pharm edaily

[Kim Saemi, Edaily Reporter] Alteogen announced on the 21st that its partner, Merck & Co. (MSD), has received U.S. Food and Drug Administration (FDA) approval for ‘KEYTRUDA QLEX™’, a subcutaneous (SC) formulation of Keytruda.

(Source: Alteogen )

KEYTRUDA QLEX incorporates Alteogen’s human hyaluronidase product, Vera-Hyaluronidase Alfa (ALT-B4), which was developed and manufactured by the Korean biotech company. ALT-B4 enables intravenous (IV) biologics to be reformulated into SC versions.

The newly approved SC Keytruda has been cleared for 38 indications across multiple cancer types, including melanoma, non-small cell lung cancer, head and neck cancer, urothelial carcinoma, gastric cancer, cervical cancer, and bile duct cancer. These largely overlap with the indications of the original IV formulation, which generated $29.6 billion in global sales last year.

Compared with the IV version, which requires around 30 minutes for infusion, SC Keytruda reduces administration time to just 1?2 minutes. It is offered in two dosing options: a one-minute SC injection every three weeks, or a two-minute injection every six weeks. Unlike IV therapy, which requires infusion center facilities, the SC formulation can be administered at a doctor’s office or community-based clinic, improving patient convenience and treatment access.

Alteogen CEO Park Soon-Jae said, “We are pleased that KEYTRUDA QLEX, the first product utilizing our ALT-B4, has obtained FDA approval in the U.S. We will continue supporting our partners’ development and commercialization of additional products such as subcutaneous ENHERTU to provide more convenient treatment options for patients worldwide.”

With the commercialization of SC Keytruda, Alteogen is set to receive up to 1.3 trillion won ($940 million) in milestone payments, along with royalties from sales. Industry analysts estimate a royalty rate of around 4-5%, suggesting the company could secure over 1 trillion won in annual profit.