Yoon Tae-young, the CEO of Oscotec, introduces recent research and development achievements at the ‘2025 R&D Day’ event on the 24th./Courtesy of Oscotec

Oscotec, whose attempt to list its subsidiary Genosco was unsuccessful, has unveiled a new growth strategy centered around new drug development. The plan is to redevelop the candidate for autoimmune disease treatment, 'cebodiaplenib', as a therapy for rheumatoid arthritis.

On the 25th, Oscotec announced that it would hold its '2025 first half research and development day (R&D Day)' and refocus the development of cebodiaplenib's indications from the existing immune thrombocytopenic purpura (ITP) back to rheumatoid arthritis. Having previously attempted to list its subsidiary Genosco in April without success, this aims to create its own growth momentum.

Cebodiaplenib is a substance that inhibits an enzyme called SYK, reducing the activity of immune cells. Oscotec and Genosco have jointly developed it as a treatment for autoimmune diseases, including rheumatoid arthritis, utilizing this principle.

Both diseases are autoimmune diseases in which the immune system attacks itself. Rheumatoid arthritis causes the immune system to attack the joints, resulting in inflammation and pain, while immune thrombocytopenic purpura occurs when the immune system attacks platelets, causing an abnormal decrease in platelet count.

Previously, Oscotec collaborated with Yuhan Corporation to develop a lung cancer new drug, lecaratizumab, which was technology-exported worth 1 trillion won to Janssen Biotech during Phase 1 clinical trials in 2018. Lecaratizumab received approval from the U.S. Food and Drug Administration (FDA) last year.

Cebodiaplenib was once noted as 'the second lecaratizumab', but development was halted in 2021 after failing to achieve primary endpoints in Phase 2 clinical trials for rheumatoid arthritis treatment. Later, in 2023, some efficacy was confirmed in Phase 2 trials for immune thrombocytopenic purpura, but expectations were lowered due to the failure to secure statistical significance.

Nevertheless, the company sees a chance for a renewed attempt. During the analysis of the detailed patient group in the Phase 2 trial for rheumatoid arthritis at that time, a certain level of efficacy was observed in moderate patients, and recently, at the 'BIO International Convention (BIO USA)' held in Boston, U.S., global pharmaceutical companies showed interest in the efficacy of this substance for rheumatoid arthritis. The company plans to revise its development strategy based on this.

Oscotec is promoting clinical Phase 3 trials and approval/commercialization for immune thrombocytopenic purpura through technology transfer, while reviewing a two-track strategy for rheumatoid arthritis involving technology transfer and joint development.

However, there are many skeptical views in the industry. Currently, the market for rheumatoid arthritis treatments is dominated by global major pharmaceuticals such as AbbVie's 'Humira' (active ingredient adalimumab) and Johnson & Johnson's (J&J) 'Remicade' (infliximab).

In addition, various new drug candidates are entering clinical Phases 2 and 3. R-Pharm from Russia has proven similar efficacy to Humira in global Phase 3 trials and has already begun commercialization in some countries, while Bristol-Myers Squibb (BMS) in the U.S. is also conducting Phase 2 trials.

For cebodiaplenib to survive in such a competitive market, clearer differentiation and solid clinical data are necessary. An industry insider noted, "The failure to secure statistical significance in Phase 2 means that the therapeutic effect is uncertain," adding, "If there was some effectiveness in certain patient groups in the subgroup analysis, the patient groups should have been segmented from the clinical design stage, which would likely increase the development period and expenses, making it difficult to keep pace in market competition."