Alteogen Inc. announced on the 18th that MSD’s Keytruda SC has obtained approval for manufacturing and sales in Japan under the name “Kiject.” Kiject is a subcutaneous injection formulation that combines MSD’s immuno-oncology drug Keytruda (generic name: pembrolizumab) with Alteogen Inc.’s vera-hyaluronidase alpha (ALT-B4).
The key significance of this approval lies in the fact that Japan is a major anticancer drug market where Keytruda is already widely used. Since its launch in Japan in 2017, Keytruda has been used to treat various types of cancer, including non-small cell lung cancer. In a market where a prescription base for the existing intravenous (IV) formulation is already established, a new subcutaneous (SC) administration option has now been added.
Kizect is characterized by reducing the administration time—which took about 30 minutes for the existing Keytruda IV formulation—to just 1–2 minutes. It is expected to reduce the burden of hospital stays for cancer patients requiring long-term, repeated treatment and to improve the efficiency of healthcare providers in administering the drug and operating injection rooms. In the immuno-oncology market, convenience of administration is emerging as a key factor determining a product’s competitiveness, alongside therapeutic efficacy.
Alteogen Inc.’s ALT-B4 is a recombinant human hyaluronidase that temporarily breaks down hyaluronic acid in subcutaneous tissue, helping large-volume biologics spread and be absorbed into the subcutaneous layer. As this is the foundational technology for converting antibody drugs—which were previously administered only intravenously—to subcutaneous injections, the expansion of Kytruda SC’s approvals across countries is cited as a case study that demonstrates the platform’s commercial potential.
Alteogen Inc. previously announced in August that it would receive its first sales milestone payment of $25 million (approximately 34.5 billion won) from MSD in connection with the sale of Keytruda SC. The licensing agreement between the two companies includes sales milestones totaling up to $1 billion. The structure is such that as actual prescriptions and sales expand, the likelihood of Alteogen Inc. receiving subsequent milestone payments also increases.
This approval in Japan was granted based on the results of the international Phase 3 joint trial “MK-3475A-D77.” The trial compared Keytruda SC combination therapy with the existing IV combination therapy in patients with advanced or recurrent non-small cell lung cancer, confirming the non-inferiority of the subcutaneous injection formulation. MSD explained that no new safety concerns were identified when compared to the existing IV formulation.
An Alteogen Inc. official explained, “As products incorporating ALT-B4 are being commercialized in major markets, the technological capabilities and commercial value of the HYBE platform are being continuously proven.”
