Keytruda SC Sales Soar 262%...Alteogen Strengthens Global Presence

Qurex Records $463 Million in Q2 Sales
Another Global Contract Signed, Highlighting Enhanced Competitiveness

The speed at which the blockbuster immunotherapy Keytruda is being converted to the subcutaneous (SC) formulation is drawing significant attention. With Keytruda Qurex, which utilizes Alteogen's SC formulation platform ALT-B4, achieving results far exceeding market expectations, Alteogen's position in the global SC formulation market is expected to strengthen further.

According to the pharmaceutical and biotech industry on August 5, Merck & Co. (MSD) announced on August 4 (local time) that Keytruda’s SC formulation Qurex recorded sales of $463 million (approximately 662.1 billion won) in the second quarter of this year. This represents a 262% increase from the previous quarter ($128 million). It also surpassed Wall Street’s consensus estimate for Qurex's second quarter sales ($283 million) by 64%.

The proportion of Qurex in total Keytruda sales increased from 1.6% in the first quarter to 5.5% in the second quarter, a rise of 3.9 percentage points. MSD explained during its earnings conference call that “Following the official assignment of a reimbursable J code for Qurex in the US last April, adoption by both physicians and patients has increased.”

Given the rapid growth in Qurex sales, it appears that the timing for Alteogen’s receipt of sales milestone payments may also accelerate. Each time Qurex’s annual and cumulative sales reach the contractual thresholds, Alteogen receives stepwise milestone payments of up to $1 billion (approximately 1.477 trillion won). After all sales milestones have been paid out, Alteogen will receive royalties linked to net sales.

Another Global Contract Signed... Expanding Platform Presence

On this day, Alteogen signed another ALT-B4 license agreement. The deal grants exclusive rights to develop and commercialize a subcutaneous (SC) formulation of a biopharmaceutical using ALT-B4 for a global pharmaceutical company, with a total potential value of up to $365 million (approximately 521.9 billion won). The counterparty and target products were not disclosed.

Alteogen is expanding its roster of partners to include not only MSD but also Daiichi Sankyo, Sanofi, GSK, AstraZeneca, and Biogen, among others. Subsequent major products include Daiichi Sankyo’s Enhertu SC and Sanofi’s high-dose Dupixent SC. At present, Qurex is the only commercialized product using ALT-B4. As the first commercial product, Qurex has rapidly established itself in the market since its launch, and is expected to serve as a reference in future discussions with global pharmaceutical companies.

As SC conversion emerges as a key strategy to maintain market dominance after the patent expiration of blockbuster drugs, competition surrounding related platforms is intensifying. However, as stability when combined with pharmaceuticals, large-scale production processes, and clinical and regulatory experience must all be secured, market entry by latecomers in a short timeframe is considered highly challenging.

Geunhee Seo, a research analyst at Samsung Securities, stated in a recent report, "The core competitiveness of the ALT-B4 platform lies not only in the performance of the enzyme itself, but also in its stability when combined with pharmaceuticals, its ability to support global GMP-level mass production processes, and the trustworthiness proven through multiple major pharmaceutical clinical trials." He added, “The technology barrier has already been established at a high level, as demonstrated by Alteogen’s commercial track record.”

This content was produced with the assistance of AI translation services.