Sobi-Handok joint venture raises expectations about Kineret launch in Korea

After Handok established a joint venture with Swedish Orphan Biovitrum (Sobi), a global biopharmaceutical company specializing in rare diseases, attention is now on the formal introduction of Kineret (anakinra), a treatment for rheumatoid arthritis.

Sobi-Handok, officially launched in Korea on April 17, is a joint venture established by Handok and Sobi with a 49:51 shareholding ratio for the rare disease business.

Sobi-Handok introduced Empaveli (pegcetacoplan), the first C3 protein-targeted therapy for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH), in Korea.

The joint venture company completed the registration for approval by the Ministry of Food and Drug Safety (MFDS) late last month, industry sources said. This means that Sobi-Handok will fully take advantage of Handok's marketing sales line, which previously marketed Soliris (eculizumab) and Ultomiris (ravulizumab).

In addition, Sobi-Handok has bolstered its hematology pipeline by selecting Doptelet (avatrombopag), an oral thrombopoietin receptor agonist (TPO-RA) for treating adult patients with immune thrombocytopenia (ITP), as the next candidate, which is currently in the process of approval.

Korean blood disease experts are keen to know whether the company will formally introduce Kineret upon the news of a joint venture.

Kineret is an interleukin-1 (IL-1) inhibitor developed to treat rheumatoid arthritis and is distributed in Korea as an unauthorized emergency introduction drug.

Until the introduction of Novartis' Ilaris (canakinumab), Kineret was the only treatment option with insurance benefits for the extremely rare disease of recurrent fever syndrome, which was introduced through the Korea Orphan and Essential Drug Center (KOEDC).

Recently, however, Kineret has emerged as an essential drug for managing cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) that occur during CAR-T cell therapy, and the need for it is growing in Korea.

"Currently, for CAR-T cell therapy in Korea, there is no way for patients to use anakinra even if they want to, as they have to pay out-of-pocket," said Dr. Kim Seok-jin, professor of hematology-oncology at Samsung Medical Center.

Although some hospitals can import and use the drug through the KOEDC, the prescription code has been set for arthritis treatment in the past, making the drug a discretionary reimbursement (considered illegal) if used for other purposes.

In response, the Korean Society of Hematology requested permission from the MFDS to use anakinra as a post-treatment for CAR-T cell therapy. However, the ministry reportedly said there is no way to review a license application that the pharmaceutical company has not requested.

Against this backdrop, Sobi, which owns Kineret, has established a joint venture with Handok, paving the way for proceeding with Kineret's formal approval.

However, according to industry sources, Sobi-Handok has no plans to introduce Kineret in Korea.

"Sobi-Handok is prioritizing the domestic licensing of Empaveli and Doptelet," a Handok official said. “The introduction of Kineret has not been finalized.”