Alteogen's subcutaneous (SC) formulation of the immuno-oncology drug Kitruuda has received manufacturing and sales approval in Japan.
On September 18, Alteogen announced that its subcutaneous formulation transition platform, Hybrozyme, has been applied to MSD's Kitruuda SC (marketed in Japan as Kiject), which has now been approved in Japan.
Kitruuda SC is a combination product containing MSD's immune checkpoint inhibitor Kitruuda (active ingredient pembrolizumab) and Alteogen's recombinant human hyaluronidase alpha. This formulation allows for administration under the skin in 1 to 2 minutes, compared to the previous intravenous (IV) administration that took about 30 minutes.
ALT-B4 temporarily breaks down hyaluronic acid under the skin, facilitating the diffusion and absorption of the drug within subcutaneous tissue. This technology enables the transition of large-volume biopharmaceuticals from IV to subcutaneous administration.
Since its launch in Japan in 2017, Kitruuda has been prescribed for various cancer indications, and the new SC formulation can be used for the same indications as the existing IV formulation.
Alteogen stated, "This approval in Japan is significant as it expands the global commercialization foundation for Kitruuda SC with ALT-B4, following approvals in the U.S., Europe, and Canada."
The Japanese approval is based on the results of a Phase 3 clinical trial (MK-3475A-D77) involving patients with advanced or recurrent non-small cell lung cancer. MSD explained that the SC formulation demonstrated non-inferiority compared to the IV formulation, with no new safety issues identified.
Earlier in August, Alteogen announced that it would receive a $25 million (approximately 34.5 billion won) milestone payment from MSD related to the sales of Kitruuda SC. This is the first of up to $1 billion (approximately 1.38 trillion won) in sales milestones included in the licensing agreement between the two companies.
An Alteogen representative remarked, "With the approval in Japan, a foundation has been established for further expansion of the SC formulation in the global market, and as products utilizing ALT-B4 are commercialized in major markets, the technological prowess and commercial value of the Hybrozyme platform are being continuously validated."
On September 18, Alteogen announced that its subcutaneous formulation transition platform, Hybrozyme, has been applied to MSD's Kitruuda SC (marketed in Japan as Kiject), which has now been approved in Japan.
Kitruuda SC is a combination product containing MSD's immune checkpoint inhibitor Kitruuda (active ingredient pembrolizumab) and Alteogen's recombinant human hyaluronidase alpha. This formulation allows for administration under the skin in 1 to 2 minutes, compared to the previous intravenous (IV) administration that took about 30 minutes.
ALT-B4 temporarily breaks down hyaluronic acid under the skin, facilitating the diffusion and absorption of the drug within subcutaneous tissue. This technology enables the transition of large-volume biopharmaceuticals from IV to subcutaneous administration.
Since its launch in Japan in 2017, Kitruuda has been prescribed for various cancer indications, and the new SC formulation can be used for the same indications as the existing IV formulation.
Alteogen stated, "This approval in Japan is significant as it expands the global commercialization foundation for Kitruuda SC with ALT-B4, following approvals in the U.S., Europe, and Canada."
The Japanese approval is based on the results of a Phase 3 clinical trial (MK-3475A-D77) involving patients with advanced or recurrent non-small cell lung cancer. MSD explained that the SC formulation demonstrated non-inferiority compared to the IV formulation, with no new safety issues identified.
Earlier in August, Alteogen announced that it would receive a $25 million (approximately 34.5 billion won) milestone payment from MSD related to the sales of Kitruuda SC. This is the first of up to $1 billion (approximately 1.38 trillion won) in sales milestones included in the licensing agreement between the two companies.
An Alteogen representative remarked, "With the approval in Japan, a foundation has been established for further expansion of the SC formulation in the global market, and as products utilizing ALT-B4 are commercialized in major markets, the technological prowess and commercial value of the Hybrozyme platform are being continuously validated."
* This article has been translated by AI.
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