阿尔特奥金将投资2532亿韩元在大田建设首个自有生物药生产工厂

Alteogen will build its first biopharmaceutical production plant in the Dungok district of Yuseong-gu, Daejeon. The company plans to produce its ALT-B4 — used to convert drugs into subcutaneous (SC) injectable form — along with its own biosimilars and new drugs. Unlike rival Halozyme, which relies entirely on contract manufacturing organizations (CMOs) for production, Alteogen will be able to directly manage its production schedule and quality, a shift expected to boost its credibility in technology-licensing negotiations.
Alteogen recently disclosed that it has decided to invest 253.2 billion won ($184 million) in new facilities to expand its biopharmaceutical business and secure production capacity for the global market, according to the pharmaceutical and biotech industry on the 23rd. The investment equals 55.7% of the company's shareholders' equity of 454.4 billion won on a consolidated basis last year. The company plans to complete the plant by September 2028.
The investment contrasts with rival Halozyme, which outsources all of its production to CMOs. The industry is paying attention to the fact that at this plant Alteogen will produce not only ALT-B4 — used in products such as Keytruda SC — but also biosimilars and new drugs. Unlike Halozyme, which has no proprietary products beyond Hylenex, a standalone hyaluronidase injection, Alteogen holds a diverse product portfolio including Tergase, the Eylea biosimilar Ai-Luxby, and its subsidiary's new drug candidate ALTS-OP01. Analysts say that with its own production facilities, the cost-saving effect will grow as the number of products increases.
The move can also reduce risks in quality control and supply chain stability. The Marketing Authorization Holder (MAH) system, operated in major developed markets such as Europe, the United States and Japan, is a structure in which the company holding product approval bears responsibility for overall drug management, including manufacturing, quality control and release. By contrast, South Korea has no MAH system, so when production is outsourced to CMOs, a developer's authority over quality control is limited, creating blind spots in quality management and evaluation.
"Quality and supply stability are factors that big pharma companies consider very important, and Alteogen has also signed a contract with MSD assuming responsibility for the supply of ALT-B4," a biotech industry official said. "Securing production facilities it can manage directly will help strengthen its control over quality management and boost its credibility in future technology-licensing negotiations."
Meanwhile, earlier this year Alteogen presented "stabilizing its global supply chain" as one of its mid- to long-term growth strategies, setting a goal of expanding commercialized products to nine or more by 2030. Along with MSD's Keytruda SC, which has already been commercialized, Sanofi's Dupixent SC and Daiichi Sankyo's Enhertu SC are in clinical stages. "Through our own plant, we will be able to directly manage the timing and volume of production and improve production efficiency," an Alteogen official said.