The domestic and international growth hormone markets are showing rapid annual growth, emerging as a hot topic in the pharmaceutical and biotech industries. As the need for growth hormone therapy increases not only for pediatric growth deficiency but also for various other indications, the demand for 'sustained-release growth hormone' formulations that maximize patient convenience is growing. Amidst this trend, the development status and future global market prospects of 'ALT-P1,' a sustained-release growth hormone developed by Korean biotech company Alteogen, are drawing attention. Based on its innovative platform technology, Alteogen is expected to overcome the limitations of existing treatments and contribute to improving patients' quality of life.
The core of Alteogen's sustained-release growth hormone 'ALT-P1' lies in its proprietary platform technology, 'NexP™.' NexP™ is a second-generation sustained-release technology that utilizes proteins abundant in human blood to extend the drug's half-life in the body. While conventional growth hormone formulations required daily injections, ALT-P1, utilizing NexP™ technology, can achieve equivalent therapeutic effects with just one injection per week, possessing the potential to dramatically improve patients' quality of life. This convenience is a significant advantage, especially for pediatric patients and their caregivers who require long-term treatment, and is evaluated to play a crucial role in enhancing treatment adherence. Alteogen is securing market competitiveness by highlighting the low immunogenicity, safety, and efficacy of the NexP™ platform as its strengths.
Alteogen's sustained-release growth hormone ALT-P1 is currently progressing smoothly in Phase 2 clinical trials in India involving 60 pediatric patients with growth hormone deficiency (PGHD). This clinical trial is being conducted in a collaborative manner where Cristália, a Brazilian pharmaceutical company, is the main sponsor and Alteogen is entrusted with production and clinical operations, following the technology export of the Latin American rights to Cristália in 2019. This Phase 2 trial aims to explore dosage and confirm the efficacy and safety compared to existing treatments. Alteogen retains the development and commercialization rights for regions excluding Latin America and plans to actively expand the market for ALT-P1 by seeking various global market partners.
The Korean growth hormone market grew rapidly from approximately 148.8 billion won in 2019 to 444.5 billion won in 2023, and the global market size is projected to exceed 10 trillion won by 2028. This market growth is intensifying competition in the development of second-generation sustained-release growth hormone formulations that enhance patient convenience, such as 'once-weekly administration.' Overseas companies like Ascendis Pharma with 'TransCon hGH,' Novo Nordisk with 'Sogroya,' and Pfizer with 'Enjaylar' already have once-weekly administration formulations commercialized or in clinical stages. Alteogen's ALT-P1 is expected to secure differentiated competitiveness amidst this competition by leveraging the originality of its NexP™ technology and clinical data. However, some perspectives suggest that long-acting injectable drugs may have limited efficacy compared to daily administration methods, and Alteogen faces the challenge of presenting clinical results that can dispel these concerns.
In addition to ALT-P1, Alteogen is expanding its pipeline through various innovative platform technologies. Notably, its 'Hybrozyme™ (ALT-B4)' technology, which converts intravenous formulations to subcutaneous injection formulations, has already been recognized for its global technological prowess through technology exports to numerous global big pharma companies like MSD for Keytruda SC and GSK for Jemperli, achieving cumulative contracts worth approximately 9 trillion won. Furthermore, 'ALT-P7,' a breast cancer treatment utilizing the antibody-drug conjugate (ADC) technology 'NexMab™,' has successfully completed Phase 1 clinical trials and is preparing for subsequent trials. This diversified portfolio provides a foundation for Alteogen to achieve sustainable growth without relying solely on specific pipelines. At the JP Morgan Healthcare Conference 2026, Alteogen declared its ambition to become a global biotech company by presenting a mid-to-long-term vision of commercializing more than nine products by 2030.
Alteogen's sustained-release growth hormone ALT-P1, with its once-weekly administration that dramatically improves patient convenience, holds the potential to secure a strong competitive advantage in the rapidly growing growth hormone market. Through innovative NexP™ platform technology and global partnerships, clinical development is accelerating, and successful clinical results are expected to speed up ALT-P1's entry into the global market. Beyond ALT-P1, Alteogen is further solidifying its position as a global biotech company through continuous technology export successes with its Hybrozyme™ technology and a diverse pipeline. Attention is focused on Alteogen's future endeavors to address unmet needs in the sustained-release growth hormone market and provide better treatment options for patients. Alteogen's continuous technological innovation and market strategy will become an important milestone in the biopharmaceutical industry.
Q1: What is Alteogen's sustained-release growth hormone formulation?
A1: Alteogen's sustained-release growth hormone formulation is 'ALT-P1.' This formulation is a biosimilar that improves upon the existing daily injection growth hormone by enabling once-weekly administration, utilizing Alteogen's proprietary NexP™ platform technology.
Q2: What are the advantages of NexP™ technology?
A2: The primary advantage of NexP™ technology is its ability to extend the drug's half-life in the body, thereby prolonging the administration interval. This dramatically reduces the number of injections for patients, enhancing medication convenience and contributing to improved treatment adherence and quality of life.
Q3: What is the current development stage of ALT-P1?
A3: ALT-P1 is currently undergoing Phase 2 clinical trials in India involving pediatric patients with growth hormone deficiency. The development is proceeding through a partnership with the Brazilian pharmaceutical company Cristália, and Alteogen holds the development and commercialization rights for regions outside of Latin America.
Q4: What is the outlook for the sustained-release growth hormone market?
A4: The global growth hormone market is continuously growing due to the increasing demand for enhanced patient convenience and is projected to exceed 10 trillion won by 2028. Once-weekly administration formulations are becoming a major trend in the market, and Alteogen's ALT-P1 also holds significant potential within this trend.
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