Alteogen said MSD’s Keytruda SC, which uses ALT-B4 from its Hybrozyme subcutaneous formulation platform, received manufacturing and sales approval in Japan on the 18th. Marketed as Keyject in Japan, the product combines MSD’s pembrolizumab immunotherapy with Alteogen’s Verahyaluronidase alfa and allows administration under the skin in about 1–2 minutes, compared with roughly 30 minutes for the existing intravenous infusion. ALT-B4 is a recombinant human hyaluronidase that temporarily breaks down hyaluronic acid in subcutaneous tissue, helping large-volume biologic medicines spread and be absorbed. Japan becomes another major market for Keytruda SC after the United States, Europe and Canada. Alteogen said in August that MSD paid a $25 million first sales milestone, while the licensing agreement provides for up to $1 billion in sales-based milestones. The Japanese approval followed phase 3 trial MK-3475A-D77 in patients with advanced or recurrent non-small cell lung cancer, which found the subcutaneous combination therapy non-inferior to intravenous treatment in primary evaluations, with no new safety issues identified.