Alteogen is a company that is constantly innovating and gaining attention in the global biopharmaceutical market. In particular, its unique technology, which converts intravenous (IV) drugs into patient-friendly subcutaneous (SC) formulations, is attracting the attention of the global pharmaceutical industry. Based on this core technology, Alteogen is expanding its cooperation with global big pharmas and opening up new horizons for new drug development. As of 2025, Alteogen is solidifying its position as a global biotech company by securing future growth engines along with the successful progress of its major pipelines.
Alteogen's innovation begins with the 'Hybrozyme™' platform. The core of this platform is the recombinant human hyaluronidase 'ALT-B4' technology. ALT-B4 temporarily breaks down hyaluronic acid, which prevents drug penetration in subcutaneous tissue, converting biopharmaceuticals administered intravenously (IV) into a quick and convenient subcutaneous (SC) formulation. This reduces the number of hospital visits for patients and dramatically shortens the administration time, greatly improving their quality of life while also increasing the efficiency of medical staff. ALT-B4 has excellent thermal stability and enzyme activity, exhibiting excellent performance even with a smaller amount of enzyme compared to existing products, and secured exclusive rights until the beginning of 2043 through US material patent registration in July 2025.
One of the most brilliant achievements of Alteogen's technology is the US Food and Drug Administration (FDA) approval of 'Keytruda Qurex (Keytruda SC formulation)', an immunotherapy drug, through collaboration with Merck (MSD) of the United States. Keytruda Qurex, approved on September 21, 2025, is the world's first commercialized subcutaneous (SC) formulation immunotherapy, reducing the intravenous (IV) administration time from more than 30 minutes to 1-2 minutes. This is applicable to 38 cancers, including melanoma and non-small cell lung cancer, maximizing patient convenience and presenting a new paradigm for immunotherapy treatment. Alteogen secured milestone payments and sales royalties totaling $452 million, including a $20 million down payment, through an exclusive contract change with MSD, and annual royalty revenue of more than 1 trillion won is expected.
Alteogen is preparing for another innovation by expanding the application of ALT-B4 technology to antibody-drug conjugate (ADC) therapeutics. In November 2024, it signed an exclusive license agreement with Daiichi Sankyo of Japan for the development and sale of the SC formulation of the ADC anticancer drug 'Enhertu', and in September 2025, Enhertu SC entered Phase 1 clinical trials for the first time in the world. This is a breakthrough that surpasses the limitations of the existing SC conversion platform, which was developed for single antibody therapeutics, and is expected to greatly contribute to the reduction of side effects and improved patient convenience of ADC therapeutics. In addition, in March 2025, it signed a technology transfer agreement with AstraZeneca of the UK worth 2 trillion won, and is accelerating the development of additional SC formulations.
Alteogen is securing future growth engines through various new drug development platforms in addition to the Hybrozyme™ platform. The 'NexP™' sustained-release biobetter platform is developing next-generation sustained-release human growth hormone (in Phase 2 clinical trials) and sustained-release hemophilia treatments, and aims to develop a once-a-month obesity treatment by 2027. In addition, through the 'NexMab™ ADC' platform, it is strengthening its position in the anti-cancer field by developing breast cancer/stomach cancer-targeted ADC anticancer drugs (completed Phase 1 clinical trials in Korea, preparing for global Phase 2 clinical trials) and ovarian cancer/lung cancer-targeted ADC anticancer drugs.
Alteogen has achieved technology exports worth more than 9 trillion won in total by exporting its Hybrozyme™ platform technology to six global pharmaceutical companies, and ALT-B4 alone. This proves that Alteogen's technology is recognized worldwide. In particular, the exclusive status of ALT-B4 has been strengthened through US material patent registration, which will enable it to gain an advantageous position in future technology transfer negotiations. Alteogen is also accelerating the development of a next-generation platform that converts all types of drugs, including synthetic drugs and RNA, into subcutaneous injections, beyond existing antibody treatments, and is discussing the combination with wearable devices.
Alteogen is leading innovation in the biopharmaceutical market based on its unique SC formulation technology, diversified new drug pipelines, and strong global partnerships. The successful FDA approval of Keytruda SC and the clinical entry of Enhertu SC clearly demonstrate the potential of Alteogen's technology to change patients' lives and contribute to the development of the medical industry. We look forward to the new technologies and new drug development achievements that Alteogen will 선보일 in the future. The latest information on Alteogen can be found on the official website (http://www.alteogen.com).
Q1: What is ALT-B4, Alteogen's core technology?
* A1: ALT-B4 is a recombinant human hyaluronidase developed by Alteogen, a technology that converts biopharmaceuticals in intravenous (IV) form into subcutaneous (SC) form, improving patient convenience.
Q2: What does the US FDA approval of Keytruda SC mean for Alteogen?
* A2: Keytruda SC is the world's first commercialized subcutaneous immunotherapy using Alteogen's ALT-B4 technology, which is an important milestone that proves Alteogen's technology worldwide and generates huge royalty income.
Q3: Is Alteogen also active in the ADC (antibody-drug conjugate) field?
* A3: Yes, Alteogen has applied its ALT-B4 technology to the development of subcutaneous formulations of ADC therapeutics such as Enhertu, entering clinical trials, which is opening up new possibilities in the ADC therapeutic market.
Q4: What are Alteogen's future new drug development plans?
* A4: Alteogen is developing growth hormone, obesity treatments, and various anticancer drugs through sustained-release biobetter (NexP™) and next-generation ADC (NexMab™) platforms, and is also promoting technology expansion to convert all types of drugs into subcutaneous injections.
0