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Biopharma

Alteogen Wins US Patent for Keytruda, Qurex Formulation

Dong-A Ilbo | Updated 2026.03.12
“A case reaffirming the novelty and independent invention achievements of ALT-B4”
“Supporting partner IP protection through multifaceted patent strategies”
CEO Tae-yeon Jeon: “Ensuring thorough IP protection for products using Hybrozyme”
Alteogen headquarters and research center
Bioplatform company Alteogen announced on the 12th that it has registered with the United States Patent and Trademark Office (USPTO) a composition patent related to the subcutaneous formulation of Keytruda that combines its Hybrozyme platform-based ALT-B4 (ingredient name: berahyaluronidase alfa) with Merck (MSD)’s Keytruda (pembrolizumab).

Through this, Alteogen stated that the Keytruda subcutaneous injection formulation using ALT-B4 (product name Keytruda Qurex) will be protected by this patent in the United States until early 2043. Keytruda Qurex received approval from the U.S. Food and Drug Administration (FDA) in September last year and has been on the market in the United States. Alteogen said it can receive milestone payments of USD 1 billion (approximately KRW 1.4792 trillion, as of March 12, 2026) from sales of this product. After receiving all milestone payments, separate sales-based royalties will be paid.

An Alteogen representative said, “Despite the intellectual property (IP) issues raised regarding ALT-B4, the USPTO has once again recognized the novelty of ALT-B4 and the rights to its independent invention,” adding, “This patent is part of the measures pursued to provide multifaceted protection for the Hybrozyme platform.”

In addition to the ALT-B4 substance patent registered in the United States last year, Alteogen plans to support its partner companies (including potential partners) that use its technology so they can pursue the development of competitive therapies on a broader patent foundation through various patent extensions.

Alteogen CEO Jeon Tae-yeon, a former U.S. patent attorney, said, “It is highly significant that the independently invented hyaluronidase ALT-B4 has secured intellectual property protection not only for the substance itself but also for the composition in combination with Keytruda,” and added, “This is a case that supports the exclusivity of Keytruda Qurex, the first product using the Hybrozyme platform.” He continued, “To ensure the stable establishment and expansion of the platform, Alteogen has from the early stages of development built a complex patent portfolio covering variants, compositions, and scopes of application with IP as a core competitive strength, and this patent registration demonstrates that this strategy is leading to tangible results.”
Screenshot of U.S. patent document related to Alteogen’s Keytruda Qurex composition

Kim Min-beom

AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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