The U.S. Food and Drug Administration (FDA) has approved Merck’s (MSD) subcutaneous (SC) formulation of its blockbuster immunotherapy Keytruda, developed using Alteogen’s proprietary technology. Following the decision, analysts forecast not only higher revenue for Alteogen but also accelerated licensing deals and capacity expansion, strengthening its medium- to long-term growth momentum.
On September 22, Shinhan Investment & Securities reaffirmed its ₩730,000 (USD 540) price target and “Buy” rating on Alteogen, calling it “the Korean biotech with the largest upside in revenue and profit growth as global royalties begin to flow.” The brokerage emphasized that this is the first time in Korean biotech history that a domestic platform has been applied to the world’s top-selling pharmaceutical product.
MSD’s newly branded Keytruda Qlex has received FDA approval for all doses and indications already authorized for the intravenous (IV) formulation, with a U.S. launch slated for late September. Alteogen is expected to recognize several hundred billion won (hundreds of millions of USD) in development milestones in the third quarter, followed by the first sales-related milestone in the fourth quarter.
“Keytruda SC can be administered in just one to two minutes, much faster than rival therapies such as Opdivo SC (five minutes) and Tecentriq SC (seven minutes),” noted Min-Yong Um, analyst at Shinhan. “With a positive recommendation already issued by the European Medicines Agency’s CHMP, approval in Europe is also likely in the fourth quarter. Importantly, this FDA approval removes the final hurdle for big pharma partners considering licensing agreements, raising the prospect of imminent deal announcements.”
Hana Securities echoed the bullish outlook: “This approval brings new licensing opportunities closer. Regulatory validation in the U.S. and Europe will give pending partners the confidence to move forward. While we previously estimated the next licensing deal at about USD 580 million—based on AstraZeneca’s transaction in March—there is potential for even larger contracts.”
Alteogen is also investing heavily to expand its supply chain. The company plans to spend about ₩250 billion (USD 185 million) to build its own manufacturing plant, breaking ground in the first quarter of 2026 with completion targeted for late 2027 and commercial GMP operations starting in 2028. Hana Securities said the plant will help stabilize Alteogen’s finances, even if licensing revenue growth slows once product sales become fully embedded.
Keytruda Qlex converts the blockbuster IV drug—which generated USD 8.0 billion (₩10.8 trillion) in the second quarter alone—into a far more convenient SC formulation. Whereas infusion typically takes 30 minutes, the SC version can be administered in about one minute for three-week dosing or two minutes for six-week dosing. Merck projects that within two years, 30–40% of Keytruda’s prescriptions will switch to the SC form, representing USD 9–12 billion (₩12–16 trillion) in annual sales. Alteogen is entitled to about 5% of Keytruda SC revenue in royalties.
The market responded immediately. Alteogen shares, which closed at ₩472,500 (USD 350) on September 19, were trading at ₩509,000 (USD 375), up 7.7%, as of 2 p.m. on September 22.
