'SC-Type Keytruda' Utilizing Alteogen Technology Approved by US FDA

First Product Utilizing ALT-B4 Technology

Alteogen announced on September 21 that the subcutaneous (SC) formulation of Merck (MSD)'s immuno-oncology drug, Keytruda Qurex, which utilizes Alteogen's technology, has received product approval from the United States Food and Drug Administration (FDA).

Keytruda SC allows for faster administration compared to the existing intravenous (IV) formulation, which requires 30 minutes of infusion. Patients have two dosing options: a subcutaneous injection that takes one minute every three weeks, or a subcutaneous injection that takes two minutes every six weeks.

The recombinant human hyaluronidase alpha (ALT-B4) applied to Keytruda Qurex is a product developed and manufactured by Alteogen. By using human hyaluronidase, it enables the conversion of IV-formulated biopharmaceuticals into SC formulations.

If sales of Keytruda Qurex become active, Alteogen is expected to generate more than 1 trillion won in annual royalty income.

Park Soonjae, CEO of Alteogen, stated, "We are delighted that Keytruda Qurex, the first product utilizing Alteogen's ALT-B4, has received approval in the United States. We will continue our efforts to support the successful development and commercialization of our partners' products, such as Enhertu SC, to provide more convenient dosing options for a greater number of patients."