Keytruda SC Wins Approval in Japan, Expanding Global Reach

Merck's (MSD) immuno-oncology drug Keytruda SC has gained manufacturing and marketing approval in Japan. The subcutaneous formulation incorporates Alteogen's ALT-B4 technology, which breaks down hyaluronic acid beneath the skin to facilitate dispersion and absorption of drugs.

The approval marks a significant milestone for Keytruda SC, which has already secured approvals in the United States, Europe, and Canada. In Japan, it will be marketed as Kiject and is expected to reduce administration time from 30 minutes to just 1-2 minutes.

Alteogen's Hybrozyme platform uses ALT-B4 to convert intravenous biologics into subcutaneous formulations. The company expects the global sales expansion of Keytruda SC to have a positive impact on future SC conversion agreements for other biologics.