From the U.S., Europe and Canada to Japan: Keytruda SC Featuring Alteogen Technology Approved

[Financial News] Following approvals in the United States, Europe and Canada, Keytruda SC featuring Alteogen's ALT-B4 has also been approved in Japan, further broadening its global commercialization base.
Alteogen announced on the 18th that MSD's Keytruda SC, which incorporates ALT-B4 (ingredient name: berahyaluronidase alfa), the key substance in Alteogen's Hybrozyme platform for converting drugs to subcutaneous (SC) formulations, had received approval for manufacturing and marketing in Japan.
The product is a combination drug containing MSD's Keytruda (active ingredient: pembrolizumab) and Alteogen's berahyaluronidase alfa. It was developed to allow Keytruda, which was previously administered intravenously (IV), to be given by subcutaneous injection (SC).
With this approval, Keytruda SC is now available in Japan as well. Keytruda has been prescribed in Japan for a wide range of cancer indications since its launch there in 2017. Conventional intravenous Keytruda takes about 30 minutes to administer through a vein, whereas the subcutaneous formulation can be administered beneath the skin in approximately one to two minutes. It is therefore expected to help reduce the treatment burden on patients and medical staff.
Alteogen's ALT-B4 is a recombinant human hyaluronidase that temporarily breaks down hyaluronic acid beneath the skin, helping drugs diffuse and be absorbed within subcutaneous tissue. It can be used to convert large-volume biologics that were previously administered intravenously into subcutaneous injections. The Japanese approval is significant because, following approvals in the United States, Europe and Canada, it further expands the global commercialization base for Keytruda SC incorporating ALT-B4.
Alteogen disclosed in August that it would receive a first sales milestone payment of $25 million (approximately 34.5 billion won) from MSD tied to sales of subcutaneous Keytruda. This was the first milestone achieved among the Keytruda SC sales milestones, worth up to $1 billion (approximately 1.38 trillion won), included in the licensing agreement between the two companies.
An Alteogen official said, "The approval in Japan of the Keytruda SC formulation incorporating ALT-B4 has established a foundation for further expansion of the global market's shift to SC formulations. As products incorporating ALT-B4 are commercialized in major markets, the technological capabilities and commercial value of the Hybrozyme platform continue to be demonstrated."

The official added, "We will continue to expand the commercialization of our platform technology by working with global pharmaceutical companies to broaden the conversion of various biologics to subcutaneous formulations and provide patients and medical professionals with more convenient treatment options."
Meanwhile, the Japanese approval was based on a Phase 3 trial in patients with advanced or recurrent non-small cell lung cancer (trial: MK-3475A-D77). A comparison of Keytruda combination regimens administered subcutaneously (SC) and intravenously (IV) in the trial confirmed the non-inferiority of the SC formulation. No new safety issues were identified compared with the existing intravenous formulation, and MSD explained that the safety profile of the SC formulation was consistent with that of the existing treatment.
 
[email protected] Reporter Myeong-jin Jeong