FDA approval and CHMP positive opinion enable U.S./EU launch within the year (Target Price : 550,000)

1.  Keytruda SC secured FDA approval and a CHMP positive opinion, allowing simultaneous U.S. and EU market entry this year, with Merck targeting a 30–40% IV-to-SC conversion within two years.

2. Ongoing PGR is not expected to hinder commercialization, as the institution decision already acknowledged potential invalidity grounds for Halozyme’s patent.

3.  FDA approval strengthens confidence for pending licensing deals, and demand growth is expected to accelerate with factory expansion and increasing partner interest in ALT-B4.