ISU Abxis Receives Russian Product Approval for Paroxysmal Nocturnal Hemoglobinuria Treatment

Aiming for 10% Market Share in the First Year of Launch

ISU Abxis announced on January 20 that 'ISU305', which was licensed out to the Russian pharmaceutical company JSC Pharmasyntez-Nord, has received product approval from the Russian health authorities.

'ISU305' is a biosimilar of the original drug 'Soliris' (ingredient: eculizumab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH). ISU Abxis completed Phase 1 clinical trials in Australia and New Zealand in 2020 and subsequently licensed out the pipeline to Pharmasyntez. After successfully completing Phase 3 clinical trials in Russia, the product has now obtained approval.

Soliris, developed by the U.S. company Alexion, is used to treat not only PNH but also other rare diseases such as atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG). As of 2024, it is a blockbuster drug with global sales of approximately 2.6 billion dollars (about 3.8 trillion won).

Following this product approval in Russia, ISU Abxis will receive milestone payments and, subsequently, royalties linked to sales performance.

According to partner company Pharmasyntez, the Russian eculizumab market for PNH indications is estimated to be about 55 million dollars (about 80 billion won) this year. ISU305 aims for a market share of around 10% in its first year of launch.

Yoo Junsu, CEO of ISU Abxis, stated, "It is very meaningful that ISU305, our first licensed-out pipeline, has completed Phase 3 clinical trials and obtained product approval in Russia. Based on our partnership with Pharmasyntez, we will also consider additional business opportunities."