growth factor receptor (EGFR)–mutant Non-small cell lung cancer (NSCLC).
The researcher said, "The fact that it was listed in the NCCN guidelines before the final overall survival (OS) results were released suggests that a one-year OS improvement already indicates that the Lazertinib and Amivantamab combination has demonstrated clinical superiority over the standard of care (SoC), Tagrisso," adding, "The longer the future OS improvement period, the more it will positively affect the expansion of market share in the United States."
However, as challenges to expanding prescriptions and sales, it has been pointed out that proof of improved efficacy and safety versus Tagrisso is needed. J&J earlier this year analyzed that the Lazertinib and Amivantamab combination would deliver OS more than one year better than Tagrisso, but there were market concerns that actual clinical benefit could be limited due to side effects.
Attention also focused on the fact that on the 18th, the subcutaneous (SC) formulation of Amivantamab received marketing approval from the U.S. Food and Drug Administration (FDA). The Amivantamab SC formulation reduced infusion-related reaction (IRR) side effects to 16% from 67% compared with intravenous (IV) administration, and improved rash—a representative EGFR-class side effect—to 13% from 36%. It was also assessed to have lowered MET-related peripheral edema to 17% from 21% and hypoalbuminemia to 15% from 30%.
In addition, as dosing time was drastically cut from several hours with IV to about five minutes with SC, the easing of side effects and the improvement in dosing convenience are expected to become important factors in driving sales growth of the Lazertinib combination therapy.
The researcher added, "Beyond Lazertinib, the visibility of a competitive clinical pipeline is anticipated." Citing allergy drug candidate YH35324 as a key prospect, the researcher explained, "It demonstrated competitiveness versus XOLAIR in phase 1 and recently entered phase 2." YH35324 is pushing ahead toward clinical entry through in-house development after it was returned in the past by Boehringer Ingelheim.