Merck's KEYTRUDA QLEX Approved in Japan for Subcutaneous Use Across All KEYTRUDA Indications

Business Wire··JPUSEU·Read original
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Merck announced that Japan's Ministry of Health, Labor and Welfare has approved KEYTRUDA QLEX, a fixed-combination of pembrolizumab and berahyaluronidase alfa-pmph, for subcutaneous use across all indications approved in Japan for KEYTRUDA, the company's anti-PD-1 therapy. In Japan, the product will carry the planned trademark KEYJECT, and it is the first and only subcutaneous immune checkpoint inhibitor in the country that can be administered by a healthcare provider in as little as one minute, dosed either in one minute every three weeks or in two minutes every six weeks. Berahyaluronidase alfa is a variant of hyaluronidase developed and manufactured by Alteogen Inc. The approval is based on the pivotal Phase 3 MK-3475A-D77 trial, which compared KEYJECT with KEYTRUDA, both given every six weeks with chemotherapy, in 377 patients with treatment-naive metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumor aberrations; the trial showed comparable pharmacokinetic exposure, with an overall response rate of 45% (95% CI, 39-52) in the KEYJECT plus chemotherapy arm versus 42% (95% CI, 33-51) for KEYTRUDA plus chemotherapy, and no notable differences in progression-free or overall survival. The U.S. Food and Drug Administration approved KEYTRUDA QLEX in September 2025 for adults across all the same solid tumor indications as KEYTRUDA, and the European Commission approved subcutaneous pembrolizumab, known as KEYTRUDA SC in the EU, in November 2025 for all KEYTRUDA indications in Europe.

Impact on assets 3

Biotech & Genomic Medicine▲ · 2 stocks
Merck & Company Inc
MRK
▲ PositiveRegulationrelevance

Japan's MHLW approved KEYTRUDA QLEX (KEYJECT) for subcutaneous use across all KEYTRUDA indications, expanding Merck's approved product reach.

ALTEOGEN Inc
196170
▲ PositiveDemandrelevance

Alteogen's berahyaluronidase alfa is the hyaluronidase component of the newly approved KEYTRUDA QLEX in Japan, driving demand for its product.

Critical Materials & Supply Chain▲ · 1 stocks

Theme Impact 2

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