Alteogen said that it has found the optimal conditions for the subcutaneous injection formulation of recombinant human hyaluronidase (ALT-B4) and filed for a patent for the formulation.
The company has continuously developed improved variants of hyaluronidase, an important component of subcutaneous injection formulations.
The recent patent application has secured a formulation technology that expands to subcutaneous injection formulations of biosimilar products, which had previously faced patent barriers by existing developers, and new antibody subcutaneous injection products, Alteogen said.
"The biosimilars of protein drug treatment, especially antibody treatment, can benefit more patients when developed after the original's patent expires, but existing developers that release blockbuster antibody therapeutics are erecting a new barrier to prevent the development of subcutaneous biosimilars by separately applying for a formulation patent to change the formulation from intravenous to subcutaneous injection," a company official said.
The official stressed that the applied patent could overcome these technological barriers and mix with the company's developed recombinant human hyaluronidase (ALT-B4) to develop a subcutaneous injection-type biosimilar with superior stability compared to existing products.
The formulation patent for subcutaneous injection of recombinant human hyaluronidase provides the company with a unique opportunity to develop subcutaneous injection biosimilars of breast cancer treatment Herceptin, Perjeta, and other blockbuster antibody treatments sold in the global market, he added.
"We will step up developing subcutaneous injection type biosimilars jointly with global pharmaceutical companies as we secured the worldwide rights to the optimal formulation technology of recombinant human hyaluronidase," the official said.
Alteogen has transferred the technology of its recombinant human hyaluronidase formulation to two of the world's top 10 pharmaceutical companies for 6.3 trillion won ($5.3 billion) since 2019 and is discussing additional technology transfer contracts with other global pharmaceutical companies.