ALTEOGEN Inc

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.

Novartis has signed a drug-delivery agreement worth up to $3.22 billion with Alteogen, aiming to convert intravenous biologic medicines into faster under-the-skin injections. The deal, which covers several potential products using Alteogen's Hybrozyme platform and ALT-B4 enzyme, is not an upfront payment; most of the money depends on achieving development, regulatory, and commercial milestones. Novartis shares slipped 0.1% to $161.05 on Wednesday, and the stock trades 23.11% above its GF Value estimate of $130.82, indicating investors are paying a premium for future execution.

Alteogen Inc. has entered into an option and license agreement with Novartis for the development and commercialization of subcutaneous products using its ALT-B4 enzyme, powered by the Hybrozyme platform. Under the deal, Novartis obtains multiple options to secure exclusive rights to develop and commercialize subcutaneous formulations for several of its products, leveraging ALT-B4 to convert intravenous biologics into more convenient subcutaneous injections. If all options are exercised and milestones met, Alteogen could receive up to US$3,223 million, including option fees, milestone payments, and royalties. This marks Alteogen's fourth licensing agreement this year, underscoring the growing value of its Hybrozyme technology. Alteogen's CEO, Tae-Yon Chun, highlighted the agreement as evidence of the platform's technological strength and commercial potential.