[Alpha Biz= Paul Lee] Seoul, September 22, 2025 – Shinhan Investment & Securities reaffirmed its Buy recommendation and a target price of KRW 730,000 for Alteogen (KOSDAQ: 196170), citing the company as the biotech firm with the strongest growth potential in sales and profits. The outlook comes as Alteogen is set to receive global royalties from partner Merck & Co. (MSD) following U.S. Food and Drug Administration (FDA) approval of the subcutaneous (SC) formulation of Keytruda.




According to analyst Minyong Um of Shinhan Investment & Securities, “On September 20, for the first time in Korean biotech history, a domestic platform technology has been applied to the world’s top-selling blockbuster drug and secured FDA approval. The decision came three days earlier than scheduled, meaning the product will launch at the end of September rather than October 1.” He added that European approval, originally expected in the first half of 2026, is now anticipated by the fourth quarter of this year, completing global approvals ahead of schedule.




The jointly developed product by Merck and Alteogen will be marketed under the brand name Keytruda Qlex. Um noted, “Compared with BMS and Halozyme’s Opdivo SC (5 minutes) and Roche and Halozyme’s Tecentriq SC (7 minutes), Keytruda Qlex enables the fastest administration at just 1–2 minutes.” He further highlighted that FDA approval included both the three-week and six-week IV dosing regimens simultaneously, calling it a “major surprise.”




Um emphasized that Merck has accelerated development with unprecedented speed: “From the start of clinical trials in October 2021 to FDA approval, the process took only four years, reflecting Merck’s full commitment.” He added that Alteogen is expected to recognize hundreds of billions of KRW in milestone payments tied to FDA approval during the third quarter, with the first sales milestone reflected in fourth-quarter earnings.



The analyst also pointed out that conditions are now in place for Alteogen’s anticipated KOSPI market transfer, and noted that “the company is maintaining its goal of signing one to two additional licensing deals with global pharma partners by year-end. As FDA approval was the final decision factor for potential partners, licensing-out (L/O) announcements can be expected soon.”

 

 

 

 

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