HK Innoen signs a contract to introduce a biosimilar for bone disease treatment ‘Denosumab’ in Korea… 2025 permit target


HK InnoN announced on the 25th that it has signed an exclusive domestic license agreement with Spain’s Mabxience for ‘Denosumab (ingredient name)’ biosimilar product for the prevention of osteoporosis and cancer-related skeletal complications. The denosumab biosimilar product developed by Map Science is still in the clinical stage. The product name has not yet been finalized.

Under this contract, HK Innoen will receive two types of denosumab biosimilars from Map Science and will be in charge of domestic licensing and sales. It is evaluated that it has laid the foundation for rapid entry into the denosumab market, which has recorded a high sales growth rate of more than 70% on average over the past five years.

Denosumab is an antibody treatment ingredient that shows a strong bone resorption inhibitory effect by targeting ‘RANKL protein’, which is essential for the survival and function of osteoclasts. The original products are ‘Prolia’, an osteoporosis treatment developed by Amgen, and ‘Xgiva’, a treatment for giant cell tumor of bone and prevention of skeletal complications in bone metastatic cancer patients. It was launched in Korea in 2016. According to IQVIA, a pharmaceutical market research company, it recorded sales of about 120 billion won from October 2021 to September last year. The patent expires in 2025. HK Innoen is aiming for domestic approval of the denosumab biosimilar at this time.

HK InnoN anticipates that the market will grow if biosimilar entry begins in earnest after the original product patent expires. Accordingly, the plan is to secure a new growth engine by promptly promoting the domestic approval of the denosumab biosimilar.

Dal-Won Kwak, CEO of HK Innoen, said, “The denosumab market is steadily growing due to its excellent efficacy and convenience,” and “through the introduction of biosimilars, we will provide new treatment options for patients with osteoporosis and cancer patients suffering from skeletal complications.” said.

Meanwhile, Map Science is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. It was acquired by Fresenius Kavi in ​​Germany last year. Currently, clinical trials are underway to confirm the clinical equivalence of the denosumab biosimilar and the original product.

Donga.com Reporter Kim Min-beom [email protected]


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