Alteogen-Enabled Subcutaneous Keytruda SC Receives European Union Marketing Authorization

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PharmaCircleMonitoring Shows: Now, MSD's subcutaneous immunotherapy anticancer agent "Keytruda SC," which uses Alteogen Inc.'s popular hyaluronidase technology from South Korea, has received a product license from the European Union (EU). Following the approval by the U.S. FDA in September this year, the European Commission (EC) approval has also been secured. It is expected that the trend of switching to subcutaneous injection (SC) in the global immunotherapy anticancer market, which is currently centered on intravenous injection (IV), will become more comprehensive. (Related reading, previous long article by PharmaCircle.)South Korean Couple Builds Billion-Dollar Pharma Company, Signs Major Deal with MSD, Kicks Off Rapid Growth Mode）

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Alteogen announced on November 20: "MSD has obtained the usage license for 'Keytruda SC' in the EU's 27 countries as well as Iceland, Liechtenstein, and Norway." This approval allows the SC formulation to be used for all 33 adult indications licensed in Europe, indicating that ALT-B4 technology, following its success in the United States, has now entered commercialization in Europe.

Keytruda SC Utilizes "Vera Hyaluronidase α (ALT-B4)," a Human Hyaluronidase Developed and Manufactured by Alteogen. This technology serves as a platform to assist in converting existing intravenous medications into subcutaneous injections. In 2020, MSD entered into a licensing agreement with Alteogen. To secure exclusive rights for Keytruda, MSD amended part of the original contract in 2024 and committed to paying additional milestones and royalties.

The convenience of using the SC formulation has greatly improved. Previously, it required a 1-hour intravenous infusion, but now it takes only about 1 minute for a 3-week dosing schedule and about 2 minutes for a 6-week dosing schedule, significantly reducing the time compared to the existing IV formulation. It can be prescribed in a wide range of medical settings, such as general hospitals and local clinics, improving patient accessibility.

The recent European approval and U.S. FDA clearance were based on the Phase 3 clinical results conducted by MSD. In the study involving non-small cell lung cancer patients, Keytruda SC demonstrated consistent results in primary efficacy endpoints such as the existing IV formulation, pharmacokinetics (PK), ORR, and PFS.

Alteogen representative Park Soon-dae (音) stated, "Following the United States, Keytruda SC has now been approved in Europe, further demonstrating the global expansion potential of ALT-B4," and added, "These results will serve as an important reference for expanding existing and new partnerships."

Reference:

https://pharma.bcpmdata.com/；https://www.koreabiomed.com/news/articleView.html?idxno=27395；

https://www.mk.co.kr/cn/it/11472842；Etc.